Haptica Ltd
                                                                                                      93 Lower...
–2–                                                  9 April 2009

•     Port positions and instrument entry points are...
–3–                                                   9 April 2009

      using number of LCs (ripped ducts or vessels)...
–4–                                          9 April 2009

The ProMIS™ Simulator has two key components: a bodyform and...
–5–   9 April 2009

AboutProMISMar09 © Haptica Ltd 2009
fiona.slevin@haptica.com +353 (0)1 676 7310          Page 5 of 5
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About ProMIS Surgical Simulator


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High level overview of Haptica's ProMIS Surgical Simulator
For more information see www.haptica.com; email info@haptica.com; tel 617 342 7270

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About ProMIS Surgical Simulator

  1. 1. Haptica Ltd 93 Lower Baggot Street Dublin 2 Ireland www.haptica.com tel +353 1 676 7310 mobile +353 1 87 969 2397 fax + 353 1 676 7311 email fiona.slevin@haptica.com About the ProMIS™ Surgical Simulator Clinical The ProMIS Basic Skills Curriculum and Surgical Procedures were developed in collaboration with leading surgeons and learning experts from the UK, Ireland and US. These included, among others, Pr Sir Ara Prof Darzi, Prof Oscar Traynor at the Royal College of Surgeons in Ireland and Members of the American College of Surgeons/ACS Committee on Education including Prof Gerald Fried and Steve Schwaitzberg. In addition, summarised below is a small number of papers published on ProMIS. Further information on ProMIS validation is is available in pdf or on our website www.haptica.com. ProMIS™ is the only simulator that has been validated with the American College of Surgeons/SAGES Fundamentals of Laparoscopic Surgery (FLS) Program. Studies using the FLS Tasks in ProMIS™ show: • FLS tasks are transferable to the ProMIS™ simulator with traditional FLS scoring and intrinsic ProMIS™ metrics being good measurement tools.1; ProMIS™ metrics are “excellent predictors of scores in the standard FLS simulator”2 and “predict readiness for FLS Certification”.3-4 • 100% of trainees felt that ProMIS™ "simulated reality effectively compared with only 38% in the VR group"5 • "Experts performed the simulated [ [LapColorectal Surgery] procedure significantly faster with more ocedure efficient use of their instruments, and made fewer intraoperative errors. Thus the simulator 6 demonstrated construct validity." • "This suturing module on ProMIS™ is a potent tool for gaining laparoscopic suturing skil The trainees skills. needed only eight repetitions on average to reach the top of the performance gain curve, with 7 significant differences in both the scoring of the assessment method as by the objective observers." Technical ProMIS™ uniquely enables users to interact with virtual and physical models in the same unit while providing accurate, comprehensive feedback on performance. In a number of studies, ProMIS™ out- performs Virtual Reality (VR) in terms of validity and user preference; see below for summary of key validation results. ProMIS™’ ‘mixed reality’ approach delivers the following unique features and benefits: ixed Surgically relevant context • External bodyform with monitor replicates real Operating Theatre set-up. Users need to select and up. create ports – thus ensuring that learning is not only focused on the internal laparoscopic skill, but rather on a more holistic procedural process; • Trainees use real instruments ensuring that users practise with the same instruments they will use in instruments, the Operating Theatre; 1 Hungness, et al. Northwestern University Chicago, SAGES 2008 University, 2 McCluney, at al. McGill University Montreal, SAGES 2006 3 McCluney, at al. McGill University Montreal, SAGES 2007 iversity 4 Ritter et al, National Naval Medical Center, SAGES 2006 5 Kanumuri et al, JSLS Jul-Sept 2008 6 Neary, et al, Surg Endosc (2008) 22:2301 22:2301-2309 7 Botden et al, Catharina Hospital Eindhoven EAES 2008 Eindhoven, Haptica Ltd., Registered in Ireland. VAT no. IE 634 9437P Directors: Bernard Collins, Geraldine Kel Dr. Gerard Lacey, Fiona Slevin, Siobhán Gardiner. Kelly,
  2. 2. –2– 9 April 2009 • Port positions and instrument entry points are totally flexible, delivering great realism and allowing for different procedures to be practised – and allowing for procedures to be taught and practised in different ways. (ProMIS™ is the only simulator to facilitate single-port access surgery.) • Realistic camera view: a model laparoscope provides high image quality and allows complete flexibility for positioning, zoom - and even team training, since it can be hand-held or fixed with a clamp; • Real tissue models, real instruments and real surgical items such as sutures, mean a more realistic and valid learning experience; because trainees are experiencing ‘real’ haptics, they gain greater understanding of the functioning of instruments and the properties of tissue, sutures, thread, etc. • A ball and socket tilt mechanism allows the user to adjust the bodyform to suit the user and the procedure; • A greater 'operating space' allows for more and different procedures to be simulated ranging from General Surgery to ObGyn to Thoracic surgery. Metrics and User Data • Standard Metrics in ProMIS™ have been validated in over 30 studies. • Proficiency levels may be set locally, and for different trainee groups. • User records are retained, including a video/recording of a user’s practice attempt. • Reports on users and proficiency are generated simply and easily in the Learning Management System and all data is exportable to standard software packages such as Excel™. Information on ProMIS Metrics and how they are generated is provided in Attachment 6. Curriculum and Research Our customers tell us that a key benefit of ProMIS™ is that they are not limited to the Modules or Tasks provided by Haptica: they can develop their own Tasks for integration into ProMIS™, and as importantly can adapt the Modules and Tasks provided by Haptica. This is particularly beneficial where the University wishes to establish its own core curriculum, and where the University wishes to conduct research on either established or new learning methods. (A high number of validation papers published on ProMIS™ were on Tasks not developed by Haptica, e.g. the American College of Surgeons/SAGES Fundamentals of Laparoscopic Surgery (FLS) Program.) Validation: ProMIS™ vs Virtual Reality There are a number of Laparoscopic Surgical Simulators available, and most offer similar curricula and learning modules. A paper presented at SAGES 2008, summarised research results to date on studies that compared Simulators. Those studies strongly favour the ProMIS™ hybrid or augmented reality approach over pure virtual reality. In summary: • In a comparison of a suturing task on SurgicalSIM and ProMIS™, 100% of trainees felt that ProMIS™ "simulated reality effectively compared with only 38% in the VR group" JSLS Jul-Sept 20088 • LapMentor, LapSim and SimSurgery SEP were compared for construct and face validity on their Laparoscopic Cholecystectomy (LC) modules. No VR simulator achieved excellent face validity and very few simulator metrics demonstrated construct validity. Construct validity was demonstrated in 2 of 19 metrics on Lap Mentor using training status (cautery time, safe cautery) and 1 of 19 metrics using number of LCs or number of advanced cases (cautery time). In LapSim, this was 1 of 16 metrics 8 Virtual Reality and Computer-Enhanced Training Devices Equally Improve Laparoscopic Surgical Skill in Novices; Kanumuri, Prathima1; Ganai, Sabha1; Wohaibi, Eyad M.1; Bush, Ronald W.1; Grow, Daniel R.2; Seymour, Neal E.1; JSLS, Journal of the Society of Laparoendoscopic Surgeons, Vol. 12, No. 3. (JulySeptember 2008), pp. 219-226 AboutProMISMar09 © Haptica Ltd 2009 fiona.slevin@haptica.com +353 (0)1 676 7310 Page 2 of 5
  3. 3. –3– 9 April 2009 using number of LCs (ripped ducts or vessels) and 2 of 16 using number of advanced cases (ducts or vessels ripped, blood loss); SimSurgery SEP showed no construct validity for any of the 5 metrics.9 • In a comparison of Suturing Tasks on ProMIS™ and SurgicalSIM (METI), "Post-task survey scores for task ProMIS™ were significantly higher for overall realism and thread behavior, reflection of clinical ability, and overall educational value."10 • ProMIS™ and LapSim (Surgical Science) were compared for basic skills and suturing. " (Surgical-Science) "ProMIS™ was regarded by all participants as a better simulator for laparoscopic skills training on all tested features". ProMIS™ was "more realistic, had better haptic feedback and was more useful".11 and • Versus the Xitact LS500, ProMIS™ was "more realistic" (70% vs. 20%) and "more useful" (65% vs. 36%). On a Dissection task, only ProMIS™ was able to distinguish between advanced trainees and beginners and had "significantly higher scor for all performance parameters".12 scores • Basic surgical skills were compared in five simulato rs: Lap Mentor (Simbionix); LapSim; SurgicalSIM; ProMIS™ and LTS2000 ISM60 (RealSim). Surgeons were asked to evaluate overall simulator effectiveness: ProMIS™ out rformed LapSim and SurgicalSim with a mean effectiveness rating of out-performed 3.56 versus 3.22 and 3.11 respectively. LapMentor also scored 3.56 while the LTS200 scored 3.78.13 • Compared with a Robotic Surgery Simulator (SimSurgery) and SurgicalSim for suturing and kno knot-tying, ProMIS™ metrics were "better at discerning predicted performance differences between experts and non-experts with a single task iteration".14 experts More information on ProMIS Validation including summaries of published Abstracts is available in pdf or on our website www.haptica.com. . Quality Assurance Support and Maintenance ProMIS™ simulators have been used by leading surgical skills training centres since 2003 and Haptica is training proud of its industry-beating track record of robustness and quality. beating ProMIS carries a CE Mark. The Royal College of Surgeons in Ireland, for example, have been using ten ProMIS™ simulators consistently and regularly over the past five years: all simulators are still operating perfectly and the number of ver support issues over the past five years has been minimal. Haptica is also proud of its reputation for fast responsiveness to questions: our policy (and our track record) is to ensure that our customers have a fully working simulator when they need it and whatever it ) takes to make it happen. 9 Comparison of Procedure Specific Virtual Reality Simulators: Construct and Face Validity; James R Korndorffer Jr. MD1, Thomas P. McIntyre MD2, John T. Paige MD3, Kent R. Van Sickle MD4, Shishir K. Maithel MD2, Dimitris Stefanidis MD1, Daniel J Scott MD5, Daniel B. Jones2;1 Tulane University Health Sciences Center; 2 Beth Israel Deaconess Medical Center; 3 Louisiana State University Health Sciences Center; 4 University of Texas Health Sciences Center at San Antonio; 5 Department University of Texas Health Sciences Center at Dallas. SAGES 2006 10 Complex Laparoscopic Task Performance on Two New Computer Based Training Devices; Erika K Fellinger MD, Michael E Ganey Computer-Based MD, Anthony G Gallagher PhD, Daniel J Scott MD, Ron W Bush BS, Neal E Seymour MD, Department of Surgery, Baystate Medical llagher Center, Springfield, MA. SAGES 2006 11 Augmented Versus Virtual Reality Laparoscopic Simulation: What is the Difference?: A Comparison of the ProMIS™ Augmented Reality Simulator Versus LapSim Virtual Reality Laparoscopic Simulator: Botden SM, Buzink SN, Schijven MP, Jakimowicz JJ. Catharina Hospital, Eindhoven, The Netherlands. World J Surg. 2007 Apr;31(4):764 Apr;31(4):764-72 12 Comparison and Validation of Two Different Surgical Skills Simulators; Dieter Hahnloser MD, Rachel Rosenthal MD, Christian Different Hammel, Daniel Oertli, Markus Müller, Pierre Alain Clavien, Department of Visceral and Transplantation Surgery, University Pierre-Alain Hospital Zurich, Switzerland. SAGES 2007 13 Criterion-Based Training with Surgical Simulators: Proficiency of Experienced Surgeons; Heinrichs, Wm, Lukoff, Brian, Based Youngblood, Patricia, Dev, Parvati, Shavelson, Richard, Hasson, M Harrith, Satava, M Richard, Mcdougall, M Elspeth, Wetter, PPaul Alan; JSLS, Journal of the Society of Laparoendoscopic Surgeons, Vol. 11, No. 3. (September 2007), pp. 273 273-302. 14 Computer-Based Laparoscopic and Robotic Surgical Simulators: Performance Characteristics and Perceptions of New Users; David Based W Lin MD, John R Romanelli MD, Renee E Thompson MD, Michael E Ganey MD, Ron W Bush BS, Neal E Seymour MD, Baystate , Medical Center, Department of Surgery. SAGES 2007 AboutProMISMar09 © Haptica Ltd 2009 fiona.slevin@haptica.com +353 (0)1 676 7310 76 Page 3 of 5
  4. 4. –4– 9 April 2009 The ProMIS™ Simulator has two key components: a bodyform and a computer. The bodyform is a simple mechanical piece moulded form with three cameras and a lighting system inside. There are no moving parts, no software and no complex or fragile electronics in the bodyform. This means that the bodyform is extremely robust. Having all the complexity within the computer and the software means that upgrades and software patches are extremely easy to upload. ‘Service and support’ including free replacement of parts and free software upgrades is included for the first year following purchase. We will be happy to provide an advance copy of our standard Supply Agreement. AboutProMISMar09 © Haptica Ltd 2009 fiona.slevin@haptica.com +353 (0)1 676 7310 Page 4 of 5
  5. 5. –5– 9 April 2009 AboutProMISMar09 © Haptica Ltd 2009 fiona.slevin@haptica.com +353 (0)1 676 7310 Page 5 of 5