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The SURGISIS® Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease. This device is supplied sterile and is intended for one-time use only.

The SURGISIS® Peyronie's Repair Graft is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in an oval configuration. The device is packaged in a lyophilized (dried) state, and is supplied sterile in a sealed double pouch system.

The applicant, Cook Biotech Incorporated, sought to market the SURGISIS® Peyronie's Repair Graft, a surgical mesh made from porcine small intestinal submucosa (SIS), intended for reinforcing soft tissue in the urological anatomy, specifically for tunica albuginea defects and Peyronie's disease repair.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and the Data Provenance:

The provided documentation does not specify a distinct "test set" in the context of an AI/ML device. The "tests" discussed are bench and biocompatibility tests conducted on the physical device itself. Therefore, specific sample sizes for a test set (e.g., number of patient cases) and data provenance (country of origin, retrospective/prospective) are not applicable or provided here. The testing was performed on the manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable. This device is a physical surgical mesh, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth on a test set of data. The ground truth for its performance is established through laboratory and animal testing, evaluated against predetermined scientific standards and regulatory guidelines.

4. Adjudication Method for the Test Set:

Not applicable. The evaluation of test results (biocompatibility, viral inactivation, mechanical properties) for a physical device is based on objective measurements and established scientific protocols, not on an adjudication method involving human interpretation of data in the way one would for a diagnostic study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This is not an AI/ML device, and therefore no MRMC study looking at human reader performance with or without AI assistance was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is based on:

• Scientific Standards and Regulatory Guidelines: For biocompatibility (e.g., ISO 10993 series), viral inactivation (established methods to ensure safety), and mechanical properties (biomechanical testing standards).
• Bench and Biocompatibility Testing Results: Objective measurements derived from laboratory tests the device underwent.
• Comparison to Predicate Device Performance: Establishing equivalence based on the known safety and effectiveness profiles of already marketed, substantially equivalent devices.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This device does not involve a "training set." The development and testing of this device relied on established scientific principles, engineering design, and regulatory compliance for medical device manufacturing.

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