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The PeriPatch Sheet is intended for use as a surgical patch material for: cardiac and vascular reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.

The PeriPatch™ Sheet is a quadrilateral shaped xenograft patch made from a sheet of glutaraldehyde fixed bovine pericardium selected for even thickness. It is designed to repair the body's natural organs and functions like natural tissue. It is intended for intra-cardiac repair procedures. It is identical to other marketed bovine pericardial patches. Extensive quality control procedures assure a consistent, high quality product for clinical use.

This document describes a 510(k) premarket notification for the "PeriPatch™ Sheet," a processed bovine pericardial patch. The submission claims substantial equivalence to previously cleared devices.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state "acceptance criteria" in a formalized, quantifiable manner for biological performance. Instead, it demonstrates substantial equivalence to predicate devices through comparisons of physical, chemical, and manufacturing characteristics. The reported device performance is presented as direct comparisons to these predicates.

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

The document does not describe a "test set" in the context of a clinical study or a specific, independent dataset used to evaluate the device's performance against defined acceptance criteria. Instead, it relies on comparisons of its physical and performance characteristics to predicate devices. The data provenance is derived from the manufacturing and characterization of the PeriPatch™ Sheet itself and "literature" and "validations" cited in Appendix A and D respectively, which are not provided in this excerpt. This is a retrospective comparison to existing, legally marketed devices.

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

Not applicable. No independent "test set" with a ground truth established by experts is described. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons rather than an independent clinical validation.

4. Adjudication Method for the Test Set

Not applicable. No "test set" or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement

No. A MRMC comparative effectiveness study was not done. This is a premarket notification for a medical device (a xenograft patch), not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This question applies to AI/ML software, not to a physical medical device like the PeriPatch™ Sheet.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established performance and safety profiles of the predicate devices, as detailed in their 510(k) clearances and scientific literature. The PeriPatch™ Sheet aims to demonstrate that its characteristics are similar enough to these established devices to be considered substantially equivalent. It is based on engineering and material property comparisons rather than clinical outcomes or pathology data from a new study.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML system. There is no "training set."

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

Not applicable. There is no "training set" for this type of device.

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