(315 days)
The XenoSure Biologic Patch is intended for use as a surgical patch material for cardiac reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.
The XenoSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. XenoSure patch is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution.
The provided text is a 510(k) summary for the XenoSure Biologic Patch, which is a medical device. This document details the pre-clinical testing performed to demonstrate substantial equivalence to a predicate device, specifically to support a labeling change allowing the device to be exposed to temperatures below 0°C (i.e., frozen).
The request asks for information typically associated with the acceptance criteria and proof of performance for an AI/ML-driven medical device, including aspects like human reader studies, training/test set sample sizes, and ground truth establishment by experts. However, the provided document does not describe an AI/ML device; it is for a physical biologic patch used as surgical material. Therefore, information about AI-specific aspects (like MRMC studies, human-in-the-loop performance, training/test set ground truth for AI, number of experts for ground truth, etc.) is not applicable to this document.
Instead, the document details laboratory and animal studies to prove the physical and biological characteristics of the XenoSure Biologic Patch are not adversely affected by freezing.
Here's an analysis of the provided text in the context of the device's performance and acceptance criteria:
Acceptance Criteria and Study for XenoSure Biologic Patch
The study described here aims to demonstrate that a frozen XenoSure Biologic Patch is substantially equivalent to the unfrozen predicate XenoSure Biologic Patch. The acceptance criteria are based on mechanical properties and biological performance, ensuring the frozen device retains its intended function and safety.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance (Frozen Device) |
|---|---|---|
| Longitudinal Tensile | ≥ 2 MPa | Mean tensile strength: 12.1 MPa. All patches passed. No statistical difference from unfrozen predicate (12.9 MPa). |
| Elongation | 5% - 50% elongation | Mean elongation: 22.3%. All patches passed. No statistical difference from unfrozen predicate (21.8%). |
| Burst Strength | ≥ 12 PSI | Mean burst strength: 113 PSI. All patches passed. Statistically different from unfrozen predicate (134 PSI), but the difference is not clinically significant as both are much higher than the 12 PSI clinical specification. |
| Suture Retention | ≥ 300 gf | Mean suture retention: 1235 gf. All patches passed. No statistical difference from unfrozen predicate (1233 gf). |
| Cross Linking | No acceptance criteria stated for this test, but comparison to predicate is implicit for substantial equivalence. | 28 ppm free amine site per gram. No statistical difference from unfrozen predicate (29 ppm free amine site per gram). |
| Collagenase Digestion | No acceptance criteria stated for this test, but comparison to predicate is implicit for substantial equivalence. | 0.18%. No statistical difference from unfrozen predicate (0.16%). |
| Water Permeability |
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).