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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:

2. Sample Sizes and Data Provenance:

• Test Set (Physical Properties):

  • Specific numbers of samples tested for each physical property (e.g., tensile strength, burst strength) are not explicitly stated in the summary, but the results indicate that "All XenoSure patches" or "All samples for both predicate and proposed devices" were tested and passed, implying a sufficient sample size was used for each test to demonstrate statistical equivalence or compliance with criteria.
  • Data Provenance: The tests are laboratory-based, performed on the manufactured device. The document does not specify the country of origin of the data, but it is for a US FDA submission, implying adherence to relevant standards for medical device testing. The studies are pre-clinical performance testing.

• Test Set (In-vivo Animal Study):

  • Sample Size: Seven Polypay sheep (6 survived to the scheduled time point). Each animal received both a frozen (test) and unfrozen (control) patch, allowing for within-subject comparison.
  • Data Provenance: The study was conducted in animals, a pre-clinical, prospective study design. The country of origin of the animal study isn't specified, but it was performed to support a US FDA submission.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable for an AI/ML device. For this physical device, "ground truth" is established through standardized laboratory testing methods (e.g., Instron for mechanical properties, spectrophotometry for chemical properties) and histological analysis by qualified veterinary pathologists in the animal study. The document does not specify the number or qualifications of individuals interpreting the histology, but it is standard for such studies to involve board-certified pathologists.

4. Adjudication Method:

• Not applicable for an AI/ML device. For the physical testing, the results are quantitative measurements or visual inspections against defined criteria. For the animal study, histological evaluation would typically follow a standardized protocol, often with consensus or independent review by pathologists, but no formal "adjudication method" in the sense of reader disagreements for an AI study is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This device is a physical patch, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

6. Standalone Performance (Algorithm Only):

• Not applicable. This pertains to an AI algorithm. The device is a physical biologic patch. The "standalone performance" of the device is assessed through the physical and biological tests described in the table above.

7. Type of Ground Truth Used:

• Laboratory Measurements: For mechanical and chemical properties, the "ground truth" is derived from direct quantitative measurements using validated test methods (e.g., Instron for force, UV-Vis Spectrophotometry for chemical levels).
• Visual Inspection: For delamination, ground truth is established by direct visual inspection.
• In-vivo Histopathology and Clinical Outcomes: For the animal study, the "ground truth" for safety and biological integration is based on gross observations, angiographic and ultrasound analysis of vessel patency, and detailed histopathologic evaluation of explanted tissues by qualified personnel.

8. Sample Size for Training Set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

9. How Ground Truth for Training Set was Established:

• Not applicable. There is no "training set" for this physical medical device.

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