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PhotoFix is indicated for the following uses: intracardiac repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).

The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch that is prepared from bovine pericardium, stabilized using dye-mediated photooxidation, processed using ethylene oxide, and sterilized using aseptic processing techniques. The photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes.

PhotoFix is intended for single use only and cannot be resterilized. PhotoFix is supplied sterile in a sealed container with 22% buffered ethanol solution. Rinsing of the pericardium prior to implantation is not required.

This document is a 510(k) summary for the PhotoFix Decellularized Bovine Pericardium. It describes the device, its indications for use, and its substantial equivalence to predicate devices based on comparative testing of biomechanical properties. However, it does not contain the specific information required to complete the table or answer the detailed questions regarding acceptance criteria and study particulars for a device performance study in the way a clinical or AI-based diagnostic device submission would.

This document focuses on biomechanical performance testing comparing the new device to existing predicate devices, not on a human-in-the-loop or standalone algorithm performance study typical for AI/ML medical devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Here is the information that can be extracted or deduced:

1. A table of acceptance criteria and the reported device performance

Note on Acceptance Criteria: The document states that testing demonstrated that PhotoFix is substantially equivalent to the identified predicate devices for the biomechanical properties. This implies that the implicit acceptance criterion was meeting a comparable performance standard to these predicate devices, which are already legally marketed. Quantitative acceptance criteria are not explicitly listed in this summary.

Regarding the study that proves the device meets the acceptance criteria:

The study described is a comparative biomechanical testing study.

• 2. Sample size used for the test set and the data provenance:

  • Sample Size: Not specified in the provided summary. The study involved comparative biomechanical testing of the PhotoFix device against two predicate devices (XenoSure and CorMatrix). The "test set" would refer to the number of PhotoFix samples tested for each biomechanical property.
  • Data Provenance: Not explicitly stated but clinical data provenance (e.g., country of origin, retrospective/prospective) is not applicable as this was a laboratory biomechanical testing study, not a clinical study. It's an in-vitro/ex-vivo material property study.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable. This was a laboratory-based biomechanical performance test, not a study requiring expert consensus for ground truth. The "ground truth" would be the measured physical properties of the materials.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

  • Not applicable. This was a laboratory-based biomechanical performance test.

• 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:

  • No. This type of study is for diagnostic devices, particularly AI/ML-based ones. This document describes a tissue patch for surgical repair.

• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

  • No. This is not an AI/ML algorithm.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

  • The "ground truth" for this type of study would be the measured physical and mechanical properties of the PhotoFix device and the predicate devices, obtained through standardized laboratory testing (e.g., force transducers, tensile testers, etc.). It is not clinical or expert-derived ground truth.

• 8. The sample size for the training set:

  • Not applicable. This is not an AI/ML algorithm that requires a training set.

• 9. How the ground truth for the training set was established:

  • Not applicable. This is not an AI/ML algorithm.

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