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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) premarket notification for a medical device called PhotoFix® Decellularized Bovine Pericardium. It describes the device and claims substantial equivalence to a previously marketed device (K172085).

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria, especially in the context of an AI/ML powered device. The document is a traditional medical device submission for a physical implant, not an AI/ML algorithm.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document focuses on the substantial equivalence of a modified physical device (a new packaging size for an existing bovine pericardium patch) to a predicate device, based on non-clinical testing related to packaging integrity and shelf-life, not clinical performance metrics or AI/ML algorithm validation.

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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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PhotoFix Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, suture line buttressing and pericardial closure.

PhotoFix® Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, great vessel repair, suture line buttressing and pericardial closure.

The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch prepared from bovine pericardium which is stabilized using a dye-mediated photooxidation process, 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 plastic container with 22% buffered ethanol solution. The package is designed to facilitate convenient aseptic transfer of the pericardium into the sterile field. Rinsing of the pericardium prior to implantation is not required.

The provided text is a 510(k) summary for the PhotoFix Decellularized Bovine Pericardium device. This document is a premarket notification for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device.

Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device is not directly applicable to this document. This document describes an implantable tissue patch, not an AI/ML device.

The "Performance Testing" section describes tests related to the physical and biological characteristics of the tissue patch and its packaging, specifically:

• Chemical characterization testing
• Biocompatibility testing (cytotoxicity and hemolysis)
• Packaging shelf-life

The "Conclusion" states that the device is substantially equivalent to its predicate.

To directly answer your questions based on the provided document, in the context of this specific medical device (PhotoFix Decellularized Bovine Pericardium), rather than an AI/ML device:

1. A table of acceptance criteria and the reported device performance:
   The document does not provide a formal table with specific acceptance criteria and detailed performance results (e.g., numerical values for cytotoxicity, hemolysis rates, or specific shelf-life data with pass/fail criteria). It only states that "The results of the testing demonstrated that the packaging is non-cytotoxic, non-hemolytic, and maintains a sterile barrier. The packaging is equivalent to the predicate device."
   Acceptance Criteria (Inferred from regulatory context):
   * Biocompatibility: Non-cytotoxic, Non-hemolytic.
   * Sterility: Sterile barrier maintained for shelf-life.
   * Equivalence: Packaging equivalent to predicate device.
   Reported Performance:
   * Biocompatibility: "non-cytotoxic, non-hemolytic"
   * Sterility/Packaging: "maintains a sterile barrier"
   * Equivalence: "The packaging is equivalent to the predicate device."

2. Sample sizes used for the test set and the data provenance: Not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For biocompatibility and chemical characterization, the "ground truth" would be established by laboratory testing standards and methods (e.g., ISO standards for biocompatibility), not expert consensus in the diagnostic sense. For shelf life, it would be based on real-time or accelerated aging studies.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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