(182 days)
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:
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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." -
Sample sizes used for the test set and the data provenance: Not specified in the document.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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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.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
§ 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).