(85 days)
The CHASE Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a cardiac patch. This type of document does not contain the detailed information requested regarding acceptance criteria, study design, expert involvement, or algorithm performance for an AI/ML medical device.
The letter is a regulatory approval based on substantial equivalence to a predicate device, which means the manufacturer demonstrated that their device is as safe and effective as a legally marketed device, not that it met specific performance metrics in a clinical study as would be required for AI/ML device validation.
Therefore, I cannot extract the requested information from this document. The document primarily focuses on regulatory classification, general controls, and compliance requirements.
§ 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).