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The CHASE Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.

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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.

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The CHASE Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Chase Cardiovascular Patch Kit." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, study details, or performance data for the Chase Cardiovascular Patch Kit. Therefore, I cannot generate the requested table and detailed information based on the input.

This type of FDA letter typically confirms that a device has passed the regulatory hurdle of substantial equivalence, but it does not usually include the technical performance data or specific study results used to demonstrate that equivalence. Those details would normally be found in the 510(k) submission itself, which is not provided here.

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The Chase Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Chase Cardiovascular Patch Kit). It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... [because] the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the clearance is based on substantial equivalence to a predicate device, rather than a detailed study proving the device meets specific performance acceptance criteria as would be described in a clinical or performance study report.

Therefore, I cannot provide the requested information from this document.

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