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The CorRestore™ Patch System Processed Bovine Pericardial Patch is intended for cardiac reconstruction and repair.

The CorRestore Patch is an oval tissue patch made from glutaraldehyde fixed boyine pericardium. It is intended to be used as an intracardiac patch for cardiac reconstruction and repair. It is identical to other marketed bovine pericardium patches except that it incorporates an integral suture bolster (also made of fixed bovine pericardium) in the shape of an oval ring and is packaged with accessories needed for cardiac repair and reconstruction. The CorRestore Patch comes as a kit including a patch and suture strip (1.4 x 16 cm), both manufactured from processed bovine pericardium. Optionally included is a set of various sutures needed for implantation. To assist the surgeon in determining the appropriate size, a separate disposable sizer kit is offered. A silicone balloon (CRB) is optional to allow the surgeon to check left ventricular diastolic volume prior to closure.

The provided text is a 510(k) Premarket Notification for the SOMANETICS CORRESTORE PATCH SYSTEM. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, ground truth types, or training set details.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA)."

This indicates that the FDA's acceptance of this device is based on its substantial equivalence to an existing (predicate) device, the Chase Medical Cardiovascular Patch Kit (K022093), rather than on a new study demonstrating performance against a specific set of acceptance criteria. The document describes the device and its intended use but does not present a performance study with detailed acceptance criteria and results.

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