(174 days)
CorMatrix(R) Cor Patch is intended for epicardial tissue support and repair.
CorMatrix Cor Patch is intended for epicardial tissue support and repair.
CorMatrix Cor Patch is derived from the same multi-laminate SIS-ECM material as the CorMatrix Tyke (2-ply, non-pressed). The CorMatrix® Cor Patch will be supplied as a 4-ply, lyophilized, sterilized sheet of SIS-ECM. With the exception of the differing layer counts and a change to the manufacturing process for the Cor Patch which does not result in a change to the fundamental technology of the device, the device design and construction are identical to the FDA-cleared CorMatrix® Tyke™ (K152127).
This document is a 510(k) premarket notification for a medical device called CorMatrix Cor Patch. It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device, the CorMatrix Tyke.
However, this document does not contain the information required to answer your specific questions regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device.
Here's why and what's missing:
- Device Type: The CorMatrix Cor Patch is a biological patch made from porcine extracellular matrix material for epicardial tissue support and repair. It is a physical medical device, not an AI/ML algorithm or software.
- Study Type: The "Non-clinical Testing" section describes material property testing (tensile strength, suture retention, burst strength) to demonstrate adequate material properties, not a clinical study involving human or even simulated human-in-the-loop performance with an AI system.
- Acceptance Criteria: The document mentions that the testing "demonstrates that the sterile SIS-ECM of the Cor Patch possesses adequate material properties for use in the indicated applications" and "exceeds the biomechanical requirements for its intended use." However, it does not provide a specific table of acceptance criteria with quantitative thresholds for AI performance metrics (like sensitivity, specificity, AUC, human reader improvement).
- Ground Truth, Experts, Adjudication, MRMC, Standalone Performance: These concepts are relevant to the evaluation of AI/ML algorithms, where the performance of the algorithm is compared against a "ground truth" established by human experts, pathology, or outcomes data. This document does not describe such studies because the device is a physical patch.
- Sample Size (for AI training/test sets): The document refers to "testing" but does not specify sample sizes in the context of test or training sets for an AI algorithm.
- Data Provenance: Not applicable in the context of material property testing for a physical device.
In summary, the provided text is about a physical medical device (a tissue patch) and its material properties, not about an AI/ML medical device and its performance evaluation against established acceptance criteria.
Therefore, I cannot extract the requested information from this document. If you provide a document that describes the development and validation of an AI/ML medical device, I would be happy to help answer your questions.
§ 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).