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The CorMatrix® ECM® for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.

The CorMatrix ECM for Vascular Repair is an extracellular matrix (ECM) scaffold derived from porcine small intestinal submucosa (SIS). The device is constructed of a multilaminate (6-ply), decellularized, non-crosslinked, lyophilized ECM cut to specific shapes and sizes and terminally sterilized using Ethylene Oxide gas.

The 6-ply CorMatrix ECM for Vascular Repair is derived from the same multilaminate SIS-ECM material as the CorMatrix ECM for Carotid Repair (6-ply), the Cook Biotech Surgisis Peripheral Vascular Patch (4-ply), and the CorMatrix ECM for Cardiac Tissue Repair (4-ply). The CorMatrix ECM for Vascular Repair will be supplied as a 6-ply, lyophilized, sterilized sheet of SIS-ECM. The device design, construction, and configurations are identical to the FDA-cleared CorMatrix ECM for Carotid Repair (K111187).

The CorMatrix® ECM® for Vascular Repair, a medical device for vascular repair, did not undergo a standalone study with acceptance criteria and reported device performance in the provided 510(k) summary. Instead, the submission relies on the substantial equivalence to previously cleared predicate devices and non-clinical testing performed for a related device, CorMatrix ECM for Carotid Repair (K111187).

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

No explicit "acceptance criteria" table with corresponding "reported device performance" from a dedicated study for the CorMatrix ECM for Vascular Repair is presented in the document. The document states that the new device's performance is supported by the non-clinical testing of the predicate device (CorMatrix ECM for Carotid Repair, K111187). The performance claims are comparative to a control device in an animal study.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated for either bench testing or animal testing. The animal study for the CorMatrix ECM for Carotid Repair (K111187) is mentioned, but the number of animals used is not provided.
• Data Provenance: Not explicitly stated. The studies were performed for a prior 510(k) submission (K111187).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the studies described are for mechanical and biological properties in an animal model, not for diagnostic interpretation by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable.

5. 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

This information is not applicable. The device is a physical vascular patch, not an AI-powered diagnostic tool requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A "standalone" study in the sense of a comprehensive performance evaluation specifically for the CorMatrix ECM for Vascular Repair was not done. Instead, the submission leveraged non-clinical testing (bench and animal) performed for its predicate device, the CorMatrix ECM for Carotid Repair (K111187). The document explicitly states: "All non-clinical testing performed for the CorMatrix ECM for Carotid Repair (K111187) supports the CorMatrix ECM for Vascular Repair as the device materials are identical."

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the animal study:

• Angiographic stenosis, tissue integration, calcification, and re-endothelialization: These would typically be determined by histological examination (pathology) and imaging (angiography) by experts in veterinary pathology or similar fields.
• Adverse events: Clinical observation and potentially pathological examination.

For bench testing:

• Suture Retention Strength, Probe Burst Strength, Tensile Strength: These are objective physical measurements with established testing standards.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable.

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