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The PFA patch is designed for use in peripheral arteries as a patch following arterial endarterectomy and as a tissue pledget for arterial surgery. It also can be used as a buttress for over sewing suture lines.

The PFA Patch is intended for peripheral vascular reconstruction of blood vessels and arteriovenous (A/V) revisions.

The PFA Vascular Patch is a cross-linked piece of bovine peritoneal / fascia tissue and is available in the following sizes:

0.8 cm x 3.0 cm 1.0 cm x 8.0 cm 2.0 cm x 9.0 cm

The device is packaged in an industry standard polymeric vial with a threaded cap sealed by a plastic shrink wrap. The tissue is packaged with a solution of glutaraldehyde. The sealed container is placed in a shelf carton with the Instructions for Use. The shelf carton contains a freeze warning indicator. The product is provided sterile and is intended for single use only. It is not intended to be resterilized or reused.

The provided 510(k) summary for the PFA Vascular Patch (K041736) does not contain a typical acceptance criteria table and reported device performance in the manner often seen for diagnostic or AI-driven medical devices. Instead, the testing described relates to the physical and biological characteristics of the vascular patch itself, comparing it to a predicate device. This is a Class II medical device, and the evaluation focuses on substantial equivalence for safety and effectiveness based on material properties and in vivo performance, rather than algorithm-driven metrics.

Therefore, the requested information elements related to AI-driven device performance (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary doesn't present a formalized table of acceptance criteria with numerical targets. Instead, it describes general product specifications and reports on the results of testing designed to demonstrate conformance and equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for In Vivo Study: "PFA patches and control patches were implanted in canines." The exact number of canines or patches implanted is not specified in the summary.
• Data Provenance: The in vivo study was conducted on canines, an animal model. This is a prospective animal study, not retrospective human data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This concept is not applicable as the testing involves physical material properties and animal in-vivo response, not a diagnostic interpretation requiring expert consensus. The "ground truth" here would be the direct observation of mechanical properties and histological examination or patency assessments in the animal model. The qualifications of the individuals performing these assessments are not specified, but would typically be engineers (for mechanical tests) and veterinarians/pathologists (for animal studies).

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or decision-making performance being evaluated that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the device aims to assist or replace that interpretation. The PFA Vascular Patch is an implantable surgical patch, not a diagnostic device.

6. Standalone Performance Study (Algorithm Only)

No, a standalone performance study was not done. The PFA Vascular Patch is a physical implant, not an algorithm.

7. Type of Ground Truth Used

• Mechanical Strength: The ground truth for mechanical strength testing is derived from direct measurements of material properties under defined conditions.
• In Vivo Animal Testing: The ground truth for the in vivo animal study was established through direct observation and histological examination of the implanted vessels. This includes patency checks, assessment for stenosis, aneurysm formation, inflammation, neointimal hyperplasia, and scarring.

8. Sample Size for the Training Set

Not applicable. The PFA Vascular Patch is a physical medical device, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary of Substantial Equivalence and Rationale for Clearance:

The PFA Vascular Patch received 510(k) clearance based on its substantial equivalence to the predicate device, Vascu-Guard Peripheral Vascular Patch (K942010). The rationale for this determination, as stated in the submission, is that the two devices share:

• Identical Indications for Use: Peripheral vascular reconstruction of blood vessels and arteriovenous (A/V) revisions.
• Basic Overall Function: Providing a patch for vessel repair or pledget/buttress for sutures.
• Methods of Manufacturing: Implied to be similar enough not to raise new safety/effectiveness concerns.
• Materials Used: "All materials used in the manufacture of the PFA Vascular Patch are suitable for this use and have been used in numerous previously cleared products." This implies the raw bovine tissue and cross-linking agents are similar or well-established in similar devices.

The testing performed (mechanical and in vivo animal studies) aimed to demonstrate that despite any minor differences, the PFA Vascular Patch performs equally safely and effectively for its intended use as the predicate device. The results reported (e.g., patency, no stenosis, no aneurysm, no inflammatory difference) supported this claim of substantial equivalence.

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