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The ACUSEAL™ Cardiovascular Patch is an ePTFE cardiovascular patch with an optional manufacturing modification consisting of an additional interpositional layer or layers of a fluoropolymer material. The additional material is intended to reduce suture hole bleeding through suture holes when stured into place using standard surgical techniques.

AI/ML Overview

This document is a 510(k) premarket notification for the ACUSEAL™ Cardiovascular Patch. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and detailed device performance data in the way a clinical trial for a new drug might.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set details) are not applicable or available within this type of regulatory submission. The primary method of demonstrating safety and effectiveness for a 510(k) is through comparison to already legally marketed predicate devices.

However, I can extract the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Devices)	Reported Device Performance (ACUSEAL™ Cardiovascular Patch)
Materials	Substantially equivalent to currently marketed ePTFE cardiovascular patch devices.	Composed of the same inert ePTFE biomaterial as the GORE-TEX® Cardiovascular Patch, plus an additional interpositional layer of a copolymer material. This is deemed substantially equivalent.
Mechanical Properties	Strength values substantially equivalent to predicate devices.	Mechanical testing data demonstrate the applicant device has strength values which are substantially equivalent to the predicate devices.
Tissue Response	Not adversely affected by the reduced bleeding feature.	In vivo testing demonstrates that the reduced bleeding feature of the applicant device does not adversely affect its material characteristics or its tissue response properties.
Safety/Effectiveness Issues	No new types of safety and effectiveness issues raised by the modification.	No new types of safety and effectiveness issues are raised by the modification of product design or materials to reduce suture hole bleeding.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated. The submission refers to "Mechanical testing data" and "In vivo testing" but does not provide specific sample sizes for these tests.
Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by or on behalf of the applicant, W.L. Gore & Associates, Inc., based in Flagstaff, AZ. The nature of the tests (mechanical and "in vivo") implies these were laboratory and/or animal studies rather than human clinical data. The submission does not specify if the in vivo testing was retrospective or prospective, but typically such testing would be prospective in an animal model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in a 510(k) submission as it's not typically required for establishing substantial equivalence through mechanical and in vivo testing. The "ground truth" here is compliance with established performance benchmarks or biological responses set by the predicate devices, not expert human interpretation of results in the way, for example, a diagnostic AI device would require.

4. Adjudication method for the test set

Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which is not the primary focus of this type of device comparison.

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

Not applicable. This device is a cardiovascular patch, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is based on engineering specifications and biological response data derived from mechanical testing and "in vivo" (likely animal model) studies, benchmarked against the established performance and safety profile of the predicate devices (GORE-TEX® Cardiovascular Patch and CVPro™ Cardiovascular Patch).

8. The sample size for the training set

Not applicable. This device is a physical medical implant, not an AI algorithm that requires a training set.

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

Not applicable. As above, this device does not involve a training set as it's not an AI algorithm.

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