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For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. which is substantially equivalent to the currently marketed devices.

Device Description

The HEMASHIELD® CARDIOVASCULAR GRAFTS are knitted and woven polyester grafts. impregnated with bovine collagen.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your requested information.

Please note that this document is a 510(k) summary for a medical device and not a detailed clinical study report for an AI/ML device. Therefore, some of the requested information (especially points 2, 3, 4, 5, 8, and 9) is not applicable or cannot be extracted from this type of regulatory submission. The device described is a traditional medical device (vascular grafts) and not an AI/ML powered device.

Acceptance Criteria and Device Performance

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

The document states that the proposed devices ("HEMASHIELD® MICROVEL® Double Velour Knitted" and "HEMASHIELD® Woven Double Velour Vascular Grafts" with modified collagen manufacturing) were tested for various characteristics to demonstrate substantial equivalence to their currently marketed PMA approved predicate devices. The acceptance criterion for each test was effectively "equivalent to marketed product."

Test Parameter	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Burst Strength	Equivalent to marketed product	equivalent to marketed product
Tensile Strength	Equivalent to marketed product	equivalent to marketed product
Suture Pull Out	Equivalent to marketed product	equivalent to marketed product
Wall Thickness	Equivalent to marketed product	equivalent to marketed product
Longitudinal Stretch	Equivalent to marketed product	equivalent to marketed product
Needle Penetration	Equivalent to marketed product	equivalent to marketed product
Crush Resistance	Equivalent to marketed product	equivalent to marketed product
Flexural Rigidity	Equivalent to marketed product	equivalent to marketed product
Integral Water Permeability	Equivalent to marketed product	equivalent to marketed product
Integral Water Permeability under load	Equivalent to marketed product	equivalent to marketed product
Strength of Collagen Bonding	Equivalent to marketed product	equivalent to marketed product
Shrinkage Temperature	Equivalent to marketed product	equivalent to marketed product
Glycerol Content	Equivalent to marketed product	equivalent to marketed product
Collagen Content	Equivalent to marketed product	equivalent to marketed product
Scanning Electron Micrographs	Equivalent to marketed product	equivalent to marketed product

Additionally, "Biocompatibility Testing" was performed to demonstrate safety for intended use and substantial equivalence in biocompatibility to the currently marketed PMA approved devices.

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

The document does not specify the sample sizes for the various mechanical and material tests conducted. There is no mention of data provenance (e.g., country of origin) or whether the data was retrospective or prospective. Given the nature of the tests, it's typically laboratory testing of manufactured devices.

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 to the type of device and testing described. The ground truth for mechanical/material properties is established through standardized laboratory testing methods, not by expert consensus in the clinical sense.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic performance studies involving human readers, which is not the case here.

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

No, an MRMC comparative effectiveness study was not done. This device is a vascular graft, not an AI-powered diagnostic tool, and involves no human readers in its functional assessment.

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

Yes, a standalone performance assessment was done, as the testing described (Burst Strength, Tensile Strength, etc.) evaluates the device's physical and material properties directly, without human interaction with the device during the test itself. This is not an "algorithm only" standalone performance as in AI, but rather a direct characterization of the physical product.

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

The ground truth for the test set was established by the characteristics and performance of the predicate devices (currently marketed PMA approved HEMASHIELD® devices). The studies aimed to show that the new devices were "equivalent to marketed product" across a range of physical, mechanical, and material properties. This is a "predicate comparison" ground truth rather than a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this is not an AI/ML device. The "training" for such a device would be the manufacturing process development itself, not a data-driven model training.

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

This information is not applicable, as there is no training set mentioned or implied for this type of medical device submission.

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