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510(k) Data Aggregation
(101 days)
HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. which is substantially equivalent to the currently marketed devices.
The HEMASHIELD® CARDIOVASCULAR GRAFTS are knitted and woven polyester grafts. impregnated with bovine collagen.
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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