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A vascular patch used for reconstructive interventions in the region of the carotid artery, profunda, femoral, arteria iliaca.

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This is an FDA 510(k) clearance letter for the B.Braun Surgical GMBH Uni-Graft® KDV Patch. The letter itself does not contain the detailed study information, acceptance criteria, or performance data you are requesting. It only states that the device is substantially equivalent to legally marketed predicate devices.

To answer your questions, you would need to refer to the original 510(k) submission (K992776) made by Atrium Medical Corporation to the FDA. This submission would contain the details of any studies performed to demonstrate substantial equivalence, including:

1. A table of acceptance criteria and the reported device performance: This would be found in the performance testing section of the 510(k) submission, comparing the new device against the predicate device or a set of defined performance specifications.
2. Sample size used for the test set and the data provenance: Details on test articles, their quantity, and the conditions under which they were tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Less likely to be relevant for a medical device like a vascular patch, where "ground truth" might refer to engineering specifications or material properties rather than clinical expert consensus. This kind of detail is more common for diagnostic algorithms.
4. Adjudication method for the test set: Again, less likely to be relevant for this type of device.
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 is entirely irrelevant for a vascular patch. MRMC studies are for diagnostic imaging devices or AI-powered assistive technologies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Also irrelevant, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a vascular patch, ground truth would likely relate to material properties (e.g., tensile strength, porosity, biocompatibility), performance in in-vitro or in-vivo models (e.g., burst pressure, suture retention), and potentially animal or limited human clinical data demonstrating safety and efficacy comparable to a predicate.
8. The sample size for the training set: Irrelevant, as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Irrelevant.

In summary, this document (the 510(k) clearance letter) does not contain the information you are requesting. You would need to access the full 510(k) submission K992776, which is typically a much larger document outlining the device description, comparison to predicate devices, and performance data from engineering tests, biocompatibility studies, and potentially other non-clinical or clinical data as required for substantial equivalence. These submissions are generally not publicly available in their entirety in an easily searchable format, though summaries might be found on the FDA website.

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