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The Vasc Band hemostat is a compression device to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.

Vasc Band hemostat (Vasc Band) is a compression device that applies mechanical pressure to achieve hemostasis of vascular access sites. Vasc Band consists of an adjustable retention strap, inflatable compression balloon, inflation tube, and an inflation valve. A 22 ml inflation syringe is also included with the device. Vasc Band is available in five band lengths: 21 cm, 27 cm, 29 cm, and 37 cm.

The provided text is a 510(k) Summary for the Vasc Band hemostat. While it discusses the device's substantial equivalence to predicate devices and mentions "bench tests to provide evidence," it does not contain detailed information about specific acceptance criteria or the study that definitively proves the device meets those criteria in the way a clinical study or detailed performance report would.

The document is a regulatory submission, primarily focused on establishing substantial equivalence to legally marketed predicate devices, rather than providing an in-depth scientific study report with specific performance metrics against pre-defined acceptance thresholds.

Here's what can be extracted and what information is missing based on your request:

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

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

• Sample size: Not specified. The document mentions "bench tests" but does not detail how many units were tested or how many measurements were taken.
• Data provenance: Not specified beyond "bench tests." It's typically ex-vivo or in-vitro for bench tests, but this isn't stated. Country of origin of the data is not mentioned. Whether retrospective or prospective is not applicable to bench tests as described here.

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

• This information is not applicable and not provided. The "bench tests" would likely involve engineering or quality control personnel evaluating physical properties, not clinical experts establishing ground truth in a diagnostic sense.

4. Adjudication method for the test set

• This is not applicable and not provided. Adjudication methods are typically used in clinical studies for interpreting ambiguous results, which is not described for these bench tests.

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 mechanical hemostat and not an AI-powered diagnostic or assistive tool for human readers.

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

• This is not applicable. The Vasc Band hemostat is a physical medical device, not an algorithm.

7. The type of ground truth used

• For the "bench tests," the "ground truth" would be the engineering specifications and performance standards for physical properties like balloon pressure and band size. This is implicitly "engineering specifications" or "physical measurements" rather than expert consensus, pathology, or outcomes data, as those apply to diagnostic or treatment efficacy studies.

8. The sample size for the training set

• This is not applicable. The device is not an AI/machine learning model that requires a training set.

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

• This is not applicable as there is no training set for this type of device.

In summary: The provided document is a regulatory submission for a physical medical device. It attests to the device's substantial equivalence to predicates based on "bench tests" verifying device design (balloon pressure and band size). It does not provide the detailed scientific study data, specific acceptance criteria values, or expert review processes that would be typical for validating diagnostic algorithms or complex clinical interventions. The focus is on demonstrating that the new device is fundamentally similar in function and safety to already-approved devices, rather than proving novel effectiveness through a comprehensive, quantitative clinical or AI performance study against acceptance criteria.

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