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The Guidant Hemostasis Valve is used to maintain hemostasis around catheters percutaneously introduced into the vasculature.
The Rotating Hemostasis Valve is intended for maintaining a fluid- tight seal around devices, including implantable coronary venous leads, during the implant procedure.

The RAPIDO™ Cut-Away Rotating Hemostasis Valve is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices such as balloon catheters, wires, and pacemaker and defibrillation leads. The RAPIDO™ Cut-Away Rotating Hemostasis Valve has a single adjustable seal that provides control over fluid loss.
The seal is a Tuohy-Borst type that may be adjusted by rotating the cap clockwise to close, and counterclockwise to open. The seal is adjusted to control leakage and device movement. An open RHV seal allows air and fluid to be purged while allowing the advancement/withdrawal of diagnostic/ interventional devices

I am sorry, but the provided text does not contain the detailed information needed to fill out all aspects of your request. The document is a 510(k) summary for a medical device and primarily focuses on establishing substantial equivalence to a predicate device.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

The document states: "The results of the verification testing demonstrate that the modified Rotating Hemostasis Valve meets the established acceptance criteria and perform in a manner equivalent to the predicate device." However, it does not provide a specific table of acceptance criteria or the reported performance data. It only makes a general statement of compliance.

What is available form the text:

What is missing: The specific quantitative or qualitative acceptance criteria used for the device and the detailed results of the performance testing against these criteria.

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

The document does not specify the sample size used for any testing. It also does not mention data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not present in the provided text. The document describes a medical device, and the "ground truth" concept as typically applied to AI/imaging studies (e.g., expert consensus on image interpretation) is not relevant in this context of a physical device's performance testing.

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

This information is not present and is not typically relevant for the type of device testing described.

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 type of study is not mentioned in the document. An MRMC study is relevant for AI-assisted diagnostic tools, not for a physical hemostasis valve.

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

This is not applicable as the device is a physical hemostasis valve, not an algorithm.

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

The concept of "ground truth" as typically used in AI/diagnostic studies is not applicable here. For a physical device, testing typically involves engineering tests, material compatibility tests, and functional performance tests against predefined specifications. The "ground truth" would be the direct measurement or observation of the device's physical properties and functional performance.

8. The sample size for the training set:

There is no mention of a training set as this is a physical medical device, not an AI model.

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

Not applicable, as there is no training set.

In summary, the provided text is a 510(k) summary for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device through verification testing, but it does not disclose the specific details of that testing (e.g., acceptance criteria, test results, sample sizes) that would be needed to answer most of your detailed questions. The concepts of "ground truth," "training set," "experts," and "AI performance" are not relevant to this type of regulatory submission for this device.

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