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The Cardiotomy Vent Valve is indicated for use to maintain a low level of vacuum in cardiotomy reservoirs.

The IBC Vent Valve is a single use, disposable, vacuum relief valve that is intended for use to maintain a low level of vacuum in reservoirs. The valve is closed until the vacuum reaches a pre-determined value in the reservoir and operates best when the pump runs at a very slow rate. The fully assembled IBC Vent Valve is basically identical to the American Omni Vent Valve, which is the predicate device for purposes of this 510(k) submission. The operating principles, performance and indications for use of the two devices are the same.

The IBC Vent Valve is manufactured in a Class 100,000 clean room. The device will be packaged and sterilized for single use. Additionally, the IBC Vent Valve will be packaged in bulk form and non-sterile for the Custom Perfusion Pack market. The materials used to manufacture the IBC Vent Valve are non-toxic and meet current ISO biocompatible tripartite standards using the FDA matrix.

A perfusionist substituting an IBC Vent Valve for an American Omni Vent Valve with his or her cardiotomy reservoir will be unable to distinguish between the two valves functionally.

This looks like a 510(k) summary for a medical device called the "IBC Vent Valve." The document states that the IBC Vent Valve is "basically identical" to a predicate device, the American Omni Vent Valve, and that a "perfusionist substituting an IBC Vent Valve for an American Omni Vent Valve with his or her cardiotomy reservoir will be unable to distinguish between the two valves functionally." This strongly suggests that the acceptance criteria for the IBC Vent Valve are tied to its functional equivalence to the American Omni Vent Valve.

However, the provided text does not contain a detailed study with specific acceptance criteria, sample sizes, expert ground truth, or statistical analysis typical of a study proving a device meets acceptance criteria. The 510(k) process often relies on demonstrating substantial equivalence to a predicate device rather than de novo clinical trials with detailed performance metrics.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide specific numerical acceptance criteria (e.g., vacuum level ranges, specific trigger pressures) or quantitative reported device performance measurements.

Regarding the study proving the device meets acceptance criteria, the document does not describe a formal study with the details requested. Instead, it relies on a claim of "substantial equivalence" to a predicate device.

Here's an analysis of the requested information based on the provided text:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
* Not provided. The document does not describe a specific "test set" or data collection for performance evaluation beyond the general statement of functional equivalence.
* The statement "A perfusionist substituting an IBC Vent Valve for an American Omni Vent Valve with his or her cardiotomy reservoir will be unable to distinguish between the two valves functionally" suggests a subjective assessment, but no details on who performed this, how many, or under what conditions are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not provided. No explicit "ground truth" establishment process or experts are detailed for device performance in the provided text. The "perfusionist" mentioned is not quantified or qualified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable/Not provided. There is no described test set or adjudication process in the provided text.

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:
* Not applicable. This device is a mechanical vacuum relief valve, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reading performance with or without AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is a mechanical component. The concept of "algorithm only" performance does not apply. Its function is standalone in the sense that it operates independently once installed, but it's not a computational algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Implied functional equivalence to a predicate device. The "ground truth" seems to be the established performance and functional characteristics of the American Omni Vent Valve, which the IBC Vent Valve claims to replicate. No independent "expert consensus, pathology, or outcomes data" is described for the IBC Vent Valve's performance.

8. The sample size for the training set:
* Not applicable/Not provided. This is a mechanical device, not a machine learning algorithm, so there is no "training set."

9. How the ground truth for the training set was established:
* Not applicable. As above, no training set or its ground truth establishment is relevant to this device.

In summary: The provided document is a 510(k) summary focusing on demonstrating "substantial equivalence" to a predicate device. It primarily relies on the claim that the new device is functionally identical to the previously cleared predicate. It does not detail specific, quantitative performance studies with controls, sample sizes, or expert assessments as would be typically found for novel device performance claims.

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