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The Stockert Air Purge Control (APC) detects air in the venous line and removes air from the venous bubble trap of the Synergy System tubing circuit that is intended to be used with the Stockert S3 Perfusion System. The S3 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S3 System.

The Stöckert Air Purge Control is a modification of the cleared S3 Level Control/Bubble Detector with the new Air Purge Control module replacing the Bubble Detector. The APC System uses the same Level Control module, Level Control sensor as the predicate device above. The modifications being made to the parent Stöckert S3 Level Control and Bubble Detector consist of three changes: (1) a change to the artwork of the display panel to show "APC" rather than "Bubble Detector," (2) replacement of the "Alarm Clear" key with the "Purge Control" key, and (3) firmware and software modifications. No modifications are being made to the hardware or electronics of any of the components.

The provided text is a 510(k) summary for a medical device modification, specifically the Stöckert Air Purge Control (APC) System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to fill out all the aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Stöckert Instrumente GmbH has verified and validated the device modifications and has demonstrated, through the testing provided in the 510(k) that the APC System complies with specifications, meets user requirements, and the differences between the parent and the proposed device do not raise new issues of safety or effectiveness."

However, the specific "specifications" (acceptance criteria) and the quantitative results from the "testing provided in the 510(k)" (reported device performance) are not included in this summary. This document is a high-level summary and doesn't delve into the detailed test report.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The summary mentions "testing provided in the 510(k)," but doesn't detail the nature or origin of the data. Given it's a device modification and verification/validation, it's likely internal testing by the manufacturer, but specifics are absent.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This information is not applicable and not provided. The device (Air Purge Control) is a bubble detector and air removal system. Its "ground truth" would likely be established through physical tests with known air volumes or conditions, rather than expert interpretation of images or observations.

4. Adjudication Method for the Test Set

• Not applicable and not provided. See point 3 above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done? No.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool for human readers. It's an automated control system.

6. Standalone Performance Study

• Was it done? Yes, implicitly. The summary states: "Stöckert Instrumente GmbH has verified and validated the device modifications and has demonstrated, through the testing provided in the 510(k) that the APC System complies with specifications, meets user requirements..." This refers to the device's performance in its intended function (detecting and removing air), which is a standalone performance validation. However, the specific results of this standalone testing are not detailed in the summary.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated but inferred to be based on engineering specifications and physical measurements. For a bubble detector and air purge system, the ground truth would involve controlled introduction of air into the system and verification of the device's ability to detect and remove it according to predetermined thresholds and operational parameters. It would likely involve instrument-based measurements rather than expert consensus or pathology.

8. Sample Size for the Training Set

• Not applicable and not provided. This device is a control system with firmware/software modifications, not a machine learning or AI model that requires a training set in the typical sense. The "firmware and software modifications" would have been developed and tested against established engineering requirements.

9. How the Ground Truth for the Training Set Was Established

• Not applicable and not provided. See point 8.

In summary:

The provided text serves as a regulatory submission summary, focusing on demonstrating substantial equivalence for a device modification. It mentions "testing" and "verification/validation" were performed to show the device meets "specifications" and "user requirements," but it does not disclose the specific acceptance criteria, the detailed results, or the methodologies (like sample sizes, ground truth establishment for AI/diagnostic devices, or MRMC studies) that you've requested. These details would typically be found in the actual test reports and validation documents submitted with the 510(k), which are not part of this public summary.

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