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The Medtronic Bio-Console 560 System with Level Sensing System (LS100) and Level Sensing Tape [LST]) is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).

The Medtronic Performer CPB System with Level Sensing System (Level Sensor [LS100] and Level Sensing Tape [LST]) is indicated for use up to 6 hours in the extracorporeal circulation of fluids for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Level Sensing System includes the Level Sensor (LS100) and the Level Sensor Tape (LST). The Level Sensor System is one of the optional safety systems that can be used with the Medtronic Bio Console 560 Extracorporeal Blood Pumping System and the Medtronic Performer Cardiopulmonary Bypass System. It is designed to be used only with a Medtronic hardshell reservoir.

The provided text is a 510(k) premarket notification for two medical devices: the Medtronic Bio Console 560 System with Level Sensing System and the Medtronic Performer CPB System with Level Sensing System. The submission claims substantial equivalence to previously cleared predicate devices.

However, the document does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the typical format of a clinical trial report or a comprehensive performance validation study with quantitative acceptance metrics. Instead, it relies on bench testing to demonstrate that the modified device's performance characteristics remain substantially equivalent to the predicate device.

Here's an attempt to extract the requested information based on the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

As per the 510(k) summary, the device is considered substantially equivalent to its predicate. The "acceptance criteria" here are implied to be that the modified device should perform comparably to the predicate device. The "reported device performance" is a general statement that the device passed various bench tests.

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

The document does not specify a "sample size" in the context of clinical or large-scale performance testing. The testing described is bench testing, which typically involves a limited number of units. The data provenance is internal to Medtronic (bench testing), and it is retrospective in the sense that it's comparing a new version of a device to an existing one, rather than a prospective clinical trial on a patient population. No country of origin for specific "data" is mentioned beyond the manufacturing location of the company.

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

This information is not provided in the document. Bench testing typically relies on engineering specifications and standard procedures, not expert adjudication in the way clinical studies do.

4. Adjudication Method for the Test Set

This information is not provided and is not relevant for the type of bench 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

An MRMC study was not done. This type of study is relevant for diagnostic imaging interpretation with AI, which is not the function of this device (a level sensing system for cardiopulmonary bypass). The submission explicitly states: "Clinical testing was not required to establish substantial equivalence."

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

A "standalone" performance evaluation in the context of an algorithm or AI (without human-in-the-loop) is not applicable to this device. The device is a mechanical/electronic level sensing system, not an AI algorithm. Its performance is evaluated through bench testing as listed above.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" would be established by:

• Engineering specifications and design requirements: For tests like visual inspection, dimensions, tensile strength, connector compatibility, electrical safety, emissions/immunity.
• Known physical properties and safe operational ranges: For threshold measurements, free-fall tests, and basic functionality in a circuit with bovine blood. The predicate device's established performance would also serve as a reference point.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI. Therefore, this question is not applicable.

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

As there is no "training set" for this type of device, this question is not applicable.

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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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The LevelSens is an accessory safety device which monitors blood or saline levels in a reservoir and sounds an alarm when the level falls below a predetermined level. It is currently configured for intended use with either Rigid Polycarbonate or Flexible Polyvinyl chloride (PVC) reservoirs.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a device called "LevelSens". This type of letter generally declares substantial equivalence to a predicate device based on performance testing but does not typically include detailed studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader studies as would be expected for AI/ML-based devices.

Therefore, the requested information cannot be fully provided from the given document as it pertains to a different type of medical device clearance.

However, based on the limited information available in the document, here's what can be inferred or stated about the device and the nature of its clearance:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the FDA 510(k) clearance letter. Such letters confirm substantial equivalence, which implies the device meets performance standards comparable to legally marketed predicate devices, but they do not typically detail the specific acceptance criteria or the reported performance data from testing.

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

This information is not provided in the document. For a non-AI/ML medical device like LevelSens, performance testing would typically involve engineering tests to verify alarm thresholds, accuracy of level detection, and durability, rather than a "test set" in the context of AI/ML validation data.

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

This information is not provided and is generally not applicable to the clearance of a device like LevelSens. Ground truth as typically understood in AI/ML (e.g., expert consensus on image interpretation) is irrelevant for a device that monitors fluid levels.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable for this type of device clearance.

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

This information is not provided and is not applicable. MRMC studies are relevant for evaluating the impact of AI on human reader performance, which doesn't apply to a fluid level monitoring device.

6. Standalone Performance Study (Algorithm Only):

This information is not provided. While the device operates independently to monitor levels, the term "standalone performance" in the context of an "algorithm only" study typically refers to AI/ML device performance without human intervention, which is not relevant here.

7. Type of Ground Truth Used:

The concept of "ground truth" as typically used in AI/ML (e.g., pathology, expert consensus) is not applicable to this device. The "ground truth" for LevelSens would be the actual physical fluid level in the reservoir against which the device's measurement and alarm activation are compared.

8. Sample Size for the Training Set:

This information is not provided and is not applicable as LevelSens is not an AI/ML device that requires a training set.

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

This information is not provided and is not applicable as LevelSens is not an AI/ML device that requires a training set.

In summary, the provided document is an FDA 510(k) clearance letter for a fluid level monitoring device. It confirms that the device is substantially equivalent to a predicate device for its stated indications for use but does not contain the detailed study information typically requested for AI/ML devices, such as acceptance criteria tables, sample sizes for test/training sets, ground truth establishment, or multi-reader studies.

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