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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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