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The Medtronic centrifugal blood pumping system 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 Bio-Console® 560 is an extracorporeal blood pumping console consisting of a Base Unit with a display and a User Interface (touch screen) with integrated flow control knob. In order to perform its intended function, the Bio-Console® 560 is compatible with the Medtronic External Drive Motor, disposable Centrifugal Pump, Flow Transducer with disposable Insert, and emergency Handcrank.

The provided document (K070286) describes the 510(k) summary for the Medtronic Bio-Console® 560, specifically focusing on modifications made to version 1.5. This device is a cardiopulmonary bypass pump speed control system.

Based on the document, here's a summary of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Functional, hardware and software testing was used to establish the performance characteristics for the modifications of this device compared to previously marketed devices." It does not provide a specific table of quantitative acceptance criteria or detailed reported performance figures for the new features (Bubble Detector, Level Sensors, AutoClamp options). Instead, it makes a general statement about testing being performed.

The "modifications for version 1.5 add optional Safety Systems: Bubble Detector, Level Sensors, and AutoClamp. User selectable options have also been added to control the speed of the centrifugal pump and/or activate the AutoClamp when air is detected or if there is low fluid in the reservoir." The performance is implied to be acceptable if it is "substantially equivalent" to the predicate devices.

Acceptance Criteria (Implied): The new features (Bubble Detector, Level Sensors, AutoClamp) and user-selectable options must perform their intended functions reliably and safely, demonstrating substantial equivalence to similar features in predicate devices.

Reported Device Performance: The document only states that "Functional, hardware and software testing was used to establish the performance characteristics." No specific metrics (e.g., sensitivity, specificity, accuracy, detection limits) are provided.

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

The document explicitly states: "Clinical testing was not required to establish substantial equivalence." This indicates that no human test set data was used. The testing described was "Functional, hardware and software testing." The provenance of this internal testing data (e.g., country of origin) is not provided, but it would typically be conducted internally by Medtronic. It is prospective testing of the device itself, not retrospective analysis of patient data.

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

Not applicable. Since no clinical testing or human test set was performed, no experts were used to establish ground truth in this context. The "ground truth" for functional, hardware, and software testing would be derived from engineering specifications and established test protocols, rather than expert judgment on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. No human test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document 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

The device, the Bio-Console® 560, is a physical medical device with hardware and software, not a standalone algorithm in the typical sense of AI/machine learning. The "performance" assessment was of the integrated system's functions. Therefore, a standalone algorithm performance study, as understood in AI, was not conducted. The functional, hardware, and software testing would assess the device's ability to operate the pump, detect air/low levels, and activate the clamp independently of a human operator, but this isn't framed as an "algorithm only" study.

7. The Type of Ground Truth Used

For the "Functional, hardware and software testing," the ground truth would be based on:

• Engineering Specifications: The device's design requirements and intended operational parameters.
• Predicate Device Performance: The known and established performance characteristics of the legally marketed predicate devices (Medtronic Bio-Console® 560 (K051303), Terumo System 1 (K022947), Rocky Mountain Research, Inc. Automatic Tubing Clamp System (K961364)). The new features were compared to these established devices for substantial equivalence.

8. The Sample Size for the Training Set

The document does not mention any training set. This suggests that the device's logic for the new functions (Bubble Detector, Level Sensors, AutoClamp) was not based on machine learning or AI that would require a distinct training set. The functionality would have been developed using traditional engineering principles and programmed software.

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

Not applicable, as no training set (in the context of AI/machine learning) was mentioned or implied.

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The Medtronic centrifugal blood pumping system 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 Bio-Console® 560 is a cardiopulmonary bypass pump speed controller. It 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 provided text does not contain specific acceptance criteria or an in-depth study description with performance metrics for the Bio-Console® 560. Instead, it describes a 510(k) premarket notification for a Class II medical device, the Bio-Console® 560, a cardiopulmonary bypass pump speed controller. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices (Bio-Console® 550 and Bio-Console® 550M).

The key takeaway is that the manufacturer performed functional, hardware, and software testing to establish the device's performance characteristics. However, the details of these tests and the specific quantitative acceptance criteria and results are not provided in this summary.

Therefore, I cannot complete the table or answer most of the specific questions as the information is not present in the provided text.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but implied to be from internal testing by the manufacturer (Medtronic Perfusion Systems). It is not stated whether it was retrospective or prospective, or the country of origin of the data.

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

• This is not applicable as the device is a pump speed controller, and the "ground truth" would likely be based on engineering specifications and measurement standards, not expert clinical interpretation.

4. Adjudication method for the test set

• Not applicable for this type of device testing.

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 hardware speed controller, not an AI-assisted diagnostic or interpretative system.

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

• The performance assessment likely focused on the device's standalone functional performance, as it's a pump speed controller. However, specific details of "standalone" testing are not provided beyond "functional, hardware and software testing."

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

• The "ground truth" for a device like this would typically involve engineering specifications, calibration standards, and established metrics for pump performance (e.g., flow rate, pressure, RPM accuracy). The document does not specify these details.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a "training set" in the conventional sense. The "training" here refers to the engineering design and development process.

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

• Not applicable. As above, this is not an AI/machine learning device.

Summary of available information:

The 510(k) summary states that "Functional, hardware and software testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices." The conclusion drawn is that the Bio-Console® 560 is "substantially equivalent to the predicate devices based upon design, test results, and indications for use." This implies that the testing performed demonstrated performance comparable to the predicate devices, meeting the requirements for substantial equivalence, but the specific details of these tests and their numerical outputs are not included in this document.

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