(107 days)
The Bard® Quantum™ CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from: (1) venous return (2) intracardiac suction (3) ventricular vent devices (4) arterial-venous shunts It defoams, filters and stores this blood before returning it to the circuit.
The Bard® Quantum™ CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from: (1) venous return (2) intracardiac suction (3) ventricular vent devices (4) arterial-venous shunts It defoams, filters and stores this blood before returning it to the circuit.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text only discusses the "Bard® Quantum™ CVR" and its comparison to predicate devices, focusing on the equivalence of its technological characteristics and performance. It does not provide specific numerical acceptance criteria for a new AI/ML device or its reported performance in those terms. Instead, it states:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Bard Quantum™ CVR) |
|---|---|---|
| Cell Damage | Equivalent to or better than predicate devices | Found to be equivalent to or better |
| Defoaming Ability | Equivalent to or better than predicate devices | Found to be equivalent to or better |
| Filtration Efficiency | Equivalent to or better than predicate devices | Found to be equivalent to or better |
| Biocompatibility | Pass all tests required by ISO 10993 | Passed all tests |
2. Sample Size and Data Provenance for Test Set:
This document describes a comparison between a new medical device (Bard® Quantum™ CVR) and predicate devices, not an AI/ML system. Therefore, the concept of a "test set" with specific sample sizes from different countries or retrospective/prospective data as used in the context of AI/ML is not directly applicable. The "test set" here refers to the actual physical devices (Bard H6770VR, Cobe HVRF, and Bard H-3700) that underwent bench testing. The provenance isn't specified beyond the manufacturer.
3. Number and Qualifications of Experts for Ground Truth:
Not applicable. The "ground truth" for this medical device is established through physical and chemical performance tests (e.g., measuring cell damage, defoaming ability, filtration efficiency, and biocompatibility) performed in a lab setting, not through expert human interpretation of data.
4. Adjudication Method for Test Set:
Not applicable. There's no human interpretation or adjudication process described for the performance testing. The results are objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This document describes the 510(k) submission for a physical medical device, not an AI/ML system that would involve human readers interpreting cases.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is not an algorithm or AI system, so the concept of standalone algorithm performance is irrelevant.
7. Type of Ground Truth Used:
The ground truth for this device's performance was based on bench testing results (objective measurements of cell damage, defoaming ability, filtration efficiency) and biocompatibility testing standards (ISO 10993).
8. Sample Size for Training Set:
Not applicable. This is not an AI/ML device that requires a training set. The "training" for such a device is its engineering design and manufacturing process.
9. How Ground Truth for Training Set Was Established:
Not applicable. There is no training set as this is not an AI/ML device.
§ 870.4230 Cardiopulmonary bypass defoamer.
(a)
Identification. A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.”