(104 days)
The Large (6") Roller Pump for the Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
The image shows a device description and indications for use of the APS 1 Large (6") Roller Pump. The device is a peristaltic pump with a 6 inch diameter race that can be mounted on the base of the Advanced Perfusion System 1 (APS1) console or positioned in an optimal location in the perfusion circuit by mounting on the pole. The large roller pump can accommodate applications requiring flow rates up to 10 L/min.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Results Summary) |
|---|---|---|
| Strength | Design Verification Protocol: Knob/Cam Follower Impact Strength Verification | Pass – All pre-defined acceptance criteria met |
| Reliability/Durability | Design Validation Protocol: Simulated use testing on new and aged parts; multiple cycles under worst-case conditions | Pass – All pre-defined acceptance criteria met |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for the test set in the performance studies. It mentions "new and aged parts" but no specific quantity.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a design change, the testing would generally be prospective, conducted in a laboratory setting by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The performance tests appear to be engineering-based (strength, reliability/durability) rather than requiring expert clinical interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the tests (Pass/Fail based on engineering criteria), formal adjudication by clinical experts is unlikely.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical pump, not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the performance tests described (Strength, Reliability/Durability) are standalone tests of the device's mechanical integrity and function. The device itself (a roller pump) is a standalone piece of equipment. The assessment of its performance did not involve a "human-in-the-loop" component for interpretation of results, but rather its mechanical operation and ability to withstand stress.
7. Type of Ground Truth Used
The ground truth used for these performance tests appears to be engineering specifications and pre-defined acceptance criteria. For "Strength," the ground truth is defined by the "Knob/Cam Follower Impact Strength Verification" protocol. For "Reliability/Durability," the ground truth is established by "Simulated use testing... under worst-case conditions." The "Pass" result indicates that the device met these engineering and design validation targets.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. The device is a mechanical pump, not an AI/ML-based system that requires a "training set" in the context of machine learning. The design and manufacturing process would involve internal testing and validation, but not a "training set" in the computational sense.
9. How Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of medical device.
§ 870.4370 Roller-type cardiopulmonary bypass blood pump.
(a)
Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.(b)
Classification. Class II (performance standards).