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The One Way Soft Valve is intended to be used for the prevention of retrograde flow in ¼/' or smaller lines subject to arterial pressure during cardiopulmonary bypass procedures for use up to six hours.

The One Way Soft Valve is a transparent one-way valve with ¼" inlet and outlet ports. The One Way Soft Valve prevents retrograde flow. A directional arrow is printed on the valve to provide the user with a visual indication of the allowable flow direction within the valve is constructed entirely of PVC and is to be used in lines subject to arterial pressures.

The provided document is a 510(k) premarket notification for the "One Way Soft Valve" and outlines the device's technical specifications and a summary of performance evaluations conducted to demonstrate its substantial equivalence to a predicate device. It is not a study report that details acceptance criteria and device performance in the format requested.

Therefore, I cannot extract the specific information about:

1. A table of acceptance criteria and the reported device performance: The document lists "Performance Evaluations" that were conducted, such as "Tubing Connection (Bond) Strength Evaluation," "Mechanical/Structural Integrity/Burst Strength Evaluation," "Opening Pressure Evaluation," "Negative Pressures and Retrograde Flow Evaluation," and "Circulation and Hemolysis Evaluation." It states that "Performance testing was conducted with substantially equivalent results" to the predicate device. However, it does not provide specific numerical acceptance criteria or the reported performance data for these evaluations.

As a result, the following points cannot be answered from the provided text as they pertain to a detailed study report that is not included:

2. Sample sizes used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of in-vitro device testing.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable as this is not an interpretive diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used: For in-vitro performance evaluations, the "ground truth" would be established by validated test methods and established engineering and medical standards, not expert consensus or pathology in the typical sense for diagnostic devices. The document implies that the "substantial equivalence" of the results to the predicate device is the key ground truth.
8. The sample size for the training set: Not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the document states that performance evaluations were conducted to demonstrate substantial equivalence, but it does not provide the detailed acceptance criteria or the specific performance results in a tabular format as requested. It also does not reference a study that would include the other requested details because the document is a 510(k) summary, not a full study report.

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