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The recirculation line is indicated for use in connecting tubing and/ or devices during cardiopulmonary bypass procedures up to 6 hours in duration.

The recirculation line consists of a 0.6 cm (1/4 in) flexible line with Y connector and female luer ports. The recirculation line provides a path from the recirculation port of the Affinity Fusion® Oxygenator with Integrated Arterial Filter to the venous reservoir. It is configured for maximum flexibility to facilitate ease of circuit set up and priming.

The provided text describes the 510(k) submission for the Medtronic Affinity Fusion® Recirculation Line. This device is a cardiopulmonary bypass tubing component, and its approval was based on demonstrating substantial equivalence to a predicate device, not on meeting specific quantitative acceptance criteria derived from a clinical study.

Therefore, many of the typical elements requested in the prompt, such as acceptance criteria tables with performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to this type of submission. This is a pre-clinical bench testing submission for a physical medical device, not a software-driven diagnostic or AI device.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The specific quantitative acceptance criteria or detailed performance results (e.g., burst pressure in psi, pull-off force in Newtons) are not disclosed in this summary. The summary only states that these tests were conducted and the device's performance was verified.

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

• Sample Size: Not specified in the summary. Performance tests typically involve a statistically relevant number of samples, but the exact count is not provided.
• Data Provenance: Pre-clinical bench testing. The country of origin of the data is implicitly the United States, given Medtronic's location and the FDA submission. The data is prospective in the sense that the device was manufactured and then subjected to these tests as part of the approval process.

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

• Not Applicable. For mechanical/physical performance tests, "ground truth" is established by direct measurement and observation against engineering specifications, not by expert consensus in a clinical context. The "experts" involved would be engineers and technicians conducting the bench tests and interpreting the results according to validated test methods.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting subjective clinical data (e.g., imaging reads). For bench testing, results are typically objective measurements or pass/fail criteria against engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is a physical medical device, not an AI or imaging-based diagnostic device. Therefore, MRMC studies are not relevant.

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

• No. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used:

• Engineering Specifications/Validated Test Methods. The "ground truth" for these tests refers to established engineering requirements and validated test protocols for integrity, bursting, and pull-off strength.

8. The Sample Size for the Training Set:

• Not Applicable. This device did not involve a "training set" in the context of machine learning or algorithms. Its design and manufacturing process would involve internal development and testing, but not a dataset for training.

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

• Not Applicable. See point 8.

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