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The ReNu Medical Reprocessed Vaso Press CTC calf, thigh and foot DVT garments are to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism.

The ReNu Medical Reprocessed Vaso Press CTC calf, thigh and foot DVT garments. (All sizes)

This document describes the 510(k) submission for the ReNu Medical Reprocessed Vaso Press CTC DVT garments. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria for a new device.

Therefore, much of the requested information about a study proving the device meets acceptance criteria cannot be extracted because such a study, with defined acceptance criteria and detailed performance metrics, is not present in the provided text. The submission relies on "bench testing" to ensure reprocessing doesn't compromise performance compared to predicate devices.

Here's what can be extracted based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative acceptance criteria (e.g., pressure output ranges, cycle life, material strength after reprocessing) are not provided. The performance is described qualitatively as "not compromised" and "substantially equivalent."

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

• Sample Size for Test Set: Not specified. The document mentions "bench testing" but does not detail the number of units tested.
• Data Provenance: Not specified. The testing was conducted by ReNu Medical, Inc., but the location or whether the data is retrospective or prospective is not mentioned.

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

• This information is not applicable as the submission describes bench testing for substantial equivalence, not a clinical study requiring expert-established ground truth for a diagnostic or AI device.

4. Adjudication Method for the Test Set

• This information is not applicable for the type of bench testing described.

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

• An MRMC comparative effectiveness study was not done. This submission is for reprocessed medical devices, not an AI-powered diagnostic or assistive device.

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

• This information is not applicable. This is not an algorithmic or AI device.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is the performance of the original, new, legally marketed predicate devices. The reprocessed device is compared against the performance characteristics of these predicate devices to demonstrate substantial equivalence, particularly that reprocessing did not degrade these characteristics.

8. The Sample Size for the Training Set

• This information is not applicable. This is not a machine learning or AI device that requires a training set.

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

• This information is not applicable as there is no training set for this type of device submission.

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