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This product is intended for use with the Huntleigh DVT Flowtron pump to aid in the prevention of deep vein thrombosis in surgical, trauma and certain medical patients at risk for DVT formation. It is not intended for use on patients with known DVT or with any other intermittent compression device. This device is restricted to sale by or on the order of a physician.

The RTM DVT PS100 ProSoft Cuff is a cotton garment designed to be wrapped around the lower extremity (calf), secured with looped tape and connected to Huntleigh DVT Flowtron pump. The outer shell of the garment is a blend of cotton and linen and encases a plastic inflatable bladder that is connected to the pump via poly vinyl tubing.

This submission describes a medical device, the RTM DVT PS100 ProSoft Cuff, seeking substantial equivalence to a predicate device, the Huntleigh Flowtron DVT System L501 Garment. The "study" conducted for this submission focuses on demonstrating technological equivalence rather than clinical effectiveness against specific performance criteria related to DVT prevention.

Here's an analysis of the provided information based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission demonstrating substantial equivalence to a predicate device, the acceptance criteria are based on directly comparing the technological characteristics of the new device to the predicate device. There aren't explicitly stated numerical performance thresholds in the way one might see for a diagnostic device's sensitivity or specificity. Instead, the acceptance criterion is a qualitative assessment of "almost identical" or "virtually no differences detected."

2. Sample Size for the Test Set and Data Provenance

The documentation does not explicitly state a numerical sample size for the "Air Flow/Volume Test" or the "Cycle Test." It implies a comparison of one RTM DVT PS100 ProSoft Cuff bladder against one Huntleigh L501 bladder. For the "Cycle Test," it implies testing one of each cuff on "a person's calf."

• Sample Size: Not explicitly stated as a numerical value for multiple instances; implied n=1 for each device type in each test scenario (unattached bladder and attached to a calf).
• Data Provenance: The tests were conducted by RT Medical. The location of these tests is not specified, but it can be assumed to be within the United States, given that the company address is in Ohio. The data is prospective as it was generated specifically for this submission.

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

There were no external experts used to establish ground truth in the traditional sense for these technological tests. The "ground truth" was established by direct measurement of physical properties (inflation/deflation times) of the devices themselves. The comparison was against the predicate device, not an expert-annotated dataset.

4. Adjudication Method for the Test Set

No adjudication method was mentioned or necessary, as the "ground truth" was based on direct physical measurements and comparison between the two devices.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study described is a technological comparison of the new device to a predicate device, not a study of clinical effectiveness or human reader performance. Therefore, there is no mention of effect size for human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the RTM DVT PS100 ProSoft Cuff. This device is a mechanical compression cuff, not a software algorithm or AI-powered device. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. The Type of Ground Truth Used

The "ground truth" used was the measured physical performance of the predicate device (Huntleigh L501 garment). The RTM DVT PS100 ProSoft Cuff's performance was compared directly to these measurements.

8. The Sample Size for the Training Set

There is no training set for this type of device submission. This is a physical medical device, not a machine learning model.

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

This question is not applicable as there is no training set for a physical medical device like the RTM DVT PS100 ProSoft Cuff.

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