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DVT-PRO is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-PRO is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis Edema - Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery Leg Ulcers, Venous Stasis / Venous Insufficiency.

In this device, sleeves continuously inflated/deflated by the air pressure generated by the pump. This pressurization increases blood flow and prevent DVT/PE. Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers are sequentially inflated from the first air chamber to the third chamber through solenoid valve.

The provided document describes the DVT-PRO device, a compressible limb sleeve intended to prevent Deep Vein Thrombosis (DVT). The submission is a 510(k) premarket notification (K203353), claiming substantial equivalence to a previously cleared device, DVT-PRO (K150980).

Here's an analysis of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail format for performance metrics. Instead, it demonstrates substantial equivalence to a predicate device. The comparison focuses on technical characteristics and specifications. The "reported device performance" is essentially that the proposed device (DVT-PRO, K203353) performs equivalently to the predicate device (DVT-PRO, K150980) based on non-clinical testing.

Here's a table comparing the proposed device to the predicate device, highlighting critical specifications and differences:

2. Sample size used for the test set and the data provenance

The document indicates that "Non-clinical test (Product performance test)" was conducted to "prove that it is substantially equivalent to the equivalent device." However, specific details about the sample size (e.g., number of devices tested, number of test cycles) for this performance test are not provided.

The data provenance is from non-clinical testing performed by the manufacturer, DAESUNG MAREF CO., LTD., likely in Korea, South, given the manufacturer's address. The testing is in support of a 510(k) submission, confirming it is retrospective in the context of device development, but the specifics of when the tests were done are not explicitly stated, beyond the date of data preparation (February 22, 2021). The document states "A test was conducted that reflected the difference from the equivalent device, and after the change, it was confirmed that the product satisfies the existing performance."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a non-clinical performance test for a mechanical device comparing its specifications to a predicate device. There is no "ground truth" established by experts in the sense of clinical diagnoses or interpretations. The "ground truth" for the performance test appears to be the expected performance range or specification as defined by the manufacturer and relevant standards (e.g., pressure output accuracy).

4. Adjudication method for the test set

Not applicable. As noted above, this involves non-clinical performance testing against specifications, not expert adjudication of clinical outcomes or interpretations.

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

Not applicable. The DVT-PRO is a physical medical device (compressible limb sleeve) and not an AI/software device that involves human readers or AI assistance in interpretation. No MRMC study was conducted or is relevant for this type of device.

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

Not applicable. The DVT-PRO is a physical device and does not involve standalone algorithm performance in the way an AI diagnostic tool would.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance testing of the DVT-PRO device consists of engineering specifications and relevant performance standards. The device's performance was compared against these established technical benchmarks and the specifications of the predicate device (K150980). For example, pressure output was verified against defined ranges (e.g., LEG: 20-65mmHg ±15mmHg).

8. The sample size for the training set

Not applicable. This device does not use an algorithm that requires a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth established for one.

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