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The Venera 508 Deep Vein Thrombosis (DVT) Prevention Therapy System is a portable treatment to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This system can be applied in either home or clinical settings to:

• . Aid in the prevention of DVT
• . Enhance blood circulation
• . Diminish post-operative pain and swelling
• . Reduce wound healing time
• . Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs
• . As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

The Venera™ 508 Deep Vein Thrombosis Prevention System is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by simulating blood flow in the extremities (simulating muscle contractions). The Venera 508 system consists of a pair of pump and cuff assemblies. The device will alternatively inflate and deflate the garment (cuff) to stimulate blood flow in the extremities (muscle contraction). The device provides a 50mmHg pressure and followed by 50 seconds of deflation period once it reaches the desired pressure.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., specific metrics like sensitivity, specificity, or reader performance improvement for an AI/device). Instead, it describes a medical device (Venera 508 Deep Vein Thrombosis Prevention System) and its 510(k) submission for substantial equivalence to a predicate device.

The "Performance Tests" section lists several tests conducted, but it does not provide the acceptance criteria for these tests or the reported performance data in a quantitative way. It only states, "The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is safe and effective."

Therefore, I cannot populate the table or provide the detailed information requested regarding acceptance criteria and study particulars for a comparative effectiveness study or standalone performance. The document explicitly states: "No animal study or clinical study was conducted." This means there is no human subject study to evaluate the device's efficacy for its intended medical purpose (DVT prevention) that would typically involve a ground truth, expert readers, or statistical comparisons of performance.

Here's a breakdown of what can be extracted or inferred based on the provided text, and where gaps exist:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not specified. The document mentions "samples of the device" were used for function and mechanical testing, but the number of devices or test repetitions is not stated.
• Data Provenance: Not specified. The tests were conducted internally by the manufacturer, Suzhou Minhua Medical Apparatus Supplies Co. Ltd. (China). The document does not indicate if external data sources or patient data were used for these performance tests. Given this is a physical medical device and not an AI/diagnostic software, the concept of "data provenance" as typically applied to image datasets is not relevant here.

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

• Not applicable. The performance tests described (Pressure Accuracy, Cycle Time, etc.) relate to the device's mechanical and functional specifications, not its diagnostic or therapeutic efficacy based on patient outcomes or expert interpretation of medical data. Therefore, no "ground truth" in the clinical sense was established by experts for these engineering tests.

4. Adjudication method for the test set

• Not applicable. Since no expert-based ground truth was established, there was no need for an adjudication method.

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

• No. The document explicitly states: "No animal study or clinical study was conducted." Therefore, no MRMC study, AI assistance evaluation, or effect size calculation was performed or reported.

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

• This device is not an AI algorithm. It is a physical medical device for DVT prevention. Therefore, the concept of a "standalone" algorithm performance study is not applicable.

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

• Not applicable in the clinical sense. The "ground truth" for the engineering performance tests would be the established engineering specifications and measurement standards (e.g., a calibrated pressure gauge for the "Pressure Accuracy Test").

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" as it is not an AI/machine learning system.

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

• Not applicable for the same reason as above.

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