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Venen-trainer (Model: FM150, SFM90) is intended for either primary or adjunctive treatment of lymphedema, peripheral edema, lipedema, venous insufficiency, and venous stasis ulcers. These devices are also intended for the prophylaxis of deep vein thrombosis (DVT). Intended for use in a home or healthcare setting.

Venen-Trainer (model: FM150, SFM90) is a compression therapy device, consists of two leg cuffs with integrated inflation and deflation air cushions, two air hoses and a handheld controller. The working principle is the air inflating and deflating the sleeve sequentially to develop the circulating pressure on the human body. Squeezing the proximal and distal of the limbs to promote blood circulation lymphatic system and improve body microcirculation. Besides, prevent thrombus, reduce limbs drops and this kind disease which is related to blood and lymph circulation directly or indirectly. The two leg cuffs are each connected to one end of an air hose, and the other end of the two air hoses is connected to the controller. The air pressure controller has a built-in vacuum pump, and the air pressure intensity can be adjusted by the air pressure controller. Turn the knob clockwise to increase the intensity. The timer of FM150 can be switched between three timings of 10 minutes, 20 minutes, and the timer of SFM90 is only one timing of 30 minutes. The two leg cuffs are inflated alternately and will not be inflated simultaneously. In addition, there are hook and loop buckles on the foot cover to adjust the leg cuff to the shape of user's leg.

This document is a 510(k) summary for the Venen-trainer (Model: FM150, SFM90), a compression therapy device. The submission aims to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance:

The document does not explicitly state acceptance criteria in the typical format of a table with specific metrics (e.g., sensitivity, specificity, accuracy) and corresponding thresholds for device performance. Instead, the "acceptance criteria" are implied by the demonstration of conformity to established medical device standards and functional equivalence to the predicate device. The device performance is primarily assessed through a series of lab bench tests.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Details:

1. Sample sizes used for the test set and data provenance:
   The document describes "lab bench testing" for electrical safety, EMC, biocompatibility, and software verification and validation. It does not mention a "test set" in the context of clinical or performance data involving human subjects or specific diagnostic outputs that would require a sample size. The testing appears to be hardware and software validation against technical standards. Therefore, information about sample size, country of origin, or retrospective/prospective nature is not applicable in this context.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
   This information is not applicable as the document does not describe a study involving expert-established ground truth on a test set (e.g., for diagnostic accuracy). The testing performed is related to compliance with engineering and safety standards.

3. Adjudication method for the test set:
   This information is not applicable as there is no mention of a test set requiring adjudication in the context of diagnostic performance or clinical outcomes.

4. 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:
   This information is not applicable. The device described is a physical compression therapy device, not an AI-assisted diagnostic or therapeutic system involving human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This information is not applicable. The device is not an algorithm-only system. Its performance is assessed as a medical device against safety and performance standards.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the technical tests (electrical safety, EMC, biocompatibility, software V&V), the "ground truth" is adherence to the specified international and FDA standards (e.g., IEC 60601-1, ISO 10993) and the manufacturer's own design specifications. There is no biological or clinical "ground truth" established from patients or pathology in this submission.

7. The sample size for the training set:
   This information is not applicable. The device is not an AI/ML device that requires a training set of data.

8. How the ground truth for the training set was established:
   This information is not applicable for the same reason as point 7.

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