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The SlendAir 4000 is a prescriptive device that induces controlled compression of the leg or the arm. The SlendAir 4000 is intended for use by medical professionals and patients at home in treating many conditions, such as: Primary lymphoedema, Post mastectomy edema, Leg ulcers, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphoedema.

The SlendAir 4000 is a prescriptive, pneumatic compression device designed to apply peristaltic compression to a limb. The device is composed of four components: Light and portable pneumatic control unit, Calf, foot, full leg, or full arm cuff composes of 1-12 cells, Pneumatic connecting tubes, Electrical transformer. The SlendAir enables different treatment pressures (30-90mmHg) and treatment times (15-60 minutes) that should be used according to physician discretion. When activated, air flows into the cuff cells in a continues, predetermined peristaltic waveform. A mechanical valve has been included in the air system for releasing air in case of over pressure in one of the compartments.

Based on the provided text, the SlendAir 4000 Compression System is a medical device, and the information is from a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific acceptance criteria and performance metrics for the device itself. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document.

Here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria or reported device performance in terms of clinical outcomes (e.g., reduction in edema, healing of leg ulcers) are provided. The "performance" described refers to compliance with voluntary engineering standards and a comparative safety and performance study for substantial equivalence determination.

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

Not available. The document mentions "a series of safety and performance testing including a comparative study," but it does not specify the sample size, the type of data (e.g., patient data, engineering data), or the provenance (country of origin, retrospective/prospective nature) of this test set.

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

Not available. The document does not describe the establishment of a "ground truth" in the context of a clinical test set, as its focus is on substantial equivalence through engineering and comparative performance.

4. Adjudication method for the test set

Not available.

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. This device is a pneumatic compression system, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study and AI improvement effect size are irrelevant.

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

Not applicable. This is not an algorithmic device.

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

Not available. The concept of "ground truth" in a clinical diagnostic sense is not discussed. The "ground truth" for demonstrating equivalence would likely be meeting the performance specifications of the predicate devices or relevant engineering standards.

8. The sample size for the training set

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

Not applicable.

Summary of available information regarding the study:

The document states:

• "Based on a series of safety and performance testing including a comparative. study, Medical Compression Systems (DBN) Ltd. believes that the SlendAir 4000 is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues."

This indicates that a comparative study was performed to demonstrate substantial equivalence to predicate devices (Talley TM300, TM500, and Multipulse Sequential Compression Systems) in terms of safety and performance. However, specific details about the methodology, sample sizes, or results of this study are not provided in this 510(k) summary. The summary focuses on regulatory compliance and the device's basic operational description rather than detailed clinical trial data.

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