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The AIROS 6P Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions:

• Lymphedema
• Venous stasis ulcers
• Venous insufficiency
• Peripheral edema
  The device is safe for both home and hospital use.

AIROS 6P Sequential Compression Device is a pneumatic compression device used for treatment and management of venous or lymphatic disorders. The application of compression is effective by increasing blood flow and encouraging extracellular fluid clearance. The device consists of the mechanical device that is used to set the treatment options and supplies cycles of air to the compression garments. There are two primary treatment modes, Gradient Mode and Peristaltic Mode. The air is supplied at adjustable pressures and sequences and inflates the compression garments from the distal to proximal areas of the body. The compression garments are supplied in various sizes for the upper and lower extremity areas of the body.

The AIROS 6P Sequential Compression Device is a pneumatic compression device used for the treatment and management of venous or lymphatic disorders. The study provided in the 510(k) summary focuses on functional performance testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithms requiring expert adjudication of ground truth.

Here's an breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" with numerical targets and "reported device performance" in a comparative table for specific clinical outcomes. Instead, it lists functional performance tests conducted to ensure the device meets its specifications and is substantially equivalent to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not mention a "test set" in the context of patient data or clinical outcomes. The testing described is functional performance testing of the device itself. Therefore, concepts like sample size of patients, data provenance (country of origin), or retrospective/prospective data collection are not applicable to the tests reported.

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

There is no mention of experts being used to establish a "ground truth" for a test set in the provided text. The testing described is engineering/functional testing.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring adjudication by experts is described.

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 AIROS 6P is a pneumatic compression device, not an AI-assisted diagnostic or therapeutic tool that would involve "human readers" or "AI assistance" in the sense of image interpretation or similar cognitive tasks.

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

Not applicable. The AIROS 6P is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the functional performance testing would be the device's design specifications and established engineering standards. For example, "cycle time accuracy" would be compared against the designed cycle times. There is no biological or clinical "ground truth" like pathology or outcomes data involved in the described testing.

8. The Sample Size for the Training Set

Not applicable. The AIROS 6P 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, as there is no training set for this device.

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