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The Flexitouch System and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as:

• Lymphedema
• Primary lymphedema
• Post mastectomy edema
• · Edema following trauma and sports injuries
• · Post immobilization edema
• · Venous insufficiency
• · Reducing wound healing time
  · Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers

The Flexitouch System and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.

The Flexitouch system consists of two main components: a garment set and a pneumatic sequential controller. The garments are wrapped around affected region so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide pneumatic compression therapy. Up to four (4) tubing harness assemblies containing eight (8) discrete individual air passage tubes connect individual garment chambers with the controller. Air passes through the tubes, delivering treatment via the sequential inflation of up to 32 air chambers in the garments.

The provided document does not contain information related to a study that uses a test set, expert adjudication, MRMC studies, or specific performance metrics with acceptance criteria for an AI/software-based medical device.

The document is a 510(k) premarket notification for the Flexitouch® System, Model PD32-G3, a pneumatic compression device. It focuses on demonstrating substantial equivalence to a predicate device (Flexitouch® System, K153311) based on existing technology characteristics and non-clinical performance testing.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies.

The document explicitly states: "Clinical testing was not required to establish substantial equivalence with the predicate devices." This implies that the device's performance was not evaluated through a study involving human subjects or the kind of data analysis typically associated with AI/software device validation.

If the device were an AI/software product, the information you requested would be critical. However, for a physical medical device like the Flexitouch® System, substantial equivalence is often shown through comparisons of design, materials, electrical safety, software validation (general, not AI-specific), biocompatibility, and physical performance tests like pressure verification.

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