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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 insufficiencies
· 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.

Device Description

The Flexitouch® system consists of two main components: a garment set and a pneumatic sequential controller. The garments are wrapped around an affected region so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide for low-level compression therapy. Up to four (4) tubing harness assemblies containing eight (8) discrete individual air passage tubes connect individual garment chambers with the controller.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Flexitouch System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria in a table format. Instead, it broadly states that "The test results verify that the safety and performance for the device met all pre-specified performance criteria and is substantially equivalent to the predicate device for its intended use."

However, based on the "Summary of Performance Testing" and "Summary of Clinical Evaluation", we can infer the reported device performance.

Criterion Type	Acceptance Criteria (Inferred)	Reported Device Performance
Non-Clinical	Equivalence in design, materials, construction, and functional parameters to the predicate device for the new anatomical location.	The Flexitouch® system has the same technological characteristics (design, materials, construction, controller design, weight, electrical requirements, enclosure material, manifold assembly, user interface, software concern level, software/hardware, chambers, pressure range, inflation time, output, inflatable garments material, port material, garment connectors, sterility) as the predicate device. Non-clinical testing (software verification and validation, garment inflation/deflation, garment pressure withstand testing) verified that safety and performance met pre-specified criteria and is substantially equivalent.
Clinical Efficacy	Reduction in head/neck lymphedema.	A majority of subjects experienced a decrease in facial composite score.
Clinical Safety	Device use in head and neck does not cause harm. Absence of adverse events.	The study confirmed that use of the device in the head and neck location does not cause harm. Adverse events related to the device safety profile were monitored. The benefit-risk profile is favorable.
Usability/Comfort	Ease of application, garment fit, garment comfort.	A majority of subjects were able to don and doff the device by the second attempt and reported that the garment was very/somewhat comfortable.

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

Sample Size for the Clinical Study (Test Set): Not explicitly stated, but described as a "single-arm, single-center study."
Data Provenance: Prospective, single-center study. The country of origin is not specified but given the FDA submission, it's typically a U.S.-based study or studies conducted under FDA guidelines.

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

The document does not mention the use of experts to establish "ground truth" for the clinical study directly. The assessment of lymphedema reduction (facial composite score) and adverse events would typically be performed by the medical professionals conducting the study. No specific number or qualifications of clinicians involved in assessing outcomes are provided beyond the study being supervised by "medical professionals."

4. Adjudication Method for the Test Set

Not applicable. This was a single-arm study evaluating the device's performance, not a comparative study requiring adjudication of diagnostic interpretations.

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 therapeutic system (compression therapy for lymphedema), not an AI-based diagnostic image analysis tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant to this submission.

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

Not applicable. The Flexitouch system is a physical medical device (pneumatic compression system) with software to control its operation, not a standalone algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the clinical study, the "ground truth" for efficacy was based on outcomes data, specifically:

Reduction in head/neck lymphedema (measured by "facial composite score").
Patient-reported comfort and ease of use.
Monitoring of device-related adverse events.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/Machine Learning algorithm that requires a separate training set. The software mentioned would have undergone typical software verification and validation, not model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, this is not an AI/ML device requiring a training set with established ground truth.

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