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The Flexitouch Plus Systems and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in 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
• Lipedema
• Phlebolymphedema

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 Plus System is an advanced pneumatic compression device clinically proven to stimulate the lymphatic system. The device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by your body. Flexitouch Plus garment chambers inflate sequentially with each chamber inflating before the adjacent distal chamber fully deflates. This creates a dynamic wave of therapy that directs fluid into the lymphatic capillaries while maintaining distal pressure to prevent distal backflow.

The provided text is a 510(k) summary for the Flexitouch Plus System. It primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the removal of a cancer contraindication. The document explicitly states that no testing was necessary to support substantial equivalence for the Flexitouch Plus system with the cancer contraindication removed.

Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria. The submission relies on the existing safety and performance data of the previously cleared primary predicate device (Flexitouch System PD32-G3, K170216).

Here's a breakdown of why the requested information cannot be provided from this document:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission asserts that no new testing was needed because the technological characteristics are the same as the primary predicate device, and the only significant change (removal of a contraindication) aligns with a secondary predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no new testing was performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no new testing was performed for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no new testing was performed for this submission.
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 pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a pneumatic compression pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no new testing was performed for this submission.
8. The sample size for the training set: Not applicable, as no new testing was performed for this submission.
9. How the ground truth for the training set was established: Not applicable, as no new testing was performed for this submission.

In summary, the 510(k) submission for the Flexitouch Plus System PD32-G3 (K203178) does not describe any new studies or testing to establish acceptance criteria or demonstrate performance. It relies on the substantial equivalence principle, stating that the device has the same technological characteristics as its primary predicate and aligns with a secondary predicate regarding the removed contraindication.

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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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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.

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.

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.

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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