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The Nimbl system is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions: - Chronic edema - Lymphedema - Venous insufficiency - Wound healing

The Nimbl system is a pneumatic compression device that delivers intermittent sequential compression treatment to affected extremities for lymphedema, chronic edema, venous insufficiency, and wound healing. This device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by the body. The Nimbl controller is used to inflate the connected garment chambers in a pre-programmed sequence from the distal end to the proximal end of the patient. The pressure gradient provides higher distal pressures. This creates a dynamic wave of therapy that directs fluid into the lymphatic capillaries while maintaining distal prevent distal backflow. The patient's healthcare provider determines what pressure setting is appropriate for the patient.

The provided text describes the 510(k) premarket notification for the Nimbl (model PD08-N1) pneumatic compression device. It establishes substantial equivalence to a predicate device (Entre, model PD08-U). The focus of this document is on the comparison of technological characteristics and performance testing to demonstrate similar safety and effectiveness.

Here's an analysis of the acceptance criteria and study data based on the provided text:

Important Note: The provided document is a 510(k) clearance letter and summary, not a detailed clinical study report for an AI/ML medical device. Therefore, many of the requested details regarding AI/ML-specific study design (e.g., number of experts for ground truth, MRMC studies, training set details) are not applicable or not present in this type of submission for a pneumatic compression device. Wearable/Pneumatic Compression devices typically rely on bench testing, electrical safety, software V&V, and usability testing to demonstrate equivalence, rather than large-scale clinical studies with AI components that require expert consensus on image interpretation or similar.

Key Findings from the Document:

The Nimbl device is a pneumatic compression device, not an AI/ML-driven diagnostic or interpretative system. The "Performance Data" section lists types of testing completed, which are typical for hardware devices:

• Electrical safety and electromagnetic compatibility (EMC) testing
• Software verification and validation (including cybersecurity)
• Mechanical bench testing (pressure verification, port strength, component life testing)
• Usability testing
• Environment and distribution testing

The document repeatedly emphasizes that the subject and predicate devices utilize "the same fundamental technology, mode of action, and principles of operation." The "Software-Concern Level" is listed as "Basic Documentation Level" for the Nimbl, although it notes "Moderate Level of Concern" for the predicate with "Minor software updates have been made." This suggests the software functionality is not for complex interpretation or diagnosis.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this device (pneumatic compression) and the document provided, "acceptance criteria" is typically defined by adherence to relevant standards and demonstration of comparable performance to the predicate through bench and usability testing. Specific quantitative "device performance" metrics in the context of diagnostic accuracy (like sensitivity, specificity, AUC) are not relevant or provided here.

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

As this is a hardware device clearance, rather than an AI/ML diagnostic algorithm, there isn't a "test set" in the context of diagnostic accuracy. The testing performed involves bench testing (e.g., pressure verification, component life testing, port strength), electrical safety/EMC testing, software verification and validation, and usability testing. The sample sizes for these tests would typically be defined by engineering standards (e.g., number of units tested for durability, number of cycles, number of users for usability). These specific details (e.g., 'N' for specific bench tests) are not provided in this summary document, as they would be in the detailed testing reports submitted to the FDA.

Data Provenance: Not applicable in the context of clinical data for an AI/ML algorithm. The data provenance here refers to the origin of the device and testing, which is Tactile Medical. The testing is assumed to be conducted in a controlled lab/test environment. It is not listed as retrospective or prospective clinical data.

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

Not Applicable. This device does not generate medical diagnoses or interpretations that require expert human adjudication for "ground truth" establishment in the way AI/ML diagnostic devices do. The "performance" is mechanical and electrical, governed by engineering specifications and standards.

4. Adjudication Method for the Test Set

Not Applicable. See point 3 above.

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 is not an AI-assisted diagnostic tool for human readers.

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

Not Applicable. This is a hardware pneumatic compression device. While it has software, it does not perform standalone diagnostic interpretation.

7. The Type of Ground Truth Used

Device Ground Truth: The "ground truth" for this device's performance relies on engineering principles, validated test methods against specifications (e.g., pressure accuracy against a manometer, force against a load cell), compliance with international standards (IEC 60601-1, IEC 62304), and comparability to the predicate device’s established safe and effective performance. Clinical outcomes data for efficacy (treating edema, lymphedema, etc.) are established for the class of devices and the predicate, not newly proven by this 510(k) submission, which focuses on substantial equivalence.

8. The Sample Size for the Training Set

Not Applicable. This device does not have a "training set" in the context of machine learning.

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

Not Applicable. See point 8 above.

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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.

Ask a specific question about this device

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.

Ask a specific question about this device

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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