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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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The entré 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 entré model PD08-U system consists of two main components: A controller and a garment. The garment is to be wrapped around the affected extremity providing a snug yet comfortable fit. The garment will have eight (8) chambers that are filled with air by the controller to provide compression on the extremity. A harness assembly consisting of eight (8) individual tubes will connect individual chambers with the controller. The controller has an internal valve manifold with a directly connected single eight (8) port connector extension that is accessible to the user on the front panel allowing easy garment connection.

Here's a breakdown of the acceptance criteria and study information for the entré Model PD08-U, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details non-clinical performance testing. The "acceptance criteria" are implied by the statement "Pressure testing was performed to verify that the target pressures were met as stated in the device labeling" and similar wording for cycle time. The reported performance is that the device met these criteria.

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

The document does not specify a separate "test set" in the context of clinical trials or data for diagnostic performance. The testing described is non-clinical performance testing of the device's physical and electrical characteristics. Therefore, information about humans in a "test set" or data provenance (country of origin, retrospective/prospective) is not applicable to the studies reported here.

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

This information is also not applicable as the studies reported are non-clinical device performance tests, not clinical evaluations requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of clinical or diagnostic performance evaluation with expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, the document does not mention an MRMC comparative effectiveness study. The evaluation focused on comparing the technical characteristics of the entré Model PD08-U to predicate devices through non-clinical testing.

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

Not applicable. This device is a physical medical device (compressible limb sleeve system for therapeutic compression), not a diagnostic algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance testing was the engineering specifications and design requirements for the device, as well as the performance characteristics of the legally marketed predicate devices. Compliance with international safety and performance standards (e.g., IEC 60601-1, -1-2, -1-6, -1-11) also served as a "ground truth" for safety and usability.

8. The Sample Size for the Training Set

Not applicable. The device described is a physical medical device. There is no concept of a "training set" in the way it is used for machine learning algorithms.

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

Not applicable. See point 8.

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The ACTitouch™ Adaptive Compression Therapy system provides graduated compression in both sustained and intermittent settings for use in:

• Enhancing venous return .
• . Reducing venous leg ulcer healing time
• . Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
• Treatment of chronic venous insufficiency .
• Reducing edema due to venous stasis
• Treatment of lymphedema

The ACTitouch™ System applies compression to the leg (lower leg, ankle, and foot). It consists of four main parts:

• . The Compression Sleeve consists of four chambers that inflate with air to apply pressure to the leg. It's simple wrap-around design with hook and loop fasteners means the Compression Sleeve can be fitted to many differently shaped legs and can be applied and removed with ease.
• The Control Unit fits into the Compression Sleeve during device use. It monitors and . adjusts the air pressure to ensure the correct level of compression is applied to the leg.
• . The Undersock is designed to draw perspiration and moisture away from the skin and has padding in key areas to provide additional comfort.
• . The Power Adapter/Charger is used to power the device directly or to charge the battery for ambulatory use.

The device has two modes of operation: Sustained Compression Mode and Intermittent Pneumatic Compression Mode. Sustained Compression Mode enables the Control Unit to provide accurate and continuously monitored compression levels to the lower limb. Intermittent Pneumatic Compression Mode enables a programmed sequence of cyclical pressures to be applied to the lower limb.

The ACTitouch™ system features a compliance monitoring feature. An LCD screen is present on the Control Unit, which displays the number of hours the device has been operational in both Sustained Compression Mode and Intermittent Pneumatic Compression Mode.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for the ACTitouch™ Adaptive Compression Therapy system, focusing on its substantial equivalence to a predicate device (Jobst Institute Extremity Pump 7500, K882683).

While it describes the device, its intended use, and a comparison of technological characteristics, it explicitly states:

"No comparative testing has been performed between the ACTitouch™ system and Jobst Extremity Pump 7500, as per 807.92 (b) (1.2.3)."

This indicates that the submission relies on the substantial equivalence argument, rather than presenting new performance data against specific acceptance criteria for this device. Therefore, none of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) can be extracted from this document.

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The Flexitouch® system is intended for use by medical professionals and patients at home who are under medical supervision in treating many conditions such as:

• Primary lymphedema .
• Post mastectomy edema .
• Edema following trauma and sports issues .
• Post immobilization edema .
• Venous insufficiencies .
• Lymphedema .
• . Reducing wound healing time
• Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; . arterial and diabetic leg ulcers

The Flexitouch® system is a prescription pneumatic compression system consisting of a garment set and a pneumatic sequential controller. The garments are wrapped around the affected body regions so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide for low-level compression in the treated areas.

The provided text is a 510(k) summary for the Flexitouch® system. It outlines the device's characteristics and its comparison to a predicate device but does not contain information about acceptance criteria or a specific study designed to prove the device meets acceptance criteria in the format typically associated with diagnostic or AI/ML device validation.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device. This means the primary "study" is a comparison to an already legally marketed device, asserting that the new device is as safe and effective as the existing one.

Therefore, the following table and explanations are derived from the available information and will highlight the absence of certain requested details, as they are not typically part of a 510(k) summary for this type of device.

Acceptance Criteria and Device Performance

Study Details (Based on available 510(k) summary)

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not specified. The document refers to "Comparative performance testing and evaluation" but does not provide details on the number of devices, components, or clinical subjects involved in these tests. For a device like a pneumatic compression system, "performance testing" might involve bench testing or engineering verification rather than a traditional clinical test set of patient data.
   • Data provenance: Not specified. Given the nature of a 510(k) for a physical medical device, the "data" would likely originate from internal engineering and manufacturing tests. No information about country of origin, retrospective or prospective data is provided, as these terms are more relevant to clinical studies involving patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not applicable and not provided. The "ground truth" for this type of device is typically established by engineering specifications, safety standards, and functional requirements, rather than expert clinical consensus on a "test set" of patient data. Performance is assessed against these established technical benchmarks.

3. Adjudication method for the test set:

   • Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert readers resolve discrepancies in interpretations of medical images or diagnoses. This type of review is not relevant for the engineering and functional tests reported in this 510(k).

4. 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:

   • No. An MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Flexitouch® system is a pneumatic compression device, not a diagnostic AI tool, so this type of study is irrelevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This question is not applicable to the Flexitouch® system. It is a physical medical device, not an algorithm. The "software validation testing" mentioned would focus on the correct functioning of the embedded software within the device to control its pneumatic operations, not on its performance as a standalone interpretive algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" in this context is implicitly engineering specifications, international safety standards, and the validated performance of the predicate device. For example, "software validation testing" would compare the software's output to its design requirements. "Device performance testing" would compare the physical performance (e.g., pressure, cycle times) to specified ranges and the predicate device's performance.

7. The sample size for the training set:

   • Not applicable and not provided. This device does not use a "training set" in the machine learning sense. Its functionality is based on established engineering principles and control logic, not learned from data.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set, there is no ground truth established for it.

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The Flexitouch system is intended for use by medical professionals and patients who are under medical supervision, in treating many conditions such as:

• . Primary lymphedema
• Post mastectomy edema .
• . Edema following trauma and sports injuries
• . Post immobilization edema
• . Venous insufficiencies
• . Lymphedema.
• Reducing wound healing time .
• . Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers

The Flexitouch® System is a powered inflatable tube massager intended for medical purposes. The primary components of the System include a pneumatic sequential controller device that delivers air to garments with inflatable chambers to be worn over the patient's afflicted areas. The inflation and deflation of the chambers simulates kneading and stroking of the tissues with the hands in order to increase circulation.

I'm sorry, but this document does not contain the information requested. The document is a 510(k) summary for the Flexitouch® System, a powered inflatable tube massager. It primarily focuses on demonstrating substantial equivalence to predicate devices for expanding its indications for use.

The document does not include:

• A table of acceptance criteria and reported device performance.
• Details of any specific study (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods) used to prove the device meets acceptance criteria.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Sample sizes for training and test sets.

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The biotouch™ device is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as:

• Primary lymphedema
• Post mastectomy edema
• Edema following trauma and sport injuries
• Post immobilization edema
• Venous insufficiencies
• · Lymphedema.

The TSTI biotouch™ device is a microprocessor controlled pneumatic compression device that applies calibrated sequentially graduated pressure to the arm, leg, trunk, and/or chest. The device consists of two major components:

• lightweight, portable pneumatic controller, and .
• extremity garments composed of 4 to 16 chambers. .
  The controller is pre-programmed with thirteen separate treatment programs. which consists of pre-determined sequences and inflation times and should be used under medical supervision. The device is provided to the end-user in individual cartons to ensure safe shipping and arrival of the device.

This document is a 510(k) summary for the biotouch™ Massage Therapy System. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain acceptance criteria or a detailed study proving the device meets specific performance metrics.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document states "Performance testing was completed to verify the design specifications necessary for the biotouch™ device. Test results support the safety and performance of the biotouch™ device for its intended use," but no specific criteria or results are detailed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
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 provided. This type of device (a pneumatic compression system) typically doesn't involve "ground truth" derived from expert image interpretation in the same way an AI-driven diagnostic tool would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 a physical therapy device, not an AI-driven diagnostic or image analysis tool. There are no "readers" in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided, and likely not applicable in the way it would be for a diagnostic algorithm. Performance for such a device would typically relate to pressure accuracy, cycle timing, durability, and safety, not diagnostic ground truth.
8. The sample size for the training set: Not applicable. This is a hardware device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The document is a 510(k) submission summary for a physical medical device. It indicates that performance testing was completed and supports the safety and performance, but it does not provide any specific acceptance criteria, performance metrics, or details about the studies conducted. The submission focuses on demonstrating substantial equivalence to a predicate device based on intended use, design, materials, and construction, rather than presenting detailed performance study results against specific criteria.

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