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The Air Relax Pro Model AR-4.0 is intended for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax Pro Model AR-4.0 simulates kneading and stroking of tissues by using an inflatable garment.

This submission is for the Diode Art Engineering Air Relax Pro Model AR-4.0. The Air Relax Pro Model AR-4.0 is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health.

The device is a Class II, type BF applied part that receives power a separately approved external IEC 60601-1 compliant power supply or optional battery pack.

The Air Relax Pro Model AR-4.0 consists of an air compressor unit with a control system, an inflatable "garment" (arms, legs and hips), plastic air tubing with a proprietary connector for connecting the device to the garment. A description of each of these components is provided below. The hip garment is also referred to as "shorts".

The user interface is a front panel display and buttons.

The Air Relax Pro Model AR-4.0 contains an air compressor with a system control that that allows the user to adjust the amount of air coming from the air compressor and going to the individual segments of the inflatable garment.

There is no electrical contact with the user and the device does not transfer or detect energy to or from the user.

The user interface of the Air Relax Pro Model AR-4.0 provides for starting and stopping the massage treatment, allows for adjusting time and intensity (pressure) of the treatment. The device also provide a proprietary keyed connector to the tubing which connects to the garment. The tubing connector at the garment is also proprietary. The proprietary connectors ensure that neither the device, tubing nor garment can be misconnected to any other device or garment.

Pressure selection is performed by pressing pressure button multiple times. Pressure level is selectable between 40 and 170 mmHg

There are four modes (Progressive, Sequential, Drain and Overlay) that determine the inflation sequence of the cells within the garments.

The provided text is a 510(k) Summary for the Air Relax Pro Model AR-4.0, a powered inflatable tube massager. It focuses on demonstrating substantial equivalence to a predicate device (Air Relax Model AR-3.0) rather than providing detailed acceptance criteria and a study proving those criteria for a novel device.

Therefore, much of the requested information regarding detailed acceptance criteria for specific performance metrics and a dedicated study to prove these against novel criteria is not present in the provided document. The document primarily highlights the similarities to a predicate device and relies on compliance with general medical device standards.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria for the Air Relax Pro Model AR-4.0's performance in terms of its intended therapeutic effect (e.g., specific thresholds for "temporary relief of minor muscle aches" or "temporary increase in circulation").

Instead, the document establishes "acceptance" by demonstrating substantial equivalence to a predicate device (Air Relax Model AR-3.0) through a comparative table (page 5). The criteria for acceptance are implicitly that the new device is as safe and effective as the predicate, meaning any differences do not raise new safety or efficacy concerns.

Here's a summary of the comparative performance and specifications, which serve as the implicit "acceptance criteria" through equivalence:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states:

• "No animal testing was performed" (page 8)
• "No clinical testing was performed" (page 9)

This indicates that there was no specific test set of patient data used to prove the device's performance against clinical acceptance criteria. The evaluation was primarily based on:

• Engineering bench testing (controls, indicators, performance)
• Compliance with recognized electrical and medical device safety standards (AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11).
• Demonstration of substantial equivalence to a legally marketed predicate device.

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. Since no clinical test set was used, there was no need for experts to establish ground truth from patient data. The "ground truth" for substantial equivalence was established by the FDA's review process comparing the device to the predicate based on technical specifications and declared compliance with standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or human interpretation was involved that would require an adjudication method.

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 physical therapy massager, not an AI-assisted diagnostic or therapeutic tool that involves human readers or interpretation of medical images. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a physical therapy massager, not an algorithm or AI system.

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

For the purpose of this 510(k), the "ground truth" for demonstrating safety and effectiveness relies on:

• Established performance of the predicate device: The predicate (Air Relax Model AR-3.0) is already legally marketed and presumed safe and effective for its indications.
• Compliance with recognized industry standards: The device's adherence to standards like IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), and IEC 60601-1-11 (home healthcare environment) provides "ground truth" for its electrical and mechanical safety and basic performance characteristics.
• Bench testing: Verifying the function of controls, indicators, and overall performance through engineering tests.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

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The Air Relax Plus Model AR-3.0 is intended for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax Plus Model AR-3.0 simulates kneading and stroking of tissues by using an inflatable garment.

This submission is for the Diode Art Engineering Air Relax Plus Model AR-3.0. The Air Relax Plus Model AR-3.0 is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health.

The device is a Class II, type BF applied part that receives power from a separately approved external IEC 60601-1 compliant power supply or optional battery pack.

The Air Relax Plus Model AR-3.0 consists of an air compressor unit with a control system, an inflatable "garment" (arms, legs and hips), plastic air tubing with a proprietary connector for connecting the device to the garment A description of each of these components is provided below. The hip garment is also referred to as "shorts".

The user interface is a front panel display and buttons.

The Air Relax Plus Model AR-3.0 contains an air compressor with a system control that allows the user to adjust the amount of air coming from the air compressorand going to the individual segments of the inflatable garment.

There is no electrical contact with the user and the device does not transfer or detect energy to or from the user.

The user interface of the Air Relax Plus Model AR-3.0 provides for starting and stopping the massage treatment, allows for adjusting time and intensity (pressure) of the treatment. The device also provides a proprietary keyed connector to the tubing which connects to the garment. The tubing connector to the garment is also proprietary. The proprietary connectors ensure that neither the device, tubing nor garment can be misconnected to any other device or garment.

Pressure selection is performed by pressing pressure button multiple times. There are four pressure levels with approximate pressure levels as below:

Level 1: 60 mmHg Level 2: 100 mmHg Level 3: 140 mmHg Level 4: 170 mmHg

There are three modes (Progressive, Sequential, Full massage P, S and F) that determine the inflation sequence.

The provided text describes the 510(k) premarket notification for the Air Relax Plus Model AR-3.0, comparing it to a predicate device (Air Relax Model AR-1.0/AR-2.0, K191441) and another reference device (Rapid Reboot Compression Therapy System, K182668, inferred). The document focuses on demonstrating substantial equivalence for regulatory clearance rather than providing a detailed study proving the device meets specific acceptance criteria through clinical or performance metrics against pre-defined thresholds.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance are not applicable or not explicitly provided in this type of regulatory submission. The goal of a 510(k) is to show the new device is as safe and effective as a legally marketed predicate, not necessarily to prove absolute effectiveness against novel criteria with dedicated clinical trials.

The document primarily relies on bench testing and comparison to the predicate device's established safety and performance profile.

Here's a breakdown of the information that can be extracted, and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in the context of a 510(k) for a device like this is typically demonstrated by meeting recognized standards and by showing similar performance characteristics to the predicate device. Explicit quantitative acceptance criteria with numerical targets for clinical performance are not presented. Instead, the "acceptance criterion" is implicitly demonstrating that the new device is substantially equivalent to the predicate and complies with relevant safety standards.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size:
  • No clinical or animal testing was performed to generate a "test set" in the traditional sense for evaluating diagnostic or predictive performance.
  • Bench testing was done to verify controls, indicators, and performance, but the sample size (e.g., number of units tested, number of cycles) is not provided.
• Data Provenance: Not applicable, as no clinical/animal data was generated. Bench testing would be internal lab data.

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

• Not applicable. There was no clinical study requiring expert ground truth for a test set.

4. Adjudication method for the test set

• Not applicable. There was no clinical study requiring adjudication.

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. The device is a massager, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.

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

• Not applicable, as this is a physical medical device, not an algorithm.

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

• Not applicable. No ground truth in the clinical sense was required for this type of device and regulatory submission. The "ground truth" for proving substantial equivalence relies on documentation of design, materials, and bench test performance against established safety standards, and direct comparison to the predicate device.

8. The sample size for the training set

• Not applicable. No training set was used as this device does not involve machine learning or AI.

9. How the ground truth for the training set was established

• Not applicable. No training set was used.

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Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) simulates kneading and stroking of tissues by using an inflatable garment.

AR-1.0, AR-2.0is combined with leg, foot, garments. Leg garment has four air chambers operated by STEP3 controller and foot has one air chamber operated by STEP1. STEP3 controls a leg garment compressing sequentially in order of foot, calf and thigh and then injecting fresh air inside a leg garment through holes of garment to prevent from generating sweat by long wear of a garment.

The provided text is a 510(k) Summary for a medical device called "Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)". It is a submission to the FDA for market clearance, arguing for substantial equivalence to predicate devices.

Based on the provided text, the device did not undergo a clinical study or performance study to prove it meets specific acceptance criteria based on human or algorithm performance metrics. The submission argues for substantial equivalence based on non-clinical testing and comparison to legally marketed predicate devices.

Therefore, many of the requested items related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of performance metrics (like sensitivity, specificity, or human improvement with AI assistance) cannot be answered directly from this document because such a study was explicitly not performed.

Here's a breakdown of the information that can be extracted and an explanation of why other requested information is not present:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are related to demonstrating substantial equivalence through adherence to recognized standards for safety and electrical performance, and through a comparative analysis against predicate devices. The implicit acceptance criterion is that the device is "as safe and effective" as the legally marketed predicates.
• Reported Device Performance: The "performance" reported is primarily in terms of compliance with non-clinical standards and the comparison of technical specifications to predicate devices. No specific diagnostic accuracy or AI performance metrics are reported.

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. The document explicitly states: "No clinical study is included in this submission." Therefore, there is no "test set" in the sense of patient data for evaluating diagnostic or intervention performance. The "tests" mentioned are non-clinical (electrical safety, EMC, biocompatibility).

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 clinical study was performed, there was no test set requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical study or test set for performance evaluation was conducted.

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 "Powered Inflatable Tube Massager," not an AI-powered diagnostic or AI-assisted interpretation device. The submission explicitly states no clinical study was done, and therefore no MRMC study.

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

• Not applicable. This is a physical device (massager), not an algorithm or AI system.

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

• Not applicable. No clinical study or performance evaluation requiring ground truth data was performed. The "ground truth" for this submission are the established safety and performance standards (IEC, ISO) and the characteristics of the predicate devices.

8. The sample size for the training set

• Not applicable. This is a physical device, not a machine learning model. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

• Not applicable. As above, no training set.

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UAM-8100, UAM-8100N is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

UAM-8100, UAM-8100N is a system to improve the blood circulation of patients and User can use it personally under their doctor's indication and guidance. UAM-8100, UAM-8100N is combined with leg and foot garments. The leg garment has four air chambers operated by a controller. The leg garment is compressed sequentially in order of foot, calf, and thigh, and then fresh air is injected inside the leg garment through holes

The provided document is a 510(k) premarket notification decision letter from the FDA for the "Air Relax/Compressible Limb Sleeve System Model No. UAM-8100, UAM-8100N." This type of document is a regulatory approval, not a clinical study report.

Therefore, the information required to answer your questions about acceptance criteria and a study proving device performance (tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not present in this document.

This document primarily focuses on demonstrating substantial equivalence to a predicate device (K130385) based on non-clinical tests (biocompatibility, electrical safety, electromagnetic compatibility, and software verification/validation) and comparing design specifications. It does not detail clinical effectiveness studies with specific performance metrics or acceptance criteria for those metrics.

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