(645 days)
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.
| Acceptance Criteria (Implicit for SE) | Reported Device Performance (Compliance/Comparison) |
|---|---|
| Electrical Safety (IEC 60601-1:2014) | Device met IEC 60601-1:2014 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. |
| Electromagnetic Compatibility (EMC – IEC 60601-1-2:2016) | Device met IEC 60601-1-2:2016 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. |
| Home Healthcare Environment Requirements (IEC 60601-1-11:2015) | Device met IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. |
| Biocompatibility (EN ISO 10993-5:2009 for Cytotoxicity) | Device met EN ISO 10993-5:2009 Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity. |
| Biocompatibility (EN ISO 10993-10:2010 for Irritation and Skin Sensitization) | Device met EN ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization. |
| Substantial Equivalence in Intended Use | The device's intended use ("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") is stated to be "Same as K182668 (Primary predicate) and K193354 (Secondary predicate)". |
| Substantial Equivalence in Principle of Operation, Technological Characteristics, and Safety/Effectiveness | The document concludes that the "subject device has same intended use and principle of operation, similar technological characteristics as that of predicate devices." It also states, "the differences between these parameters would not adversely impact the safety and effectiveness" and that the device "is at least as safe and effective as the all predicate devices and technologically comparable to the reference device and doesn't raise any new safety and/or effectiveness concerns." |
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.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).