(361 days)
POWER RECOVERY is intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER RECOVERY simulates kneading and stroking of tissues by using an inflatable garment (cuff).
Compressible Limb and Circulation Therapy System Model POWER RECOVERY is a powered inflatable tube massager, and comprised of a main body, an AC-DC adapter, cuffs with hose, and a hose adapter and a main hose for connecting the device to the cuffs. The device is powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery. There are three cuffs to apply to different body areas, such as leg, arm, and hip. Leg cuff and arm cuff have 6-chambers and hip cuff has 5-chambers. The cuffs can be inflating and deflating sequentially to apply the pressure on the target body areas which are controlled by the main body. The device simulates kneading and stroking of tissues by using an inflatable garment (cuff) to temporarily relieve minor muscle aches and pains and to temporarily increase blood circulation to the tested areas in people who are in good health.
The provided text describes a 510(k) premarket notification for the "Compressible Limb and Circulation Therapy System, Model POWER RECOVERY" and its comparison to a predicate device, the "Rapid Reboot Compression Therapy System."
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1. Table of Acceptance Criteria and Reported Device Performance
This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technological characteristics. It does not present a table of specific acceptance criteria (e.g., minimum sensitivity/specificity thresholds) or quantitative performance metrics typically seen in studies evaluating the diagnostic or predictive accuracy of a device.
Instead, the "acceptance criteria" here are implicitly related to meeting safety and performance standards for a powered inflatable tube massager and having indications for use and technological features that are substantially equivalent to a legally marketed predicate device.
| Category | Acceptance Criteria (Implicit from 510(k) process and comparison) | Reported Device Performance (as presented) |
|---|---|---|
| Safety & Essential Performance Standards | Compliance with relevant medical electrical equipment and usability standards for safety and essential performance. | IEC 60601-1:2005+A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) |
| ANSVAAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R)2012 | ||
| IEC 60601-1-6 Edition 3.1 2013-10 (Medical electrical equipment - Part 1-6: General requirements for safety and essential performance - Collateral Standard: Usability) | ||
| IEC 60601-1-11 Edition 2.0 2015-01 (Medical electrical equipment - Part 1-11: General requirements for safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment) | ||
| ANSI/AAMI HA60601-1-11:2015 | ||
| IEC 60601-1-2 Edition 4.0 2014-02 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests) | ||
| IEC 62366-1 Edition 1.0 2015-02 (Medical device – Part 1: Application of usability engineering to medical devices) | ||
| IEC 62304 Edition 1.1 2015-06 (Medical device software - Software life cycle process) |
The device has been tested and met the requirements of these standards. |
| Indications for Use | Indications for use must be substantially equivalent to the predicate device. | POWER RECOVERY: "intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER RECOVERY simulates kneading and stroking of tissues by using an inflatable garment (cuff).
Predicate Device: "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 Rapid Reboot Compression Therapy System simulates kneading and stroking of tissues by using an inflatable garment."
Reported as "Identical." |
| Technological Characteristics | Key technological characteristics (operation mode, pressure range, cuffs, etc.) should not raise new questions of safety or effectiveness compared to the predicate. | Operation Mode: 5 modes (SEQUENTIAL, ADDITION, MASSAGE) vs. 2 (Sequential, Peristaltic). Massage mode of subject device is a combination of SEQUENTIAL and Addition modes, which are similar to predicate modes.
Pressure Range: 60-150 mmHg vs. 0-200 mmHg. Subject device has a smaller pressure range.
Number of Inflatable Appliance Segments: 6 or less for leg/arm, 5 or less for hip vs. 4. Subject device has more segments.
Sleeve and Chamber: Leg: 6-chambers, Arm: 6-chambers, Hip: 5-chambers vs. Leg: 4-chambers, Arm: 4-chambers, Hip: 4-chambers. Subject device has more chambers.
Power Source(s): 15 VDC via IEC 60601-1 compliant power supply (100-240 VAC input), Optional integrated rechargeable battery vs. 110VAC, 60Hz. Minor difference.
Weight: 2 kg including battery vs. 2.63 kg (5.8 pounds). Minor difference.
Dimensions: 114 x 141 x 245 mm vs. 25.4 x 16.51 x 12.7 cm (10" x 6.5" x 5"). Minor difference.
Treatment Time: User can select 10, 20, and 30 minutes vs. User determines therapy time, choose from 10, 20, or 30 minute session time, with option to add additional 10 minutes. Reported as "Identical."
Anatomical site: Identical.
Prescriptive or OTC: Identical (OTC).
Environment of Use: Identical. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical testing was performed." Therefore, there is no test set in the sense of a clinical trial or a dataset of patient cases. The evaluation relies entirely on non-clinical testing for standards compliance and a comparison of technical specifications to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as no clinical testing or test set involving expert ground truth existed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no clinical testing or test set involving expert ground truth existed.
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 physical therapeutic device (powered inflatable tube massager), not an AI-based diagnostic or imaging interpretation system. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical therapeutic device, not an algorithm, and does not operate in a standalone algorithmic capacity as would be understood in the context of AI or diagnostic software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of device (a massager), ground truth related to diagnostic accuracy is irrelevant. The "ground truth" for its safety and claimed physiological effects (e.g., temporary increase in blood circulation) would typically come from well-controlled clinical studies demonstrating these effects, but the document states "No clinical testing was performed." Instead, compliance with safety and performance standards and substantial equivalence to a predicate device with established safety and efficacy (for its limited indications) forms the basis of its clearance.
8. The sample size for the training set
Not applicable. The device is a physical therapeutic device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable for the reason stated above.
§ 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).