(88 days)
Leg Massager RF-ALM070 is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
Leg Massager RF-ALM070 is consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor.
Leg Massager RF-ALM070, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.
This FDA 510(k) summary for the Leg Massager RF-ALM070 (K222924) does not contain information about acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device.
The document is a substantial equivalence determination for a physical massager, not an AI/ML diagnostic or therapeutic device. Therefore, the questions related to AI/ML device performance (e.g., sample size for test set, expert ground truth, MRMC studies, standalone performance) are not applicable to the content provided.
Instead, the document details a comparison of the Leg Massager RF-ALM070 to a predicate device (Air Compression Therapy Device, K193354) to demonstrate substantial equivalence based on technological characteristics and non-clinical performance data.
Here's an analysis based on the available information, addressing the spirit of your request where possible given the device type:
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria
For the Leg Massager RF-ALM070, the "acceptance criteria" are implicitly defined by its substantial equivalence to the predicate device (Air Compression Therapy Device, K193354). The study proving the device meets these criteria is the comparison of its specifications and adherence to recognized standards with those of the predicate device.
The primary goal of this 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and meets relevant performance standards.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence comparison for a non-AI/ML device, the "acceptance criteria" are essentially the specifications and performance of the predicate device. The "reported device performance" is how the subject device matches or is similar to these.
Table: Comparison of Subject Device (Leg Massager RF-ALM070) to Predicate Device (Air Compression Therapy Device)
| Aspect | Predicate Device (K193354) Specification (Implicit Acceptance Criteria) | Subject Device (K222924) Reported Performance | Comparison / Rationale for Equivalence |
|---|---|---|---|
| Indications for Use | Temporary relief of minor muscle aches and pains; temporary increase in circulation to treated areas in people who are in good health. | Same | Same |
| Pressure Range | 0~240mmHg | 0~240mmHg | Same |
| Inflation Time | 3-30s | 3-30s | Same |
| Deflation Time | 1-5s | 1-5s | Same |
| Treatment Time | 20 minutes | 20 minutes | Same |
| Mode of Compression | Sequential / Peristaltic | Sequential | The subject device offers 6 work modes, which are described as similar to the predicate device's modes, with differences primarily in the inflatable order of chambers. The pressure range remains the same across modes, not raising adverse impact on safety and effectiveness. |
| Power Consumption | 12W | 7.2W | Similar. (Difference is minor and likely acceptable as lower power consumption is generally not a safety/effectiveness concern for this type of device, provided function is maintained). |
| Number of Chambers | 3 | 3 | Same |
| Safety Feature | Button to stop or pause therapy session at any time | Button to stop or pause therapy session at any time | Same |
| Standards Adhered To | ES 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, IEC 60601-1-11 | ES 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, IEC 60601-1-11 | The subject device meets all applicable technical requirements of these standards, demonstrating electrical safety, EMC compatibility, and biocompatibility, mirroring the predicate device's compliance. |
| Performance Testing | Not applicable (Clinical/Animal) | Not applicable (Clinical/Animal) | Both predicate and subject devices did not require clinical or animal performance testing for their 510(k) clearances, indicating that non-clinical data (such as engineering and comparative testing) was sufficient to demonstrate safety and effectiveness for this device type. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document explicitly states "Performance Testing - Clinical: Not Applicable" and "Performance Testing - Animal: Not Applicable." The demonstration of substantial equivalence relies on comparison of design specifications, technological characteristics, and adherence to recognized electrical and biocompatibility standards, rather than clinical or animal test data. No "test set" of patient data was used.
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. This pertains to AI/ML device validation with expert-annotated data, which is not relevant for this physical massager.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This pertains to AI/ML device validation with expert-annotated data, which is not relevant for this physical massager.
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 pertains to AI/ML device validation with human-in-the-loop studies, which is not relevant for this physical massager.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This pertains to AI/ML device validation, which is not relevant for this physical massager.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, ground truth as understood in AI/ML validation (e.g., disease presence/absence) is not established in the same manner. The "ground truth" for the non-clinical performance aspects would be objective measurements (e.g., pressure output, timing, electrical safety parameters) compared against specified engineering requirements and recognized standards.
8. The sample size for the training set
Not applicable. There is no AI/ML component described which would require a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML component described which would require a training set or its associated ground truth establishment.
In summary, the provided FDA document is for a non-AI/ML medical device. The "study" for demonstrating acceptance criteria is a comprehensive comparison of the device's technical specifications and compliance with safety standards against those of a legally marketed predicate device. The detailed questions about AI/ML performance testing are not applicable in this context.
§ 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).