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Leg Massager (Models:RP-ALM070H, RP-ALM071H) 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 (Models:RP-ALM070H, RP-ALM071H) 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 (Models:RP-ALM070H, RP-ALM071H), in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.

Here's an analysis of the provided FDA 510(k) summary, specifically addressing acceptance criteria and study information related to the device.

Key Observation: The document describes a traditional medical device (Leg Massager) and an application for substantial equivalence based on a comparison to predicate devices, not an AI/ML-powered device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this type of submission. This document focuses on demonstrating substantial equivalence through technical specifications, indications for use, and adherence to recognized standards, rather than clinical performance based on AI/ML algorithms.

Acceptance Criteria and Device Performance (Not Applicable - Traditional Device)

Since this is a traditional medical device submission for a Leg Massager (Models: RP-ALM070H, RP-ALM071H) and not an AI/ML-powered device, the concept of "acceptance criteria" and "reported device performance" in the context of an algorithm's diagnostic accuracy is not directly applicable.

Instead, the submission demonstrates substantial equivalence by showing that the device meets the same indications for use and has similar technological characteristics to existing legally marketed predicate devices, and that it complies with recognized safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Summary of Study:

The study presented in this 510(k) submission is a comparison study to demonstrate substantial equivalence to legally marketed predicate devices. It is not a clinical trial evaluating the device's efficacy or an AI/ML performance study. The "study" involves a detailed comparison of the subject device's (Leg Massager Models: RP-ALM070H, RP-ALM071H) indications for use, technological characteristics, safety features, performance specifications, and adherence to recognized electrical and biocompatibility standards against two predicate devices:

1. Shenzhen Dongjilian Electronics Co., Ltd. - Air Compression Therapy Device (K193354)
2. Medella Health Limited - FLOWpresso (K223729)

The core methodology is a side-by-side comparison table (Table 6A and 6B) detailing each characteristic and providing a "Differences Discussion" to justify why any minor differences do not raise new questions of safety or effectiveness.

Detailed breakdown of requested information:

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 is not an AI/ML performance study with a test set of data. The submission relies on a comparison of technical specifications and adherence to standards.

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. Ground truth establishment by experts is relevant for diagnostic accuracy studies, typically involving AI/ML. This submission is for a physical medical device.

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

• Not applicable. No test set or expert adjudication is involved in this type of 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 is a physical device, not an AI/ML-powered diagnostic aid involving human readers.

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

• Not applicable. There is no algorithm for standalone performance in this device.

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

• Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their FDA clearance and compliance with recognized consensus standards (e.g., IEC 60601-1, ISO 10993).

8. The sample size for the training set

• Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

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

Conclusion from the document:
The FDA's decision to clear the device (K232965) indicates that based on the provided comparison and adherence to standards, the Leg Massager (Models: RP-ALM070H, RP-ALM071H) is considered substantially equivalent to the predicate devices and is deemed as safe, effective, and performs as well. The acceptance is based on alignment of functional characteristics, intended use, and compliance with general safety and performance standards.

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