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The Air Compression Massager is an air pressure massager intended to temporarily relieve minor muscle aches and or pains, and to temporarily increase circulation to the treated areas.

The Air Compression Massager is a medical device that utilizes the principle of air pressure to provide massage to the legs by inflating and deflating. It aims to provide temporary relief for minor muscle aches or pains while temporarily increasing circulation in treated areas. It consists of a sleeve, a main unit and a battery. It mimics manual kneading and stroking of tissues through the use of an inflatable pressure sleeve. The sleeve features 5 chambers designed for different body areas including the foot/ankle, calf, knee, lower quad and upper quad. Controlled by the main unit, it can be sequentially inflated and deflated to apply circulating pressure on targeted body areas. The main component materials of the sleeve are Nylon cloth, thermoplastic polyurethane (TPU). It is available in four sizes: XL (Extra large), L (large), M (medium) and S (small). We offer four models of main unit, ACM-A1, ACM-A2, ACM-A3 and ACM-A4.The main unit is made of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS). It is the integrated control center that is responsible for starting and stopping treatments, regulating pressure, and mode selection to ensure a precise and safe treatment process. The user interface is a series of buttons showing battery level, pressure level, mode adjustment. The user interface provides for: Starting and stopping the massage treatment; Adjusting intensity (pressure) of the treatment; Select the treatment mode. The air compression massager is charged using® an external compliant power supply as well as powered by an internal IEC 62133-2 compliant lithium-ion battery. All four models of the Air Compression Massager are available with 800mAh, 1000mAh and 2000mAh batteries. In addition, the devices have Bluetooth capability that allows the use of a Mobile app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.

This document is a 510(k) summary for the Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4). It does not contain information about a study that proves the device meets specific acceptance criteria in the context of clinical performance or effectiveness for the stated indications.

The document focuses on demonstrating substantial equivalence to a predicate device (Normatec Elite, K240122) based on technological characteristics, intended use, and conformance to recognized safety and performance standards. It does not present a clinical study with an acceptance criteria table, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's a breakdown of the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria for clinical performance or a direct comparison of the device's performance against such criteria. Instead, it lists standards the device has met, which serve as performance requirements in a different context (safety, electromagnetic compatibility, biocompatibility).

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. The document does not describe a clinical test set or study of this nature. The testing mentioned is bench testing and conformance 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. No clinical test set requiring expert ground truth is described.

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

Not applicable. No clinical test set is described.

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 an air compression massager, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

Not applicable. This is not an algorithm-only device.

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

Not applicable. No clinical study with ground truth is described. The "ground truth" for the engineering and safety tests would be the established specifications and regulatory standards.

8. The sample size for the training set

Not applicable. The device is not an AI/Machine Learning device that requires a training set.

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

Not applicable. No training set is involved.

Summary of what is provided:

The document states that the Air Compression Massager was tested for various performance characteristics and met the requirements of several international standards related to medical electrical equipment safety, electromagnetic compatibility, home healthcare environments, wireless coexistence, and biocompatibility. Additionally, specific bench testing for pressure accuracy, seam strength, and failure mode verification for over-pressurization risk due to software failure was conducted. These tests are presented as evidence that the device is as safe and effective as the predicate device and thus substantially equivalent. However, these are primarily engineering and safety tests, not clinical performance studies to assess the "temporary relief of minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas" against specific clinical acceptance criteria.

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