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Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Leg Massager (Model: EMK-701) is a portable and rechargeable device. lt is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.

Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled leg wraps actuated by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Handheld Controller. Function buttons and light emitting diode (LED) indicators on the Handheld Controller make up the user interface. There are 3 ports at the bottom of Handheld Controller for connecting the alternating current (AC) adapter plug and two air hoses.

Each leg wrap has an air hose for connection to Handheld Controller, and both encase a 2chamber air bladder inside. Feet and calves can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance.

In operation, the user turns the power on via the Power button. Then the Handheld Controller controls the inflating and deflating of the air bladders according to preset program parameters. The air pressure is monitored by an internal pressure sensor and microprocessor. Once the pressure of the air bladder reaches the proper level, the pump is turned off for a rest period. The cycle of inflation and deflation repeats until the unit is turned off.

The provided text is a 510(k) summary for the "Air Compression Leg Massager (model: EMK-701)," which is a medical device for temporary relief of muscle aches and improved circulation. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices through a comparison of technical specifications and performance testing. It does not describe a study that involves statistical acceptance criteria, human readers, or a clinical effectiveness study.

Based on the information provided, here's a breakdown of what is and isn't available:

1. A table of acceptance criteria and the reported device performance:

The document includes a "Test Summary" section that lists several international standards to which the device was evaluated for its safety and performance. However, it does not provide specific acceptance criteria values (e.g., "Pass/Fail" thresholds) or quantitative reported device performance results against those criteria. It merely states that the device "has been evaluated for its safety and performance by lab bench testing as following:" and then lists the standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document explicitly states: "No Clinical Test conducted." Therefore, there is no test set in the sense of patient data for a clinical study. The evaluations conducted were "lab bench testing" which typically refers to laboratory experiments on the device hardware and software, not human subjects.

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 test was conducted and no "ground truth" based on expert consensus was established for a test set.

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

Not applicable, as no clinical test was conducted and no "ground truth" based on expert consensus was established for a test set.

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 Leg Massager," not an AI-powered diagnostic or interpretive device that would involve human readers or AI assistance in the way an MRMC study would measure.

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

Not applicable, as this is a physical therapy device and not an AI algorithm.

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

Not applicable, as no clinical test involving patient data was conducted. The ground truth for the lab bench tests would be the specifications and requirements defined by the listed international standards themselves (e.g., "EMC emissions must be below X level," "biocompatibility tests must show no cytotoxicity").

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device that requires a training set of data.

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

Not applicable, as this is not an AI/machine learning device that requires a training set of data.

In summary:

The provided document is a regulatory submission for a medical device that relies on establishing substantial equivalence to predicate devices through technical comparisons and compliance with recognized safety and performance standards via lab bench testing. It does not involve clinical studies, AI algorithms, human readers, or the typical "acceptance criteria" and "study" framework associated with evaluating software-as-a-medical-device or AI-driven diagnostics. The "study" mentioned for demonstrating compliance refers to the series of lab tests against international standards, rather than a clinical trial with patient data and expert ground truth.

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The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:
-Temporary relief of minor muscle and joint pain stiffness
-Temporary relief of minor joint pain associated with arthritis
-Temporary increase in local circulation where applied

• Relaxation of muscles
  The Air Cell Massager (only CGM MB-1701) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas. The Air Cell Massager stimulates kneading of tissues by using an inflatable garment.

The Ceragem Automatic Thermal Massager with Air Cell Massager is an updated version of the predicate device with an addition of a leg massaging feature. This feature utilizes an "air compression transfer," and its principle is as follows: Air Cell Massager consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has 4 compression chambers. The compression massage direction is from foot to thigh. 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. Software controls the timing and pressure cognized to the sensor, cycling airflow into and out of sleeves to compress body.

The provided text is related to a 510(k) premarket notification for a medical device (Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702). It discusses the device's indications for use, description, and a comparison to predicate and reference devices to demonstrate substantial equivalence.

However, the document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies. The document specifically states "The subject device has undergone safety and performance tests, and the results conformed with the test requests," and lists several non-clinical tests (Skin Temperature Study, Usability Study, EMC and electrical safety testing, software validation, and Biocompatibility studies). These are general tests demonstrating safety and compatibility, not a study designed to evaluate performance against specific clinical acceptance criteria as typically seen for AI/ML devices.

Therefore, I cannot provide the requested information from the given text. The text does not detail a study proving the device meets specific performance acceptance criteria for clinical efficacy or accuracy in the way the prompt implies (e.g., for an AI/ML algorithm). The listed tests primarily focus on electrical safety, EMC, biocompatibility, software functionality, and user manual usability, which are safety and basic functional performance aspects, not clinical performance against acceptance criteria.

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