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The air compression leg massager is 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 air compression leg massager simulates kneading and stroking of tissues by using an inflatable garment.

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This document is an FDA clearance letter for a medical device called an "Air compression leg massager" (K240981).

Based on the provided text, the document does not contain information about acceptance criteria or supporting studies related to device performance.

The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls of the Act. It outlines regulatory requirements, such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. It also mentions other applicable regulations like the Quality System (QS) regulation.

Therefore, I cannot provide the requested information about acceptance criteria and study details because it is not present in the provided FDA clearance letter.

The letter focuses on the regulatory clearance process, not on the specific performance data or study results of the device.

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Air compression leg massager HY-1117A 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.

Air compression leg massager HY-1117A 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. Air compression leg massager HY-1117A, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.

The provided document is a 510(k) Pre-market Notification for a medical device called "Air compression leg massager HY-1117A". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study for a novel device. Therefore, the document does not describe:

• Specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy).
• A "study that proves the device meets the acceptance criteria" in the sense of a clinical trial or algorithm performance study.
• Sample sizes for test or training sets for an AI/algorithm.
• The number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Types of ground truth for an AI/algorithm.
• How ground truth for a training set was established.

Instead, the document focuses on demonstrating that the subject device is similar enough to a predicate device (Air Compression Therapy Device, K193354) by comparing their indications for use, technological characteristics, and conformance to recognized safety standards. The "Performance Testing - Clinical" and "Performance Testing - Animal" sections explicitly state "Not Applicable", indicating that no such studies were conducted for this submission.

The "acceptance criteria" in this context refer to meeting recognized safety and performance standards for a device of its class, and demonstrating substantial equivalence to a predicate device.

Here's a breakdown of what is provided, framed in the context of your request to the extent possible:

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

The document doesn't present "acceptance criteria" in a typical quantitative performance metric table. Instead, it compares the subject device's characteristics against those of a predicate device to demonstrate substantial equivalence. The "performance" is implicitly deemed acceptable if it is "substantially equivalent" to the predicate.

Study that proves the device meets the acceptance criteria:

The "study" to demonstrate acceptability in this 510(k) submission is a comparison to a predicate device (K193354) and conformance to recognized consensus standards. The document explicitly states "Performance Testing - Clinical" and "Performance Testing - Animal" are "Not Applicable". This means no new clinical trials or animal studies were conducted. The device's safety and effectiveness are supported by its substantial equivalence to the predicate device and demonstration of meeting fundamental electrical safety, electromagnetic compatibility, home healthcare environment requirements, and biocompatibility standards.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical or algorithmic performance test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical massager, not an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/algorithm context. The "ground truth" for this submission is that the predicate device is legally marketed and generally considered safe and effective for its intended use, and the subject device shares sufficient characteristics.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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