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The Micro Health Systems, MHS MED LIGHT 1000 is a device which helps to temporarily increase local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains through the use of heat applied in a non-contact manner.

The Micro Health Systems, MHS MED LIGHT 1000 is a device which helps to temporarily increase local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains through the use of heat applied in a non-contact manner. Aiming means adjustable by users from the heat ceramic filament in which there is no hazard for contacting high temperature lamps. An adjustable timer control for safety functions is also incorporated into the MHS MED LIGHT 1000. The Micro Health System MHS MED LIGHT 1000 cooling method is related to temperature of the enclosure, and the enclosure, and the enclosure temperatures of the three devices listed in the comparison table are assured. According to the different wattages and the maximum temperatures, we also know the ceramic type lamp of the AP-2018 is more efficient that the other two lamps. The maximum temperatures for these three devices listed in the comparison table are above 100 degrees Fahrenheit, and can reach the intended results. The timer controls and the continuous intensity controls exist on the MHS MED LIGHT 1000. The user can control the timer function and intensity control the receiving heat amount, thus assuming the safety level.

This document is a 510(k) clearance letter from the FDA for a device called "MHS Med Light 1000". It states that the device is substantially equivalent to legally marketed predicate devices. This type of document, particularly one from 2002, does not typically contain detailed information about acceptance criteria or specific study designs in the way that currently submitted AI/ML device clearances do.

Therefore, for this specific document, I cannot provide the requested information because it is not present. The letter primarily focuses on regulatory clearance based on substantial equivalence to existing predicate devices, rather than presenting a performance study against predefined acceptance criteria.

Based on the provided document, the following information is not available:

1. A table of acceptance criteria and the reported device performance: This document does not specify acceptance criteria for quantitative performance metrics or report specific device performance data.
2. Sample sizes used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not relevant as this is not an AI/ML device and human reader studies are not discussed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: Not relevant.
9. How the ground truth for the training set was established: Not relevant.

What the document does state regarding device function and comparison:

• Indications For Use: The device temporarily increases local blood circulation and temporarily relieves minor muscle and joint aches and pains through non-contact heat application.
• Safety Features: Adjustable aiming, adjustable timer control for safety, and an enclosed ceramic filament to prevent contact with high-temperature lamps.
• Comparison Point: It mentions a "comparison table" (not provided in the document) which presumably compared the MHS Med Light 1000 to predicate devices.
• Temperature: It states that the maximum temperatures for the three devices listed in the comparison table are "above 100 degrees Fahrenheit, and can reach the intended results." It also notes the ceramic type lamp of a device called "AP-2018" is "more efficient than the other two lamps."
• User Control: Users can control the timer and intensity to manage the received heat amount, implying a safety level.

The document's primary purpose is to grant K021956 clearance based on substantial equivalence, not to detail a rigorous performance study.

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