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The WS(TM) Far-Infrared Therapy Unit, Model: KP-B210, may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains.

The WSTM Far-Infrared Therapy Unit, Model: KP-B210, is an infrared heating system which delivers 3~25 um Far-infrared energy through Far Infrared (FIR) radiation plate. The device is a non-invasive physiology therapy device and emits topical heat to the human forearm and upper arm for therapeutic applications without direct contact. The model, KP-B210 is a single object without additional assembly which contains an emitter, a user control panel, a power switch and safety distance reminder.

This document pertains to a 510(k) premarket notification for a medical device (WSTM Far-Infrared Therapy Unit, Model: KP-B210) and does not describe a study involving an algorithm's performance, human readers, or ground truth establishment in the context of AI. Therefore, I cannot extract the requested information.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (electrical safety, EMC, spectrum, functional certification, usability, and temperature safety tests) and comparing technical specifications. No clinical test data was used to support the decision of substantial equivalence, and there is no mention of an algorithm or AI.

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The WS™ THERAPY UNITS, TY-101N and TY-101F, may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The WS™ THERAPY UNIT (Model # TY-101 series), is an infrared heating system which emits topical heat to the human body for therapeutic applications. It consists of an IR emitter (Emission spectrum ranges from 3 ~ 25 microns.), a control box, a supporting arm to allow for adjustment of the emitter locations, and a protection net or the emitter to prevent fire or direct touch by the user. The entire unit is mounted on base that is easy to move. The device uses 110 Vac as power source. it meets the related requirement of IEC 60601-1 Electrical Safety.

This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided 510(k) summary for the WS™ THERAPY UNIT (Model # TY-101 series).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not contain information about a specific "test set" in the context of clinical performance or data analysis. The evaluation relies on:

• Conformance to recognized standards (IEC 60601-1, IEC 60601-1-2) which are typically assessed through bench testing and documentation.
• A comparison to a predicate device based on intended use and technological characteristics, supported by bench testing.

Therefore, there is no mention of a "test set" in terms of patient data, sample size, or data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable or available from the provided text. As noted above, there's no mention of a clinical "test set" and subsequently no need for expert ground truth establishment for such a set.

4. Adjudication Method for the Test Set

This information is not applicable or available from the provided text, as there is no described clinical "test set" that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or indicated in the provided 510(k) summary. The device is evaluated primarily through compliance with standards and substantial equivalence to a predicate device based on its intended use and technological characteristics ("bench testing").

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This is not applicable. The WS™ THERAPY UNIT is an infrared heating device, not an AI/algorithm-driven diagnostic or treatment system. Its performance isn't measured in terms of an algorithm operating "standalone."

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic device evaluation (e.g., pathology, outcomes data) is not applicable here. The device's "truth" or effectiveness is established through its compliance with safety and performance standards relevant to infrared heating lamps, and its substantial equivalence to a predicate device. The performance claims (e.g., "temporary relief of minor muscle and joint pain") are based on the established effectiveness of the device type, not on a specific clinical study with a defined "ground truth" for this particular submission.

8. Sample Size for the Training Set

This information is not applicable or available from the provided text. The device is not an AI/machine learning product that would have a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or available from the provided text, as the device is not an AI/machine learning product requiring a "training set" with ground truth.

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