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810 nm and 980nm wavelength:

LiteCure Therapy System, Model L TS-1500 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

980nm wavelength:

LiteCure Therapy System, Model L TS-1500 is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Tmentagrophytes, and/or yeasts Candida albicans, etc.).

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The provided text focuses on the FDA's 510(k) clearance for the LiteCure Therapy System, Model LTS-1500. This is a regulatory document and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

Specifically, the document performs the following functions:

• Confirms 510(k) clearance: States that the device is substantially equivalent to a legally marketed predicate device.
• Lists device names and regulatory information: Provides the Trade/Device Name, Regulation Number, Regulation Name, and Regulatory Class.
• Defines Indications for Use: Specifies the medical conditions and purposes for which the device is intended (e.g., pain relief, increased local blood circulation, temporary increase of clear nail in onychomycosis).
• Provides regulatory guidance: Reminds the manufacturer of ongoing responsibilities under the Act.

The document does NOT contain any information about:

• Acceptance criteria: No specific metrics (e.g., sensitivity, specificity, accuracy, or a defined therapeutic outcome threshold) are mentioned.
• Device performance metrics: No reported performance data (e.g., how much pain relief was achieved, or the percentage increase in clear nail).
• Details of a study: No information on study design, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, based solely on the provided text, I cannot complete the table or answer the specific questions about the study that proves the device meets acceptance criteria. The FDA 510(k) clearance process primarily evaluates substantial equivalence to a predicate device, and while it requires evidence of safety and effectiveness, the detailed study results and acceptance criteria are typically found in the 510(k) submission itself (which is not provided here), rather than in the final clearance letter.

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LiteCure Therapy System, Model LTS-1500 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

LiteCure Therapy System, Model LTS-1500 is a compact medical laser system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight handpiece. Activation occurs when the operator enables the laser and presses the foot/finger switch. Depending on laser system configuration, the foot/finger switch can function as on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.

This 510(k) summary focuses on the LiteCure Therapy System, Model LTS-1500, which is an infrared lamp device. The documentation provided does not contain information about software performance or an AI/ML-driven device, so many of the requested categories about acceptance criteria, study design, and AI model performance will be not applicable or not mentioned based on the provided text.

Specifically, this submission is for a medical device that emits infrared energy for topical heating and pain relief, and its substantial equivalence is based on its physical characteristics and intended use, not on diagnostic accuracy or algorithmic performance.

Here's a breakdown of the requested information based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for LiteCure Therapy System, Model LTS-1500

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable / Not mentioned. This submission describes a physical medical laser device, not an AI/ML device that requires a test set for performance evaluation in the context of diagnostic or predictive accuracy. The substantial equivalence relies on comparison to predicate devices, compliance with standards, and demonstration of similar physical and operational characteristics.

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

• Not applicable / Not mentioned. As this is for a physical therapy device and not a diagnostic AI system, there is no "ground truth" to establish in the context of expert consensus on image interpretation or disease diagnosis.

4. Adjudication Method for the Test Set

• Not applicable / Not mentioned. There is no test set or adjudication method described for this type of device submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size

• Not applicable / Not mentioned. An MRMC study is relevant for diagnostic imaging interpretation devices, which this infrared therapy device is not.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable / Not mentioned. This device does not involve an algorithm for standalone performance.

7. The Type of Ground Truth Used

• Not applicable / Not mentioned. The concept of "ground truth" (e.g., pathology, outcomes data) as it applies to diagnostic or prognostic AI systems is not relevant to this infrared lamp device. The "truth" here relates to the device's physical output specifications, safety, and therapeutic effects, none of which are typically established by expert consensus on cases or pathology reports in this context.

8. The Sample Size for the Training Set

• Not applicable / Not mentioned. This device does not have a "training set" in the context of an AI/ML algorithm.

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

• Not applicable / Not mentioned. Correspondingly, there is no training set ground truth to establish for this type of medical device.

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