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LC Therapy, Model LCT-1000 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.

LC Therapy, Model LCT-1000 Laser is a compact medical laser system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight wand. Activation occurs when the operator enables the laser and presses the foot switch. Release the foot switch to deactivate the laser. Depending on laser system configuration, the foot 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.

The provided document is a 510(k) summary for the LiteCure, LLC. LCT-1000 laser, and it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic accuracy studies.

This summary is focused on demonstrating substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, contraindications, warnings, and cautions, and lists the technological characteristics, including compliance with voluntary consensus standards.

Therefore, I cannot extract the requested information regarding:

1. Table of acceptance criteria and reported device performance: This document does not establish performance criteria in terms of sensitivity, specificity, accuracy, or similar metrics typically seen for diagnostic or AI/ML devices.
2. Sample size used for the test set and data provenance: No such test set or related data is mentioned.
3. Number of experts used to establish ground truth and qualifications: Not applicable as there's no diagnostic performance study involving expert review.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable, as this is a physical medical device (laser system), not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The document states: "According to non-clinical testing, the Litecure LCT 1000 system has the same intended uses, functional and performance characteristics as the predicate devices listed. The testing demonstrated compliance to the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Food and Drug Administration." This indicates non-clinical testing related to therapeutic heat performance but does not provide details on specific acceptance criteria or study methodologies that would fit the requested format, especially concerning AI/ML evaluation.

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