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The LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is a desk-top device used for the treatment of chronic pain by emitting energy in the near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is a high intensity lamp intended for various pain relief type applications by emitting light in the wavelength range 650-690nm (near-IR) with fluences of order 10-100mW/cm². The principle parts of the system comprise of a desktop base unit and a Fibre Optic Probe (FOP) delivery system. The base unit contains a mains supplied power supply unit which powers a 250W halogen bulb, the duration of the illumination being controlled by a timing pcb with user-accessible controls. The FOP delivery system comprises of a ruggedised fibre bundle assembly and (crucially) an optical filter which selectively transmits only the therapeutic near-IR light. A mechanical fixture is also optionally available for holding the output of the FOP delivery system at an adjustable distance and direction relative to the skin treatment area.

The provided text does not describe acceptance criteria for a device, nor does it detail a study that proves the device meets such criteria.

Instead, the documents are part of a 510(k) submission for the LumaCare LC-122M Non-coherent Light Source. This submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a direct study as might be done in a clinical trial.

Therefore, most of the requested information cannot be extracted from the provided text because it describes a different regulatory pathway (510(k) substantial equivalence) than what the questions are looking for (performance against acceptance criteria via a study).

However, I can extract information related to the device description and the basis of its FDA clearance:

1. A table of acceptance criteria and the reported device performance

• Not applicable. The document focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific acceptance criteria through a performance study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No test set or data provenance for a performance study is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No test set or ground truth established by experts is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set or adjudication method is mentioned.

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. No MRMC study or AI component is mentioned. This is a light therapy device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a hardware light therapy device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable. No ground truth for device performance is mentioned. The clearance is based on substantial equivalence to a predicate device.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is mentioned.

9. How the ground truth for the training set was established

• Not applicable. No training set or ground truth establishment is mentioned.

Information that can be extracted from the document related to the device submission:

• Predicate Device: Quantum WARP 10 Light Delivery System (K032229)
• Basis for Substantial Equivalence:
  • Same intended use.
  • Same general and specific indications for use.
  • Similar or same spectral output, mode of operation, and general operating principles.
  • Differences in method of light production and delivery do not raise new questions of safety or efficacy.
• Pre-clinical Testing Mentioned (for safety, not performance against criteria):
  • Electrical Performance Data: Safety and EMC testing, including requirements of IEC 60601-1:1988/A1/A2 and IEC 60601-1-2:2002.
• Date of Preparation of 510(k) Summary: 6th July 2007
• FDA Clearance Date: November 16, 2007 (as indicated by the letter)
• 510(k) Number: K072048

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