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The MedX 1000 Series is an infrared lamp, as per 21 CFR 890.5500. It emits energy to provide topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis. For use when heat is indicated for the treatment of the fore mentioned conditions.

MedX 1000 Series equipment consists of a console - (MBM 1050) and two different light emitting diodes (LED) accessories - (MCT 150 and MCT 600). The console unit supports the LED semiconductors and assembly, electronics, control panel and labels. The features of the accessories include energy emitted in the near infrared spectrum to provide therapeutic heating.

Here's an analysis of the provided text regarding the MedX 1000 Series device, focusing on acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the MedX 1000 Series is a therapeutic heating device intended for temporary relief of various musculoskeletal conditions. Its acceptance criteria appear to be rooted in demonstrating substantial equivalence to a predicate device, the LightForce Therapy Acubeam, rather than specific, quantified performance metrics for clinical efficacy.

Study Proving Device Meets Acceptance Criteria:

The "study" or justification for meeting acceptance criteria is primarily a substantial equivalence claim based on a comparison to the predicate device, the LightForce Therapy Acubeam (K001179).

Detailed Information about the "Study":

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

  • Sample Size for Test Set: Not applicable. There is no mention of a clinical trial test set for the MedX 1000 Series itself to establish efficacy through patient outcomes. The evaluation focuses on technical characteristics and safety testing of the device hardware.
  • Data Provenance: Not applicable for clinical efficacy data. The safety testing (mechanical, electrical, thermal, electromagnetic compatibility) would have been performed by MedX Health Corp. (Canada).

• 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)

  • Number of Experts & Qualifications: Not applicable. "Ground truth" in the sense of clinical diagnoses or outcomes established by experts for a test set is not present in this submission. The "ground truth" for the substantial equivalence claim would implicitly rely on the prior approval and established safety/efficacy of the predicate device, as determined by the FDA.

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

  • Adjudication Method: Not applicable. No test set requiring expert adjudication for clinical outcomes is described.

• 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

  • MRMC Study: No. This device is an infrared lamp, not an AI-assisted diagnostic tool.

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

  • Standalone Performance: Not applicable. This is a physical therapy device, not an algorithm.

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

  • Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and intended use of the legally marketed predicate device (LightForce Therapy Acubeam). The MedX 1000 Series aims to demonstrate it is substantially equivalent to this predicate. The relevant "ground truth" for its own performance is its compliance with safety standards and its ability to emit energy in the near-infrared spectrum for topical heating.

• 8. The sample size for the training set

  • Sample Size for Training Set: Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.

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

  • Ground Truth for Training Set: Not applicable.

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