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The MB System is a device that emits energy in the infrared spectrum to provide temporary increase in local blood circulation, temporary relief of muscle pain, spasms and stiffness, temporary relief of minor pain and joint aches associated with arthritis, and relaxation of muscles.

The MB BioEnergy Light Therapy System provides easy to use front pancl controls and display for the operation of an array of infrared light emitting diodes that can apply topical heat to areas of the patient body. The user can set the frequency of oscillation, intensity level, and time of operation to control delivery of the radiation.

The provided text is a 510(k) Summary for the MB BioEnergy Light Therapy System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a standalone study with specific acceptance criteria and performance metrics.

Therefore, the study design elements typically associated with acceptance criteria and a detailed clinical study (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training/test sets) are not present in this document.

The document primarily states that the device: "has been tested to support compliance with industry standards, and therefore raises no new issues of safety or efficacy." This indicates compliance with general safety and performance standards for similar devices, rather than specific performance metrics against clinical acceptance criteria.

Here's an attempt to answer the request based on the absence of this information in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not applicable for this type of submission. There is no specific test set data provided for clinical performance evaluation.
• Data Provenance: Not applicable. The document does not describe a clinical study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. No ground truth establishment for a test set is described.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No test set or adjudication process 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 a light therapy system, not an AI-assisted diagnostic or therapeutic tool that would involve human readers.

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

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

7. The type of ground truth used

• Type of Ground Truth: Not applicable. Clinical ground truth for performance metrics is not described in this 510(k) summary. The "ground truth" for this submission is based on the established safety and efficacy of the predicate devices.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. There is no mention of a training set as this is not an AI/algorithm device requiring one.

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

• Ground Truth Establishment (Training Set): Not applicable.

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