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The Biolight Biodynam Device is a portable instrument intended to provide infrared light therapy to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue. The Biolight Biodynam consists of a hand unit with diodes that delivers the light therapy in accordance with pre-programmed treatments.

The Biolight Biodynam consists of a hand unit with diodes that delivers the light therapy in accordance with pre-programmed treatments.

This is an FDA Premarket Notification (510(k)) K130866 for the Biolight Biodynam device, an infrared lamp. This document primarily focuses on the substantial equivalence determination and regulatory compliance, and as such, it does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a specific study proving device performance.

Here's what can be extracted and what cannot:

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

• Not available in this document. This 510(k) summary only states that the device provides "topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue." It does not provide quantitative acceptance criteria (e.g., specific temperature ranges, pain reduction scales, or timeframes) or direct performance data from a clinical study to meet those criteria.

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

• Not available in this document. This document does not describe a clinical study or a test set.

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 available in this document. This document does not describe a clinical study or the establishment of ground truth by experts.

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

• Not available in this document. This document does not describe a clinical study or an adjudication method.

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 and not available in this document. The Biolight Biodynam is an infrared lamp for pain relief, not an AI-assisted diagnostic device that would involve human readers or MRMC studies.

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

• Not applicable and not available in this document. As an infrared lamp, this device does not involve an algorithm with standalone performance.

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

• Not available in this document. This document does not describe a clinical study or the type of ground truth used.

8. The sample size for the training set:

• Not applicable and not available in this document. This document describes a medical device (infrared lamp), not an algorithm that would require a training set.

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

• Not applicable and not available in this document. This document describes a medical device (infrared lamp), not an algorithm that would require a training set with established ground truth.

In summary: This 510(k) document is a regulatory approval letter based on "substantial equivalence" to a predicate device. It primarily addresses the device's indications for use and regulatory classification, not the detailed performance data or clinical study results that would be required to answer most of your questions. To obtain such information, one would typically need to review the specific clinical trials or performance studies submitted by the manufacturer to the FDA, which are generally not part of the publicly available 510(k) decision letter itself.

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