(182 days)
Sec. 878.4630, Ultraviolet lamp for dermatologic disorders - to provide ultraviolet (UVB) radiation of the body to photoactivate a drug in the treatment of dermatologic disorders.
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This document is a 510(k) clearance letter from the FDA for a medical device called UVBioTek 3200B / 4000B, an ultraviolet lamp for dermatologic disorders. This type of document does not contain information about acceptance criteria, study designs, or performance metrics in the way a clinical study report or a premarket approval (PMA) application would.
The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy or safety through new clinical studies. Therefore, the detailed information requested in your prompt (acceptance criteria, study design, sample sizes, expert qualifications, etc.) is not present in this document.
Here's why and what can be inferred:
- Acceptance Criteria and Reported Device Performance: Not applicable and not present. A 510(k) submission generally compares technical specifications and potentially safety data to a predicate, rather than setting and reporting against specific performance acceptance criteria from a new clinical study.
- Sample size for test set and data provenance: No new test set or clinical study data is reported here. The substantial equivalence is based on comparison to an existing predicate.
- Number of experts and qualifications, adjudication method: Not applicable as no new clinical study requiring expert review is described.
- MRMC comparative effectiveness study: Not mentioned and highly unlikely for a 510(k) for this type of device.
- Standalone performance: Not applicable in the context of this 510(k) summary.
- Type of ground truth used: Not applicable as there's no new data being generated through a study requiring ground truth establishment.
- Sample size for training set: Not applicable as this is not an AI/machine learning device requiring a training set in the conventional sense.
- How ground truth for training set was established: Not applicable for the same reason as above.
In summary, this document is a regulatory approval based on demonstrating substantial equivalence to a predicate device, not a report of a study proving a device meets specific performance criteria through new data.
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.