(43 days)
The TheraLight UV120-2 UVA / UVB Phototherapy System is indicated for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the System UVB channel is indicated for the treatment of leukoderma.
The TheraLight UV120-2 UVA / UVB Phototherapy System is a microprocessorcontrolled, high-intensity ultraviolet light source. The desired dose of UVA or UVB light is selected using controls on the System front panel. The System provides "targeted" phototherapy, whereby the specified dose of UVA or UVB light is delivered via a flexible Lightguide and Handpiece. The System delivers a homogenous UV light dose to a localized ¾" square patch of skin without exposure to neighboring, healthy tissues.
The provided text is a 510(k) summary for the TheraLight UV120-2 UVA / UVB Phototherapy System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a performance study against a specified ground truth.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) cannot be answered from the provided document as they are not included.
Here's a summary of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria with corresponding performance metrics. Instead, it states that "System performance data (UVB output spectra) is the same or very similar that for the claimed predicate devices." This implies that the acceptance criterion was likely substantial equivalence in its UVB output spectra to the predicate devices, rather than meeting specific quantifiable clinical performance thresholds.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantially equivalent UVB output spectra to predicate devices | "Same or very similar" UVB output spectra as predicate devices |
2. Sample size used for the test set and the data provenance:
Not applicable. No specific "test set" in the context of a clinical performance study is mentioned. The assessment was based on comparing device specifications, particularly UVB output spectra, with predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically understood for diagnostic or prognostic devices (e.g., expert consensus on images, pathology results) was not established. The comparison was against predicate device specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set 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:
No. This device is a phototherapy system, not an AI-assisted diagnostic or imaging device for which MRMC studies would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a phototherapy system, not an algorithm. Its performance is based on its physical output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" implicitly used for comparison was the UVB output spectra of the legally marketed predicate devices.
8. The sample size for the training set:
Not applicable. As this is not an AI/machine learning device, there is no concept of a "training set."
9. How the ground truth for the training set was established:
Not applicable.
§ 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.