(15 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.
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 ¼'' square patch of skin without exposure to neighboring, healthy tissues.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the TheraLight UV120-2 UVA/UVB Phototherapy System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| UVA Spectral Output: 330-380nm | TheraLight System emits UVA within spectral band of 330-380nm |
| UVB Spectral Output: 290-330nm | TheraLight System emits UVB within spectral band of 290-330nm |
| Safety and Effectiveness (implied): | "similar to spectra emitted by predicate devices" (for UVB) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not mention a test set sample size in the traditional sense of a clinical or performance study with patient data. The "Performance Data" section focuses on instrumental verification of spectral output.
- Test Set Sample Size: Not applicable/Not specified in the provided document for clinical performance. The "test" here refers to device characterization.
- Data Provenance: The document does not provide details on the origin of data for spectral output measurements (e.g., country of origin, retrospective/prospective). It simply states that "Performance data were submitted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or not provided. Since the device performance data described is related to spectral output measurements, there isn't a need for expert-established ground truth in the context of clinical outcomes or diagnostic accuracy. The ground truth for spectral output would be established by calibrated measurement instruments.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. As explained above, the "test set" in this context refers to instrumental measurements, not a set of clinical cases requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance
- No, an MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable. The device is a phototherapy system, not an AI-assisted diagnostic or interpretative tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in a way, a standalone performance was done for the device itself. The performance data section describes the inherent spectral output of the device (UVA and UVB bands) without human intervention in its operation or interpretation for this specific performance metric.
- However, this is not in the context of an "algorithm only" performance as would be relevant for an AI device. It's a statement of the physical characteristics of the light emitted by the device.
7. The Type of Ground Truth Used
The ground truth used for the "Performance Data" is instrumental measurement of spectral output. This involves comparing the device's emitted wavelengths against a defined range (e.g., 330-380nm for UVA, 290-330nm for UVB). This is based on established physics and measurement standards, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable or not provided. The device is a physical light therapy system, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided as there is no training set for a phototherapy device of this nature.
§ 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.