(71 days)
The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders. The 1-Series, equipped with PL-L36W /03 blue lamps, is indicated for the treatment of mild to moderate acne vulgaris
The 1 Series Unit is a partial-body phototherapy panel ultraviolet light source controlled by an integrated digital timer or a microprocessor controller. The operator interface consists of two main components: a LCD, and a Membrane with 4 buttons. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit ultraviolet light or blue light. The spectral output peaks at wavelengths of 305nm,311nm,350nm,365nm, or 420nm depending on lamp. The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders or blue light radiation for acne vulgaris.
This 510(k) summary for the Daavlin 1 Series Phototherapy Unit is a substantial equivalence submission, not a study demonstrating the device meets performance criteria in the way a clinical trial would for an AI algorithm. Instead, it argues that the new device is safe and effective because it is essentially the same as already legally marketed devices.
Therefore, many of your requested items (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) are not applicable (N/A) to this type of regulatory submission and device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Substantially Equivalent to Predicate Devices |
| - Intended Use | Same or similar |
| - Design Configuration | Same |
| - Energy Sources | Identical (UV or blue light lamps) |
| - Materials | Identical composition |
| - General/Specific Indications for Use | Same or similar |
| - Spectral Output | Same or similar |
| - Mode of Operation | Same or similar |
| - Labeling | Same or similar |
| - Treatment Area | Same or similar |
| - General Operating Principles | Same or similar |
| Performance Data | UV or blue light lamps and cabinet construction are similar to predicate devices. |
2. Sample size used for the test set and the data provenance
- N/A. This device approval is based on substantial equivalence to existing devices, not a test set and performance metrics derived from data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. Ground truth establishment for a test set is not relevant for this type of device submission.
4. Adjudication method for the test set
- N/A. Not applicable.
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
- N/A. This is a phototherapy unit, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an algorithm; it's a physical medical device.
7. The type of ground truth used
- N/A. Not applicable. The "ground truth" for this submission is that the predicate devices are already legally marketed and presumed safe and effective.
8. The sample size for the training set
- N/A. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- N/A. 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.