(57 days)
The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.
The Enhanced AURORA™ Medical Diode system and related accessories is designed to allow a clinician to easily apply UVA or UVB light to the patient's affected skin. The clinician selects the desired treatment type (UVA or UVB light) and applies the light through the appropriate handpiece by pointing the exit aperture towards the affected skin area.
The device is comprised of four main components:
- A base station
- A touchscreen where the user can enter system commands
- Two handpieces connected to the base by power cables. One handpiece contains diode emitters that, when activated, emit UVA light. The other handpiece emits UVB light. Either handpiece will only operate if the appropriate wavelength is selected, so a user cannot accidentally activate the incorrect handpiece. Activation of energy occurs on depression of a trigger in the handpiece.
- A printer accessory that can print out verification of treatment parameters for hard copy records.
The document describes the acceptance criteria and study for the Enhanced AURORA™ Medical Diode system.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| UVA energy dosage output within 10% of user-selected power settings | Confirmed within 10% of user-selected power settings |
| UVB energy dosage output within 10% of user-selected power settings | Confirmed within 10% of user-selected power settings |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a 'test set' in the context of clinical data or patient samples. The performance data is based on bench testing only. Therefore, there is no sample size for a test set of patient data, nor is there information about data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance data is derived from bench testing of the device's output, not from expert interpretation of medical images or patient data requiring ground truth establishment by experts.
4. Adjudication method for the test set
Not applicable, as a test set requiring adjudication by experts (e.g., for diagnostic accuracy) was not conducted. The assessment was based on physical measurements during bench testing.
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. This device is a phototherapy system, not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a medical phototherapy system, not an algorithm. Its performance is assessed by its physical output characteristics during bench testing, not by an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance was the user-selected power settings, against which the actual UVA and UVB energy dosage output was measured. This is a technical performance measurement, not a clinical ground truth.
8. The sample size for the training set
Not applicable. This document describes a medical device for phototherapy, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, for the same reason as above.
§ 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.