(83 days)
The Resolve™ UVB Phototherapy System is an ultraviolet light emitting medical device indicated for phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. The Allux Medical Resolve™ UVB Phototherapy System is intended to be used with all Skin Types (I - VI).
The Resolve™ UVB Phototherapy System is designed to deliver therapeutic ultraviolet-B light to a localized area onto a patient's skin surface. This system is designed to be easy to operate and is intended to be used in an outpatient setting such as a dermatologist's office under supervision of trained medical personnel. The device is comprised of two distinct components. The first is a patient attached unit and the second is a medical grade power supply. The patient attached unit is small and lightweight and is intended to be held in place or affixed to a patient at the desired treatment site. A portion of one side of the patient attached unit is composed of a fused silica transparent window out of which ultraviolet light is emitted; this window surface is intended to make contact with and lay flush to the skin thus enabling a localized treatment. The patient attached unit houses an array of ultraviolet light emitting diodes (UV-LEDs) that serve as the therapeutic light source. Additionally, the drive and control circuitry necessary to operate the UV-LEDs, as well as a fan and heat sink to dissipate waste thermal energy, are located inside the patient attached unit's protective housing. Operator interface features include on-off switch and both visual and audible status indicators.
The Allux Medical Resolve™ UVB Phototherapy System is an ultraviolet light emitting medical device indicated for phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. It is intended for use with all Skin Types (I - VI).
Here's an analysis of the provided text regarding acceptance criteria and performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria for the Resolve™ UVB Phototherapy System in terms of efficacy for treating dermatological conditions. Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices.
However, the text mentions general performance aspects:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| UVB Emissions within Specification (for the device itself) | Performance data are included with the 510(k) to demonstrate that UVB emissions are within specification for the device. |
| UVB Spectra Similarity to Predicate Devices | Performance data demonstrate that UVB emissions "are the same or very similar to the spectra emitted by the predicate UVB devices." |
| Electrical Safety | Information to support electrical safety was included with the 510(k). |
| Electromagnetic Compatibility (EMC) | Information to support electromagnetic compatibility was included with the 510(k). |
| Biocompatibility | Information to support biocompatibility was included with the 510(k). |
| Functionality | Information to support functionality was included with the 510(k). |
| Safety and Effectiveness (comparable to predicate devices, no new questions raised) | The device "is judged to pose no new questions of safety and effectiveness when compared with devices that have been cleared." "This technological feature [LEDs] is not considered by Allux Medical to raise new questions of safety or efficacy." |
| Intended Use Equivalence (same as predicate devices) | The Resolve UVB Phototherapy System "has the same indications for use as those cleared for the claimed UVB predicate devices." |
| Technological Equivalence (similar technologies, despite LED light source) | "The Resolve device uses LEDs as a UVB light source. LEDs are used in other medical devices to provide light at spectra other than UVB. Since the Resolve UVB System... employs similar technologies..." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a clinical study with a "test set" in the context of dermatological efficacy for the Resolve™ UVB Phototherapy System. The submission relies on performance data related to the device itself (UVB emissions, electrical safety, etc.) and a claim of substantial equivalence to predicate devices.
There is no mention of a patient-based test set or data provenance (e.g., country of origin, retrospective/prospective). The "performance data" mentioned refers to engineering and technical evaluations of the device's physical properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since there is no described clinical study with a "test set" for diagnostic accuracy or treatment efficacy, there is no information about experts used to establish ground truth.
4. Adjudication Method
Not applicable, as no clinical study with a "test set" and ground truth establishment is described for the Resolve™ UVB Phototherapy System.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done comparing human readers with and without AI assistance. The device is a phototherapy system that directly treats patients, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study
The text describes a standalone performance evaluation in terms of the device's inherent characteristics. The "performance data" included with the 510(k) are:
- Demonstration that UVB emissions are within specification for the device.
- Confirmation that the UVB spectra are the same or very similar to predicate UVB devices.
- Information supporting electrical safety, electromagnetic compatibility, biocompatibility, and functionality.
This represents a standalone evaluation of the device's physical and operational attributes, not a clinical efficacy study.
7. Type of Ground Truth Used
For the "standalone" performance evaluations mentioned (UVB emissions, electrical safety, etc.), the "ground truth" would be established by technical specifications, industry standards, and measurements against those standards. For example, a spectroradiometer would be used to measure the UVB spectrum, and electrical safety would be tested according to relevant safety standards.
For the claim of substantial equivalence regarding the intended use and efficacy, the "ground truth" is based on the established clinical effectiveness of the predicate UVB phototherapy devices for the stated dermatological conditions.
8. Sample Size for the Training Set
Not applicable. The device is a phototherapy system; it does not involve machine learning or a "training set" in the context of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
§ 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.