(31 days)
The Levia Phototherapy System is intended for use in UVB phototherapy for the treatment of psoriasis including scalp psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The Levia Phototherapy System is intended for use on all skin types (I -VI).
The Levia Phototherapy System is an ultraviolet Light Source and energy delivery system. The System emits UV-B (290-320 nm) light for use in phototherapy and allows delivery of controlled doses. The desired dose is selected using controls on the panel of the Light Source and activated with a switch on the panel or remotely by a foot switch. A Spot Handpiece and a Fiber-optic Brush allow for selective treatment of skin lesions without exposure to neighboring, healthy tissues. The Spot Handpiece and Fiber-optic Brush connect to Light Source with a flexible Light Guide. The system is powered by a common household AC outlet. Protective eyewear is supplied with the system.
The provided text describes a 510(k) premarket notification for the Levia Phototherapy System, a device intended for UVB phototherapy. The submission aims to establish substantial equivalence to predicate devices, rather than presenting a study proving performance against defined acceptance criteria in the way a clinical trial for a novel AI device might.
Therefore, the requested information elements (1-9) which are typically associated with AI/software device studies demonstrating performance against acceptance criteria, are largely not applicable or cannot be extracted from this documentation for the Levia Phototherapy System. The document focuses on demonstrating substantial equivalence to existing, legally marketed devices.
Here's an analysis based on the provided text, highlighting what is present and what is not:
Acceptance Criteria and Study Details for Levia Phototherapy System
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance |
|---|---|
| Spectral output within UVB range of 290-320 nm | "The Levia Phototherapy System emits UVB light within the spectral band of 290 -320 nm similar to that of the predicate device Panosol II UVB-206 device." |
| "Performance data were submitted as part of the 510(k) application to confirm that the spectral output of the Levia System is between 290 and 320 nm..." | |
| Similar technological specifications to predicate devices | "Other performance data included in the application show that the technological specifications are similar to those of the claimed predicate devices." |
| Indications for Use (treatment of specific dermatologic conditions and all skin types I-VI) | The "Indications for Use" section states: "The Levia Phototherapy System is intended for use in UVB phototherapy for the treatment of psoriasis including scalp psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma. The Levia Phototherapy System is intended for use on all skin types (I -VI)." This aligns with the conditions that predicate UVB phototherapy systems are indicated for, implying similar efficacy for these conditions. |
| Safety and Effectiveness (no new questions raised by differences from predicate) | "Lerner Medical Devices, Inc. believes that this difference [Fiber-optic Brush] is an added convenience and does not raise new questions about safety or effectiveness." This is a statement of belief, not empirical data from a study. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission is based on engineering and performance characteristics comparing the device to predicates, not a clinical study with a test set of patients or data samples. The "Performance Data" mentioned refers to engineering measurements of spectral output and technological specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No expert ground truth establishment for a test set is described.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is described.
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 is a hardware medical device (phototherapy system), not an AI or imaging diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a phototherapy system and does not involve an algorithm with standalone performance.
7. The type of ground truth used:
- Not applicable, or inferred. The "ground truth" for this device's submission is effectively the established performance and safety profile of the predicate devices. The Levia System's spectral output and technological specifications are compared to these known and accepted benchmarks.
8. The sample size for the training set:
- Not applicable. No training set for an algorithm is relevant to this device submission.
9. How the ground truth for the training set was established:
- Not applicable. No training set or ground truth establishment for a training set is relevant.
§ 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.