(184 days)
The 3 Series NeoLux, full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).
The 3 Series NeoLux Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. The 3 Series NeoLux Phototherapy Unit delivers a 360 degree full body treatment, with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and/or 350 nm (UVA), through an array of 24-48 fluorescent lamps. Treatments are controlled through the Soft Touch Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.
The provided document describes the Daavlin 3 Series NeoLux Phototherapy Unit, a medical device for dermatologic disorders. However, it is a 510(k) summary for substantial equivalence to a predicate device, not a study demonstrating the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously cleared device. Therefore, a direct answer to the request to populate a table of acceptance criteria and reported device performance related to a diagnostic or clinical outcome study, and details about sample sizes, ground truth establishment, or multi-reader studies, cannot be fully provided from this document.
The document does however, provide information regarding performance standards and non-clinical testing for compliance with electrical and EMC standards.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a phototherapy unit based on substantial equivalence, the "acceptance criteria" are primarily related to safety, electrical performance, and functional equivalence to the predicate device. It is not a diagnostic device with performance metrics like sensitivity, specificity, or AUC.
| Criteria Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Clinical Performance | Not applicable for this 510(k type. | Not applicable for this 510(k type. |
| Functional Equivalence | Identical indications for use, patient population, application environment, lamp types, spectral output, labeling, treatment area, electrical requirements, and ventilation requirements as predicate device. | The 3 Series NeoLux is stated to be "identical in nearly every aspect" to the predicate, with only exterior cosmetics and lamp covering changes. |
| Safety and EMC (Non-clinical) | Conformance to IEC 60601-1-2:2007 (EMC), IEC 60601-1:2012 (Safety), and IEC 60601-2-57:2011 (Safety-specific for phototherapy equipment). | Performance testing for conformance to these standards was conducted. (Implied successful conformance). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. This document describes a medical device, not a diagnostic algorithm or AI system that uses medical image data for a test set. The substantial equivalence relies on design, function, and safety testing, not on a clinical test set of patient data with ground truth.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As stated above, there is no test set of patient data requiring expert ground truth in this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set of patient data.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a phototherapy unit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth for clinical outcomes data is discussed in this 510(k) summary, as it is based on substantial equivalence to a predicate device for its intended use, rather than proving new clinical efficacy through trials. The "ground truth" for the device's performance is adherence to electrical and safety standards, and functional equivalence to the predicate.
8. The sample size for the training set
- Not applicable. This is not an AI/ML-driven device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set exists for this device.
Summary based on the provided document:
The Daavlin 3 Series NeoLux Phototherapy Unit is a medical ultraviolet device intended for the treatment of psoriasis, vitiligo, and atopic dermatitis. Its acceptance criteria for FDA clearance (via 510(k)) were primarily based on demonstrating substantial equivalence to a previously cleared predicate device (the 3 Series SP/PC Phototherapy Unit, K063621).
The study that proves the device meets the "acceptance criteria" (i.e., substantial equivalence) is the comparison of the new device's design, materials, manufacturing, indications for use, and performance characteristics (e.g., spectral output, electrical requirements) to that of the predicate device, along with non-clinical performance testing for adherence to recognized electrical and safety standards (IEC 60601-1-2:2007, IEC 60601-1:2012, and IEC 60601-2-57:2011). The document explicitly states that the new device is "identical in nearly every aspect" to the predicate, with the only differences being changes in exterior cosmetics and lamp covering. This implies that the performance in these non-clinical tests was successful and confirmed the device's safety and functional equivalence to the predicate.
§ 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.