(70 days)
The ML24000 PC UVA-1 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 or visible radiation for diagnosed skin disorders.
The ML24000 PC UVA-1 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 or visible radiation for diagnosed skin disorders. The ML 24000 PC UVA-1 Phototherapy Unit delivers a 360 degree full body treatment, with spectral output at peak wavelengths of 370-390 nm, through an array of 24 metal halide lamps in conjunction with a filtering system that absorbs infrared output and eliminated emissions below 320 nm. The 24 metal halide lamps are arranged in a four column modular design containing six lamps in each column.
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.
I am unable to provide the detailed information requested regarding acceptance criteria and study data for the ML24000 PC UVA-1 Phototherapy Unit. My analysis of the provided text reveals that the document is a 510(k) premarket notification letter from the FDA to Daavlin Distributing Company, confirming the substantial equivalence of the ML24000 PC UVA-1 Phototherapy Unit to a legally marketed predicate device.
The document does not contain:
- A table of specific acceptance criteria and reported device performance values. Instead, it states that "The ML24000 PC UVA-1 Phototherapy Unit performance data is the same as or very similar to that of the claimed predicate device." This is a general statement of equivalence, not a presentation of detailed performance metrics against defined acceptance criteria.
- Details of a study proving the device meets acceptance criteria. The submission focuses on demonstrating substantial equivalence to a predicate device, largely based on similarities in design, materials, and intended use, rather than presenting a new clinical study with specific performance outcomes.
- Information regarding sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, or ground truth details for either a test or training set. These are typically elements of a clinical performance study, which is not described in this 510(k) summary.
Key points from the document relevant to your request, but not directly answering it, are:
- Predicate Device: ML24000 UVA-1 Phototherapy Unit (K103708)
- Core Equivalence Argument: The new device is "identical in nearly every aspect" to the predicate, with the only difference being the incorporation of a "Smart Touch Control System." This control system has been safely used in another legally marketed phototherapy unit (K063621).
- Performance Claim: The performance data for the subject device is "the same as or very similar" to the predicate, and "The ultraviolet lamps and cabinet construction used in the production of the predicate device and the ML24000 PC UVA-1 Phototherapy Unit are the same."
Therefore, based on the provided text, I cannot extract the specific acceptance criteria and study details you've requested. The document primarily serves to establish substantial equivalence based on a comparison to a predicate device, rather than presenting a self-contained performance study with defined acceptance criteria.
§ 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.