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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.

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The ML24000 UVA-1 Phototherapy Unit is a medical ultraviolet light source, which is intended for use by or under the direction of a licensed physician for the treatment of atopic dermatitis (eczema) on all skin types (I - VI).

The ML24000 UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for the treatment of atopic dermatitis (eczema) on all skin types (I - VI).

The ML24000 UVA-1 Phototherapy Unit is a microprocessor controlled full body ultraviolet light source, with spectral output at peak wavelengths of 370-390 nm. It is intended for use by or under the direction of a physician, for the treatment of atopic dermatitis (eczema). The desired dose is selected using the operator interface located on the front panel of the device. The ML24000 UVA-1 Phototherapy Unit delivers full body phototherapy, whereby Philips CLEO HPA 1018 Medium Pressure Lamps, which surround the patient, deliver the specified dose of UVA-1.

The provided document is a 510(k) summary for the ML24000 UVA-1 Phototherapy Unit. It states that the device is substantially equivalent to a legally commercialized predicate device. This type of submission relies on demonstrating similarity to an already approved device rather than conducting new clinical studies with detailed acceptance criteria and performance statistics as would be found in a PMA (Pre-Market Approval) application.

Therefore, many of the specific details requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not present in this document because they are not typically required for a 510(k) submission that demonstrates substantial equivalence to a predicate device for this type of medical device.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no explicit table of acceptance criteria or reported device performance metrics in the provided 510(k) summary. The submission focuses on demonstrating "substantial equivalence" to a predicate device, meaning its performance is considered comparable enough that specific new performance metrics are not required.

2. Sample Size for the Test Set and Data Provenance:

No specific test set or clinical study data is provided to determine sample size or data provenance. The substantial equivalence argument relies on the design, materials, and intended use being similar to the predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. No new clinical study data with ground truth established by experts is mentioned or required for this type of 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable. No new clinical study or test set requiring adjudication is mentioned.

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 unit, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device for treatment, not an algorithm.

7. The type of ground truth used:

Not applicable. The basis for approval is substantial equivalence to a predicate device, not a new clinical study generating ground truth data.

8. The Sample Size for the Training Set:

Not applicable. This document refers to a phototherapy unit, not an AI/ML algorithm that would require a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for an AI/ML algorithm.

Summary of the Device's Justification for Marketing based on Substantial Equivalence:

The ML24000 UVA-1 Phototherapy Unit is considered substantially equivalent to its predicate devices (Daavlin Distributing Company 3 Series PC & SP Phototherapy Cabinet Ultraviolet Phototherapy Cabinet K063621 and Flex Controlled Phototherapy Equipment 3 Series X Ultraviolet Phototherapy Cabinet K0050695) based on the following:

• Design Configuration: Constructed in the same design configuration.
• Energy Sources: Utilizes similar energy sources (UV lamps).
• Materials: Uses materials of similar and/or identical composition.
• Intended Use: The intended use, general and specific indications for use (treatment of atopic dermatitis (eczema) on all skin types I-VI), mode of operation, labeling, treatment area, and general operating principles are the same or similar.
• Performance Data: The performance data is stated to be "the same as or very similar to that of the claimed predicate devices." The UV lamps and cabinet construction are also noted as similar.

The primary difference noted is the peak wavelength of the UV lamps: the ML24000 has a peak wavelength of 365nm (output spectrum 340nm to 400nm), while the predicate devices had a peak wavelength of 350nm (output spectrum 320nm to 400nm). This change was deemed not to impact the substantial equivalence for its intended use.

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