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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 Houva-NET Control System is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for the treatment of psoriasis and vitiligo.

The Houva V with Houva -NET Control System is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.

The Houva V with Houva-NET Control System is simply the integration of the new Houva-NET Control System software, into the predicate device, the Houva III Phototherapy System with PhotoSense II™. The Houva -NET Control System software is utilized to monitor multiple phototherapy devices from a single computer, the Houva-NET Central Computer. The central computer may be used to monitor mulitiple phototherapy devices from one central location. A custom built interface board. 5PCB-040, supplied by National Biological Corporation is installed in each phototherapy device. An "off-the shelf" replacement is not possible and a replacement may only be obtained from National Biological Corporation. Schematics are located in the Device Description of this 510(k) submission, Section 11.

The integration of the new Houva-NET Control System software into the predicate device, the Houva III Phototherapy System with PhotoSense II™, results in the modified system or the Houva V with Houva-NET Control System. The modification, as compared to the predicate, is limited to the replacement of the PhotoSense II Controller with the new Houva-NET Control. The Houva V with Houva-NET Control System software is designed to provide Ultraviolet A (UVA) and/or Ultraviolet B (UVB) radiation treatments in the same manner as the predicate device.

The Houva-NET Control System may be retrofitted into any Houva Phototherapy Systems, constructed in the same design configuration as the predicate device. Houva III Phototherapy System with PhotoSense II™ (K041212) and utilizing identical energy source (UV Lamps) and materials of identical composition. The Houva V with Houva-NET Control System's only variation from the predicate device is that the control system hardware and software have been updated to control multiple phototherapy units. The intended use, general and specific indications for use, spectral output, mode of operation, labeling, treatment area, and general operating principals of the Houva V with Houva-NET Control System are the same as those of the predicate. Additionally, the use of control system software and interface board to manage multiple phototherapy devices have already received FDA market clearance under K110912 integrated into the Daavlin Smart Touch Multi-Machine Software.

This document describes the Houva-NET Control System, a therapeutic product designed for ultraviolet radiation therapy for psoriasis and vitiligo. It is a control system that can be integrated into existing phototherapy devices to monitor multiple devices from a central computer.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a specific diagnostic performance metric (like sensitivity, specificity, or AUC). Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance data" refers to showing that the modified device performs as well as the predicate, particularly in terms of safety and technical functionality.

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

• Sample Size for Test Set: The document does not specify a "test set" in terms of patient data or a specific number of devices tested. The testing involved "bench tests" focused on system verification and software validation, not clinical trials with patient samples.
• Data Provenance: Not applicable, as no human or clinical data was used. The focus was on engineering and software validation.

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

• Experts and Qualifications: Not applicable. The "ground truth" for this device's evaluation was based on compliance with engineering standards (IEC 60601-1 Ed.2) and functional verification against design specifications of the predicate device. This typically involves engineers and quality assurance personnel, not medical experts establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since no clinical data or expert review of outputs was performed, there's no need for an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The device is a control system for phototherapy, not a diagnostic imaging device typically evaluated with MRMC studies. The document explicitly states: "Clinical testing was not required to establish equivalency of the device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Standalone Study: The evaluation performed was effectively "standalone" in the sense that the system (Houva-NET Control System) was tested for its functional capabilities and compliance with safety standards without evaluating its interaction or impact on human clinical decision-making. The "performance" assessment was of the system's technical operation, not its diagnostic or therapeutic efficacy in a human-in-the-loop context.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was based on:
  • Engineering Specifications and Design Documentation: The device's performance was compared against its own design specifications and the known, approved specifications of the predicate device.
  • Compliance with International Standards: Specifically, IEC 60601-1 Ed.2 for electrical safety.
  • Functional Verification: Ensuring the software and hardware performed as intended (e.g., controlling multiple phototherapy units, maintaining wavelength output, timer accuracy).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a control system, not an AI/ML algorithm that requires a "training set" of data. Its development involved traditional software engineering and hardware design, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there was no training set for an AI/ML algorithm.

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