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The Solarc/SolRx E-Series Ultraviolet Phototherapy Lamp Family is a wall-mounted or self-supporting ultraviolet phototherapy lamp unit used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use as a spot or full-body treatment device. It is intended for use on all skin types. (I -VI)

This device is intended for Prescriptive Use only, per Part 21 CFR 801 Subpart D.

A new family of medical devices that can be used singly, or ganged together in any number and combination of models. The devices use various numbers and lengths of tubular ultraviolet fluorescent bulbs. The model numbering system for single devices is as follows: Ehn0t-waveband-suffix. The proposed device is constructed primarily of sheet metal, and has provision for connecting additional lighting banks. The proposed device can be made in 2-foot, 4-foot and 2-metre lengths. The proposed device has provision for ultraviolet reflective side panel doors. The treatment area of the proposed device can be reduced by using the "Face Shield" accessory. The proposed device uses low pressure mercury vapor fluorescent ultraviolet bulbs. The proposed device uses 2 to 12 bulbs per device, or multiples thereof when devices are ganged together. The proposed device uses a digital countdown timer. The proposed device has a keyed switchlock or timer password entry to prevent unauthorized usage, wire guards or an acrylic window to reduce the chance of bulb breakage, and FDA compliant ultraviolet protective goggles.

The provided text is a 510(k) Summary for a medical device called the Solarc/SolRx E-Series Ultraviolet Phototherapy Lamp Unit Family. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

The document does not include information about specific acceptance criteria or a study proving the device meets those criteria in the way you've outlined for performance studies. Instead, it focuses on demonstrating substantial equivalence to existing devices, primarily by comparing intended use, technological characteristics, and safety features.

Therefore, many of your requested items, such as a table of acceptance criteria and reported performance, sample sizes for test sets, ground truth establishment, MRMC studies, or standalone performance, are not present in this type of submission. This device is a phototherapy lamp, and its "performance" is generally related to its ability to emit specific UV light, which would be covered by technical specifications rather than diagnostic accuracy metrics.

Here's a breakdown of what can be extracted and what is not available from the provided text, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document states that the device "can be demonstrated that the proposed device is as safe and effective as the legally marketed devices and does not raise different questions regarding safety and effectiveness than the predicate devices." This is a general statement about substantial equivalence, not a report of specific performance metrics against defined acceptance criteria.

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

Not applicable/Not available. This is a device for delivering UV light therapy, not a diagnostic or AI-based device that would typically have a "test set" in the context of clinical performance evaluation. The substantial equivalence argument relies on comparison to predicate devices, not on a new clinical study with a test set of patient data.

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

Not applicable/Not available. See point 2.

4. Adjudication Method for the Test Set

Not applicable/Not available. See point 2.

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/Not available. This device is a UV phototherapy lamp and does not involve AI or human "readers" interpreting output in a diagnostic context. Therefore, an MRMC study is not relevant to its regulatory submission.

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

Not applicable/Not available. This device is a physical phototherapy lamp, not an algorithm.

7. The Type of Ground Truth Used

Not applicable/Not available. The submission focuses on demonstrating that the new device has "the same intended use and similar technical characteristics" as predicate devices, and that it is "as safe and effective." The "ground truth" here is essentially that the predicate devices are already deemed safe and effective for their intended use.

8. The Sample Size for the Training Set

Not applicable/Not available. This device is a hardware product, not a machine learning algorithm that requires a training set.

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

Not applicable/Not available. See point 8.

Summary of what the document does provide regarding substantial equivalence:

The document argues for substantial equivalence by comparing the proposed device to several predicate devices (e.g., Solarc/SolRx 1000 Series, Daavlin "7-Series," National Biological Corp. "Foldalite-32") across several characteristics:

• Intended Use: Identical – phototherapeutic treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) in home, physician's office, or clinic.
• Design Concept: Constructed primarily of sheet metal, with provision for connecting additional lighting banks, similar to predicate devices.
• Treatment Area & Anatomical Sites: Available in 2-foot, 4-foot, and 2-meter lengths for partial or full-body treatment (excluding eyes), similar to predicate devices. Includes reflective side panel doors and a "Face Shield" accessory, comparable to predicate features.
• Type of Ultraviolet Bulbs: Uses low-pressure mercury vapor fluorescent UV bulbs comparable to predicate devices in spectral distribution, irradiance levels, ballasts, and circuitry.
• Quantity of Ultraviolet Bulbs: Uses 2 to 12 bulbs per device (or multiples when ganged), within electrical current limits, compared to predicate devices using 1 to 48 bulbs.
• Electrical Rating: Voltage and frequency ratings are comparable, meeting industry and medical device standards for high voltage breakdown, current leakage, and EMC.
• Timer: Uses a digital countdown timer technically comparable to predicate devices.
• User's Manual: Written for layman users, provides comprehensive exposure guidelines, and is at least as effective as predicate devices.
• Safety Features: Includes a keyed switchlock or timer password, wire guards or an acrylic window, and FDA compliant UV protective goggles, all comparable to predicate device features.
• Regulatory Requirements: Designed and manufactured according to FDA GMP and ISO13485 (Solarc Systems Inc. is ISO-13485:2003 certified).

The core of the submission is that because these characteristics are similar or equivalent, the new device is "as safe and effective" as legally marketed predicate devices and "does not raise different questions regarding safety and effectiveness." There is no detailed performance study presented because the device type and the regulatory pathway chosen (510(k)) emphasize comparison to existing devices rather than de novo clinical efficacy trials for a novel technology.

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