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The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototheraputic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and lenkoderma on all skintypes (I-VI).

Device Description

The Clarify Phototherapy System is a handheld medical device that produces UVB light for the purpose of phototherapy. It was developed and will be marketed by Skylit Medical, Inc. DBA Clarify Medical, Inc. and is referred to herein as "Clarify Medical" or "Clarify". The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical device. It is indicated for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI). The system consists of the following components and accessories:

Handheld UV light Emission device that delivers the UVB light
Mobile Software Application that runs on smartphone (Android and iOS) platforms. This Application is the primary user interface, and provides patient guidance when phototherapy is delivered and treatment reminders
Physician Portal Software is a cloud based software application that links the patient to the prescribing physician during home therapy.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Skylit Phototherapy System" (later referred to as "Clarify Medical Phototherapy System"). This device is a handheld UV light treatment system for dermatologic conditions. The submission aims to demonstrate substantial equivalence to previously marketed devices.

Based on the provided document, the device in question is a phototherapy system, not an AI/algorithm-based device. Therefore, the questions related to AI acceptance criteria, sample size for AI test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information are not applicable to this medical device submission.

The acceptance criteria provided focus on the electrical, optical, software, and biocompatibility safety and performance of the phototherapy device. The study proving these criteria are met consists of various performance tests and validations.

Here's a breakdown of the applicable information:

1. A table of acceptance criteria and the reported device performance:

Element of Comparison	Method for Safety Assessment	Test Result Meet Design Input Specifications and Demonstrate Equivalence	Notes
UBV light Source, Max Power Output	Performance Testing (optical emissions spectrum measured at the treatment surface, biologically weighted emissions curve computed using the International Commission on Illumination accepted erythema curve, optical power at treatment surface measured). Evaluated in accordance with IEC 60601-2-57.	Yes	Verification testing demonstrated weighted peak of emissions within established therapeutic range (300-320nm) and optical power at treatment surface met specified requirements.
Power Source	Electrical Safety Testing, Battery Performance Testing. Evaluated in accordance with IEC 60601-1 and IEC 60601-1-4.	Yes	Not explicitly detailed in the provided text beyond "Yes."
Prescription Stored on the device	System Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304.	Yes	This refers to prescriptions being stored on a cloud server for the subject device, a feature that distinguishes it from some predicate devices.
Treatment Reminders	Software Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304.	Yes	This feature is built into the mobile software application.
Auto Calculation of treatment adjustment	System Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304.	Yes	This capability is built into the software in accordance with the prescribed protocol.
Skin Contact Materials	Performance testing. Evaluated for biocompatibility in accordance with ISO 10993-1 (cytotoxicity, sensitization, irritation) as a "surface device" with limited contact duration (< 24 hours).	Yes	The distal end material has been tested to ISO-10993.
Wireless communications between handheld and console	System Validation. Compliance with relevant FDA guidance documents for Mobile Medical Applications and Radio Frequency Wireless Technology in Medical Devices. Also, electromagnetic compatibility (EMC) assessed according to IEC 60601-1-2.	Yes	The device uses Bluetooth wireless communication between the handheld unit and the mobile phone software application.
Records Retention	System Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304.	Yes	Treatment data is stored and uploaded to a server.
Remote Physician Review of the results	System Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304.	Yes	This feature is enabled by the cloud-based Physician Portal Software.
Electrical Safety	Testing to applicable sections of IEC 60601-1 and IEC 60601-1-4.	Not explicitly stated as a row in Table 2, but mentioned in "Standards and Guidance Documents" section.	Not explicitly detailed beyond "Yes."
Software and Wireless Safety	Review and compliance with FDA guidance documents: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Mobile Medical Applications, Radio Frequency Wireless Technology in Medical Devices. Consideration of IEC 62304.	Covered by System Validation	Not explicitly detailed beyond "Yes."
Electromagnetic Compatibility (EMC)	Assessed according to IEC 60601-1-2.	Covered by Wireless Communications validation	Not explicitly detailed beyond "Yes."
Human Factors/Usability	Formative studies and software validation. Compliance with IEC 62366 to be verified by an independent third party prior to marketing.	Will be confirmed	The document states: "Clarify medical will not market the device until compliance with IEC 62366: Medical devices – Application of usability engineering to medical devices is verified by an independent third party." This is a pre-market condition.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. This submission relies on performance testing and comparison to predicate devices, not a clinical study with a test set of patient data as might be used for an AI/algorithm-based device.
Data Provenance: Not applicable. The "data" here refers to engineering test results and compliance with medical device standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth as understood in the context of AI (e.g., expert labels on medical images) is not relevant for this device's testing. Safety and performance are established through engineering and systems validation against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There is no external "test set" requiring adjudication.

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 device.

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

Not applicable. This is not an AI or algorithm-only device. It's a hardware device with associated software to manage its function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Ground Truth: For this type of device, "ground truth" relates to compliance with engineering and safety standards. Examples include:
- Optical Emissions: Measured values against specified therapeutic ranges (300-320nm).
- Electrical Safety: Compliance with IEC 60601-1 standards.
- Software Functionality: Validation against design input specifications and recognized software lifecycle processes (IEC 62304) and FDA guidance for medical device software.
- Biocompatibility: Results of cytotoxicity, sensitization, and irritation tests against ISO 10993 standards.
- These are objective, measurable criteria, not subjective interpretations requiring expert consensus as in AI image analysis.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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