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The Exciplex308nm is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.

The Exciplex 308m" is a compact handheld excimer device that emits a narrow-band UVB light at 308nm. This ultraviolet wavelength of light is known to be beneficial in the treatment of various dermatological conditions such as psoriasis and vitiligo. The UVB light is homogeneously delivered through a 5x5cm² output window at an irradiance of 100mW/cm². Treatments are performed by applying the output window over the affected area with the help of treatment tips or silicone masks to shield the surrounding healthy skin. A treatment might consist of a series of light "shots" where the device is used multiple times along the affected area.

The provided text describes a 510(k) premarket notification for the Exciplex308nm device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with predefined acceptance criteria. Therefore, the information requested in the prompt, which typically relates to clinical trials and statistical endpoints, is not fully present in the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria and reported device performance in the context of a clinical study with pre-defined statistical endpoints. Instead, it describes non-clinical performance and substantial equivalence to predicate devices.

The "performance" described relates to:

• Irradiance uniformity: This is mentioned as part of the testing performed.
• Ability of masks and tips to block UV light: Also mentioned as testing performed.
• Classification of the UV lamp: This refers to safety standards.
• Software and hardware verification testing: This ensures the device functions as designed.

The acceptance of the device is based on demonstrating that these technical aspects meet relevant industry standards and that the device is substantially equivalent to existing predicate devices.

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

No clinical test set is mentioned for evaluating the device's efficacy against specific acceptance criteria. The performance data discussed are non-clinical, related to the device's technical specifications and safety.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The document does not describe a study where experts established ground truth for a test set.

4. Adjudication Method:

Not applicable. No clinical test set requiring adjudication is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or is referenced in this document. The submission is not for an AI-assisted device in that context.

6. Standalone Performance:

The document describes the device's technical performance (e.g., irradiance, UV blocking by accessories, software/hardware function) which could be considered "standalone" in the sense of evaluating the device's intrinsic characteristics. However, this is not a standalone clinical performance study against a specific clinical ground truth.

7. Type of Ground Truth Used:

For the non-clinical performance evaluation, the "ground truth" would be the established engineering and safety standards (e.g., IEC standards, irradiance specifications).

8. Sample Size for the Training Set:

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

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

Not applicable.

Summary of what is present in the document regarding "acceptance":

The acceptance of the device by the FDA is based on demonstrating substantial equivalence to existing predicate devices (K073066, K150752, K051428) in terms of:

• Intended Use: "treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma."
• Technological Characteristics: light source, wavelength (308nm), treatment area size (5x5cm²), fluence range.
• Performance: Non-clinical testing was performed to demonstrate safety based on current industry standards. These tests include:
  • Software Verification (compliance to IEC 60601-1, IEC 62304, ISO 14971)
  • Electromagnetic Compatibility and Electrical Safety (compliance to IEC 60601-1, IEC60601-1-2, IEC 60601-2-57)
  • Performance and usability testing (compliance to IEC 62471, IEC 62366-1, IEC 60601-1-6)
  • Irradiance uniformity
  • Ability of masks and tips to block UV light
  • Classification of the UV lamp

The conclusion states that based on this testing, the device "does not raise new issues of safety or effectiveness compared to the predicate devices."

In essence, the "acceptance criteria" here are that the new device is functionally and safely similar enough to already cleared devices that it doesn't require a full clinical trial to prove efficacy and safety from scratch.

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