(231 days)
The exciplex® is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. The reusable polycarbonate/ABS reduction tips and reusable silicone masks are for use on intact skin only.
The Exciplex is a compact handheld excimer device that emits a narrow-band UVB light at 308 nm. 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 5x5 cm² output window at an irradiance of 100 mW/cm². Treatments are performed by applying the output window over the affected area with the help of reduction tips or silicone masks to shield the surrounding healthy skin. A treatment might consist of a series of light pulses where the device is used multiple times along the affected area.
The provided text is a 510(k) summary for the Exciplex device, which is an ultraviolet lamp for dermatologic disorders. The summary focuses on establishing substantial equivalence to a predicate device (K171702, also named Exciplex308nm/Clarteis) rather than presenting a study demonstrating the device meets a set of performance acceptance criteria.
The key information provided is that the subject device has identical design, dimensions, materials, intended use, and technological characteristics (light source, wavelength, treatment area size, fluence range) as the predicate device. The main differences are:
- Reprocessing of existing silicone masks and reduction tips: In the subject device, these components are reusable, whereas in the predicate device, they were single-use.
- Minor software changes: These changes do not affect the intended use.
Therefore, the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in this context are focused on these differences, specifically demonstrating that the reusability and software changes do not negatively impact safety and effectiveness compared to the predicate.
Here's the information requested, extrapolated from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Testing |
|---|---|---|
| Reprocessing Validation | Reprocessing methods for reusable components (reduction tips and silicone masks) must be acceptable and not raise new safety and effectiveness issues compared to the predicate device. | Reprocessing of reduction tips and silicone masks was validated per AAMI TIR 12:2010 ("Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers") and AAMI TIR 30:2011 ("A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices"). |
| Software Verification | Software changes must not affect the safety and effectiveness of the device compared to the predicate. | Software development and testing were executed in compliance with IEC 62304 ("Medical device software – Software life cycle processes") and ISO 14971 ("Medical devices - Application of risk management to medical devices"). Verification and validation testing were conducted to ensure that the software changes do not affect safety and effectiveness. |
| Clinical Performance | (Implicit: Clinical performance is substantially equivalent to predicate) | No clinical data were provided to demonstrate substantial equivalence, based on the assertion that the device has identical design, intended use, and technological characteristics to the predicate, with differences only in reusability and minor software changes. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set sample size" in the context of clinical data for the subject device because no clinical data were provided. The testing performed was non-clinical (reprocessing validation and software verification). For these non-clinical tests, specific sample sizes (e.g., number of tips/masks reprocessed, number of software test cases) are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical expert-driven ground truth was established for the subject device's performance demonstration. Non-clinical testing relied on industry standards and internal verification/validation processes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method (like 2+1, 3+1) was used as there was no clinical study generating data requiring such 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 device is an ultraviolet lamp for dermatologic disorders, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an ultraviolet lamp, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Reprocessing Validation: "Ground truth" was adherence to established industry standards (AAMI TIR 12:2010 and AAMI TIR 30:2011) and demonstrating that cleaning methods are acceptable and do not compromise material integrity or safety.
- Software Verification: "Ground truth" was adherence to established software development and risk management standards (IEC 62304 and ISO 14971) and successful completion of verification and validation testing, ensuring software functions as intended and does not negatively impact device safety or effectiveness.
8. The sample size for the training set
Not applicable. This device is an ultraviolet lamp; no training set in the machine learning sense is relevant for its safety and effectiveness demonstration in this submission.
9. How the ground truth for the training set was established
Not applicable, as there was no training set.
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.