(99 days)
The Fencer 308 Excimer Laser will be indicated for use the Psoriasis, vitiligo, atopic dermatitis and leukoderma.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Fencer 308 Excimer Laser. It states that the device is substantially equivalent to legally marketed predicate devices for the indications of use: psoriasis, vitiligo, atopic dermatitis, and leukoderma.
However, this document does not contain information about:
- Acceptance criteria and reported device performance: The letter states substantial equivalence, but doesn't detail performance metrics or specific acceptance criteria.
- Sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods for a test set, or details about a training set.
- Whether MRMC or standalone performance studies were conducted, or any effect size of AI assistance.
Therefore, based solely on the provided text, I cannot answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement. These details would typically be found in the 510(k) submission itself, not in the clearance letter.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.