(86 days)
The Q-Switched Nd: Yag laser is indicated for the treatment of: benign cutaneous lessons, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and the removal of black or blue tattoos.
The Q-switched laser therapy device is laser system which delivers laser at a wavelength 1064nm or 532nm and the pulse mode is single pulse. In laser handpiece, there is one optical cavity containing the Nd: YAG crystal. The laser beam is directed to the treatment zone. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect.
The provided document is a 510(k) premarket notification letter from the FDA regarding a Q-Switched Nd:Yag laser device. This type of document establishes substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical data, especially not for AI/machine learning devices where such studies would be critical.
The document explicitly states:
- "No clinical study is included in this submission." (Page 9)
- The entire evaluation for substantial equivalence is based on "Non-Clinical Test Conclusion," showing compliance with various electrical safety, biocompatibility, and laser safety standards (ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, ISO 10993-10), and Software Validation & Verification Test.
Therefore, I cannot provide the requested information for an acceptance criteria table, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided FDA 510(k) summary for this laser device.
The questions you've posed (acceptance criteria, sample size, expert ground truth, MRMC, etc.) are highly relevant for the validation of AI/ML-based medical devices or devices with a diagnostic component whose performance is assessed against human interpretation or clinical outcomes. The device in this document is a physical laser for treatment, and its FDA clearance is based on demonstrating equivalence in its technical specifications and adherence to relevant safety standards, not on diagnostic accuracy or AI performance.
§ 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.