(27 days)
Not Found
Not Found
I am sorry, but the provided text is a letter from the FDA to Cynosure, Inc. regarding the 510(k) premarket notification for their Cynosure Accolade II Laser. This document does not contain any information about acceptance criteria or the study that proves the device meets those criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, nor can I provide the detailed information about sample sizes, ground truth establishment, or multi-reader studies that you've requested.
The letter focuses on:
- Confirming the substantial equivalence determination.
- Listing relevant regulations and responsibilities for the manufacturer.
- Providing contact information for various FDA offices.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report that details the device's performance, testing methods, and acceptance criteria.
§ 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.