(75 days)
The CyberScan Device is intended for use for all cleared Heraeus LaserSonics CO2 soft tissue surgical applications.(K955734)
Not Found
The provided text is a Summary of Safety and Effectiveness for the CyberScan Device System (K970017). It states that the device is substantially equivalent to a predicate device (ParaScan Dosimeter Device, K955734).
However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given input. The document focuses on regulatory classification, indications for use, and a comparison to a predicate device for substantial equivalence, rather than detailing performance studies and their results.
§ 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.