(203 days)
The Cryoflow 700 and Cryoflow 1000 are intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
The Cryoflow 700 and Cryoflow 1000 consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets specific performance metrics. The document is a 510(k) submission for the Cryoflow 700 and Cryoflow 1000 devices, which primarily focuses on demonstrating substantial equivalence to a predicate device (Cryo 5 Zimmer, K040727).
The document states:
- "Performance Standards: None established (as a medical device) under section 514."
- "The Uniphy Cryoflow 700 and Cryflow 1000 are substantially equivalent to the compared device on the basis of similarities in operating principles, intended use and functional performance."
This indicates that the submission relies on demonstrating similarity to an already approved device rather than presenting new performance study data against specific acceptance criteria. Therefore, I cannot provide the requested table or details about a study, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
§ 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.