(32 days)
The Cryo 5 Cold Air Device is intended, to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
The Cryo 5 consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
The provided text is a 510(k) summary for the Zimmer Cryo 5 device, which is a skin refrigerant. This document is a premarket notification to the FDA for market clearance and not a study report detailing acceptance criteria and performance against those criteria. As such, the input does not contain the information requested regarding acceptance criteria and a study proving the device meets them.
Specifically, the document states:
- "Performance Standards: None established (as a medical device) under section 514." This indicates that there are no specific performance standards or acceptance criteria defined by a regulatory body for this type of device.
- "Summary of Substantial Equivalence: The Zimmer Cryo 5 is substantially equivalent to the compared devices on the basis of similarities in operating principles, intended use and functional performance." The 510(k) process relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, I cannot extract the following information because it is not present in the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.