(10 days)
The Cynosure CO3 Er: YAG Laser is used for skin resurfacing, and for the incision, excision, ablation or vaporization of soft bodily tissues.
Typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology, arthroscopy, general surgery, ENT and opthalmology.
The CO3 Er:YAG Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench.
This submission is a 510(k) summary for the Cynosure CO3 Er:YAG Laser, which was cleared on September 10, 1998. The document explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None".
Therefore, based solely on the provided information, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria, as no such data was submitted or reviewed for this clearance.
The clearance was based on substantial equivalence to a predicate device (Cynosure PhotoGenica ER Laser) in terms of treatment wavelength, pulse duration, pulse energy, and biological effects, implying that the predicate device's prior clearance and established safety/effectiveness served as the basis.
To answer your request based on the absence of this information in the provided document:
Acceptance Criteria and Study for Cynosure CO3 Er:YAG Laser
-
Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Not applicable based on provided document. The 510(k) summary explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." Therefore, no specific acceptance criteria for performance (e.g., efficacy rates, safety endpoints quantified directly for this device) and corresponding reported device performance values were provided in the submission for independent evaluation of this specific device's clinical or nonclinical performance. Not applicable based on provided document. The 510(k) submission states that the Cynosure CO3 Er:YAG Laser is "substantially equivalent to the Cynosure PhotoGenica ER Laser in terms of treatment wavelength, pulse duration, pulse energy, and biological effects." The reported performance is implicitly that it performs equivalently to the predicate device for its intended use (skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues) based on this substantial equivalence claim and the absence of specific new performance data for the device. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable. No test set data (clinical or nonclinical performance) was submitted for this device. The clearance was based on substantial equivalence without new performance data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. No test set data requiring expert ground truth establishment was submitted.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set data requiring adjudication was submitted.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a laser system, not an AI-assisted diagnostic or imaging system. No MRMC study was conducted or relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser system, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No new performance data requiring ground truth was submitted for this device. The basis for clearance was substantial equivalence to a legally marketed predicate device.
-
The sample size for the training set:
- Not applicable. No training set for an algorithm was used or described.
-
How the ground truth for the training set was established:
- Not applicable. No training set was used or described.
§ 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.