(144 days)
The Candela GentleYAG Laser is intended for use in the treatment of facial wrinkles.
The GentleYAG laser consists of the following main components: a laser system console (including software and control electronics), a control and display panel, a lens-coupled, user replacement optical fiber handpiece, a skin cooling device integrated into the handpiece, a footswitch or handswitch, a remote interlock connector.
The Candela GentleYAG Laser System (K022951) was found substantially equivalent to predicate devices based on design aspects, indications for use, and a review of safety and effectiveness information. No specific acceptance criteria table or detailed study results demonstrating device performance against specific metrics were provided in the document.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain a table of acceptance criteria or specific reported device performance metrics. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed performance data against pre-defined acceptance criteria.
The "Safety and Effectiveness Information" section states: "The new indications for use are based on the indications for use for the predicate laser systems. Technologically, the Candela GentleYAG Laser is identical to the previous predicate Candela Long Pulse Nd: YAG Laser (K010104), and the Laserscope Lyra Surgical Laser System (K02002) therefore the risks and benefits for the GentleY AG Laser are comparable to these predicate device(s). We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the device."
This implies that the acceptance criterion for this 510(k) submission was a demonstration of substantial equivalence to the predicate devices regarding indications for use, technological characteristics, and comparable risks and benefits.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a specific clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). As explained above, the submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting new comprehensive clinical study data for the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications:
This information is not applicable as there is no description of a separate test set requiring expert ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable as there is no description of a separate test set requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses on substantial equivalence, not a comparative effectiveness study with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable as the device is a laser system, not an algorithm, and its performance is not evaluated in a standalone algorithmic context.
7. The Type of Ground Truth Used:
This is not explicitly stated as there isn't a new clinical study with a defined ground truth reported for the GentleYAG Laser itself. The "ground truth" for the submission is the established safety and effectiveness of the predicate devices for their indicated uses, which the GentleYAG is claimed to be substantially equivalent to.
8. The Sample Size for the Training Set:
This information is not applicable. The GentleYAG is a physical laser system, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reasons as #8.
§ 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.