(190 days)
The Candela GentleYAG Laser is intended for use for:
- Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue black tattoos) and plaques.
- Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- Removal of unwanted hair in skin types I to VI
- Photocoagulation and hemostasis of pigmented and vascular lesions
- Coagulation and hemostasis of soft tissue.
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
This is a 510(k) summary for a medical device (Candela GentleYAG Laser System), which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria through a study with performance metrics. Therefore, many of the requested elements for a study describing acceptance criteria and device performance are not present in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy, or a specific treatment outcome percentage) for the GentleYAG Laser System. Its rationale for clearance is based on substantial equivalence to existing predicate devices, not on meeting new quantitative performance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
No new clinical study data or test set information is provided for the GentleYAG Laser System demonstrating its performance against specific acceptance criteria. The submission relies on the established safety and effectiveness of its predicate devices.
3. 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, as no new clinical study data or test set requiring ground truth establishment is presented for the GentleYAG Laser System in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no new clinical study data or test set requiring adjudication is presented for the GentleYAG Laser System in this document.
5. 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 software/diagnostic tool, so MRMC studies and AI assistance metrics are irrelevant.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical study data requiring ground truth is presented for the GentleYAG Laser System in this document. The "ground truth" for its equivalence argument comes from the established safety and effectiveness of its predicate devices through their prior clearances and market use.
8. The sample size for the training set
Not applicable. This document is for a medical device (laser system), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set is relevant to this device submission.
Summary based on the provided text:
The core of this 510(k) submission is to demonstrate substantial equivalence to currently legally marketed predicate devices, not to present new clinical study data proving the GentleYAG Laser System meets specific, newly defined quantitative performance acceptance criteria.
The document explicitly states:
- VI. Rationale for Substantial Equivalence: "The Candela GentleYag Laser shares the same indications for use, matches key design aspects, including spot size, similar wavelength and/or the same maximum delivered power as the predicate devices, and therefore are substantially equivalent to the currently marketed Candela Long Pulse Nd: YAG Laser System (K010104) and the Altus Family of Cool Glide Lasers (K014040)."
- VII. Safety and Effectiveness Information: "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), therefore the risks and benefits for the GentleYAG Laser are comparable to this predicate device. We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the device."
Therefore, the "study that proves the device meets the acceptance criteria" is implicitly the prior regulatory review and market performance of the predicate devices. The "acceptance criteria" are effectively the established safety and effectiveness profiles and engineering specifications of those predicate devices, which the GentleYAG Laser System is declared to match.
§ 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.