(86 days)
The GentleYAG Laser is intended for the treatment of Pseudofolliculitis Barbae.
The GentleY AG 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 .
Please note that the provided document is a 510(k) summary for the Candela GentleYAG Laser System, which focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting detailed acceptance criteria and a deep dive into a standalone study for a novel AI device.
Therefore, many of the requested categories for AI device studies (especially relating to sample sizes, ground truth expert details, MRMC studies, training set details) are not applicable or not provided within this type of regulatory submission. This document describes a laser system, not an AI or software-as-a-medical-device (SaMD) product.
However, I will extract the available information and indicate where information is not present or not relevant to this type of device and submission.
Acceptance Criteria and Study Information (Based on Provided Document)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device is safe. | "The GentleYAG is safe and effective for the treatment of Pseudofolliculitis Barbae." |
| Effectiveness: Device is effective for the stated indication. | "The GentleYAG is safe and effective for the treatment of Pseudofolliculitis Barbae." |
| Substantial Equivalence: Device shares indications for use, key design aspects, similar wavelength, and/or same maximum delivered power as predicate devices. | "The Candela GentleY AG 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 is substantially equivalent to the predicate devices." |
| No New Questions of Safety/Effectiveness: Device does not introduce new risks/benefits compared to predicates. | "Technologically, the Candela GentleY AG Laser is identical to the previous predicate Candela Long Pulse Nd: YAG Laser (K010104), the Laserscope Lyra Surgical Laser System (K003147) and the Altus CoolGlide Laser (K014040), 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." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document states that "A clinical study produced results that indicate the GentleY AG is safe and effective for the treatment of Psuedofolliculitis Barbae." However, the sample size for this clinical study is NOT provided in the 510(k) summary.
- Data Provenance: Not specified in this 510(k) summary (e.g., country of origin, retrospective/prospective). This level of detail is typically in the full submission, not the summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable/Not provided. For a laser device, "ground truth" as conceived for AI diagnostic devices (e.g., expert consensus on images) is not directly relevant. The clinical study would involve patient outcomes assessed by clinicians, but the number or specific qualifications of experts establishing "ground truth" in the AI sense are not discussed.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. Adjudication methods (like 2+1) are typically for resolving discrepancies in expert interpretations, common in AI diagnostic tool evaluation. This is not mentioned for this laser device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic AI systems where human readers interpret cases with and without AI assistance. The Candela GentleYAG is a therapeutic laser device.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- No. This is a laser system, not an algorithm. Therefore, a standalone (algorithm only) performance study as understood for AI software is not relevant or applicable. The reported performance refers to the full device.
7. Type of Ground Truth Used
- For the effectiveness claim, the "ground truth" would implicitly be clinical outcomes observed in patients treated for Pseudofolliculitis Barbae during the clinical study. The specifics of how these outcomes were measured or confirmed (e.g., physician assessment, patient self-report, objective measurements) are not detailed in this summary.
8. Sample Size for the Training Set
- Not applicable. This is a hardware medical device, not an AI algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
- Not applicable. No training set for an AI algorithm is involved.
Summary of Limitations due to Document Type:
This 510(k) summary focuses on demonstrating that a new medical device (a laser system) is "substantially equivalent" to existing legally marketed devices. It is not designed to present a detailed AI performance study. Consequently, most questions related to AI-specific study methodologies (like sample sizes for test/training sets, expert qualifications for ground truth, adjudication, MRMC studies) are not addressed or are not applicable within this document. The core argument for safety and effectiveness for this device relies on its technological similarity to approved predicate devices and the results of a generic "clinical study" without detailing its methodology in this summary.
§ 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.