(88 days)
The Candela Smoothbeam Laser System is indicated for Use in dermatology for incision, excision, ablation, vaporization with hemostasis of soft tissue and the treatment of periorbital wrinkles.
The intended use of the Candela Dynamic Cooling Device is: Cooling of the skin prior to laser treatment Reduction of pain during laser treatment
The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, for use in dermatology for the treatment of periorbital wrinkles. The Candela Smoothbeam Laser System is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams on the skin. The Dynamic Cooling Device provides a short burst of cryogen spray during the laser treatment. The cryogen is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin during the laser treatment minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela Smoothbeam Laser System is equipped with safety interlock systems to protect patients and operators. Users of the device, make selections from a control panel to regulate operation during the laser treatment.
The provided text describes a 510(k) premarket notification for the "Candela Smoothbeam Laser System" for the treatment of periorbital wrinkles. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the format requested.
The document primarily focuses on regulatory approval based on substantial equivalence to predicate devices (Laser Aesthetics CoolTouch K003715 and Candela 1450 nm Diode laser K002421). It confirms that "Clinical trials produced results that the Smoothbeam Laser System is effective in the treatment of periorbital wrinkles," but it doesn't elaborate on the methodology, sample sizes, ground truth establishment, or specific quantitative performance metrics.
Therefore, I cannot provide a complete answer to your request in the specified format from the given text.
Here's what I can extract and what is missing based on your request:
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated in quantitative terms. The primary acceptance criterion appears to be "substantial equivalence" to predicate devices and demonstration of "effectiveness in the treatment of periorbital wrinkles."
- Reported Device Performance: "effective in the treatment of periorbital wrinkles." No quantitative metrics (e.g., percentage reduction in wrinkles, physician global assessment scores, patient satisfaction scores) are provided.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document only mentions "Clinical trials."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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/Not mentioned. This device is a laser system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not mentioned. This is a medical device for direct treatment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied to be clinical outcomes related to "treatment of periorbital wrinkles." The specific method (e.g., blinded physician assessment, photographic analysis, patient questionnaires) is not detailed.
8. The sample size for the training set:
- Not applicable/Not mentioned for a laser treatment device. This concept is typically relevant for machine learning algorithms.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned.
In summary: The provided document is a regulatory submission focused on demonstrating substantial equivalence and does not contain the detailed clinical study data, acceptance criteria, and performance metrics typically found in scientific publications or more comprehensive clinical study reports.
§ 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.