(183 days)
The Candela Smoothbeam Laser System is indicated for use in the treatment of facial wrinkles.
The Diode laser is a continuous wave, diode medical laser, controlled by an embedded processor, to be used for use in dermatology for treatment of periorbital wrinkles. The laser system operates with a Dynamic Cooling Device, which provides a short burst of cryogen spray during the laser treatment. The laser output energy is delivered via an optical fiber to a hand piece, which produces a circular beam on the skin. The cryogen is delivered via a hose to a nozzle located in the hand piece. 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 system is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device.
The Candela Smoothbeam Laser 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 treatment.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Candela Smoothbeam System, presented in the requested format:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety & Effectiveness for treatment of facial wrinkles | Substantially equivalent to predicate devices (Cool Touch Laser for fine lines/wrinkles, Candela Smoothbeam for periorbital wrinkles and atrophic acne scars) based on identical or similar operating principles, design aspects (spot size, wavelength, max power). |
| Conformance to Laser Performance Standard (21 CFR 1040) | The device conforms. |
| Conformance to UL 544 electrical safety standard | The device conforms. |
| Conformance to Essential Requirements of European Union Medical Device Directives | The device conforms. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information about a specific clinical study with a test set for the new indication of "treatment of facial wrinkles." The submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting new clinical study data for this specific claim. Therefore, information about sample size and data provenance for a test set is not available in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no new clinical study data is presented for the "treatment of facial wrinkles" indication, no information is available regarding experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
As no new clinical study data is presented for the "treatment of facial wrinkles" indication, no information is available regarding adjudication methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done as part of this 510(k) submission. The submission focuses on substantial equivalence to predicate devices.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is a physical laser system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable.
7. Type of Ground Truth Used
For the new indication of "treatment of facial wrinkles," the "ground truth" implicitly used for the substantial equivalence claim is the demonstrated effectiveness and safety of the predicate devices (Cool Touch Laser for fine lines and wrinkles, and Candela Smoothbeam for periorbital wrinkles and atrophic acne scars). The assumption is that because the new device operates on identical/similar principles and design, it will achieve similar outcomes. No new, independent ground truth (e.g., pathology, outcomes data from a new trial) was established for this specific 510(k).
8. Sample Size for the Training Set
There is no information about a "training set" as this 510(k) submission is for a physical medical device (laser system), not an AI/machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/machine learning algorithm, this question is not applicable.
§ 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.