(82 days)
The Candela Gentlelase GL Dermatology Laser is indicated for the following uses: 1. the photocoagulation of dermatological vascular lesions. The Candela GentleLase GL Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for: 1. the reduction of pain. 2. cooling of skin prior to laser treatment.
The Candela (Modified) Gentlelase GL Laser utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed area via an optical fiber/handpiece delivery system. The Candela Gentlelase Lasers are designed with five major components: - High voltage power supply and modulator system 1. - Optical laser head 2. - Circulator system 3. - 4. Optical delivery system - Software control system 5. The Candela Gentlelase Lasers are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment. The intended use of the laser system is for the photocoagulation of dermatological vascular lesions. The Candela (Modified) Gentlelase GL Laser also includes the Candela Dynamic Cooling Device integrated into the laser system. The DCD consists of 1) a source of skin refrigerant fluid, 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with the laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of refrigerant, just prior to the delivery of the laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates. The intended use of the Dynamic Cooling Device is to cool the skin prior to laser treatment, to minimize thermal damage to skin during laser treatment and to reduce pain associated with laser treatment.
The provided text describes the regulatory clearance of the Candela (Modified) GentleLase GL Laser System, which includes the Candela Dynamic Cooling Device (DCD). However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for an AI/medical device. Instead, the document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not applicable to the information provided in this 510(k) summary.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document establishes "substantial equivalence" as the primary acceptance criterion, rather than specific performance metrics (like sensitivity, specificity, or reader improvement). The reported performance is implicitly that the device is "substantially equivalent" to its predicate devices concerning its intended use, operating principles, and key design aspects.
Given the nature of this document (a 510(k) summary for a laser system, not an AI/diagnostic device), quantitative performance metrics in the traditional sense are not explicitly stated, nor are acceptance criteria for such metrics. The "performance" is demonstrated by similarity to an already approved device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| For Candela (Modified) Gentlelase GL Laser System: | |
| Same intended use as predicate device (Candela Gentlelase GL laser cleared under 510(k) 972767). | The Candela Gentlelase Lasers have the same intended use: photocoagulation of dermatological vascular lesions. |
| Same operating principles as predicate device. | The Candela Gentlelase Lasers utilize the same operating principles (Alexandrite rod, 755nm wavelength, pulsed energy, optical fiber/handpiece delivery). |
| Match key design aspects (similar spot size, same wavelength, same maximum delivered power) as predicate device. | The Candela Gentlelase Lasers match key design aspects, including similar spot size, the same wavelength (755nm), and the same maximum delivered power. |
| For Dynamic Cooling Device (DCD) integrated into the laser system: | |
| Same intended use as predicate DCD (Candela Dynamic Cooling Device). | The DCD has the same intended use: cooling the skin prior to laser treatment, to minimize thermal damage during laser treatment, and to reduce pain associated with laser treatment. |
| Same operating principles as predicate DCD. | The DCD utilizes the same operating principles (source of skin refrigerant fluid, electronically controlled solenoid delivery valve, electronic timing circuitry, connected in line with laser's triggerswitch for pulsed spray just prior to laser pulse). |
| Same technological and performance characteristics as predicate DCD. | The DCD has the same technological and performance characteristics. |
| Overall substantial equivalence to predicate devices based on assembly, operation, and uses. | "On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela (modified) Gentle Lase System is substantially equivalent to the predicate devices." (Predicate for DCD: Candela Dynamic Cooling Device; Predicate for laser: Candela Gentlelase GL laser cleared under 510(k) 972767). Component testing and functional testing of the completed laser system (including DCD) were performed. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is a 510(k) summary for a laser surgical instrument, not an AI/diagnostic device. The "testing" mentioned refers to component and functional testing of the hardware, not a clinical study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2.
4. Adjudication method for the test set:
- Not Applicable. See point 2.
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 for photocoagulation, not an AI-powered diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. See point 5.
7. The type of ground truth used:
- For a traditional medical device like this laser, "ground truth" typically relates to engineering specifications, safety standards, and functional performance, verified through "component testing and functional testing." It's not about diagnostic accuracy against pathology or outcomes data in the way an AI diagnostic device would be evaluated. The core "truth" being established here is that it functions as intended and is safe, similar to its predicate.
8. The sample size for the training set:
- Not Applicable. This is a hardware device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. See point 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.