(90 days)
The GentleLASE Family of lasers is indicated for use for the treatment of benign pigmented lesions.
The Candela GentleLASE Family of Lasers utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed to the target area via optical fiber/handpiece delivery system. The laser output energy is delivered via an optical fiber to a handpiece, which produces a circular beam on the skin. The GentleLASE Family of Laser Systems are designed with six major components:
- High voltage power supply and modulator system
- Optical laser head
- Circulator system
- Optical delivery system
- Software control system
The Candela GentleLASE Family of Laser Systems 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 provided text is a 510(k) premarket notification for the Candela GentleLASE Family of Laser Systems. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this document.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria for clinical performance or detailed device performance metrics. Instead, it relies on demonstrating adherence to established safety standards and substantial equivalence to predicate devices.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as stated in document) |
|---|---|
| Conformance to Laser Performance Standard (21 CFR 1040) | The Candela GentleLASE Family of Laser Systems conforms to 21 CFR 1040. |
| Conformance to UL 2601 Electrical Safety Standard | The Candela GentleLASE Family of Laser Systems conforms to UL 2601. |
| Conformance to Harmonized Standard EN 60601-1-2 | The Candela GentleLASE Family of Laser Systems conforms to EN 60601-1-2. |
| Substantial Equivalence to Predicate Devices (Candela GentleLASE GL - K994260) in terms of intended use, operating principles, design aspects, spot size, wavelength, and fluence. | The Candela GentleLASE Family of Laser Systems has the same intended use, utilizes similar operating principles, design aspects, spot size, wavelength, and fluence as the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the document. The submission states that the "indications for use for the treatment of benign pigmented lesions is based on a controlled clinical study using a device that has been cleared for use in the market." This implies reliance on data from the predicate device's studies, not new data from a specific test set for this 510(k) submission.
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)
This information is not present in the document. As stated above, the submission refers to prior studies on the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the 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
There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described in the device. This device is a laser system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a laser system, not an algorithm, and it is intended for use by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present for a specific clinical study conducted for this 510(k) submission. The document implies that the predicate device's clinical evidence (which would have required some form of ground truth for assessing treatment of benign pigmented lesions, likely based on clinical assessment or possibly photographic evidence over time) is being leveraged.
8. The sample size for the training set
This information is not present in the document. As the submission relies on substantial equivalence and safety standards, a "training set" in the context of an AI/algorithm is not applicable here.
9. How the ground truth for the training set was established
This information is not present in the document.
§ 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.