(94 days)
The DuraLite-GL is a replacement fiber optic component for the Candela GentleLASE family of lasers. The DuraLite-GL may be used as a replacement part for ail procedures as cleared by the FDA for the Candela GentleLase family of lasers.
The DuraLITE-GL is an exact replacement component for the Candela GentleLASE Plus fiber optic.
Here's a breakdown of the acceptance criteria and study information for the DuraLITE-GL, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria (Explicitly Stated or Implied) | Reported Device Performance |
|---|---|---|
| Physical | Not explicitly stated, but implied to be equivalent to predicate. | Testing validated that the performance of the DuraLITE-GL is identical to the fiber optic components manufactured by Candela for the GentleLase family of lasers. |
| Optical | Not explicitly stated, but implied to be equivalent to predicate. | Testing validated that the performance of the DuraLITE-GL is identical to the fiber optic components manufactured by Candela for the GentleLase family of lasers. |
| Connectivity | Not explicitly stated, but implied to be equivalent to predicate. | Testing validated that the performance of the DuraLITE-GL is identical to the fiber optic components manufactured by Candela for the GentleLase family of lasers. |
| Environmental | Not explicitly stated, but implied to be equivalent to predicate. | Testing validated that the performance of the DuraLITE-GL is identical to the fiber optic components manufactured by Candela for the GentleLase family of lasers. |
| Clinical Equivalence | The DuraLite-GL must be able to be used as a replacement part for all procedures as cleared by the FDA for the Candela GentleLase family of lasers. | The submission concludes the DuraLITE-GL is substantially equivalent to other existing fiber optic components in commercial distribution for use in Dermatology and Plastic Surgery, based on physical, optical, connectivity, and environmental testing. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for a "test set" in the context of clinical or diagnostic performance. The testing described is for physical, optical, connectivity, and environmental performance of the device itself, rather than evaluating a diagnostic algorithm on a dataset.
Data Provenance: Not applicable in the context of this type of device and testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is an accessory to a laser, and the "ground truth" for its performance is related to its physical and functional equivalence to the predicate device, not clinical outcomes directly. No experts in a clinical "ground truth" capacity are mentioned for the test set.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set or adjudication process is described.
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:
No MRMC comparative effectiveness study was done. This document describes a replacement component for a laser, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical component, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" in this context is the performance of the legally marketed predicate device (Candela GentleLASE Plus Fiber Optic). The study aimed to demonstrate that the DuraLITE-GL's physical, optical, connectivity, and environmental performance was "identical" to this predicate.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical component, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set is involved.
§ 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.