(86 days)
The Viridis Derma laser is intended for photocoagulation of pigmented lesions in dermatology. These include the following specific applications: Benign Vascular Lesions, Facial Telangiectasias, Port Wine Stains, Café au-lait, Erythrosis, Benign Pigmented Lesions, Cuperosis, Senile Lentigo, Keratoses, Hemangiomas (spider and cherry/strawberry), Dermatosis Papulosis Nigra (DPN), Leg Telangiectasia - only as a complement to sclerotherapy and for small superficial red vessels.
The Viridis Derma frequency doubled Nd:YAG laser emits a beam of coherent light at 532 microns.
The Viridis Derma laser device is a frequency-doubled Nd:YAG surgical laser.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| None explicitly stated as quantitative acceptance criteria. The submission focuses on substantial equivalence. | The device is deemed "substantially equivalent" to predicate devices for the indicated uses. |
| Intended for photocoagulation of pigmented lesions in dermatology, specifically: Facial Telangiectasias, Benign Vascular Lesions, Café au-lait, Port Wine Stains, Benign Pigmented Lesions, Erythrosis, Senile Lentigo, Cuperosis, Hemangiomas (spider and cherry/strawberry), Keratoses, Dermatosis Papulosis Nigra (DPN), Leg Telangiectasia (only as a complement to sclerotherapy and for small superficial red vessels). | The FDA confirmed substantial equivalence for these stated Indications for Use. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document explicitly states: "Performance Data: None required." This indicates that no specific clinical study or test set data was used to demonstrate the device's efficacy or safety. The approval was based on demonstrating substantial equivalence to existing predicate devices.
Therefore, there is no information regarding:
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
As no performance data or test set was required, there is no mention of experts being used to establish a ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as no test set data was required or provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The submission specifically states "Performance Data: None required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone performance study was not done. This device is a laser surgical instrument, not an AI algorithm.
7. The Type of Ground Truth Used:
Not applicable, as no performance data or test set was required for this 510(k) submission. The basis for approval was substantial equivalence to predicate devices, not direct evidence of efficacy against a defined ground truth derived from a study.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device (laser), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this device is not an AI algorithm requiring a training set.
§ 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.