(97 days)
The Laserscope Gemini™ Laser System & Accessories is indicated for: KTP/532 Applications: Dermatology: To treat moderate inflammatory Acne vulgaris. ND:YAG/1064 Applications: Dermatology: For use in the Dermatological Applications for the treatment of facial wrinkles. It is also intended to effect stable long-term, or permanent hair reduction in skin types I - VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term, stable, reduction in the number of hairs re-growing after a treatment regimen.
The Laserscope Gemini™ Surgical Laser System and Accessories consists of four major subsystems: The Optical and Laser resonator System. The Electronics and Electrical System Operator Interface. A variety of Delivery Devices and Accessories A Cooling Sub-system
Acceptance Criteria and Study Details for Laserscope Gemini™ Surgical Laser System & Accessories
This document describes the acceptance criteria and supporting study details for the Laserscope Gemini™ Surgical Laser System & Accessories, based on the provided 510(k) summary.
The 510(k) summary does not contain specific acceptance criteria with performance metrics, nor does it detail a standalone clinical study to prove the device meets such criteria. Instead, the submission relies on the concept of substantial equivalence to legally marketed predicate devices.
Therefore, the "acceptance criteria" presented below are inferred from the stated claims of substantial equivalence and the device's intended uses. The "reported device performance" is essentially the claim that its performance is equivalent to the predicate devices for the specified indications.
1. Table of Acceptance Criteria and Reported Device Performance
| Indication for Use | Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Claimed via Substantial Equivalence) |
|---|---|---|
| KTP/532 Applications: | ||
| Dermatology: To treat moderate inflammatory Acne vulgaris. | Demonstrated effectiveness for treating moderate inflammatory acne vulgaris, equivalent to predicate devices. | The Gemini™ system, like the predicate devices, effectively treats moderate inflammatory acne vulgaris. |
| ND:YAG/1064 Applications: | ||
| Dermatology: For use in the Dermatological Applications for the treatment of facial wrinkles. | Demonstrated effectiveness for the treatment of facial wrinkles, equivalent to predicate devices. | The Gemini™ system, like the predicate devices, effectively treats facial wrinkles. |
| Dermatology: To effect stable long-term, or permanent hair reduction in skin types I - VI through selective targeting of melanin in hair follicles. (Permanent hair reduction defined as a long-term, stable, reduction in the number of hairs re-growing after a treatment regimen). | Demonstrated ability to achieve stable long-term or permanent hair reduction across skin types I-VI, equivalent to predicate devices, with evidence of long-term stable reduction in hair regrowth. | The Gemini™ system, like the predicate devices, achieves stable long-term or permanent hair reduction in skin types I-VI by targeting melanin in hair follicles, resulting in a long-term, stable reduction in hair regrowth. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a test set or a dedicated study with a specific sample size. The submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting new clinical study data with a test set. Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
As there is no new clinical study presented in the 510(k) summary, there is no information regarding experts used to establish ground truth.
4. Adjudication Method
Without a new clinical study or test set, there is no adjudication method mentioned in the summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The 510(k) summary does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on demonstrating equivalence of the device itself, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The Laserscope Gemini™ Surgical Laser System & Accessories is a physical medical device (laser system), not an AI algorithm. Therefore, a standalone performance study for an algorithm without human-in-the-loop performance is not applicable and not presented in this 510(k) summary.
7. Type of Ground Truth Used
Given the reliance on substantial equivalence, the "ground truth" for the device's efficacy is implicitly the established safety and effectiveness of the predicate devices for their respective indications. The summary does not refer to new pathology, expert consensus, or outcomes data specifically for the Gemini™ system in a standalone study.
8. Sample Size for the Training Set
The 510(k) summary does not refer to a training set. This is because the submission is for a physical medical device, not an AI/ML algorithm that would undergo a "training" phase with data.
9. How Ground Truth for the Training Set Was Established
As there is no training set for this type of device, 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.