(90 days)
The ThermoLase SoftLight Q-Switched Nd: YAG Laser is indicated for use with the beam-shrinking handpiece for the removal or significant reduction in intensity of black and/or blue-black tattoos. The laser, without the beam-shrinking handpiece is also indicated for use in combination with the ThermoLase supplied topical lotion in removing or lightening unwanted facial or body hair and for laser skin resurfacing.
The SoftLight Q-Switched Nd:YAG Laser Tattoo Removal System consists of the laser device and a beam-shrinking handpiece which is attached to the aperture of the laser. The handpiece focuses the beam from the laser. The absorption of energy from the beam by the dyes in the tattoo results in the formation and liberation of mechanical and heat energy sufficient to lighten the pigment of the tattoo.
The provided text describes the 510(k) premarket notification for the ThermoLase SoftLight™ Laser Tattoo Removal system, which received clearance in 1999. The information primarily focuses on the device's technical specifications and intended use, with limited details on the study design for its performance data beyond a brief mention of "clinical trials." The acceptance criteria are not explicitly stated as quantitative metrics.
Here's an attempt to extract and organize the requested information based on the provided text:
Acceptance Criteria and Device Performance for Laser Tattoo Removal
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety Assessment: No safety issues after multiple treatments. | "Clinical trials... showed no safety issues." |
| Effectiveness: Reduce intensity of black and/or blue-black tattoos. | "The treatments were shown to reduce the intensity of tattoos in the treated areas." |
Note: The acceptance criteria are inferred from the safety and efficacy statements in the "Performance data" section. Specific quantitative thresholds (e.g., a percentage reduction in tattoo intensity) are not provided in the document.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document only mentions "Clinical trials involving human subjects."
- Data Provenance: The trials involved "human subjects" but the country of origin is not specified. The text doesn't indicate if the study was retrospective or prospective, but clinical trials involving treatments and follow-up are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC study was not described. The document focuses on the device's direct effect on tattoos, not on comparing human readers' performance with and without AI assistance (as AI assistance is not part of this device).
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable as this is not an AI-assisted device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, in the sense that the device's performance was evaluated for its direct effect on tattoos. The "Performance data" section describes the device's standalone action of reducing tattoo intensity on human subjects, without mention of a human-in-the-loop component for this specific indication.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for effectiveness appears to be a subjective assessment of "reduction in intensity" of tattoos. It's likely based on visual assessment by clinicians or potentially patient-reported outcomes, but the specific method (e.g., standardized photography, scoring scales) is not detailed. It is mentioned that "no safety issues" were observed, implying clinical observation as the ground truth for safety.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not provided. This device is a laser system, not an AI model requiring a training set in the conventional sense. The "training" would refer to engineering and design iterations rather than data training.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. This question is relevant for AI/machine learning models, not for a laser device. The "ground truth" during device development would be related to engineering specifications and preclinical testing, which are not outlined here.
§ 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.