(185 days)
The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure™ workstation with the 3mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.
The PicoSure™ workstation is a high powered Alexandrite system that delivers laser energy in the 755-nm wavelength. The system consists of a console that houses the power supply, control electronics and the laser. Laser energy is delivered to the skin via an articulated arm. The laser is activated using a footswitch.
The provided text describes the Cynosure Picosure™ Workstation and its indications for use. It includes a summary of clinical study findings related to the device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correct identification of post-treatment photograph in 80% or greater of subjects. | The three blinded evaluators correctly identified the "before" and "after" images in 91% of the 38 subjects who returned for 4-month evaluation. This meets the 80% or greater criterion. |
| Fitzpatrick Wrinkle Severity Scale (FWSS) improvement score of "1" or greater at four months. | The mean improvement score using the Fitzpatrick Wrinkle Severity Scale at four months was 1.2. This meets the "1" or greater criterion. |
| No deaths, serious adverse events (SAEs), or unanticipated adverse device effects (UADEs). | No deaths, serious adverse events (SAEs), or unanticipated adverse device effects (UADEs) were reported in this study. The events that were logged were typical reactions to laser treatments. This criterion was met. |
2. Sample size used for the test set and the data provenance
- Sample Size for the Test Set:
- The study included 40 subjects.
- 38 subjects returned for the 4-month evaluation, which is the test set for the photo and FWSS evaluations.
- Data Provenance: The document does not specify the country of origin. The study was conducted as a prospective clinical trial, as evidenced by "before and after" evaluations and follow-up at 4 months post-treatment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Three blinded evaluators were used.
- Qualifications of Experts: The document does not specify the qualifications of these evaluators (e.g., dermatologists, plastic surgeons, years of experience).
4. Adjudication method for the test set
- The document implies a consensus or independent evaluation method, as it states "three blinded evaluators, who were able to identify correctly the before and after images in 91% of the 38 subjects." It doesn't explicitly state an adjudication method like 2+1 or 3+1 for discrepancies, but given the high agreement (91%), it might not have been a significant issue or simply not detailed in this summary. It appears each evaluator made an independent judgment, and the percentage reflects the overall agreement across all three for the majority of cases.
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, an MRMC comparative effectiveness study involving AI assistance was not done. The study evaluated the effectiveness of the laser device itself, with human evaluators assessing the outcome of the treatment without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm-only performance study was not done. The primary focus was on the efficacy of the Picosure™ Workstation when applied to human subjects, with human evaluators determining the success of the treatment.
7. The type of ground truth used
- The ground truth for the effectiveness of the treatment was established by expert assessment of photographs (for correct identification of before/after images) and the Fitzpatrick Wrinkle Severity Scale (FWSS) scores, also assessed by experts, indicating a clinical improvement. Safety ground truth was based on reported adverse events.
8. The sample size for the training set
- This document describes a clinical study to demonstrate the effectiveness of the medical device as a treatment. It is not describing the development or validation of an AI algorithm, so there is no mention of a training set in the context of machine learning. The "training set" for the device's efficacy would be considered the prior research and development that led to the device's design, but this is not a data set in the AI sense.
9. How the ground truth for the training set was established
- As there is no AI algorithm being described, there is no training set ground truth in the context of an AI algorithm. The device's "ground truth" for its intended performance is based on the underlying scientific principles of laser-tissue interaction and prior clinical research on similar technologies, not on a labeled dataset for an algorithm.
§ 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.