(128 days)
755mm:
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure Workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I - IV.
532mm:
The PicoSure 532mm Laser Delivery System is indicated for tattoo removal and benign pigmented lesion removal in Skin Types I - III.
1064nm:
The PicoSure 1064nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.
The PicoSureTM Workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers fast and efficient treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755nm handpiece, optional 532nm Laser Delivery System and/or 1064nm Laser Delivery System can replace the 755nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755nm laser energy into a 532nm wavelength or a 1064 nm wavelength, and are available in multiple spot sizes.
Based on the provided text, the device in question is the PicoSure Workstation, a laser system used for tattoo removal, benign pigmented lesion removal, and treatment of acne scars and wrinkles. The information related to acceptance criteria and the study that proves the device meets them primarily pertains to the 532nm Delivery System for benign pigmented lesion removal in Skin Types I-III.
Here's an analysis of the provided information to address your request:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets for device performance. Instead, it describes a clinical study designed to demonstrate the safety and effectiveness of the 532nm Delivery System for benign pigmented lesions. The "acceptance criteria" here appear to be qualitative, focused on demonstrating a high level of improvement and acceptable safety profile.
Table of Performance (Inferred from Clinical Study Results):
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (532nm Delivery System for Benign Pigmented Lesions) |
|---|---|---|
| Clinical Efficacy | Significant improvement in benign pigmented lesions | 91.1% of subjects at 1-month follow-up had a score of "1 – Very Much Improved" on the Global Aesthetic Improvement Scale (GAIS). |
| Safety | Minimal, transient, and expected adverse effects | All adverse effects were transient (resolving in 2-11 days) and in the form of reddening and blistering (expected side effects from laser treatments). No serious or unexpected adverse events reported. |
Study Information:
2. Sample Size and Data Provenance
- Test Set Sample Size: 30 treatment areas (from 15 subjects).
- Data Provenance: The document does not specify the country of origin. The study was prospective as it involved treating subjects and following them up.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three.
- Qualifications of Experts: Blinded, board-certified Dermatologists. No explicit mention of years of experience.
4. Adjudication Method for the Test Set
- The clinical efficacy endpoint was evaluated "through comparison of the pre-treatment images by three blinded, board certified Dermatologists as independent reviewers." This implies a consensus-based or independent review approach, but the specific adjudication rule (e.g., majority vote, specific tie-breaking rule if opinions differed) is not detailed beyond "independent reviewers." It wasn't 2+1 or 3+1 as stated; they were independent reviewers of the images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not done. This study is a clinical trial assessing the laser device's direct performance on patients, not an AI-assisted diagnostic or assistive tool.
6. Standalone Performance (Algorithm Only)
- This is not applicable as the device is a physical laser workstation, not an AI algorithm. The reported performance is of the physical device as operated by a clinician.
7. Type of Ground Truth Used
- The ground truth for efficacy was established through expert consensus/independent review of pre-treatment and post-treatment images by board-certified Dermatologists, coupled with the clinical investigator's evaluation using the GAIS. For safety, it was the observation and reporting of adverse events during the follow-up period.
8. Sample Size for the Training Set
- This is not applicable as the PicoSure Workstation is a physical medical device (laser) and not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "training" for such a device would be its engineering, calibration, and manufacturing processes.
9. How Ground Truth for the Training Set Was Established
- Not applicable for the same reason as point 8. The "ground truth" for the device's design and function would be based on established medical physics principles, engineering standards, and pre-clinical testing, rather than a data-driven "ground truth" for model training.
§ 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.