(207 days)
The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal.
The PicoSure™ workstation is a high-powered, laser system that delivers energy in the 755-nm wavelength. Same as its predicates, the PicoSure™ workstation is intended for tattoos and benign pigmented lesions removal. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed.
The provided document is a 510(k) summary for the PicoSure™ workstation, a laser surgical instrument for tattoo and benign pigmented lesion removal. It describes the device's intended use, technological characteristics, and performance data from non-clinical and clinical studies. However, the document does not explicitly state predefined acceptance criteria for the clinical studies nor detailed quantitative results against such criteria. It provides a general statement of "safety and effectiveness" and "high level of overall tattoo clearance." Therefore, some of the requested information cannot be fully extracted or will be based on inference.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state quantitative acceptance criteria for clinical effectiveness. It broadly states the device was found "safe and effective, with high level of overall tattoo clearance." For safety, it states "All treatment arms had a comparable safety profile. None of the events were classified as adverse device reaction. No serious or unexpected adverse events were reported."
| Acceptance Criteria (Inferred from study goals) | Reported Device Performance |
|---|---|
| Effectiveness (Tattoo Clearance) | - "High level of overall tattoo clearance" |
- "Demonstrated more significant % of highest clearance score than control device in controlled studies" |
| Safety (Adverse Events) | - "Comparable safety profile" across treatment arms - No adverse device reactions
- No serious or unexpected adverse events
- Majority of AEs were mild, no severe AEs
- Most common AEs: pain and blistering |
| User Satisfaction | - "Extreme" physician satisfaction (physician evaluation) - Subject satisfaction surveyed and analyzed (no specific results provided) |
2. Sample Size and Data Provenance for Test Set
- Sample Size (Clinical Studies): Not explicitly stated. The document mentions "Three clinical studies (two controlled and one uncontrolled)," but does not provide the number of subjects or lesions included in these studies.
- Data Provenance: Not explicitly stated. The document does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of clinical trials for device approval, it is highly likely the studies were prospective.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The evaluation of tattoo clearance was done by "evaluation of before-and-after photos and calculation the % of tattoo clearance." Physician satisfaction was also surveyed. It can be inferred that treating physicians or other qualified medical personnel were involved in these assessments, but their specific qualifications (e.g., dermatologists, years of experience) are not provided.
4. Adjudication Method for Test Set
- Adjudication Method: Not explicitly stated. The document mentions "evaluation before-and-after photos and calculation the % of tattoo clearance." It does not describe any specific adjudication process like 2+1 or 3+1 for discrepancies in evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: Not explicitly mentioned. The clinical studies involved "two controlled studies" where the device "demonstrated more significant % of highest clearance score than control device." This suggests a comparison between the PicoSure™ workstation and a control (likely another laser device or a sham treatment). However, it does not describe a setting where human readers interpret images with and without AI assistance. The PicoSure™ workstation itself is a laser device, not an AI for image interpretation. Therefore, a traditional MRMC study comparing human readers with and without AI assistance is not applicable in this context.
- Effect Size of Human Readers with AI vs. without AI: Not applicable, as this is not an AI-based diagnostic/interpretive device.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Not applicable. The PicoSure™ workstation is a physical laser device for treatment, not an algorithm for standalone diagnostic performance.
7. Type of Ground Truth Used
- Type of Ground Truth: The effectiveness was assessed by "evaluation before-and-after photos and calculation the % of tattoo clearance." For safety, "Treatment-emergent adverse events were recorded and evaluated." This indicates that clinical assessment (visual clearance from photos) and reported adverse events/clinical observations served as the ground truth for effectiveness and safety, respectively. There is no mention of pathology or outcomes data beyond the clinical observations.
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable. The PicoSure™ workstation is a physical laser device, not a machine learning model that requires a training set. The clinical studies mentioned are for validation of the device's safety and efficacy, not for training an algorithm.
9. How Ground Truth for Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for a machine learning model.
§ 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.