(263 days)
The PicoSure™ workstation is indicated for tattoo and benign pigmented lesion removal.
The PicoSure™ workstation operating with the 3mm or 6mm handpiee and the FOCUS lens array is indicated for the treatment of acne scars in Fitzpatrick skin types I-IV.
The PicoSure™ workstation is a high-powered, Q-switched 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 document describes the PicoSure™ Workstation, a laser system indicated for tattoo and benign pigmented lesion removal, and for the treatment of acne scars when operating with specific handpieces and the FOCUS lens array. The document presents two clinical studies to support the safety and effectiveness of the device for acne scar treatment. Below is an analysis of the acceptance criteria and study data based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (Acne Scars Study) |
|---|---|
| Efficacy - Improvement in Acne Scars | Mean Improvement Score (scale 0-3): 1.9 |
| Evaluator Identification Rate | Blinded Evaluators' Correct Identification of Before/After Photos: 70% of 17 subjects |
| Physician Satisfaction Rate | Non-blinded Treating Physician Overall Satisfaction: 100% (47% "satisfied", 53% "extremely satisfied") |
| Subject Satisfaction Rate | Subjects' Overall Satisfaction: 87% (53% "satisfied", 27% "extremely satisfied") |
| Safety - Tissue Response | - Immediate Post-treatment: Focal epidermal vacuolization and small foci of degenerated keratinocytes. |
- 7 and 15 Days Post-treatment: Intact epidermis with mild, superficial dermal lymphocytic infiltrates in peri-vascular pattern. (This indicates localized and transient tissue response, which is generally acceptable for laser procedures.) |
Note: The document does not explicitly state pre-defined acceptance criteria values for these metrics. The reported performance implies these results were considered sufficient to demonstrate substantial equivalence.
2. Sample Size and Data Provenance for the Test Set
-
Acne Scars Study (Clinical Study 1):
- Sample Size (Test Set): 17 patients completed the study, with a total of 46 acne scars treated.
- Data Provenance: The document does not explicitly state the country of origin. It is a prospective clinical study, as it describes treatment and follow-up observations.
-
Tissue Response Study (Clinical Study 2):
- Sample Size (Test Set): 3 subjects (2 on arm, 1 on leg).
- Data Provenance: The document does not explicitly state the country of origin. It is a prospective clinical study, as it describes treatment and subsequent biopsies.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
-
Acne Scars Study:
- Number of Experts: Three blinded evaluators.
- Qualifications: The specific qualifications (e.g., radiologist, years of experience) of these evaluators are not specified in the provided text. They were described as "blinded evaluators."
-
Tissue Response Study:
- Number of Experts: Not explicitly stated for establishing ground truth from biopsies, but biopsies would typically be analyzed by pathologists.
- Qualifications: Not specified.
4. Adjudication Method for the Test Set
- Acne Scars Study: The method for reaching consensus among the three blinded evaluators regarding the "before and after images" or for determining the "mean improvement score" is not explicitly detailed. It can be inferred that their evaluations were aggregated, but the specific adjudication (e.g., voting, expert consensus meeting) is not described.
- Tissue Response Study: For the biopsy analysis, an adjudication method is not detailed. Typically, a qualified pathologist would interpret the biopsies, and potentially a second opinion might be sought for complex cases, but this is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A formal MRMC comparative effectiveness study, comparing human readers with AI assistance versus without AI assistance, was not performed, nor is it applicable to this device. The PicoSure Workstation is a laser device, not an AI diagnostic or assistance tool for human readers. The study involved human evaluators assessing photographic outcomes of a treatment device.
6. Standalone Performance
- A standalone (algorithm only without human-in-the-loop performance) study was not applicable and therefore not conducted. The PicoSure Workstation is a physical laser device used for treatment, not a standalone AI algorithm.
7. Type of Ground Truth Used
- Acne Scars Study: The ground truth for effectiveness was based on:
- Expert Consensus/Opinion: Evaluations by three blinded evaluators of before/after photographs.
- Subjective Satisfaction: Non-blinded treating physician's satisfaction scores and subjects' self-reported satisfaction.
- Tissue Response Study: The ground truth for safety (tissue response) was based on Pathology via biopsies taken at various time points after treatment.
8. Sample Size for the Training Set
- The document describes clinical studies used to assess the performance of the device, not to train an AI algorithm. Therefore, a "training set" in the context of machine learning is not applicable to this device and its studies. The clinical studies served as validation for the device's efficacy and safety.
9. How the Ground Truth for the Training Set Was Established
- As a training set for an AI algorithm is not applicable, the method for establishing its ground truth is not relevant to the information provided. The "ground truth" discussed in the context of these studies refers to the outcomes measured in the clinical trials themselves by evaluators, physicians, and pathological examination.
§ 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.