(66 days)
The PicoWay Laser System is indicated for the following at the specified wavelength:
532nm; Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
The PicoWay Laser System is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm at short durations less than or equal to 900 picoseconds (ps) at repetition rates up to 5 Hz. The device system is comprised of a system console, an articulated arm, and an attached handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a zoom handpiece (HP). The light-weight and ergonomic zoom handpiece allows the spot size on the skin to be easily adjusted from 3 mm to 6 mm in steps of 1 mm. The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the laser beam into the articulated arm. The PicoWay system control panel enables the user to select the desired energy density (fluence) level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
The PicoWay Laser System was evaluated for its safety and effectiveness in the removal of benign pigmented lesions.
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Efficacy Endpoint: | More than 70% of treated pigmented lesions achieve 50% or more clearance at the primary endpoint visit. | Successfully met. The clinical study demonstrated that more than 70% of the treated pigmented lesions achieved 50% or more clearance at the primary endpoint visit, based on blinded, independent review. Additional statistical analyses supported the robustness of these results. |
| Investigator Assessments of Clearance: | Substantial degree of pigmented lesions clearance. | Successfully met. Consistent with the primary endpoint, investigator assessments similarly demonstrated a substantial degree of pigmented lesions clearance. |
| Subject Pain Assessment: | Generally considered low pain. | Successfully met. Subject assessments confirmed that the device treatment was generally considered low pain. |
| Subject Satisfaction: | Trended towards overall satisfaction with treatment. | Successfully met. Available satisfaction data from subjects trended towards overall satisfaction with treatment. |
| Device-Related Serious Adverse Events (SAEs): | No device-related serious adverse events. | Successfully met. No device-related serious adverse events were reported. There were no deaths and no withdrawals due to adverse events. |
| Adverse Events (AEs): | Number and severity of AEs should be acceptable and resolve/improve. | Successfully met. Out of 107 treatments, only 3 adverse events were reported for 2 subjects. These events were not severe and resolved or improved during the study. Anticipated treatment-associated responses did not present new safety questions compared to predicate devices. |
| Overall Safety and Effectiveness: | Favorable safety and effectiveness profile similar to predicate devices. | Successfully met. The study demonstrated a strong safety profile and clinical performance comparable to predicate devices, supporting the conclusion of similar safety and effectiveness. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: 26 subjects (29 lesions)
- Data Provenance: Retrospective or prospective is not explicitly stated, but the study is described as a "single arm, prospective, self-controlled multicenter study," indicating a prospective design for data collection. The country of origin of the data is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "blinded, independent review" for assessing lesion clearance. However, the exact number of experts and their specific qualifications (e.g., radiologist with X years of experience) are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document states "blinded, independent review." It does not specify a particular adjudication method like 2+1 or 3+1.
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 human readers with and without AI assistance was not done. This study solely evaluated the performance of the PicoWay Laser System as a standalone treatment device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The clinical study evaluated the PicoWay Laser System's performance as a treatment device, not as an AI algorithm assisting human readers. The "algorithm" in this context refers to the laser system's operating parameters and its direct effect on the lesions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for efficacy was primarily based on blinded, independent review of lesion clearance, which implies expert assessment.
- For safety, the ground truth was based on the occurrence and severity of adverse events and their resolution, which is outcomes data gathered from clinical observations.
8. The sample size for the training set:
- The document does not mention a training set as this is a clinical study for a medical device (laser system), not an AI algorithm requiring a machine learning training phase. The device itself is the "intervention" being tested.
9. How the ground truth for the training set was established:
- As there is no mention of a training set for an AI algorithm, this question is not applicable.
§ 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.