(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-V) to treat the following tattoo colors: black, brown, green, blue, and purple.
The PicoWay Laser System is a solid state laser capable of delivering energy at waveleneths of 1064 nm or 532 nm at short durations of 240-750 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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: PicoWay Laser System
Intended Use: Removal of tattoos for specific Fitzpatrick skin types and tattoo colors at 532nm and 1064nm wavelengths.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effectiveness: At least 50% tattoo clearance (score ≥3) after 3, 6, or 9 treatments OR at 3 months post final treatment, as agreed by at least 2 of 3 evaluators. | 86% of treated tattoos achieved at least 50% clearance after 3 treatments. (Primary effectiveness endpoint met) |
| Safety: Low rate of occurrence and severity of adverse events; no serious adverse events; no subjects discontinued due to adverse events; occurrence and severity of adverse events do not increase with additional treatments. | Low rate of adverse events: Only 9 subjects with device-related adverse events out of 391 treatments performed. |
| No serious adverse events. | |
| No subjects discontinued due to adverse events. | |
| Occurrence and severity of adverse events did not increase with additional treatments. | |
| None or mild responses observed for nearly all treatment-associated responses. | |
| Consistent trend of low levels of pain/discomfort. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 60 subjects with 75 tattoos.
- Data Provenance: Prospective, self-controlled multicenter study conducted at 3 investigational sites in the U.S.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Three blinded independent evaluators.
- Qualifications: Not specified in the provided text (e.g., "radiologist with 10 years of experience" is not mentioned).
4. Adjudication Method for the Test Set
- Adjudication Method: Agreement by at least 2 of the 3 evaluators for the primary effectiveness endpoint. This is a 2-out-of-3 consensus method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done comparing human readers with and without AI assistance. The study focused on the standalone performance of the PicoWay Laser System.
6. If a Standalone Study (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 device, not as an AI-powered diagnostic aide for human readers. While human evaluators assessed the tattoo clearance, their role was to establish the outcome of the device's treatment, not to be augmented by or compared against an AI algorithm performing a diagnostic task.
7. The Type of Ground Truth Used
- Ground Truth Type: Expert consensus (three blinded independent evaluators assessing global percent tattoo clearance based on photographs and clinical observation).
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. This device is a laser system, not an AI/ML algorithm that requires a "training set" in the conventional sense for model development. The "training" here refers to the engineering and manufacturing of the device itself rather than data for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided. As explained above, this isn't an AI/ML algorithm requiring a data-driven training set. The device's "ground truth" for its performance specifications would be established through a combination of engineering specifications, bench testing, and clinical validation against established medical standards.
§ 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.