(84 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-V.
The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm at short durations of 240-750 picoseconds (ps) at repetition rates up to 10 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 skin to be easily adjusted from 2 mm to 10 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 provided FDA 510(k) summary for the PicoWay Laser System includes information regarding acceptance criteria and a clinical study to demonstrate its performance.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Endpoint Threshold) | Reported Device Performance (PicoWay Laser System) |
|---|---|
| 50% or more tattoo clearance after up to 3 treatments, based on blinded, independent review. (Endpoint threshold: 85% of treated tattoos) | 86% of the treated tattoos achieved 50% or more clearance after up to 3 treatments. |
| Favorable safety profile (no device-related serious adverse events). | No device-related serious adverse events reported. Mild adverse events all resolved. |
| Consistency with results of prior PicoWay studies. | Results of blinded review and investigator review were consistent with prior PicoWay studies. |
| (Secondary Efficacy Endpoint) At least 50% tattoo clearance after up to 3 treatments, based on investigator assessment. | 97% of subjects achieved at least 50% tattoo clearance after up to 3 treatments. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 60 subjects (69 tattoos/pigmented lesions).
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "single arm, self-controlled study." It is a prospective clinical study as it was conducted to evaluate the safety and effectiveness of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document states "blinded, independent review," implying at least one, and likely more, independent experts. The exact number of experts is not specified.
- Qualifications of Experts: The qualifications of the experts are not explicitly stated, beyond being "independent reviewers."
4. Adjudication Method for the Test Set
- The document mentions "blinded, independent review." It does not specify a formal adjudication method like "2+1" or "3+1" for discrepancies. It's implied that their assessment directly formed the basis for the primary endpoint.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This study focuses solely on the performance of the PicoWay Laser System for tattoo and benign pigmented lesion removal.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable as the PicoWay Laser System is a physical medical device (laser system), not an AI algorithm. Its performance is directly tied to its physical operation and the human operator's use of it.
7. The Type of Ground Truth Used
- Expert Consensus/Clinical Assessment: The primary endpoint was determined by "blinded, independent review" of tattoo clearance, and a secondary endpoint was based on "investigator assessment." This indicates the ground truth was established through expert clinical evaluation.
8. The Sample Size for the Training Set
- The document does not mention a "training set" in the context of an algorithm or AI. This study is a clinical trial evaluating a physical medical device. The "training set" concept is not relevant here.
9. How the Ground Truth for the Training Set was established
- Not applicable, as there is no "training set" for this device.
§ 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.