(153 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.
785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
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 Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm, 785 nm, or 532 nm at short durations of 240-540 picoseconds (ps) at repetition rates up to 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm). The device system is comprised of a system console, an articulated arm, and an attached Zoom or Resolve 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 Handpiece. The light-weight and ergonomic Zoom Handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System when using the Zoom Handpiece (up to 10 mm). The Resolve Handpieces are available with 6 x 6 mm spot size for both wavelengths. 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 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 a breakdown of the acceptance criteria and study findings for the PicoWay Laser System, based on the provided text:
Acceptance Criteria and Device Performance
| Criteria | Reported Device Performance |
|---|---|
| Improvement in acne scar appearance (Primary Endpoint) | 94% of treated areas showed improvement, exceeding the 70% criterion. |
| Mean improvement level | 1.17, exceeding the 1 unit improvement defined in the primary endpoint. |
| Safety Profile | Very positive safety profile; no adverse events during the study. |
| Resolution of anticipated treatment responses | Erythema, edema, tingling, pinpoint bleeding, crusting, and acne breakout resolved within days. |
| Pain and discomfort levels | Low levels of pain during treatment and discomfort in the week following treatment. |
| Investigator satisfaction rate | 89% at the last visit. |
| Subject satisfaction rate | 78% at the last visit. |
| Performance to specifications | All performance testing demonstrated the device performs according to specifications and functions as intended. |
| Conformity with electrical safety and EMC standards | Conformed to IEC 60601-1, IEC 60601-1-2, IEC 62366, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1. |
| Biocompatibility | Established per ISO 10993 guidelines, based on the predicate device. |
| Software Validation | Software verification and validation testing results were acceptable. |
| Bench Testing (energy measurements) | Verified that energy measurements met specifications. |
Study Details
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 36 subjects.
- Data Provenance: Prospective, from 3 sites in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: 3 blinded evaluators.
- Qualifications: The document does not specify the exact qualifications (e.g., "radiologist with 10 years of experience"). It only states they were "blinded evaluators" who assessed improvement by "correct identification of the post treatment photograph."
4. Adjudication Method for the Test Set:
- A consensus-like method was used: "as assessed (by the correct identification of the post treatment photograph) by at least 2 of 3 blinded evaluators." This implies that agreement from at least two out of three evaluators was sufficient for a positive assessment.
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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing AI assistance to human readers was not done. This study solely evaluated the device's performance based on expert assessment of photographs. This device is a laser system, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (laser system), not a standalone algorithm. Its performance is directly tied to its physical operation and the in-human results.
7. The Type of Ground Truth Used:
- Expert Consensus: The primary endpoint relied on the consensus of at least 2 out of 3 blinded evaluators assessing photographic improvement.
- Investigator Assessments: Investigators also provided assessments of improvement rates.
- Patient Reported Outcomes (PROs): Subject satisfaction rates were collected.
- Histology Data: Biopsy samples provided histological evidence of treatment effects and healing.
8. The Sample Size for the Training Set:
- The document refers to "several prospective studies" that have been conducted previously to evaluate the PicoWay System, suggesting a broader dataset exists. However, for the specific expanded indication (acne scars), no separate "training set" is described for this premarket notification. The 36-subject study appears to be the primary clinical evidence for this specific indication.
9. How the Ground Truth for the Training Set Was Established:
- As no explicit "training set" for the acne scar indication is detailed in this document, the method for establishing its ground truth is not provided. For the test set described, ground truth was established through blinded evaluators' consensus, investigator assessments, and histological data.
§ 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.