(86 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 Resolve handpieces are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
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 240–750 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 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 handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System (up to 10 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 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.
The provided text describes the FDA 510(k) summary for the PicoWay Laser System, primarily focusing on its expansion of indications for use to include the treatment of wrinkles.
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
Expanded Indication: Treatment of wrinkles using the Resolve handpieces (532nm or 1064nm wavelengths)
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Endpoint Criterion) | Reported Device Performance |
|---|---|
| 80% of treated areas showing improvement in wrinkles appearance, as assessed by the correct identification of the post-treatment photograph and assessment of at least one Elastosis Score unit. | 82% of treated areas showed improvement in wrinkles appearance (exceeding the primary endpoint criterion). |
| Additional findings: |
- Investigator assessments: 92% improvement rate at 12-week follow-up.
- Mean elastosis score improvement: 1.44 ± 0.83.
- Investigator satisfaction rate: 88%.
- Subjects' satisfaction rate: 74% at the last visit.
- Very positive safety profile with no adverse events (though 2 subjects reporting severe pain were counted as AEs out of caution, but resolved next day without intervention).
- Anticipated treatment responses (erythema, edema, tingling, crusting, acne breakout) observed and resolved within days without medical intervention.
- Most subjects reported low levels of pain during treatment and discomfort in the week following treatment, indicating good tolerability. |
Study Details:
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Sample Size and Data Provenance:
- Test Set Sample Size: A total of 74 subjects were enrolled, and 72 subjects were treated.
- Data Provenance: The study was a "multicenter study conducted at 4 sites in the United States." The data is prospective.
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Number and Qualifications of Experts for Ground Truth:
- Number of Experts: Two blinded evaluators.
- Qualifications: Not explicitly stated beyond "blinded evaluators." It's common in dermatology/cosmetic studies for these to be board-certified dermatologists or plastic surgeons, but the document does not specify.
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Adjudication Method for the Test Set:
- The assessment was performed by "2 blinded evaluators." The text implicitly suggests consensus or independent agreement was sought for the "correct identification of the post treatment photograph and assessment of at least one Elastosis Score unit." However, a formal adjudication process like 2+1 or 3+1 is not explicitly described. It simply states "as assessed by 2 blinded evaluators," implying their combined assessment formed the ground truth for the primary endpoint.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was conducted for human readers with and without AI assistance. This device is a laser system, not an AI diagnostic tool that assists human readers. The clinical study was a direct evaluation of the device's effect on wrinkles.
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Standalone Performance (Algorithm Only):
- N/A. This is a hardware device (laser system) used for treatment, not an algorithm for diagnosis or image analysis. The "performance" here refers to the clinical efficacy and safety of the physical device.
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Type of Ground Truth Used:
- The ground truth for the primary endpoint was established by expert assessment ("2 blinded evaluators") based on "correct identification of the post treatment photograph and assessment of at least one Elastosis Score unit." This is a subjective, observer-reported outcome measure in a clinical setting.
- Additional ground truth indicators included investigator assessments, subject satisfaction, and adverse event reporting.
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Sample Size for the Training Set:
- N/A. This is a medical device (laser system), not a machine learning algorithm that requires a separate training set. The study describes a clinical trial evaluating the device's performance directly on human subjects.
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How the Ground Truth for the Training Set Was Established:
- N/A. (See point 7).
§ 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.