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510(k) Data Aggregation
(125 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-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 240-750 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 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 an analysis of the acceptance criteria and study detailed in the provided text, formatted as requested:
Acceptance Criteria and Device Performance Study for PicoWay Laser System
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the clinical study. Instead, it reports specific outcomes and compares them to expectations based on predicate devices. I have inferred the implied performance goals based on the reported favorable safety profile and substantial clearance for tattoo removal, aligning with the "perfoRMS as intended" declaration.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Favorable Safety Profile | No device-related serious adverse events. Mild erythema, edema, and pinpoint bleeding observed (anticipated responses). None to moderate discomfort/pain, consistent with predicate. No adverse events in additional Resolve handpiece studies (114 subjects). |
| Substantial Clearance of Blue and Green Tattoos (785nm) | 100% of tattoos correctly identified as pre/post-treatment by 3 blinded reviewers. 83% of blue/green tattoos demonstrated at least 50% clearance compared to baseline after only 2 treatments. Investigator assessment: 83% (15/18) of blue/green tattoos achieved substantial to complete clearance. |
| Equivalent Performance to Predicate Devices (Safety & Efficacy) | Study results did not present any new types of safety questions compared to predicate devices. Histological evaluation shows effects on treated area using picosecond laser energy with Resolve handpieces are equivalent between PicoWay and PicoSure devices. |
| Electrical Safety & EMC Conformance | Conforms 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 predicate). |
| Software Verification & Validation | Testing results found acceptable for software release. |
| Bench Testing (Energy Measurements) | Met specifications. |
| Bench Testing (Resolve Handpiece efficacy)* | Clears pigment particles similarly to previously cleared Zoom handpiece. 100 pulses of PicoWay 785nm resulted in greater ink clearance than 200 pulses of another legally marketed device. Achieved ink particle fracturing/de-aggregating pigment particles in a substantially equivalent manner to other systems. |
Note: The bench testing on Resolve handpiece efficacy is an important performance indicator, even if not phrased as a "criterion" in the same way as safety or clinical clearance percentages.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 15 subjects (22 tattoos).
- Data Provenance: The document does not explicitly state the country of origin. It describes the study as a "single arm, self-controlled study," implying it was a prospective clinical trial conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: 3 blinded reviewers.
- Qualifications of Experts: Not specified. The document only states "independent review by 3 blinded reviewers."
4. Adjudication Method for the Test Set
- Method: Not explicitly described as part of an adjudication process in the traditional sense for determining "ground truth." The reviewers "correctly identified the pre and post treatment for all (100%) of the tattoos," suggesting their role was to evaluate the visibility of change rather than to establish a definitive, gold-standard diagnosis or measurement. The percentage clearance was likely based on a subjective rating scale or objective measurement method applied to the images, with the reviewers' agreement confirming the detectability of this change.
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 MRMC study was done. This study evaluated the performance of the device itself (PicoWay Laser System) and not an AI-assisted diagnostic tool or human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a laser system, not an algorithm. The clinical study evaluated the device's efficacy and safety on patients, not its performance as a standalone diagnostic tool.
7. The Type of Ground Truth Used
- For Tattoo Clearance: The "ground truth" for tattoo clearance appears to be a combination of:
- Blinded Expert Assessment: Independent review by 3 blinded reviewers who confirmed identify pre/post-treatment images.
- Quantitative/Semi-Quantitative Clinical Assessment: "At least 50% clearance compared to baseline" (how this was measured isn't detailed, but implies a scoring system).
- Investigator Assessment: "Substantial to complete clearance" assessed by the clinical investigators.
- For Safety: Clinical observation of adverse events and patient discomfort.
- For Technological Equivalence: Histological evaluation.
8. The Sample Size for the Training Set
- Not applicable. The document describes clinical studies conducted to evaluate the device, not to train a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As no training set for an AI/algorithm is discussed, this question is not relevant.
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