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510(k) Data Aggregation
(60 days)
The PICOCAREMAJESTY is indicated for the following at the specified wavelength:
· 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I - VI) to treat the following tattoo colors: black,brown, green, blue and purple.
· 532 nm: Removal of tattoos for Fitzpatrick skin types I · III to treat the following tattoo colors: red, yellow and orange.
· Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.
The PICOCAREMAJESTY is the solid state laser capable of delivering energy at wavelengths of 1064mm or 532nm at short durations. The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm delivery system terminated by the handpiece. The fluence (energy density) and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
For treatment, the user can select the appropriate fluence value. (The treatmented is provided in the user Manual) The energy is changed automatically in accordance with the selected fluence (down) button and then, the fluence is increased / decreased by 0.1 J/cm2.
The selectable fluence values are 0.2 to 10.0 J/cm2 at 1064nm and 0.1 to 2.5 J/cm2 at 532nm
The provided text is a 510(k) summary for the WON TECH Co., Ltd. Picosecond Nd:YAG Laser (PICOCAREMAJESTY). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a novel device, especially not data related to complex AI algorithms or diagnostic accuracy studies.
Therefore, many of the specific details requested in your prompt, particularly those related to AI algorithm performance, human-in-the-loop studies, ground truth establishment, and training/test set sample sizes, are not present in this document. The device in question is a laser for tattoo and pigmented lesion removal, which typically undergoes performance testing based on physical parameters, and electrical/software safety, rather than diagnostic accuracy studies with expert readers.
However, I can extract information related to what is available in the document:
Acceptance Criteria and Device Performance (Based on provided documentation's summary of testing):
The document primarily relies on comparisons to predicate devices and adherence to established safety and performance standards for laser surgical instruments. It doesn't present "acceptance criteria" in the sense of a statistical threshold for diagnostic accuracy for a new AI algorithm, but rather lists the device's technical specifications and verifies compliance with recognized standards.
| Acceptance Criteria (from Non-Clinical Tests) | Reported Device Performance (from "Performance Testing") |
|---|---|
| Electrical Safety & EMC Compliance: | Complies with: |
| - ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 | - Met basic safety and essential performance requirements. |
| - ANSI AAMI IEC 60601-1-2:2014 | - Met electromagnetic compatibility requirements. |
| - IEC 60601-1-6 Edition 3.1 2013 | - Met usability requirements. |
| - IEC 60601-2-22 Edition 3.1 2012-10 | - Met specific requirements for surgical, cosmetic, therapeutic, and diagnostic laser equipment. |
| - IEC 60825-1:2014 (Third Edition) | - Met laser product classification and safety requirements. |
| Software Validation: | |
| - Moderate level of concern software verified and validated. | - Software designed and developed according to a software development process and was verified and validated. |
| Biocompatibility: | |
| - Handpiece material (Aluminium Powder) biocompatible for intact skin, limited contact (<24 hours). | - Material is the same as previous cleared devices; deemed biocompatible. |
| Performance Testing: | |
| - Laser wavelength: 1064nm±10%, 532nm±10% | - 1064nm±10%, 532nm±10% |
| - Laser output power: | |
| - 1064nm mode: (30 to 500)mJ | - 1064nm mode: (30 to 500)mJ |
| - 532nm mode: (20 to 250)mJ | - 532nm mode: (20 to 250)mJ |
| - Pulse Width: | |
| - 1064nm mode: 300-400 ps | - 1064nm mode: 300-400 ps |
| - 532nm mode: 300-400 ps | - 532nm mode: 300-400 ps |
| - Pulse repetition rate: | |
| - 1064nm mode:1-10Hz | - 1064nm mode:1-10Hz |
| - 532nm mode: 1-10Hz | - 532nm mode: 1-10Hz |
| - Radiation diameter: | |
| - 1064mm mode: (2 to 10mm) step: 1mm | - 1064mm mode: (2 to 10mm) step: 1mm |
| - 532nm mode: (2 to 10mm) step: 1mm | - 532nm mode: (2 to 10mm) step: 1mm |
Missing Information and Why it's Not Applicable/Present:
The prompt asks for details typically found in submissions for Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices, particularly those for diagnostic purposes. This 510(k) pertains to a physical laser device for tattoo and lesion removal, which does not employ AI for decision-making or diagnosis. Therefore, the following information is not covered in this document:
- Sample sizes used for the test set and data provenance: No test set in the context of diagnostic accuracy is described. Performance is based on bench testing of physical parameters.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as there's no diagnostic component or "ground truth" to establish for a test set in this context.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not AI-enabled, nor is it a diagnostic aid for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable as there is no AI model being trained.
- How the ground truth for the training set was established: Not applicable.
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