(255 days)
The Picocare is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm
The 1064 nm wavelength of the Picocare system is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).
532 nm
The 532 nm wavelength of the Picocare system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
The Picocare is the solid state laser capable of delivering energy at wavelengths of 1,064 nm or 532 nm at short durations of 750 ps (picoseconds). 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.
This document is a 510(k) premarket notification for the Picocare laser system, indicating its substantial equivalence to a predicate device. It primarily focuses on the technical and safety aspects, rather than clinical efficacy studies with specific acceptance criteria as might be seen for AI/software-as-a-medical-device (SaMD) products.
Therefore, the requested information, particularly regarding acceptance criteria, device performance tables, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC comparative effectiveness studies, is not explicitly provided in the provided text.
The document details non-clinical tests to verify the device's technical specifications and safety, indicating that performance was assessed against design specifications and relevant international standards.
Here's a breakdown of what can be inferred or directly stated from the document, with caveats for missing information:
1. Table of Acceptance Criteria and Reported Device Performance
Specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and a table of reported device performance in those terms are not provided. The document states that "Bench tests were conducted to verify that the proposed device met all design specifications" and "Following performance testing were conducted to verify that the proposed device met all design specifications including pulse energy, pulse width, wavelength spectrum, beam profile, spot size, and repetition rate." This implies that the device's measured technical parameters (pulse energy, pulse width, etc.) were within the specified design ranges, but the exact ranges and measured values are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a laser device, not an AI/SaMD. Therefore, there are no "test sets" in the context of clinical data for algorithmic performance. The tests mentioned are for non-clinical performance and safety of the laser hardware and software.
- Sample Size for performance tests: Not specified. It generally refers to the number of units or measurements performed to verify technical specifications.
- Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed on the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for a laser device's technical performance is typically established by engineering standards and validated measurement equipment, not by medical experts.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for subjective interpretations of clinical data, which is not the focus of this document for a laser device's technical performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. An MRMC comparative effectiveness study is used to assess the impact of AI on human reader performance, which is not relevant for this laser device's technical performance and safety submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document mentions "Software Validation" and states "The Picocare contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated." This indicates a standalone validation of the software components was performed, but the specific performance metrics (e.g., accuracy of internal calculations, control logic) are not detailed.
7. The Type of Ground Truth Used
For the non-clinical tests described:
- Engineering Specifications: For pulse energy, pulse width, wavelength spectrum, beam profile, spot size, and repetition rate.
- International Standards: For electrical safety (IEC 60601-1, 60601-1-2, 60601-2-22), laser safety (IEC 60825-1), and biocompatibility (ISO 10993-5, ISO 10993-10).
8. The Sample Size for the Training Set
Not applicable. This is a hardware device with software, not a machine learning model that undergoes a "training set" in the common AI/ML sense for clinical applications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.