(28 days)
PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064nm
The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
532nm
The 532nm wavelength of the PicoLO laser system is indicated for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
The PicoLO laser system is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm). The PicoLO Nd: YAG Picosecond Laser System consists of a set of Q-switched Nd:YAG lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.
This document describes the PicoLO Nd:YAG Picosecond Laser System, a device intended for surgical and aesthetic applications in dermatology and general and plastic surgery, specifically for tattoo removal.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for the device's performance in terms of clinical outcomes (e.g., percentage of tattoo clearance). Instead, it focuses on demonstrating substantial equivalence to a predicate device (PicoWay Laser System) through technical performance data and adherence to regulatory standards.
Therefore, the "acceptance criteria" are implied by the equivalency claims and adherence to safety and performance standards. The reported device performance is presented as compliance with these standards and technical specifications comparable to the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence and Standards) | Reported Device Performance |
|---|---|
| Safety & Essential Performance | Tested and evaluated according to AAMI/ANSI ES60601-1:2005 and A1:2012. All results demonstrate general requirements for basic safety and essential performance. |
| Electromagnetic Compatibility (EMC) | Tested and evaluated per FDA-recognized consensus standard IEC 60601-1-2:2007. All results demonstrate requirements and tests for electromagnetic disturbances. |
| Usability | Tested and evaluated per FDA-recognized consensus standard IEC 60601-1-6:2010/AMD1:2013 and documented according to IEC 62366:2008. All results demonstrate usability requirements. |
| Particular Requirements for Surgical Lasers | Tested and evaluated per FDA-recognized consensus standard IEC 60601-2-22:2007 (Third Edition) + A1:2012. All results demonstrate particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment. |
| Laser Product Safety Classification & Requirements | Evaluated per IEC 60825-1:2014. All results demonstrate equipment classification and requirements. |
| Risk Management | Recorded according to FDA-recognized consensus standard ISO 14971:2012. All results demonstrate the application of risk management to medical devices. |
| Biocompatibility | Tested and evaluated per FDA-recognized consensus standard ISO 10993-5:2009 and ISO 10993-10:2010. |
| Technical Characteristics (vs. Predicate K170597 PicoWay Laser System) | Wavelengths: 1064nm, 532nm (The proposed device produces these two wavelengths, which are within the scope of the predicate's 532nm, 1064nm, and 785nm wavelengths). |
| Pulse Duration: 450ps (1064nm), 380ps (532nm) (Accuracy ±20%) - Similar to predicate's 450ps (1064nm), 375ps (532nm). | |
| Pulse Energy (max): 500mJ (1064nm), 350mJ (532nm) (Accuracy ±20%) - Comparable to predicate's 400mJ (1064nm), 200mJ (532nm). | |
| Peak Power (Gigawatts): 1.1 - Comparable to predicate's Up to 0.9. | |
| Repetition Rate: Single, M3, M5, 1-10Hz (Accuracy: ±20%) - Similar to predicate's Single, 1-10 Hz. | |
| Laser Type: Q-switched Nd:YAG Laser - Matches predicate. |
2. Sample size used for the test set and the data provenance:
The document focuses on non-clinical (engineering and regulatory standard) testing and explicitly states: "Non-clinical tests: Testing conducted on the PicoLO Nd:YAG Picosecond Laser System shows that it refers to the relevant mandatory performance standards for laser products..."
- Sample Size: The document does not specify a "sample size" in the context of human subjects or clinical data for performance testing. The "tests" described are related to the device itself and its compliance with engineering and safety standards (e.g., electrical safety, EMC, laser safety).
- Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based evaluations of the device's physical and electronic characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the submission relies on demonstrating substantial equivalence through technical testing and adherence to recognized consensus standards, rather than a clinical study requiring expert-established ground truth for a test set. The "ground truth" for the non-clinical tests is defined by the requirements of the standards themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided and is not applicable to the non-clinical testing performed. Adjudication methods are typically used in clinical studies where human interpretation or assessment of an outcome is required.
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:
This is not applicable. The device is a laser system for tattoo removal, not an AI-assisted diagnostic or interpretative tool. Therefore, no MRMC study or AI assistance evaluation was performed or required.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical laser system, not an algorithm, and its use inherently involves a human operator (a medical professional).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical performance data presented, the "ground truth" is established by adherence to and measurement against the requirements and specifications detailed in the cited FDA-recognized consensus standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60825-1, ISO 14971, ISO 10993).
8. The sample size for the training set:
This is not applicable. There is no mention of a "training set" as the submission is for a physical laser device and its substantial equivalence, not a machine learning or AI-based product.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated above.
§ 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.