(55 days)
The Picowon is indicated for tattoo and benign pigmented lesions removal.
The Picowon laser system is Alexandrite laser system. The Picowon laser system consists of an Alexandrite laser head, a power supply, a cooling system, a delivery system and other electrical components. The laser head contains Alexandrite laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed, in the special adjustable holders composed the laser cavity. And Picowon does not contain any external wired and/or wireless communication interfaces (Wired: USB, ethernet, SD, CD, RGA, etc. or Wireless: Wi-Fi, Bluetooth, RF, inductive, Cloud, etc.).
The laser energies generated by the medium of Alexandrite is converted to the heat energy once it gets to human skin surface and used for tattoos and benign pigmented lesions removal. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragment particles eventually surface and fade as the epidermal layer or the skin is renewed. The system delivers laser energy at a wavelength of 755 nm. The output of the laser is delivered to the treatment area through an articulated Arm with a handpiece. A trigger (Foot Switch) controls the delivery of pulses. The treatment parament parameters and other functions operated by software on the graphical user interface.
This 510(k) premarket notification describes a laser surgical instrument (Picowon) and compares it to a predicate device (Picosure™ workstation) to establish substantial equivalence.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly define acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for clinical outcomes, as it's a laser surgical instrument rather than a diagnostic AI device. Instead, the "acceptance criteria" are implied by the comparison to the predicate device and compliance with established electrical, EMC, and laser safety standards. The "device performance" refers to the Picowon meeting the specifications similar to or safer than the predicate.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Proposed Device Performance (Picowon) |
|---|---|---|
| K Number | K121346 | K201406 |
| Manufacturer | Cynosure, Inc. | WON TECH Co., Ltd. |
| Model | Picosure™ workstation | Picowon |
| Product Code | GEX | GEX |
| Indications for Use | Tattoo and benign pigmented lesions removal. | Tattoo and benign pigmented lesions removal. |
| Laser Type | Flash lamp-excited, Solid state Alexandrite laser | Flash lamp-excited, Solid state Alexandrite laser |
| Wavelength | 755nm | 755nm |
| Maximum Average Fluence | 6.37 J/cm² | 6.37 J/cm² |
| Pulse Duration | 450-900 ps | 600-800 ps |
| Repetition Rate | 1-10 Hz | 1-5 Hz |
| Spot Size | Zoom 2-6 mm, Fixed 2,3,4,6,8,10 mm | Zoom 2, 3, 3.5, 4, 5, 5.5, 6, 7, 8 mm |
| Safety and Effectiveness | Demonstrated by predicate device | Demonstrated through non-clinical testing for compliance with standards IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, software validation, biocompatibility, and in-house performance tests. |
2. Sample size used for the test set and the data provenance
No clinical studies were conducted or deemed necessary for the Picowon device, as explicitly stated in the "Clinical Test Summary" section: "No clinical studies were considered necessary and performed." Therefore, there is no "test set" in the context of patient data for clinical performance evaluation. The testing involved non-clinical bench tests and in-house performance tests related to electrical, electromagnetic, and laser characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical studies were performed, there was no clinical "ground truth" to be established by experts for a test set.
4. Adjudication method for the test set
Not applicable. No clinical test set was used.
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
Not applicable. This device is a laser surgical instrument, not an AI diagnostic or assistance tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Picowon is a physical medical device, a laser system, not an algorithm, and therefore does not have a standalone algorithm-only performance.
7. The type of ground truth used
For the technical performance aspects, the "ground truth" was established by engineering specifications, international safety standards (IEC, AAMI), and the performance characteristics of the legally marketed predicate device. For instance, laser output accuracy, pulse width, and repetition rate were verified against predefined limits derived from design specifications and predicate comparison.
8. The sample size for the training set
Not applicable. This device is a laser surgical instrument, not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. There was no training set for an AI/ML algorithm.
§ 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.