(105 days)
The Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery: such as tattoos removal and benign pigmented lesions.
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, blue, green and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Picosecond Nd: YAG Laser Systems, pulse width:
This document describes the Smedtrum Medical Technology Co., Ltd. Picosecond Nd:YAG Laser System (K240118) and compares it to a predicate device (K200116).
Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from IEC Standards) | Reported Device Performance (from Bench Testing) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1:2005+A1:2012 | Complies with IEC 60601-1:2005+A1:2012 |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2:2020 | Complies with IEC 60601-1-2:2020 |
| Laser Safety | Compliance with IEC 60825-1:2014 | Complies with IEC 60825-1:2014 |
| Laser Device Performance | Compliance with IEC 60601-2-22:2019 | Complies with IEC 60601-2-22:2019 |
| Laser Energy Output | Within ±20% of specified output | Within ±20% (verified with laser energy meter) |
| Frequency | Consistent with specification | Consistent with specification (Oscilloscope) |
| Pulse Width | Consistent with specification | Consistent with specification (Oscilloscope) |
| Spot Size | Consistent with specification | Consistent with specification (photo paper + ruler) |
| Wavelength | 532 nm and 1064 nm | 532 nm and 1064 nm (Spectrum Analyzer) |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The "testing" primarily refers to bench testing and electrical/software verification. Therefore, no information is available regarding sample size or data provenance (country of origin, retrospective/prospective) for a test set of patient data, as this kind of study was not conducted or reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth based on expert consensus for clinical data was established or reported.
4. Adjudication method for the test set
Not applicable. No adjudication method for clinical data was reported.
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 system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a standalone hardware medical device (laser system) and does not involve an algorithm with human-in-the-loop performance. The "software verification and validation testing" refers to the control software of the laser system, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the technical performance of the device, the "ground truth" was based on engineering specifications and established international standards (IEC). These standards define acceptable ranges and behaviors for laser energy output, electrical safety, electromagnetic compatibility, and specific laser device performance parameters. The measurements obtained through bench testing were compared against these established standards and specifications.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this device is a laser system and does not utilize machine learning or AI models that require data training.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a "training set" for which ground truth would need to be established.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria primarily consists of engineering and bench testing.
- Electrical safety and electromagnetic compatibility: The device was tested for compliance with recognized international standards: IEC 60601-1 (general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), and IEC 60601-2-22 (particular requirements for surgical, cosmetic, therapeutic, and diagnostic laser equipment).
- Laser Safety: Compliance with IEC 60825-1 (safety of laser products, equipment classification and requirements) was verified.
- Software Verification and Validation: Testing was conducted in accordance with FDA's guidance for software in medical devices, considering the software a "moderate" level of concern.
- Bench Testing: This involved instrumental measurements of key laser parameters:
- Laser energy output: Verified within ±20% using a laser energy meter that meets IEC 60825 standards.
- Wavelength: Checked with a Spectrum Analyzer to confirm 532 nm and 1064 nm.
- Frequency and Pulse Width: Measured with an Oscilloscope to ensure consistency with specifications.
- Spot Size: Determined by emitting a laser onto photo paper and measuring the spot size with a ruler.
The conclusion states that "The non-clinical data and performance testing reports in this submission demonstrate that Picosecond Nd:YAG Laser System meets the expected performance requirements." This indicates that the device's performance characteristics, as measured during these tests, fell within the acceptable ranges and standards established for safety and effectiveness.
§ 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.