(206 days)
1064 nm wavelength: Tattoo Removal (Dark Ink, Black & Blue ) Ota's nevus
532 nm wavelength: Tattoo Removal (Light Ink, Red, Sky Blue and Green) Treatment of Pigmented Lesions Solar Lentiginos Senile Lentiginos
The proposed device includes three models as YILIYA- 1064QCH, YILIYA- 1064QCL and Aeslight-1064QEH, the differences between three models described in the subsection 5 specification. The proposed device is the laser system with modularization and multi-wavelength, includes the waveform as 1064 nm and 532 nm. The proposed device consisted by control system, power supplier, cooling system, laser generator, articulated arm and foot switch.
The provided text is a 510(k) Summary for a Q-Switched ND: YAG Laser Device. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for a clinical study with acceptance criteria and performance reporting in the same way a new, high-risk device might be.
Therefore, many of the requested categories for a clinical study will not be explicitly present or applicable in this document. The submission focuses on bench tests and technological characteristics comparison to show equivalence.
Here's the information extracted and organized based on your request, with notes on what is not available in this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Note: This document does not present acceptance criteria and performance in the "acceptance criteria" vs. "reported performance" format typically found in clinical studies validating device effectiveness. Instead, it demonstrates Substantial Equivalence (SE) to a predicate device by comparing technical specifications and ensuring compliance with recognized standards.
The table below summarizes the key technical specifications compared to the predicate device to demonstrate SE. The implicit "acceptance criteria" here is that the proposed device's specifications are within an acceptable range or are equivalent to the predicate device, especially regarding safety and intended use.
| Feature / Acceptance Criteria (Implicit for SE) | Predicate Device (RevLite™ Q-Switched Nd: YAG Laser System - K063834) | Proposed Device (YILIYA-, Aeslight- models) |
|---|---|---|
| Laser Medium | Nd: YAG | Nd: YAG |
| Wavelength | 1064 nm, 532 nm | 1064 nm, 532 nm |
| Output Energy | 1600 mJ @ 1064 nm, 500 mJ @ 532 nm | 800 mJ at max. (Wavelength not specified, implying for both) |
| Max. Energy Density | 22.64 J/cm² | 25.47 J/cm² at max. |
| Spot Size | 3, 4, 6 & 8 mm (1064 nm); 2, 3, 4 & 6 mm (532 nm) | 2-7 mm |
| Pulse Width | 5-20 ns | 6-10 ns |
| Repetition Rate | 1, 2, 5, 10 Hz | 1-10 Hz |
| Power Calibration | --- (Not explicitly detailed, likely internal) | Calibrated by laser energy/power meter no less than 1 time each year |
| Laser Class | Class 4 | Class 4 |
| Aiming Beam | Red Aiming Beam | A focusing device (viewfinder) or a red aiming beam for 1064 QEH |
| Compliance with Safety Standards | (Implicit for predicate) | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1 |
| Intended Use | Tattoo Removal (Dark Ink, Light Ink), Treatment of Pigmented Lesions, Solar Lentiginos, Senile Lentiginos, Ota's nevus | Tattoo Removal (Dark Ink, Black & Blue, Light Ink, Red, Sky Blue and Green), Ota's nevus, Treatment of Pigmented Lesions, Solar Lentiginos, Senile Lentiginos |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission relies on non-clinical bench tests and comparison of technical specifications rather than a clinical human subject test set. The "test set" would be the device itself undergoing various engineering and electrical tests.
- Data Provenance: The data comes from bench tests conducted by the manufacturer, Beijing Honkon Technologies Co., Ltd. (P.R.China). This is a prospective evaluation of the newly designed device's physical and electrical characteristics against established standards and the predicate device's specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth in the context of clinical expert consensus or diagnostic accuracy is not relevant here. The "ground truth" for non-clinical bench tests is defined by international safety and performance standards (e.g., IEC standards) and the specifications of the legally marketed predicate device.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication is a process for resolving discrepancies among expert readers in clinical studies. This document describes non-clinical bench testing.
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
- No. This is not an AI-assisted diagnostic device, nor is it a multi-reader, multi-case study. It's a laser device for dermatological and aesthetic procedures.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device does not involve an algorithm working in standalone mode. Its performance is evaluated through its physical and electrical outputs.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- The "ground truth" for this submission are the international safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and the established technical specifications and Intended Use of the predicate device (RevLite™ Q-Switched Nd: YAG Laser System, K063834). Compliance with these standards and equivalence to the predicate's technical characteristics serves as the basis for demonstrating safety and effectiveness.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of machine learning or clinical trials for this type of device submission.
9. How the Ground Truth for the Training Set Was Established
- Not applicable L. As there is no training set, this question is not relevant.
§ 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.