(56 days)
The Nd: YAG Laser Therapy Systems is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, ablation, vaporization of soft tissue for general dermatology as follows: 532nm wavelength: * Removal of light ink (red. sky blue, green, purple, and orange) tattoo * Treatment of benign vascular lesions including, but not limited to: telangiectasias, * Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses ( Treatment of Post Inflammatory Hyper-Pigmentation 1064nm wavelength: * Removal dark ink (black, blue and brown) tattoo * Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma. * Removal or lightening of unwanted hair with or without adjuvant preparation * Skin resurfacing procedures for the treatment of acne scars and wrinkles
The Nd: YAG Laser Therapy Systems is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology.
The Nd: YAG Laser Therapy Systems includes five modules described as following: Control Panel, Main Control Module, Auxiliary Control Module, Laser, laser RF power supply and DC power supply module, Light arm module.
The provided text is a 510(k) summary for the "Nd: YAG Laser Therapy Systems Model: HM-YL900." This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a dedicated study with outcome measures.
The document discusses non-clinical testing performed to verify compliance with various safety and performance standards for medical electrical equipment and laser products. However, it explicitly states:
"No clinical study is performed to support substantial equivalence."
Therefore, I cannot provide detailed information about acceptance criteria and a study that proves the device meets them in the way typically associated with a clinical trial or performance study. The information below is derived from the non-clinical testing and the comparison tables within the document, rather than a standalone clinical study to establish performance metrics.
Here's an attempt to answer your request based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical study with explicit performance acceptance criteria and results is mentioned, the "acceptance criteria" here refer to compliance with recognized standards and similarity to predicate devices' specifications during non-clinical testing. The "reported device performance" refers to the device's technical specifications and its demonstrated compliance with safety and electrical standards.
Note: This table reflects technical specifications and compliance with safety standards, not therapeutic efficacy metrics which would typically be derived from a clinical performance study.
| Acceptance Criteria (from recognized standards & predicate comparison) | Reported Device Performance (from non-clinical testing & specifications) |
|---|---|
| Electrical Safety (IEC 60601-1, IEC 60601-2-22): Device meets basic safety and essential performance requirements. | Complies with IEC 60601-1:2005/A1:2012, IEC 60601-2-22:2012. |
| Electromagnetic Compatibility (IEC 60601-1-2): Device meets EMC requirements. | Complies with IEC 60601-1-2:2014. |
| Laser Safety (IEC 60601-2-22, IEC 60825-1): Device meets laser safety requirements and is classified appropriately. | Complies with IEC 60601-2-22:2012, IEC 60825-1:2014. Classified as Class 4 Laser. |
| Software Validation & Verification: Software is validated and verified to prevent serious patient/operator injury. | Software verification and validation testing conducted; documentation provided as per FDA guidance. Software classified as "major" level of concern. |
| Wavelength: Operates at 1064 nm and 532 nm. | Operates at 1064 nm and 532 nm. |
| Aiming Beam Wavelength: Operates at 650 nm. | Operates at 650 nm. |
| Output Energy: Specified output energy levels for 1064nm and 532nm. | 1000mJ for 1064nm; 500mJ for 532nm. |
| Fluence: Specified fluence range for 1064nm and 532nm. | 1.27 - 31.8 J/cm² for 1064nm; 0.6 - 15.9 J/cm² for 532nm. |
| Spot Size: Specified spot size range. | 2-10mm. |
| Pulse Width: Specified pulse width range. | 4ns-6ns. |
| Frequency: Specified maximum frequency. | 10 Hz Max. |
| Intended Use: For tattoo removal, treatment of benign vascular/pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as specified. | Matches the Indications for Use of the predicate devices, demonstrating substantial equivalence in intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No clinical test set or human data was used for performance evaluation. The "test set" implies non-clinical tests on the device hardware and software.
- Data Provenance: Not applicable for a clinical test set. The data presented is from internal non-clinical testing performed by the manufacturer to demonstrate compliance with standards and equivalence to predicate devices, as well as publicly available information on the predicate devices. The country of origin for the device manufacturer is China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no clinical test set requiring expert-established ground truth for evaluation of clinical outcomes. The "ground truth" here is compliance with engineering and safety standards, established through testing against those standards.
4. Adjudication method for the test set
Not applicable. No clinical test set requiring adjudication 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. The device is a laser therapy system, not an AI-assisted diagnostic tool. No MRMC study was performed, and no AI component is described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in a non-clinical context. The "standalone" performance here refers to the device's technical specifications and its ability to meet safety and electrical standards independently, as verified through non-clinical testing. This is purely device-centric performance, not a clinical "algorithm only" performance.
7. The type of ground truth used
For the technical and safety performance, the "ground truth" was compliance with established international consensus standards (e.g., IEC 60601-1, IEC 60825-1) and the technical specifications of legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model, there is no ground truth establishment process for it.
§ 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.