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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.

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.

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The device is indicated for the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm wavelength:
-Tattoo removal: light ink(red, tan, purple, orange, skyblue, green)
-Removal of Epidermal Benign Pigmented Lesions
-Removal of Minor Benign Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines
-Treatment of Cafe-Au-Lait
-Treatment of Seborrheic Keratoses
-Treatment of Post Inflammatory Hyper-Pigmentation
-Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
-Tattoo removal: dark ink (black, blue and brown)
-Removal of Nevus of Ota
-Removal or lightening of unwanted hair with or without adjuvant preparation.
-Treatment of Common Nevi
-Skin resurfacing procedures for the treatment of acne scars and wrinkle

The proposed device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce 1064nm and 532nm two different laser wavelengths to treat the different color skin. It consists of power supply module, microprocessor control module, laser treatment handpiece module, operation display module and cooling system module. The physician is able to select the desired wavelength and the related output energy via control panel.

The provided text is a 510(k) Summary for a medical device (Nd:YAG Laser Therapy Systems). It states explicitly in section 11 "Clinical Testing" that "No clinical study is included in this submission."

Therefore, I cannot provide information on acceptance criteria and the study that proves the device meets those criteria, a table of acceptance criteria and reported device performance, sample sizes, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details, as no clinical studies were conducted or provided in this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (CuRAS Nd: YAG Laser, K173038) based on non-clinical testing, including electrical safety, EMC, biocompatibility, and software validation. It compares device specifications and indications for use, showing they are identical or very similar to the predicate.

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