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Intended Use: The Nd: Yag Laser Therapy Systems is indicated for the incision, excision, 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

Nd:Yag Laser Therapy Systems is a kind of laser pigment treatment instrument. It uses the principle of "photo-blasting". The laser emits high energy instantaneously, causing the pigment particles to absorb the laser energy and rapidly expand and rupture. Part of the pigment is broken down into smaller particles and excreted from the body, and the other part is swallowed by human macrophages and excreted through the lymphatic system.
The Nd: Yag laser therapy systems is mainly composed of a host, an operating hand tool and a foot switch. The operation hand is a treatment hand. The host is composed of a power module, a control module and a display module.

I apologize, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

The document you provided is an FDA 510(k) clearance letter and an associated 510(k) Summary for a Nd:Yag Laser Therapy System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving specific performance criteria through clinical studies in the way you've described for, for example, an AI/ML software as a medical device.

Here's why the requested information isn't present in this document:

• Type of Device: This is a laser hardware device, not an AI/ML algorithm. The performance evaluation focuses on physical parameters (wavelength, pulse energy, etc.) and compliance with electrical, EMC, and laser safety standards.
• 510(k) Process: The 510(k) pathway (Traditional, Abbreviated, or Special) primarily relies on demonstrating that the new device is "substantially equivalent" to a predicate device. This often involves comparing technological characteristics, intended use, and non-clinical performance data (like compliance with recognized standards).
• Lack of Clinical Studies: The "10. Clinical Test Conclusion" section explicitly states: "No clinical study is included in this submission." This means there was no human clinical trial to assess the device's effectiveness or safety in patients, which would typically be required for an AI/ML device to demonstrate performance against acceptance criteria in a real-world scenario.
• No AI/ML Specifics: There's no mention of AI/ML, image analysis, diagnostic performance metrics (like sensitivity, specificity, AUC), or human reader studies (MRMC, standalone algorithm performance) because this device does not perform those functions.

Therefore, the document does not contain the information required to answer your specific questions regarding acceptance criteria, test sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device.

The tables provided (Table 1: General Comparison, Table 2: Performance Comparison, Table 3: Safety Comparison) compare the characteristics of the proposed device to a predicate device and a reference device to demonstrate substantial equivalence, focusing on physical and safety parameters, not diagnostic or AI performance.

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The ND: YAG Laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and the removal of black or blue tattoos.

The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm.

The device is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos. It is for prescription use only.

This document is a 510(k) Pre-market Notification for a medical device called the "ND:YAG Laser" (Model SL-NY602) from Beijing Superlaser Technology Co., Ltd. It seeks to demonstrate substantial equivalence to a predicate device, the "ND YAG Q-switch Laser Therapy Machine" (K161926) from Beijing ADSS Development Co., Ltd.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Strictly speaking, this document does not present "acceptance criteria" in the traditional sense of specific performance metrics with defined thresholds for sensitivity, specificity, accuracy, etc. Instead, it aims to demonstrate substantial equivalence (SE) based on comparative tables for general, technical, and safety aspects. The "acceptance criteria" for this type of submission are that the proposed device is as safe and effective as the predicate device. The reported performance is implicitly the device meeting the described characteristics.

2. Sample Size used for the Test Set and the Data Provenance

The submission does not rely on a test set of patient data for clinical performance evaluation. Instead, it relies on demonstrating equivalence through comparison to a legally marketed predicate device and non-clinical testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. No ground truth was established by experts for a clinical test set in this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in this submission.

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 is a laser device, not an AI-assisted diagnostic or imaging system, so an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a laser device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. Clinical ground truth (e.g., pathology, outcomes data) was not used in this 510(k) submission. The "ground truth" for demonstrating substantial equivalence relied on established safety and performance standards for similar laser devices and the characteristics of the predicate device.

8. The sample size for the training set

Not applicable. This is a hardware medical device (laser system), not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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