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MIN, Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) is indicated for use in incision, excision, ablation, vaporization of soft tissue for general dermatologic and general surgical procedures for coagulation and hemostasis as follows:

1064 nm wavelength

• · Tattoo Removal (dark ink: blue and black)
• · Dermal Pigmented Lesions; including, but not limited to: Nevus of Ota, Lentigines, Nevi, Melasma and Cafe-au-lait
• · Removal or lightening of hair with or without adjuvant preparation.
• · Skin Resurfacing for Acne Scars and Wrinkles
• · Benign cutaneous lesions; including, but not limited to: striac and Scars (excludes the 650mm wavelength)
• · Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)

532 nm Wavelength

• · Tattoo removal (light ink: red, sky blue, green)
• · Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, spider nevi
• · Epidermal Pigmented lesions; including, but not limited to: cafe-au-lait birthmarks, solar lentiginos, Becker's nevi, Freckles, Nevus spilus, seborrheic keratosis
• · Skin Resurfacing for Acne Scars and Wrinkles
• · Benign cutaneous lesions; including, but not limited to: striae and scars, (excludes the 6S0nm wavelength)
• · Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)

MIN applies the Nd:YAG laser source and it is composed of main body part, hand piece part and arm part mainly. The main body part is consisted of laser module from which beam is irradiated, power module, control module and touch screen.

MIIN, The Q-Switched Nd:YAG Laser Systems is based on the Q-Switched Nd: YAG (1064nm) and frequency Nd: YAG (532nm) Laser Technology. There is one optical cavity containing the Nd: YAG Crystal

The MIIN Q-Switched Nd: YAG Laser Therapy Systems works based on laser selective photothermal therapy and blasting mechanism of Q-switched laser. Energy form particular wavelength with accurate dose will act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanophore from derma and epidermis. When suddenly being heated. pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enters into lymph circulation system and finally be discharged out of body.

The physician is able to select the desired wavelength and the related output energy, spot size and fluency via control panel.

The provided document (K193266) is a 510(k) Premarket Notification FDA Clearance Letter and 510(k) Summary for a Q-Switched Nd:YAG Laser Therapy System (MIIN). It is primarily focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria based on a clinical performance study with defined metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, effect size of human reader improvement) are not applicable to this type of FDA submission. This document does not describe a clinical study of AI performance, but rather a performance evaluation of a physical medical device (laser system) against electrical, safety, and performance standards.

Here's an attempt to address the applicable information from the provided text:

Acceptance Criteria and Device Performance for MIIN Q-Switched Nd:YAG Laser Therapy System (K193266)

This FDA 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device and adherence to recognized electrical and safety standards, rather than a clinical trial with specific performance metrics such as those used for AI algorithms. The "acceptance criteria" here refer to demonstrating compliance with relevant performance and safety standards and showing that the device operates as intended without raising new safety or effectiveness concerns compared to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The document describes engineering and bench testing against standards, not a clinical test set with a patient sample size. Performance data focuses on device specifications and compliance with standards.
• Data Provenance: Not applicable. The tests are described as performance and safety evaluations of the device itself (e.g., "The subject device was tested to evaluate its performance"). No patient data or geographical origin is mentioned. The testing is non-clinical.

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

• Not applicable. This is not a study requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

• Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. This is a laser device clearance, not an AI algorithm requiring human reader performance studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not applicable. This is not an AI algorithm. The device itself (the laser system) was tested for its standalone performance against technical standards.

7. The Type of Ground Truth Used

• The "ground truth" in this context refers to the established technical standards and specifications (e.g., IEC 60601-1, ISO 10993, declared power output, wavelength accuracy) that the device must meet to demonstrate safe and effective operation and substantial equivalence to a predicate. It is not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a training set as it's not an AI/machine learning product.

9. How the Ground Truth for the Training Set Was Established

• Not applicable.

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The indications for use are UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.

Laseroptek Co. Ltd.'s PALLAS 308/311 Solid-State UV laser system is a self-contained ultraviolet laser light source and optical energy delivery system that provides targeted energy to the treatment site while avoiding exposure to non-affected tissue. The light source is contained within the protective console. The complete system also includes a hand piece connected to the console via an articulating arm. Timing and dosing parameters and the user interface are controlled through a display on the console. The delivery system allows UV-B light to pass through the hand piece to selectively treat skin legions without exposure to the unwanted skin.

The provided text describes the PALLAS 308/311 Solid-State UV Laser System and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-driven medical device.

The document is a 510(k) premarket notification for a laser system. It focuses on demonstrating that the new device is substantially equivalent to existing predicate devices based on:

• Intended Use: UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma.
• Technological Characteristics: Comparison of wavelength, pulse characteristics, output energy, fluence, and physical characteristics.
• Performance Data: Non-clinical tests measuring wavelength, average output power, and energy fluence, and compliance with various IEC and ISO consensus standards for electrical safety, electromagnetic compatibility, laser safety, and risk management. Biocompatibility of patient-contacting materials is also mentioned.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to an AI/algorithm.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. Standalone performance of an algorithm.
7. Type of ground truth (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document pertains to a physical medical device (a laser system) and its performance is evaluated through engineering and safety standards, not through AI/algorithm performance metrics with associated testing methodologies.

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