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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 PicoWay Laser System is indicated for the following at the specified wavelength:

532nm; Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

The PicoWay Laser System is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm at short durations less than or equal to 900 picoseconds (ps) at repetition rates up to 5 Hz. The device system is comprised of a system console, an articulated arm, and an attached handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a zoom handpiece (HP). The light-weight and ergonomic zoom handpiece allows the spot size on the skin to be easily adjusted from 3 mm to 6 mm in steps of 1 mm. The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the laser beam into the articulated arm. The PicoWay system control panel enables the user to select the desired energy density (fluence) level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

The PicoWay Laser System was evaluated for its safety and effectiveness in the removal of benign pigmented lesions.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: 26 subjects (29 lesions)
• Data Provenance: Retrospective or prospective is not explicitly stated, but the study is described as a "single arm, prospective, self-controlled multicenter study," indicating a prospective design for data collection. The country of origin of the data is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The document mentions "blinded, independent review" for assessing lesion clearance. However, the exact number of experts and their specific qualifications (e.g., radiologist with X years of experience) are not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• The document states "blinded, independent review." It does not specify a particular adjudication method like 2+1 or 3+1.

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, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This study solely evaluated the performance of the PicoWay Laser System as a standalone treatment device.

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

• Yes, a standalone study was done. The clinical study evaluated the PicoWay Laser System's performance as a treatment device, not as an AI algorithm assisting human readers. The "algorithm" in this context refers to the laser system's operating parameters and its direct effect on the lesions.

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

• The ground truth for efficacy was primarily based on blinded, independent review of lesion clearance, which implies expert assessment.
• For safety, the ground truth was based on the occurrence and severity of adverse events and their resolution, which is outcomes data gathered from clinical observations.

8. The sample size for the training set:

• The document does not mention a training set as this is a clinical study for a medical device (laser system), not an AI algorithm requiring a machine learning training phase. The device itself is the "intervention" being tested.

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

• As there is no mention of a training set for an AI algorithm, this question is not applicable.

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