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The PICO LEGEND Nd: Y AG Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

-The 1064nm wavelength of the PICO LEGEND Nd: Y AG Laser System is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).

-The 532mm wavelength of the PICO LEGEND Nd:YAG Laser System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.

This device comprises the main body, including the optics laser generator, power supply, cooling system, operation panel, articulated arm, handpiece, foot-switch, protective goggles, power supply cord, etc. Applying a high voltage to the laser generator generates 1064nm and 532nm laser emission wavelengths. The maximum output is 500mJ.

The optical laser generator (optics), power supply, chiller, touch LCD panel, switching mode power supply, main control board, air pump, etc., are operated by a microprocessor.

The Optical Laser Generator (Optics) is comprised of Nd: YAG Rod, which is the solid laser medium, Flash lamp for optical generation, various Reflector for optical transmission, etc., and permits high voltage in flash lamp connected with power supply and operates to generate laser. After turning on the device, once the Wavelength, frequency, Frequency, Spot Size, etc., have been set, press the Foot Switch in the READY state; the laser energy will be produced and transferred through the Articulated Arm and handpiece.

The provided document is a 510(k) Premarket Notification for the PICO LEGEND Nd:YAG Laser System. This document does not describe a study involving an AI/Machine Learning device. Instead, it focuses on demonstrating substantial equivalence of a laser medical device to a predicate device.

Therefore, the specific information requested in the prompt regarding AI/ML device performance, such as acceptance criteria for AI models, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI, is not present in this document.

The document states:

• "9. Clinical Testing: No clinical testing provided." This explicitly indicates that no human subject studies were conducted to prove the device's efficacy or safety.
• The performance data section (Section 8) describes non-clinical testing related to electrical safety, EMC, usability, laser safety, and biocompatibility, as well as bench testing to confirm energy output specifications. It also mentions "Software Verification and Validation Testing" but this refers to traditional software engineering V&V, not AI/ML model performance evaluation against clinical ground truth.

In summary, this document is irrelevant to the request for information on an AI/ML device's acceptance criteria and performance study. The device is a laser system, and its clearance is based on substantial equivalence to a predicate device and compliance with applicable non-clinical performance standards.

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The Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.

• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

• Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.

• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

The BL-C10 Picosecond ND:YAG Laser Systems is designed with a mains electricity (AC-powered) light amplification by stimulated emission of radiation (LASER) device assembly based on neodymium-doped yttrium-aluminium-garnet (Nd:YAG) and frequency-doubled Nd:YAG laser technology. The laser system generates ultra-short pulses in the picosecond range (1 picosecond = 10^-12 seconds). The pulses are then amplified within the Nd:YAG crystal. The system operates at two wavelengths: 1064nm and 532mm. These wavelengths are chosen to target different colors of pigments in tattoos and pigmented lesions.

• 1064nm Wavelength: Used for treating tattoos with colors like black, brown, green, blue, and purple, as well as for treating benign pigmented lesions.

• 532nm Wavelength: Used for removing tattoos with colors such as red, yellow, and for treating benign pigmented lesions. The ultra-short pulses have very high peak power, allowing them to interact with target (tattoos or pigmented lesions) in a precise and controlled manner. The short duration of the pulses helps minimize heat buildup in surrounding tissues.

I am sorry, but the provided text from the FDA 510(k) K240386 submission for the "Picosecond Nd: YAG Laser Systems (BL-C10)" does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

The document primarily focuses on:

• Regulatory correspondence: FDA's substantial equivalence determination letter.
• Device description: Information about the Picosecond Nd:YAG Laser System (BL-C10), its wavelengths, and intended uses.
• Comparison to predicate devices: Discussion of technological similarities and minor differences between the BL-C10 and its predicates.
• Non-clinical testing: A list of international standards (IEC 60601-1, IEC 60601-1-2, etc.) that the device complies with, related to electrical safety and electromagnetic compatibility.
• Conclusion: Statement that the device is substantially equivalent to the predicate based on performance testing and validation studies which are not detailed in this public summary.

Specifically, the section "Non-Clinical and/or Clinical Tests Summary & Conclusions" states:

• "Non-Clinical Testing: A battery of tests was performed to verify that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards: [lists electrical safety and EMC standards]."
• "Clinical Testing: It is not applicable."

This clearly indicates that no clinical studies were performed or reported for this device in this submission, which means there would be no data on human-in-the-loop performance, standalone AI performance, or ground truth for such studies.

Therefore, I cannot fulfill your request for the information outlined in your prompt because the provided text does not contain it. The device in question is a laser system, not an AI/ML-driven diagnostic or therapeutic device for which such detailed performance study information would be typically found in a public 510(k) summary.

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The Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery: such as tattoos removal and benign pigmented lesions.

1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, blue, green and purple.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

• Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

Picosecond Nd: YAG Laser Systems, pulse width:

This document describes the Smedtrum Medical Technology Co., Ltd. Picosecond Nd:YAG Laser System (K240118) and compares it to a predicate device (K200116).

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The "testing" primarily refers to bench testing and electrical/software verification. Therefore, no information is available regarding sample size or data provenance (country of origin, retrospective/prospective) for a test set of patient data, as this kind of study was not conducted or reported.

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

Not applicable. No ground truth based on expert consensus for clinical data was established or reported.

4. Adjudication method for the test set

Not applicable. No adjudication method for clinical data was reported.

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 device is a laser system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant and was not conducted.

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

Not applicable. This device is a standalone hardware medical device (laser system) and does not involve an algorithm with human-in-the-loop performance. The "software verification and validation testing" refers to the control software of the laser system, not an AI algorithm.

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

For the technical performance of the device, the "ground truth" was based on engineering specifications and established international standards (IEC). These standards define acceptable ranges and behaviors for laser energy output, electrical safety, electromagnetic compatibility, and specific laser device performance parameters. The measurements obtained through bench testing were compared against these established standards and specifications.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is a laser system and does not utilize machine learning or AI models that require data training.

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

Not applicable. There is no mention of a "training set" for which ground truth would need to be established.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria primarily consists of engineering and bench testing.

• Electrical safety and electromagnetic compatibility: The device was tested for compliance with recognized international standards: IEC 60601-1 (general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), and IEC 60601-2-22 (particular requirements for surgical, cosmetic, therapeutic, and diagnostic laser equipment).
• Laser Safety: Compliance with IEC 60825-1 (safety of laser products, equipment classification and requirements) was verified.
• Software Verification and Validation: Testing was conducted in accordance with FDA's guidance for software in medical devices, considering the software a "moderate" level of concern.
• Bench Testing: This involved instrumental measurements of key laser parameters:
  • Laser energy output: Verified within ±20% using a laser energy meter that meets IEC 60825 standards.
  • Wavelength: Checked with a Spectrum Analyzer to confirm 532 nm and 1064 nm.
  • Frequency and Pulse Width: Measured with an Oscilloscope to ensure consistency with specifications.
  • Spot Size: Determined by emitting a laser onto photo paper and measuring the spot size with a ruler.

The conclusion states that "The non-clinical data and performance testing reports in this submission demonstrate that Picosecond Nd:YAG Laser System meets the expected performance requirements." This indicates that the device's performance characteristics, as measured during these tests, fell within the acceptable ranges and standards established for safety and effectiveness.

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The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

• The 1064nm wavelength of the PICOSECOND Nd:YAG Laser System (PICO PREMIUM ) is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).
• The 532nm wavelength of the PICOSECOND Nd: YAG Laser System (PICO PREMIUM ) is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzparick skin types I-III.

The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) is comprised of the Main Body which includes an optics laser generator, power supply, cooling system, operation panel, etc., and the Articulated Arm, Handpiece, Foot Switch, Protective Goggles, Power Supply Cord, etc. and by applying high voltage to the laser generator 1064nm and 532nm wavelength and emission wavelength of the laser, the maximum output is 5 00mJ. This device is comprised of an Optical Laser Generator (Optics), power supply, chiller, touch LCD panel and switching mode power supply, main control board, air pump, etc., and is operated by microprocessor software.

The Optical Laser Generator (Optics) is comprised of Nd: YAG Rod which is the solid laser medium, Flash lamp for optical generation, various Reflector for optical transmission, etc., and permits high voltage in flash lamp connected with power supply and operates to generate laser energy.

After turning on the device, set the Wavelength, Fluence, Frequency, Spot Size, etc. to be used then press the Foot Switch in the READY state, the laser will be energized and transferred through the Articulated Arm and handpiece. A cooling system controls the febrility caused by the laser output.

The provided text is a 510(k) summary for the PICOSECOND Nd:YAG Laser System (PICO PREMIUM). It outlines the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, the document does not describe a clinical study with human subjects, nor does it present acceptance criteria and performance metrics in the context of an AI/algorithm-based diagnostic or therapeutic device.

The "Performance Data (Non-clinical)" section (Page 6, Section 8) explicitly states that "All acceptance criteria were met," but these listed criteria are for engineering and safety standards (e.g., IEC 60601-1, IEC 60825-1, ISO 10993 for biocompatibility, and FDA guidance for software verification and validation). These are not performance metrics related to diagnostic accuracy, sensitivity, specificity, or the improvement of human reader performance, as would be expected for an AI-enabled device that requires such rigorous clinical validation.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/algorithm-based device and its clinical performance. The provided document concerns a laser system device that is evaluated against established safety, electrical, and biocompatibility standards, not an AI or algorithm that would undergo the type of performance evaluation you've outlined.

Based on the provided document, the following information is either not applicable or not available:

1. A table of acceptance criteria and the reported device performance: The acceptance criteria mentioned are engineering standards (e.g., IEC, ISO) and the document states they "were met." No specific quantitative performance data for the device's clinical effectiveness (e.g., in terms of tattoo removal efficiency or safety in human subjects against specific metrics) is provided in a comparative table.

2. Sample sizes used for the test set and the data provenance: No test set for clinical performance is described. The "test set" here refers to the engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical ground truth establishment is described.

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 not mentioned. The device is a laser system, not a diagnostic AI that would typically undergo such a study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable, as there's no mention of an algorithm 'training set'.

9. How the ground truth for the training set was established: Not applicable.

The document's purpose is to demonstrate substantial equivalence to a predicate laser device based on technical characteristics and compliance with safety and performance standards, not clinical efficacy measured through a study design typically associated with AI/ML products.

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