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The Q-Swithched Nd:YAG Laser is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for for General Dermatology, Dermatologic and General Surgical Procedures as follows:

1064nm:

• Tattoo removal
  • dark ink: blue and black
• Treatment of Benign Pigmented Lesions
  • Nevus of ota

532nm:

• Tattoo removal
  • Light ink: red, sky blue and green.
• Treatment of benign vascular lesions
  • Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi.
• Treatment of benign pigmented lesions
  • Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

Nd:YAG laser is a type of solid laser that is stimulated through Yttrium Aluminum Garnet (YAG Crystal) doped with a very small amount of Neodymium (Nd). Nd:YAG laser can generate pulsed or continuous laser, emitting laser with specific wavelength (usually 532nm or 1064nm). The principle of Nd:YAG laser product is that electrons in atoms can absorb energy and change from a lower energy level to higher energy level, then these electrons fall back to the lower energy level, releasing energy in the form of photons. Compared with ordinary light source, laser is monochromatic, directional and brighter.

Q-Switched Nd:YAG Laser is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce two wavelengths, 1064nm and 532nm, to treat different skin color. It consists of control panel module, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired wavelength and the related output energy via control panel.

Machine System
Q-Switched Nd:YAG Laser (hereinafter referred to as "Machine") consists of machine main body (including Laser Device, Transmission and Target Indicating Device, Laser Power Supply and Control System, Safety Protection System, Cooling System, Power Supply System, Control System), 7-Joint Laser Arm, Vari-Focusing Handpiece, Foot Switch, Laser Protective Glasses, Power Cable, Support Bar (A Group of Support Bar and 2 Support Clamps), Casters and Attached Machine Accessories, etc. As shown by Figure 1, the machine shell is ABS shell, its accessories are aluminum alloy parts.

The provided FDA 510(k) clearance letter and summary for the Q-Switched Nd:YAG Laser (SHE-LSP101-1) does not describe acceptance criteria, nor does it detail a study that proves the device meets specific performance criteria related to clinical outcomes or diagnostic accuracy.

The summary focuses on non-clinical tests to verify that the device meets safety and performance standards for laser equipment, and that its technological characteristics are similar to predicate devices. It explicitly states, "Clinical study is not applicable." This indicates that the regulatory pathway for this device did not require a study demonstrating its effectiveness or diagnostic performance against defined acceptance criteria in a clinical setting.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable or cannot be extracted from the provided text.

Here's the information that can be derived from the document:

Acceptance Criteria and Device Performance (Based on Non-Clinical Engineering Specifications)

Since no clinical acceptance criteria or performance against such criteria are explicitly stated in the document, the "performance" presented here relates to the engineering specifications and safety standards adherence.

Study Details (Non-Clinical)

1. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical tests (engineering and safety standards adherence), not a test set of data for clinical performance or AI evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established from experts for performance evaluation.

3. Adjudication method for the test set: Not applicable. No test set for clinical performance.

4. 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 surgical instrument, not an AI-powered diagnostic or assistive tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests was adherence to established international safety and performance standards for medical electrical equipment and laser products (e.g., IEC, ISO standards) and verification of its stated engineering specifications (wavelength, energy, spot size). There is no clinical "ground truth" discussed.

7. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.

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

Summary of the Study:

The "study" refers to a series of non-clinical tests conducted to verify that the Q-Switched Nd:YAG Laser (SHE-LSP101-1) met its design specifications and complied with relevant international safety and performance standards for medical devices and lasers. These tests confirmed parameters such as laser peak wavelength, spot size, laser pulse energy, and maximum fluence, finding them to be within the specified ranges. Additionally, the device demonstrated compliance with a comprehensive set of standards, including:

• Electrical Safety: IEC 60601-1 (general requirements for basic safety and essential performance).
• Electromagnetic Compatibility (EMC): IEC 60601-1-2 and IEC/TR 60601-4-2.
• Laser Specific Safety: IEC 60601-2-22 (for surgical, cosmetic, therapeutic, and diagnostic laser equipment) and IEC 60825-1 (safety of laser products).
• Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and delayed-type hypersensitivity), and ISO 10993-23 (irritation).

The conclusion of these non-clinical tests was that the device is substantially equivalent to its predicate devices based on these performance and validation studies. The document explicitly states that a "Clinical study is not applicable," indicating that clinical efficacy or diagnostic accuracy studies were not required for this 510(k) clearance.

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The Q Switched Nd: YAG Laser machine (QNHF-01) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, ablation, vaporization of soft tissue for general dermatology as follows: 1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532mm: -Tattoo Removal Light ink: red, Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

Q Switched Nd: YAG Laser machine (QNHF-01) is laser system which delivers laser at a wavelength 1064nm or 532nm. It consists of control panel module, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired wavelength and the related output energy via control panel.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device: the Q Switched Nd:YAG Laser machine (QNHF-01). This type of document is a notification of intent to market and not a detailed study report providing acceptance criteria and performance data for an AI/ML-driven device, particularly not in the format requested.

Therefore, I cannot provide the requested information as the document does not contain details about:

• Acceptance criteria table and reported device performance for an AI/ML component.
• Sample sizes for test sets or their provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Details of multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

The document explicitly states: "No clinical study is included in this submission." This further confirms that it does not contain the kind of performance data usually required to demonstrate AI/ML device capabilities against pre-defined acceptance criteria.

The submission focuses on demonstrating substantial equivalence to a predicate device (K163123) based on technological similarities and non-clinical performance testing against recognized safety and performance standards (e.g., IEC 60601-1, ISO 10993 series for biocompatibility). This is typical for a traditional medical device, not an AI/ML device that requires complex evaluation of predictive accuracy or clinical utility improvements due to AI assistance.

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The PICOCAREMAJESTY is indicated for the following at the specified wavelength:

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

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

· Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.

The PICOCAREMAJESTY is the solid state laser capable of delivering energy at wavelengths of 1064mm or 532nm at short durations. The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm delivery system terminated by the handpiece. The fluence (energy density) and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

For treatment, the user can select the appropriate fluence value. (The treatmented is provided in the user Manual) The energy is changed automatically in accordance with the selected fluence (down) button and then, the fluence is increased / decreased by 0.1 J/cm2.

The selectable fluence values are 0.2 to 10.0 J/cm2 at 1064nm and 0.1 to 2.5 J/cm2 at 532nm

The provided text is a 510(k) summary for the WON TECH Co., Ltd. Picosecond Nd:YAG Laser (PICOCAREMAJESTY). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a novel device, especially not data related to complex AI algorithms or diagnostic accuracy studies.

Therefore, many of the specific details requested in your prompt, particularly those related to AI algorithm performance, human-in-the-loop studies, ground truth establishment, and training/test set sample sizes, are not present in this document. The device in question is a laser for tattoo and pigmented lesion removal, which typically undergoes performance testing based on physical parameters, and electrical/software safety, rather than diagnostic accuracy studies with expert readers.

However, I can extract information related to what is available in the document:

Acceptance Criteria and Device Performance (Based on provided documentation's summary of testing):

The document primarily relies on comparisons to predicate devices and adherence to established safety and performance standards for laser surgical instruments. It doesn't present "acceptance criteria" in the sense of a statistical threshold for diagnostic accuracy for a new AI algorithm, but rather lists the device's technical specifications and verifies compliance with recognized standards.

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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 PICOANDY is indicated for the following at the specified wavelength:

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

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

· Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.

The PICOANDY is the solid state laser capable of delivering energy at wavelengths of 1064nm or 532nm at short durations. The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm delivery system terminated by the handpiece. The fluence (energy density) and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

The provided document lists information for a medical device called PICOANDY (Q-Switched Nd:YAG Laser), which is a laser surgical instrument. It includes a 510(k) summary for FDA clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a table format with specific target values for performance in the context of a clinical study or effectiveness evaluation. Instead, it details the technical specifications of the PICOANDY device and compares them against a predicate device (PICOHIGH), claiming "substantial equivalence."

However, we can infer performance specifications from the "Performance Testing" section and the comparison to the predicate device.

• Zoom 532nm: 10 ~ 200mJ ±10%
• Collimation Mode: 38 ~ 500mJ ±10%
• MLA (1064nm): 30 ~ 550mJ ±10%
• MLA (532nm): 10 ~ 200mJ ±10%
• 1064nm DOE: 30 ~ 550mJ ±10%
• 532nm DOE: 20 ~ 200mJ ±10% | Reported within these ranges. | Similar (Predicate range for handpiece output is only slightly different, including error range) |
  | Spot Size: | 2 to 10 mm (by 1mm step) | 1064nm mode: (2 to 10mm) step: 1mm, 532nm mode: (2 to 10mm) step: 1mm | Similar (Proposed device range included in predicate) |
  | Pulse Repetition Rate: | Max. 10Hz | 1064nm mode: 1-10Hz, 532nm mode: 1-10Hz | Same |
  | Laser Delivery Type: | Articulated Arm with Handpiece | Articulated Arm with Handpiece | Same |
  | Handpiece Types: | Zoom, Collimated, MLA, DOE | Zoom, Collimated, MLA, DOE | Same |
  | Patient Contact Material: | Aluminum Powder (Handpiece) | Aluminum Powder (Handpiece) | Same |

The "acceptance criteria" here are implicitly the specifications of the device and its demonstrated ability to perform within those specifications, and critically, to be "substantially equivalent" to a legally marketed predicate device.

Study Type and Details to Prove Acceptance:

The document states: "No clinical studies were considered necessary and performed." This indicates that the device's clearance was based on non-clinical data and comparison to a predicate device.

Therefore, the following information is not applicable or extractable from the provided document as no clinical or comparative effectiveness study was conducted:

• Sample size used for the test set and data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Multi Reader Multi Case (MRMC) comparative effectiveness study
• Effect size of human readers improving with AI vs. without AI assistance
• Standalone (algorithm only) performance study

Here's what was used to prove the device meets acceptance criteria (i.e., substantial equivalence):

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

• Not applicable / Not provided. No clinical test set. The evaluation relies on bench tests and comparison to a predicate device.

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

• Not applicable / Not provided. No ground truth established by experts for a clinical test set since no clinical studies were performed.

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

• Not applicable / Not provided. No clinical test set requiring adjudication.

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 study was not done. This device is a laser system, not an AI-assisted diagnostic tool.

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

• Not applicable / Not provided. This device is a physical laser system, not a software algorithm for standalone performance. "Software Validation" refers to the internal software controlling the device, not a standalone diagnostic algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" implicitly refers to the engineering specifications and established safety and performance standards (e.g., IEC standards) and the characteristics of the predicate device. Compliance with these standards and demonstrating similar functionality to a predicate forms the basis of "truth" for substantial equivalence.

8. The sample size for the training set:

• Not applicable / Not provided. There is no "training set" in the context of an AI/ML algorithm for this device. The software validation mentioned is for the device's operational software, not for an AI model trained on data.

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

• Not applicable / Not provided. As there's no training set for an AI/ML algorithm described.

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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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The Q-Switched Nd: Yag laser is indicated for the treatment of: benign cutaneous lessons, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and the removal of black or blue tattoos.

The Q-switched laser therapy device is laser system which delivers laser at a wavelength 1064nm or 532nm and the pulse mode is single pulse. In laser handpiece, there is one optical cavity containing the Nd: YAG crystal. The laser beam is directed to the treatment zone. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect.

The provided document is a 510(k) premarket notification letter from the FDA regarding a Q-Switched Nd:Yag laser device. This type of document establishes substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical data, especially not for AI/machine learning devices where such studies would be critical.

The document explicitly states:

• "No clinical study is included in this submission." (Page 9)
• The entire evaluation for substantial equivalence is based on "Non-Clinical Test Conclusion," showing compliance with various electrical safety, biocompatibility, and laser safety standards (ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, ISO 10993-10), and Software Validation & Verification Test.

Therefore, I cannot provide the requested information for an acceptance criteria table, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided FDA 510(k) summary for this laser device.

The questions you've posed (acceptance criteria, sample size, expert ground truth, MRMC, etc.) are highly relevant for the validation of AI/ML-based medical devices or devices with a diagnostic component whose performance is assessed against human interpretation or clinical outcomes. The device in this document is a physical laser for treatment, and its FDA clearance is based on demonstrating equivalence in its technical specifications and adherence to relevant safety standards, not on diagnostic accuracy or AI performance.

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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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