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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 PICOCAREMAJESTY Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064nm
The 1064nm wavelength of the PICOCAREMAJESTY 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)

532nm
The 532nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III

The PICOCAREMAJESTY is the solid state laser capable of delivering energy at wavelengths of 10641m or 532nm at short durations. The device system consists of a main unit, an articulated ann, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated am 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 energy is changed automatically in accordance with the selected fluence (down) button and then, the fluence is increased by 0.1 J/cm².

The selectable fluence values are 0.2 to 16.0 J/cm². at 1064nm and 0.1 to 7.96 J/cm² at 532nm

The provided document is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for a laser system called PICOCAREMAJESTY. This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study of the device against specific acceptance criteria for a new AI/medical device.

Therefore, the information required to populate a table of acceptance criteria and reported device performance for an AI-based medical device study (as implied by questions about sample size, ground truth, expert adjudication, MRMC studies, etc.) is not present in this document.

The document describes a physical laser device, not an AI software. The "software validation" section refers to the device's internal control software, not a diagnostic or AI algorithm.

However, I can extract information related to the device's specifications and performance tests that were conducted to ensure its physical operation aligns with its intended use and safety standards. This is distinct from a performance study for an AI diagnostic device.

Here's how to address the questions based on the provided document, acknowledging its limitations regarding AI-related performance studies:

1. A table of acceptance criteria and the reported device performance

The document does not specify "acceptance criteria" in the context of an AI-driven performance study (e.g., sensitivity, specificity, AUC). Instead, it provides performance specifications for the laser device itself and states that bench tests (non-clinical) were conducted to verify these.

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The Picocare Family is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064nm
The 1064nm wavelength of the Picocare Family 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).
532nm
The 532nm wavelength of the Picocare Family system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.

The Picocare Family is the solid state laser capable of delivering energy at wavelengths of 1,064 nm or 532 nm at short durations of 450 ps (picoseconds). 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.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Picocare Family device:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a detailed clinical study with acceptance criteria in the same way a de novo application might. Therefore, explicit "acceptance criteria" and "reported device performance" against those criteria for a clinical effectiveness study are not clearly defined in the text as they would be for a clinical trial establishing effectiveness from scratch. Instead, the document relies on comparing technical characteristics and existing safety/effectiveness profiles of predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document is a 510(k) submission for substantial equivalence. It doesn't present a clinical study with primary and secondary endpoints and corresponding acceptance criteria. Instead, it compares the proposed device's technical characteristics to predicate devices and asserts that the changes do not alter safety or efficacy. The "acceptance criteria" for this submission are essentially that the device's characteristics are within an accepted range or similar enough to predicate devices such that new safety/efficacy concerns are not raised.

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

• Test Set (Clinical Data): The document explicitly states: "no animal or new clinical data was required to show safety, efficacy or substantial equivalence to the currently cleared model." Therefore, there was no clinical test set in the traditional sense for evaluating the modified device's performance through patient data.
• Data Provenance: Not applicable as no new clinical data was gathered.

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

• Not applicable as no new clinical data requiring expert review for ground truth was gathered. The determination of "substantial equivalence" relies on regulatory review and comparison to existing devices.

4. Adjudication Method for the Test Set

• Not applicable as no clinical test set was used to establish ground truth.

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

• No, an MRMC comparative effectiveness study was not done. The document states that "no animal or new clinical data was required."

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

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

7. The Type of Ground Truth Used

• For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence was primarily:
  • Regulatory definitions and established safety/efficacy profiles of the predicate devices (Picocare K162755 and Picoway Laser System K153527).
  • Engineering and performance specifications of the proposed device, verified through non-clinical testing.
  • Risk analysis to confirm no new risks were introduced by the modification.

8. The Sample Size for the Training Set

• Not applicable. No AI algorithm is being trained here. This refers to a medical device.

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

• Not applicable. No AI algorithm and thus no training set.

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The Picocare is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064 nm

The 1064 nm wavelength of the Picocare 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).
532 nm

The 532 nm wavelength of the Picocare system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.

The Picocare is the solid state laser capable of delivering energy at wavelengths of 1,064 nm or 532 nm at short durations of 750 ps (picoseconds). 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.

This document is a 510(k) premarket notification for the Picocare laser system, indicating its substantial equivalence to a predicate device. It primarily focuses on the technical and safety aspects, rather than clinical efficacy studies with specific acceptance criteria as might be seen for AI/software-as-a-medical-device (SaMD) products.

Therefore, the requested information, particularly regarding acceptance criteria, device performance tables, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC comparative effectiveness studies, is not explicitly provided in the provided text.

The document details non-clinical tests to verify the device's technical specifications and safety, indicating that performance was assessed against design specifications and relevant international standards.

Here's a breakdown of what can be inferred or directly stated from the document, with caveats for missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and a table of reported device performance in those terms are not provided. The document states that "Bench tests were conducted to verify that the proposed device met all design specifications" and "Following performance testing were conducted to verify that the proposed device met all design specifications including pulse energy, pulse width, wavelength spectrum, beam profile, spot size, and repetition rate." This implies that the device's measured technical parameters (pulse energy, pulse width, etc.) were within the specified design ranges, but the exact ranges and measured values are not detailed in this summary.

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

This document describes a laser device, not an AI/SaMD. Therefore, there are no "test sets" in the context of clinical data for algorithmic performance. The tests mentioned are for non-clinical performance and safety of the laser hardware and software.

• Sample Size for performance tests: Not specified. It generally refers to the number of units or measurements performed to verify technical specifications.
• Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed on the device itself.

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

Not applicable. The "ground truth" for a laser device's technical performance is typically established by engineering standards and validated measurement equipment, not by medical experts.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for subjective interpretations of clinical data, which is not the focus of this document for a laser device's technical performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC comparative effectiveness study is used to assess the impact of AI on human reader performance, which is not relevant for this laser device's technical performance and safety submission.

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

The document mentions "Software Validation" and states "The Picocare contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated." This indicates a standalone validation of the software components was performed, but the specific performance metrics (e.g., accuracy of internal calculations, control logic) are not detailed.

7. The Type of Ground Truth Used

For the non-clinical tests described:

• Engineering Specifications: For pulse energy, pulse width, wavelength spectrum, beam profile, spot size, and repetition rate.
• International Standards: For electrical safety (IEC 60601-1, 60601-1-2, 60601-2-22), laser safety (IEC 60825-1), and biocompatibility (ISO 10993-5, ISO 10993-10).

8. The Sample Size for the Training Set

Not applicable. This is a hardware device with software, not a machine learning model that undergoes a "training set" in the common AI/ML sense for clinical applications.

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

Not applicable. See point 8.

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