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S2 Pigment Removal System is intended for use in removal of tattoo ink. The S2 Pigment Removal System is indicated for the removal of tattoo ink according to the following wavelengths:

800 nm:

The LightSense S2 800 nm Ti:Sapphire laser system is indicated for tattoo removal for Fitzpatrick Skin Types I-III.

532 nm:

The LightSense S2 532 nm Nd-YAG laser system is indicated for tattoo removal for Fitzpatrick Skin Types I - III.

1064 nm:

The LightSense S2 1064 nm Nd-YAG laser system is indicated for tattoo removal for Fitzpatrick Skin Types I-VI.

The S2 Pigment Removal Laser System (S2) uses high intensity laser pulses to remove tattoo ink from skin. The S2 includes the two treatment lasers, an aiming beam, a small galvanometric scanner, an articulating arm, a hand-piece with an adjustable spacer, and a foot pedal. The S2 uses two lasers to deliver three working wavelengths: (1) 800nm, ultra-short pulsed Ti:Sapphire laser, and (2) 1064 and 532nm Nd:YAG short pulse laser. The combined lasers are designed to remove tattoos.

The document provided is a 510(k) Premarket Notification from the FDA regarding the "S2 Pigment Removal System." It outlines the device's technical specifications, intended use, and studies conducted to support its substantial equivalence to a predicate device.

However, the document is a regulatory approval letter and a summary of the device, not a detailed study report with specific acceptance criteria tables or a full breakdown of the methodologies for establishing ground truth or multi-reader studies. It discusses the results of studies, but not the acceptance criteria in a quantifiable, detailed manner typically found in a clinical study report.

Therefore, I cannot extract a table of acceptance criteria and reported device performance directly from the provided text as it would typically appear in a clinical trial protocol focusing on specific metrics. The document broadly states that primary and secondary endpoints were successfully reached in terms of efficacy and safety, and provides qualitative information on performance.

Based on the provided text, here's what can be extracted and inferred regarding the study and its performance:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, there isn't a specific table of quantified acceptance criteria with corresponding performance metrics like "minimum percentage reduction in tattoo ink" by a certain time point. The document describes the "primary endpoint" and its reach, which implies the acceptance criteria were met.

Here's an attempt to present the performance findings in a table format, reflecting the efficacy reported, recognizing that the explicit acceptance criteria are not numerically defined in the text:

2. Sample Size and Data Provenance

• Test Set (Clinical Study): 58 subjects.
• Data Provenance (Clinical Study): The document does not explicitly state the country of origin for the clinical study. It implies it's a prospective clinical study conducted for the regulatory submission ("A clinical study was conducted...").
• Real-world data:
  • 957 patients (total, unspecified provenance but likely commercial clinical practice).
  • 136 patients (532nm wavelength, unspecified provenance).
  • 109 patients (Fitzpatrick V, 1064nm wavelength, unspecified provenance).
  • This real-world data is described as "data gathered in commercial clinical practice," suggesting a retrospective collection of data from actual use.

3. Number of Experts and Qualifications for Ground Truth

• The primary endpoint of the clinical study was "an evaluation of tattoo clearing as rated by a panel of blinded reviewers based on a photographic assessment."
• Number of Experts: Not specified. It refers to "a panel of blinded reviewers."
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• The text mentions "a panel of blinded reviewers," which suggests multiple reviewers.
• Adjudication Method: Not explicitly stated (e.g., 2+1, 3+1). The term "panel" usually implies a consensus or majority vote, but the specific method is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of comparing human readers with and without AI assistance. This device is a laser system for tattoo removal, not an AI diagnostic tool that assists human readers in interpreting medical images.
• The comparison is between the device's performance and the performance of a predicate device (Cynosure, PicoSure Workstation), and to established clinical outcomes.

6. Standalone (Algorithm Only) Performance

• This question is not applicable to this device. The "S2 Pigment Removal System" is a laser medical device that physically removes tattoos, not a software algorithm that provides a diagnosis or analysis without human intervention. The performance evaluated is the physical effect of the laser on tattoo ink.

7. Type of Ground Truth Used

• Clinical Study: "evaluation of tattoo clearing... based on a photographic assessment performed 8 weeks post-final treatment based on a 5 point global assessment scale." This can be considered expert consensus/assessment based on observational photographic data.
• Animal Preclinical Studies:
  • One study "to validate findings from the bench testing and to confirm optimal parameters for tattoo removal."
  • Another study "to establish optimal treatment protocols."
• Bench Testing: Verification of "device output parameters, including wavelength and fluence transmission."
• Real-world data: Outcome data from "commercial clinical practice" (unspecified how tattoo clearance was systematically assessed in this data, but likely clinical observation/documentation).

8. Sample Size for the Training Set

• Not applicable/Not mentioned. This device does not appear to be an AI/Machine Learning device that utilizes a "training set" in the conventional sense for algorithm development. The studies described are for verifying the physical parameters, safety, and efficacy of a laser system.

9. How Ground Truth for the Training Set Was Established

• Not applicable/Not mentioned. As this is not an AI/ML device, the concept of establishing ground truth for a training set does not apply here. The "ground truth" for the device's performance is established through physical measurements (bench testing), animal studies, and human clinical outcomes.

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