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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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The PicoWay laser system is indicated for the following at the specified wavelength:

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

730 nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.

785 nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.

1064 nm: 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 Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

The Resolve handpieces (532 nm HE, 532 nm, 1064 nm) are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV

The Resolve Fusion handpiece (1064 nm) is indicated for the treatment of wrinkles as well as benign pigmented lessons in Fitzpatrick Skin Types I-IV

The Resolve Fusion handpiece (532 nm) is indicated for the treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV

The PicoWay System has been previously cleared (K170597, K162454, K160607, K150326, K142372 and K153527) for tattoo removal and treatment/removal of benign pigmented lesions as well as treatment of acne scars and wrinkles. There are minor modifications to the current system to add four (4) new handpieces, minor system specifications, and new wavelengths. The additional new handpieces will work in the same way as the currently cleared PicoWay handpieces as in they will operate in the same manner as the predicate devices.

The PicoWay Laser System is a solid-state laser capable of delivering energy at wavelengths of 1064 nm, 532 nm, 730 nm (new) or 785 nm at extremely short duration in the range of 240-500 ps. The laser system contains one 755 nm (Alexandrite) laser head which is used to 'pump' (create) the 1064 nm picosecond wavelength. The 1064 nm wavelength can be frequency-doubled to 532 nm as desired. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532 nm or 1064 nm wavelengths. The current 785 nm and new 730 nm wavelength contain a Ti:Sapphire laser rod that is pumped with the 532 nm energy. All these energies are delivered through an articulated arm and corresponding handpiece. Currently there are two cleared Resolve handpieces (1064 nm and 532 nm), a 785 nm handpiece and a Zoom handpiece that works on two wavelengths (532 nm and 1064 nm).

The provided document is a 510(k) summary for the Candela PicoWay Laser System (K191685). It focuses on adding new handpieces and wavelengths to an already cleared device. This type of submission relies heavily on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical study with specific acceptance criteria for a novel AI device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as one would expect for an AI/ML medical device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm. The document primarily addresses the safety and performance of laser hardware.
• Sample size and data provenance for a test set to evaluate an AI/ML algorithm.
• Details on experts used to establish ground truth or adjudication methods for an AI/ML test set.
• Information on MRMC comparative effectiveness studies or standalone AI performance.
• Details on training set sample size or ground truth establishment for an AI/ML algorithm.

The document primarily discusses:

• Device Description: The PicoWay Laser System and the new handpieces/wavelengths.
• Technological Characteristics: Highlighting their similarity to the predicate device.
• Performance Data (for hardware safety and function):
  • Electrical Safety and Electromagnetic Compatibility
  • Biocompatibility
  • Software (V&V for updated functionality, not an AI algorithm)
  • Bench Testing (for hardware specifications)
  • Ship Testing (for packaging integrity)
• Clinical Data: Explicitly states, "The PicoWay Laser System did not require clinical performance data." This further confirms the absence of clinical studies evaluating performance against acceptance criteria for an AI solution.

In summary, the provided text describes a submission for a laser system where the substantial equivalence argument is based on hardware modifications and engineering verification/validation, not on the performance of a new AI algorithm against pre-defined clinical acceptance criteria.

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