Search Results

755mm:
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma. The PicoSure Workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I – IV.

532nm:
The PicoSure 532-nm delivery system is indicated for tattoo removal and benign pigmented lesions removal in Skin Types I-III.

1064nm:
The PicoSure 1064-nm delivery system is indicated for tattoo and benign pigmented lesions removal.

The PicoSure Workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755nm handpiece, optional 532nm Laser Delivery System and/or 1064nm Laser Delivery System can replace the 755nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755nm laser energy into a 532nm wavelength or a 1064 nm wavelength and are available in multiple spot sizes.

The provided document is a 510(k) summary for the PicoSure Workstation, a laser surgical instrument. It details the device's indications for use and compares it to predicate devices. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance directly in the format you requested, especially regarding quantitative performance metrics, sample sizes for test sets, and details about expert involvement in establishing ground truth.

The document indicates that to support the expanded indications for use (Nevus of Ota, Hori macules, and Melasma), a literature search was conducted. This means the clinical evidence is based on existing published studies rather than a new, dedicated clinical trial performed for this 510(k) submission.

Here's an attempt to answer your questions based on the provided text, with clear indications where information is not available from this document:

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

The document does not specify quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or specific improvement percentages) directly associated with this 510(k) submission. Instead, it relies on demonstrating substantial equivalence to a predicate device and supporting new indications through literature review. The reported "performance" is qualitative, focusing on whether the existing literature showed "acceptable clinical effectiveness and safety" for the new indications.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample size: Not explicitly stated as a single test set size. The document mentions "at least ten individuals" in each of the six identified articles. Thus, the total number of individuals across all six studies is at least 60. Individual study sizes are not detailed.
• Data provenance: The document states "peer reviewed, published articles." No specific countries of origin are mentioned.
• Retrospective or prospective: The articles were identified as "prospective studies."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable / Not Available. Since the evidence is based on published clinical studies, the "ground truth" and its establishment would be inherent to the methodologies of those individual studies. The 510(k) summary does not provide details on how ground truth was established within these external studies or the qualifications of any experts involved in those studies.

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

• Not Applicable / Not Available. This information would pertain to the specific methodologies of the clinical studies identified in the literature search. The 510(k) summary does not provide these details.

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 document is for a laser workstation, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance effect size is relevant or mentioned.

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

• Not Applicable. This is a hardware device (laser workstation), not an algorithm or AI system.

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

• Not Applicable / Not Available. The "ground truth" would relate to the diagnosis of the benign pigmented lesions (Nevus of Ota, Hori macules, Melasma) and the success of their removal or clinical improvement. The specific method used to establish these in the surveyed literature is not detailed in this 510(k) summary. It likely involved clinical diagnosis by dermatologists and visual assessment of treatment outcomes.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device. The device's operation is based on its physical properties and established laser physics, not on a machine learning model trained on data. The clinical literature reviewed supported the indications for use, not a training process for the device itself.

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

• Not Applicable. As there is no training set, this question is not relevant.

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755mm:

The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure Workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I - IV.

532mm:

The PicoSure 532mm Laser Delivery System is indicated for tattoo removal and benign pigmented lesion removal in Skin Types I - III.

1064nm:

The PicoSure 1064nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.

The PicoSureTM Workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers fast and efficient treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755nm handpiece, optional 532nm Laser Delivery System and/or 1064nm Laser Delivery System can replace the 755nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755nm laser energy into a 532nm wavelength or a 1064 nm wavelength, and are available in multiple spot sizes.

Based on the provided text, the device in question is the PicoSure Workstation, a laser system used for tattoo removal, benign pigmented lesion removal, and treatment of acne scars and wrinkles. The information related to acceptance criteria and the study that proves the device meets them primarily pertains to the 532nm Delivery System for benign pigmented lesion removal in Skin Types I-III.

Here's an analysis of the provided information to address your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets for device performance. Instead, it describes a clinical study designed to demonstrate the safety and effectiveness of the 532nm Delivery System for benign pigmented lesions. The "acceptance criteria" here appear to be qualitative, focused on demonstrating a high level of improvement and acceptable safety profile.

Table of Performance (Inferred from Clinical Study Results):

Study Information:

2. Sample Size and Data Provenance

• Test Set Sample Size: 30 treatment areas (from 15 subjects).
• Data Provenance: The document does not specify the country of origin. The study was prospective as it involved treating subjects and following them up.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three.
• Qualifications of Experts: Blinded, board-certified Dermatologists. No explicit mention of years of experience.

4. Adjudication Method for the Test Set

• The clinical efficacy endpoint was evaluated "through comparison of the pre-treatment images by three blinded, board certified Dermatologists as independent reviewers." This implies a consensus-based or independent review approach, but the specific adjudication rule (e.g., majority vote, specific tie-breaking rule if opinions differed) is not detailed beyond "independent reviewers." It wasn't 2+1 or 3+1 as stated; they were independent reviewers of the images.

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

• No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not done. This study is a clinical trial assessing the laser device's direct performance on patients, not an AI-assisted diagnostic or assistive tool.

6. Standalone Performance (Algorithm Only)

• This is not applicable as the device is a physical laser workstation, not an AI algorithm. The reported performance is of the physical device as operated by a clinician.

7. Type of Ground Truth Used

• The ground truth for efficacy was established through expert consensus/independent review of pre-treatment and post-treatment images by board-certified Dermatologists, coupled with the clinical investigator's evaluation using the GAIS. For safety, it was the observation and reporting of adverse events during the follow-up period.

8. Sample Size for the Training Set

• This is not applicable as the PicoSure Workstation is a physical medical device (laser) and not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "training" for such a device would be its engineering, calibration, and manufacturing processes.

9. How Ground Truth for the Training Set Was Established

• Not applicable for the same reason as point 8. The "ground truth" for the device's design and function would be based on established medical physics principles, engineering standards, and pre-clinical testing, rather than a data-driven "ground truth" for model training.

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755 nm:
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I - IV.

532 nm:
The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I - III.

1064 nm:
The PicoSure 1064 nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.

The PicoSure™ workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers fast and efficient treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755 nm handpiece, optional 532 nm Laser Delivery System and/or 1064 nm Laser Delivery System can replace the 755 nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755 nm laser energy into a 532 nm wavelength or a 1064 nm wavelength and are available in multiple spot sizes.

The provided text describes a 510(k) premarket notification for the PicoSure Workstation, specifically focusing on the addition of a 1064 nm Laser Delivery System. The information necessary to fully answer all aspects of your request is not entirely present in the provided document, but I will extract what is available.

Here's a breakdown of the acceptance criteria and study information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific numerical thresholds for efficacy or safety. Instead, it concludes that the device is "as effective as the predicate device" and "safe and effective."

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

• Sample Size: 66 subjects with a total of 79 tattoos.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study design indicates it was a clinical study, suggesting it was prospective.

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

• Number of Experts: Three blinded reviewers.
• Qualifications of Experts: Not specified beyond being "blinded reviewers." It does not state if they were dermatologists, radiologists, or had any specific years of experience.

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

• Adjudication Method: "Mean scores for all three evaluators were calculated per subject to determine overall mean scores." This implies an averaging or consensus approach, rather than a specific 2+1 or 3+1 adjudication where dissenters might be reviewed by a tie-breaker.

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

• MRMC Study: This was a clinical study comparing a new device (PicoSure) to a predicate device (RevLite) for tattoo removal, not an MRMC study assessing human reader performance with or without AI assistance. Therefore, this question is not applicable to the provided information.

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

• This device is a laser system, not an AI algorithm. Therefore, this question about "algorithm only" performance is not applicable. The study assessed the device's clinical performance in patients.

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

• The ground truth for efficacy was established by expert consensus (mean scores from three blinded reviewers) using a 6-point categorical efficacy scoring scale based on photographic evaluation.
• Safety ground truth was based on the reporting of adverse events (deaths, SAEs, UADEs).

8. The sample size for the training set

• This was a clinical study evaluating a medical device, not an AI algorithm that requires a training set. Therefore, this question is not applicable. The only "training" mentioned for the device itself would be internal engineering and development, not a data training set as understood in AI/ML contexts.

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

• As explained above, this was not an AI algorithm study requiring a training set. Therefore, this question is not applicable.

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755 nm:
The PicoSure workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 3mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.
532 nm:
The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I-III.

The PicoSure™ workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers fast and efficient treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755 nm handpiece, an optional 532 nm Laser Delivery System can replace the 755 nm handpiece at the distal end of the articulated arm. This 532 nm Laser Delivery System converts the 755 nm laser energy into a 532 nm wavelength and is available in multiple spot sizes.

The provided document describes the Cynosure PicoSure™ Workstation with 532 nm Laser Delivery System (K143105) for tattoo removal. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with specific thresholds for device performance. Instead, it describes a comparative clinical study where the PicoSure device was deemed "as effective as" a predicate device (RevLite Q-Switched Nd:YAG Laser System K133254) based on a qualitative scoring scale.

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

• Sample Size: 18 subjects with a total of 23 tattoos.
• Data Provenance: Not explicitly stated, but clinical trials for FDA submissions are typically conducted in the US or in countries with comparable regulatory standards. The document doesn't specify if it was retrospective or prospective, but clinical studies for regulatory approval are generally prospective.

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

• Number of Experts: Three (3) blinded reviewers.
• Qualifications of Experts: Not specified in the document.

4. Adjudication Method for the Test Set

• Adjudication Method: "Mean scores for all three evaluators were calculated per subject to determine overall mean scores." This indicates that the scores from the three reviewers were averaged. It's not a 2+1 or 3+1 method, but rather a direct averaging.

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 comparative effectiveness study involving AI assistance was not done. This study solely compared the PicoSure device to a predicate laser device (RevLite) in the context of human-conducted laser treatments. AI assistance is not mentioned.

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

• No, a standalone algorithm performance study was not done. The device in question is a laser system, not an AI algorithm. The performance evaluation was for the laser system's ability to remove tattoos when operated by humans.

7. The Type of Ground Truth Used

• Ground Truth Type: Expert consensus based on a "6 point categorical efficacy scoring scale" applied to photographs. This is a form of clinical assessment/subjective evaluation.

8. The Sample Size for the Training Set

• Not applicable. The device is a physical laser system, not a machine learning algorithm that requires a training set in the conventional sense. The "training" for this device would be its engineering design, development, and manufacturing processes, which are informed by scientific principles and prior knowledge of laser-tissue interaction, not a data training set.

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

• Not applicable. As explained above, this is a physical device, not an AI/ML algorithm that uses a training set with established ground truth.

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The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure™ workstation with the 3mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.

The PicoSure™ workstation is a high powered Alexandrite system that delivers laser energy in the 755-nm wavelength. The system consists of a console that houses the power supply, control electronics and the laser. Laser energy is delivered to the skin via an articulated arm. The laser is activated using a footswitch.

The provided text describes the Cynosure Picosure™ Workstation and its indications for use. It includes a summary of clinical study findings related to the device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

• Sample Size for the Test Set:
  • The study included 40 subjects.
  • 38 subjects returned for the 4-month evaluation, which is the test set for the photo and FWSS evaluations.
• Data Provenance: The document does not specify the country of origin. The study was conducted as a prospective clinical trial, as evidenced by "before and after" evaluations and follow-up at 4 months post-treatment.

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

• Number of Experts: Three blinded evaluators were used.
• Qualifications of Experts: The document does not specify the qualifications of these evaluators (e.g., dermatologists, plastic surgeons, years of experience).

4. Adjudication method for the test set

• The document implies a consensus or independent evaluation method, as it states "three blinded evaluators, who were able to identify correctly the before and after images in 91% of the 38 subjects." It doesn't explicitly state an adjudication method like 2+1 or 3+1 for discrepancies, but given the high agreement (91%), it might not have been a significant issue or simply not detailed in this summary. It appears each evaluator made an independent judgment, and the percentage reflects the overall agreement across all three for the majority of cases.

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 comparative effectiveness study involving AI assistance was not done. The study evaluated the effectiveness of the laser device itself, with human evaluators assessing the outcome of the treatment without AI assistance.

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

• No, a standalone algorithm-only performance study was not done. The primary focus was on the efficacy of the Picosure™ Workstation when applied to human subjects, with human evaluators determining the success of the treatment.

7. The type of ground truth used

• The ground truth for the effectiveness of the treatment was established by expert assessment of photographs (for correct identification of before/after images) and the Fitzpatrick Wrinkle Severity Scale (FWSS) scores, also assessed by experts, indicating a clinical improvement. Safety ground truth was based on reported adverse events.

8. The sample size for the training set

• This document describes a clinical study to demonstrate the effectiveness of the medical device as a treatment. It is not describing the development or validation of an AI algorithm, so there is no mention of a training set in the context of machine learning. The "training set" for the device's efficacy would be considered the prior research and development that led to the device's design, but this is not a data set in the AI sense.

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

• As there is no AI algorithm being described, there is no training set ground truth in the context of an AI algorithm. The device's "ground truth" for its intended performance is based on the underlying scientific principles of laser-tissue interaction and prior clinical research on similar technologies, not on a labeled dataset for an algorithm.

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The PicoSure™ workstation is indicated for tattoo and benign pigmented lesion removal.

The PicoSure™ workstation operating with the 3mm or 6mm handpiee and the FOCUS lens array is indicated for the treatment of acne scars in Fitzpatrick skin types I-IV.

The PicoSure™ workstation is a high-powered, Q-switched Alexandrite system that delivers laser energy in the 755-nm wavelength. The system consists of a console that houses the power supply, control electronics and the laser. Laser energy is delivered to the skin via an articulated arm. The laser is activated using a footswitch.

The provided document describes the PicoSure™ Workstation, a laser system indicated for tattoo and benign pigmented lesion removal, and for the treatment of acne scars when operating with specific handpieces and the FOCUS lens array. The document presents two clinical studies to support the safety and effectiveness of the device for acne scar treatment. Below is an analysis of the acceptance criteria and study data based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

• 7 and 15 Days Post-treatment: Intact epidermis with mild, superficial dermal lymphocytic infiltrates in peri-vascular pattern. (This indicates localized and transient tissue response, which is generally acceptable for laser procedures.) |

Note: The document does not explicitly state pre-defined acceptance criteria values for these metrics. The reported performance implies these results were considered sufficient to demonstrate substantial equivalence.

2. Sample Size and Data Provenance for the Test Set

• Acne Scars Study (Clinical Study 1):

  • Sample Size (Test Set): 17 patients completed the study, with a total of 46 acne scars treated.
  • Data Provenance: The document does not explicitly state the country of origin. It is a prospective clinical study, as it describes treatment and follow-up observations.

• Tissue Response Study (Clinical Study 2):

  • Sample Size (Test Set): 3 subjects (2 on arm, 1 on leg).
  • Data Provenance: The document does not explicitly state the country of origin. It is a prospective clinical study, as it describes treatment and subsequent biopsies.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Acne Scars Study:

  • Number of Experts: Three blinded evaluators.
  • Qualifications: The specific qualifications (e.g., radiologist, years of experience) of these evaluators are not specified in the provided text. They were described as "blinded evaluators."

• Tissue Response Study:

  • Number of Experts: Not explicitly stated for establishing ground truth from biopsies, but biopsies would typically be analyzed by pathologists.
  • Qualifications: Not specified.

4. Adjudication Method for the Test Set

• Acne Scars Study: The method for reaching consensus among the three blinded evaluators regarding the "before and after images" or for determining the "mean improvement score" is not explicitly detailed. It can be inferred that their evaluations were aggregated, but the specific adjudication (e.g., voting, expert consensus meeting) is not described.
• Tissue Response Study: For the biopsy analysis, an adjudication method is not detailed. Typically, a qualified pathologist would interpret the biopsies, and potentially a second opinion might be sought for complex cases, but this is not mentioned.

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

• A formal MRMC comparative effectiveness study, comparing human readers with AI assistance versus without AI assistance, was not performed, nor is it applicable to this device. The PicoSure Workstation is a laser device, not an AI diagnostic or assistance tool for human readers. The study involved human evaluators assessing photographic outcomes of a treatment device.

6. Standalone Performance

• A standalone (algorithm only without human-in-the-loop performance) study was not applicable and therefore not conducted. The PicoSure Workstation is a physical laser device used for treatment, not a standalone AI algorithm.

7. Type of Ground Truth Used

• Acne Scars Study: The ground truth for effectiveness was based on:
  • Expert Consensus/Opinion: Evaluations by three blinded evaluators of before/after photographs.
  • Subjective Satisfaction: Non-blinded treating physician's satisfaction scores and subjects' self-reported satisfaction.
• Tissue Response Study: The ground truth for safety (tissue response) was based on Pathology via biopsies taken at various time points after treatment.

8. Sample Size for the Training Set

• The document describes clinical studies used to assess the performance of the device, not to train an AI algorithm. Therefore, a "training set" in the context of machine learning is not applicable to this device and its studies. The clinical studies served as validation for the device's efficacy and safety.

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

• As a training set for an AI algorithm is not applicable, the method for establishing its ground truth is not relevant to the information provided. The "ground truth" discussed in the context of these studies refers to the outcomes measured in the clinical trials themselves by evaluators, physicians, and pathological examination.

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The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal.

The PicoSure™ workstation is a high-powered, laser system that delivers energy in the 755-nm wavelength. Same as its predicates, the PicoSure™ workstation is intended for tattoos and benign pigmented lesions removal. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed.

The provided document is a 510(k) summary for the PicoSure™ workstation, a laser surgical instrument for tattoo and benign pigmented lesion removal. It describes the device's intended use, technological characteristics, and performance data from non-clinical and clinical studies. However, the document does not explicitly state predefined acceptance criteria for the clinical studies nor detailed quantitative results against such criteria. It provides a general statement of "safety and effectiveness" and "high level of overall tattoo clearance." Therefore, some of the requested information cannot be fully extracted or will be based on inference.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state quantitative acceptance criteria for clinical effectiveness. It broadly states the device was found "safe and effective, with high level of overall tattoo clearance." For safety, it states "All treatment arms had a comparable safety profile. None of the events were classified as adverse device reaction. No serious or unexpected adverse events were reported."

• "Demonstrated more significant % of highest clearance score than control device in controlled studies" |
  | Safety (Adverse Events) | - "Comparable safety profile" across treatment arms
• No adverse device reactions
• No serious or unexpected adverse events
• Majority of AEs were mild, no severe AEs
• Most common AEs: pain and blistering |
  | User Satisfaction | - "Extreme" physician satisfaction (physician evaluation)
• Subject satisfaction surveyed and analyzed (no specific results provided) |

2. Sample Size and Data Provenance for Test Set

• Sample Size (Clinical Studies): Not explicitly stated. The document mentions "Three clinical studies (two controlled and one uncontrolled)," but does not provide the number of subjects or lesions included in these studies.
• Data Provenance: Not explicitly stated. The document does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of clinical trials for device approval, it is highly likely the studies were prospective.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The evaluation of tattoo clearance was done by "evaluation of before-and-after photos and calculation the % of tattoo clearance." Physician satisfaction was also surveyed. It can be inferred that treating physicians or other qualified medical personnel were involved in these assessments, but their specific qualifications (e.g., dermatologists, years of experience) are not provided.

4. Adjudication Method for Test Set

• Adjudication Method: Not explicitly stated. The document mentions "evaluation before-and-after photos and calculation the % of tattoo clearance." It does not describe any specific adjudication process like 2+1 or 3+1 for discrepancies in evaluation.

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

• MRMC Study: Not explicitly mentioned. The clinical studies involved "two controlled studies" where the device "demonstrated more significant % of highest clearance score than control device." This suggests a comparison between the PicoSure™ workstation and a control (likely another laser device or a sham treatment). However, it does not describe a setting where human readers interpret images with and without AI assistance. The PicoSure™ workstation itself is a laser device, not an AI for image interpretation. Therefore, a traditional MRMC study comparing human readers with and without AI assistance is not applicable in this context.
• Effect Size of Human Readers with AI vs. without AI: Not applicable, as this is not an AI-based diagnostic/interpretive device.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Not applicable. The PicoSure™ workstation is a physical laser device for treatment, not an algorithm for standalone diagnostic performance.

7. Type of Ground Truth Used

• Type of Ground Truth: The effectiveness was assessed by "evaluation before-and-after photos and calculation the % of tattoo clearance." For safety, "Treatment-emergent adverse events were recorded and evaluated." This indicates that clinical assessment (visual clearance from photos) and reported adverse events/clinical observations served as the ground truth for effectiveness and safety, respectively. There is no mention of pathology or outcomes data beyond the clinical observations.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. The PicoSure™ workstation is a physical laser device, not a machine learning model that requires a training set. The clinical studies mentioned are for validation of the device's safety and efficacy, not for training an algorithm.

9. How Ground Truth for Training Set was Established

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for a machine learning model.

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