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

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

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

1064nm: 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 are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.

The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm, 785 nm, or 532 nm at short durations of 240–750 picoseconds (ps) at repetition rates up to 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm). The device system is comprised of a system console, an articulated arm, and an attached handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a handpiece. The light-weight and ergonomic handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System (up to 10 mm). The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the articulated arm. The PicoWay system control panel enables the user to select the desired energy density level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

The provided text describes the FDA 510(k) summary for the PicoWay Laser System, primarily focusing on its expansion of indications for use to include the treatment of wrinkles.

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

Device: PicoWay Laser System
Expanded Indication: Treatment of wrinkles using the Resolve handpieces (532nm or 1064nm wavelengths)

Acceptance Criteria and Reported Device Performance

• Investigator assessments: 92% improvement rate at 12-week follow-up.
• Mean elastosis score improvement: 1.44 ± 0.83.
• Investigator satisfaction rate: 88%.
• Subjects' satisfaction rate: 74% at the last visit.
• Very positive safety profile with no adverse events (though 2 subjects reporting severe pain were counted as AEs out of caution, but resolved next day without intervention).
• Anticipated treatment responses (erythema, edema, tingling, crusting, acne breakout) observed and resolved within days without medical intervention.
• Most subjects reported low levels of pain during treatment and discomfort in the week following treatment, indicating good tolerability. |

Study Details:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: A total of 74 subjects were enrolled, and 72 subjects were treated.
   • Data Provenance: The study was a "multicenter study conducted at 4 sites in the United States." The data is prospective.

2. Number and Qualifications of Experts for Ground Truth:

   • Number of Experts: Two blinded evaluators.
   • Qualifications: Not explicitly stated beyond "blinded evaluators." It's common in dermatology/cosmetic studies for these to be board-certified dermatologists or plastic surgeons, but the document does not specify.

3. Adjudication Method for the Test Set:

   • The assessment was performed by "2 blinded evaluators." The text implicitly suggests consensus or independent agreement was sought for the "correct identification of the post treatment photograph and assessment of at least one Elastosis Score unit." However, a formal adjudication process like 2+1 or 3+1 is not explicitly described. It simply states "as assessed by 2 blinded evaluators," implying their combined assessment formed the ground truth for the primary endpoint.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC study was conducted for human readers with and without AI assistance. This device is a laser system, not an AI diagnostic tool that assists human readers. The clinical study was a direct evaluation of the device's effect on wrinkles.

5. Standalone Performance (Algorithm Only):

   • N/A. This is a hardware device (laser system) used for treatment, not an algorithm for diagnosis or image analysis. The "performance" here refers to the clinical efficacy and safety of the physical device.

6. Type of Ground Truth Used:

   • The ground truth for the primary endpoint was established by expert assessment ("2 blinded evaluators") based on "correct identification of the post treatment photograph and assessment of at least one Elastosis Score unit." This is a subjective, observer-reported outcome measure in a clinical setting.
   • Additional ground truth indicators included investigator assessments, subject satisfaction, and adverse event reporting.

7. Sample Size for the Training Set:

   • N/A. This is a medical device (laser system), not a machine learning algorithm that requires a separate training set. The study describes a clinical trial evaluating the device's performance directly on human subjects.

8. How the Ground Truth for the Training Set Was Established:

   • N/A. (See point 7).

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

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

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

1064nm: 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 PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm, 785 nm, or 532 nm at short durations of 240-540 picoseconds (ps) at repetition rates up to 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm). The device system is comprised of a system console, an articulated arm, and an attached Zoom or Resolve Handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a Handpiece. The light-weight and ergonomic Zoom Handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System when using the Zoom Handpiece (up to 10 mm). The Resolve Handpieces are available with 6 x 6 mm spot size for both wavelengths. The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the laser beam into the articulated arm. The PicoWay system control panel enables the user to select the desired energy density level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

Here's a breakdown of the acceptance criteria and study findings for the PicoWay Laser System, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Sample Size: 36 subjects.
• Data Provenance: Prospective, from 3 sites in the United States.

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

• Number of Experts: 3 blinded evaluators.
• Qualifications: The document does not specify the exact qualifications (e.g., "radiologist with 10 years of experience"). It only states they were "blinded evaluators" who assessed improvement by "correct identification of the post treatment photograph."

4. Adjudication Method for the Test Set:

• A consensus-like method was used: "as assessed (by the correct identification of the post treatment photograph) by at least 2 of 3 blinded evaluators." This implies that agreement from at least two out of three evaluators was sufficient for a positive assessment.

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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing AI assistance to human readers was not done. This study solely evaluated the device's performance based on expert assessment of photographs. This device is a laser system, not an AI diagnostic tool.

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

• Not applicable. This is a medical device (laser system), not a standalone algorithm. Its performance is directly tied to its physical operation and the in-human results.

7. The Type of Ground Truth Used:

• Expert Consensus: The primary endpoint relied on the consensus of at least 2 out of 3 blinded evaluators assessing photographic improvement.
• Investigator Assessments: Investigators also provided assessments of improvement rates.
• Patient Reported Outcomes (PROs): Subject satisfaction rates were collected.
• Histology Data: Biopsy samples provided histological evidence of treatment effects and healing.

8. The Sample Size for the Training Set:

• The document refers to "several prospective studies" that have been conducted previously to evaluate the PicoWay System, suggesting a broader dataset exists. However, for the specific expanded indication (acne scars), no separate "training set" is described for this premarket notification. The 36-subject study appears to be the primary clinical evidence for this specific indication.

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

• As no explicit "training set" for the acne scar indication is detailed in this document, the method for establishing its ground truth is not provided. For the test set described, ground truth was established through blinded evaluators' consensus, investigator assessments, and histological data.

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The Profound System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Specifically, the 25º Dermal handpiece and cartidge are used for percutaneous treatment of facial wrinkles, and the 75° SubQ handpiece and cartridge are used to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III as supported by long-term clinical data (6 months).

The Profound System is comprised of the following components: a re-usable console containing a radiofrequency (RF) generator and graphical user interface; two re-usable treatment applicators; and two disposable, single use, sterile electrode cartridges. Bipolar RF energy is delivered from the RF generator through the electrodes into the dermal layers beneath the surface of the skin. The volume of the treated area is defined by the geometry of the individual micro-electrode needle pairs, which are all electrically isolated from each other and controlled independently by separated RF channels within the console. In addition, temperature sensors provide real-time feedback of tissue temperature. The treatment dose is controlled by the physician.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): 50 treated subjects (100 thighs).
• Data Provenance: The study was conducted across 4 U.S. sites. The study was prospective, single-arm, and self-controlled.

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

The document states "blinded review" but does not specify the number or qualifications of the experts who performed this blinded review for establishing the ground truth.

4. Adjudication Method for the Test Set

The document states "blinded review" for assessing improvement in cellulite. However, it does not specify a formal adjudication method like 2+1 or 3+1. It implies direct assessment by the blinded reviewers against baseline photos.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a single-arm, self-controlled study focused on the Profound System's performance rather than comparing it against human readers or other devices in a multi-reader context. Therefore, there is no effect size reported for human readers improving with AI vs without AI assistance, as AI assistance in image interpretation is not the function of this device.

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

This device (Profound System) is an electrocoagulation and hemostasis device used for percutaneous treatment of facial wrinkles and cellulite. It is a physical medical device that delivers energy, not an AI algorithm for diagnostic interpretation. Therefore, a standalone algorithm-only performance study is not applicable and was not performed. The performance evaluated is that of the device itself on patients, not an AI interpreting data.

7. The Type of Ground Truth Used

The ground truth for the effectiveness endpoints was established through blinded expert review of clinical photographs at various follow-up intervals compared to baseline photos. Additionally, investigator assessments and patient self-assessments contributed to the understanding of effectiveness.

8. The Sample Size for the Training Set

The document describes a single clinical study of the device for its new indication. It does not refer to a "training set" in the context of an AI model. The 50 subjects (100 thighs) are the test set for evaluating the device's clinical efficacy for its intended use. If this device had AI components, its training set would be mentioned separately. As it is a physical device, this concept does not apply in the same way.

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

As explained in point 8, the concept of a "training set" for an AI model is not applicable in this context. The clinical study described served as the primary evidence to demonstrate the device's performance for regulatory clearance.

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

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

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

1064nm: 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-V.

The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm, 785 nm, or 532 nm at short durations of 240-750 picoseconds (ps) at repetition rates up to 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm). The device system is comprised of a system console, an articulated arm, and an attached Handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a Handpiece. The light-weight and ergonomic Handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System (up to 10 mm). The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the laser beam into the articulated arm. The PicoWay system control panel enables the user to select the desired energy density level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

Here's an analysis of the acceptance criteria and study detailed in the provided text, formatted as requested:

Acceptance Criteria and Device Performance Study for PicoWay Laser System

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the clinical study. Instead, it reports specific outcomes and compares them to expectations based on predicate devices. I have inferred the implied performance goals based on the reported favorable safety profile and substantial clearance for tattoo removal, aligning with the "perfoRMS as intended" declaration.

Note: The bench testing on Resolve handpiece efficacy is an important performance indicator, even if not phrased as a "criterion" in the same way as safety or clinical clearance percentages.

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

• Sample Size: 15 subjects (22 tattoos).
• Data Provenance: The document does not explicitly state the country of origin. It describes the study as a "single arm, self-controlled study," implying it was a prospective clinical trial conducted specifically for this submission.

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

• Number of Experts: 3 blinded reviewers.
• Qualifications of Experts: Not specified. The document only states "independent review by 3 blinded reviewers."

4. Adjudication Method for the Test Set

• Method: Not explicitly described as part of an adjudication process in the traditional sense for determining "ground truth." The reviewers "correctly identified the pre and post treatment for all (100%) of the tattoos," suggesting their role was to evaluate the visibility of change rather than to establish a definitive, gold-standard diagnosis or measurement. The percentage clearance was likely based on a subjective rating scale or objective measurement method applied to the images, with the reviewers' agreement confirming the detectability of this change.

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 MRMC study was done. This study evaluated the performance of the device itself (PicoWay Laser System) and not an AI-assisted diagnostic tool or human reader performance.

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

• Not applicable. This device is a laser system, not an algorithm. The clinical study evaluated the device's efficacy and safety on patients, not its performance as a standalone diagnostic tool.

7. The Type of Ground Truth Used

• For Tattoo Clearance: The "ground truth" for tattoo clearance appears to be a combination of:
  • Blinded Expert Assessment: Independent review by 3 blinded reviewers who confirmed identify pre/post-treatment images.
  • Quantitative/Semi-Quantitative Clinical Assessment: "At least 50% clearance compared to baseline" (how this was measured isn't detailed, but implies a scoring system).
  • Investigator Assessment: "Substantial to complete clearance" assessed by the clinical investigators.
• For Safety: Clinical observation of adverse events and patient discomfort.
• For Technological Equivalence: Histological evaluation.

8. The Sample Size for the Training Set

• Not applicable. The document describes clinical studies conducted to evaluate the device, not to train a machine learning model.

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

• Not applicable. As no training set for an AI/algorithm is discussed, this question is not relevant.

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The PicoWay Laser System is indicated for the following at the specified wavelength:

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

1064nm: 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-V.

The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm at short durations of 240-750 picoseconds (ps) at repetition rates up to 10 Hz. The device system is comprised of a system console, an articulated arm, and an attached handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a zoom handpiece (HP). The light-weight and ergonomic zoom handpiece allows the skin to be easily adjusted from 2 mm to 10 mm in steps of 1 mm. The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the laser beam into the articulated arm. The PicoWay system control panel enables the user to select the desired energy density (fluence) level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

The provided FDA 510(k) summary for the PicoWay Laser System includes information regarding acceptance criteria and a clinical study to demonstrate its performance.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 60 subjects (69 tattoos/pigmented lesions).
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "single arm, self-controlled study." It is a prospective clinical study as it was conducted to evaluate the safety and effectiveness of the device.

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

• Number of Experts: The document states "blinded, independent review," implying at least one, and likely more, independent experts. The exact number of experts is not specified.
• Qualifications of Experts: The qualifications of the experts are not explicitly stated, beyond being "independent reviewers."

4. Adjudication Method for the Test Set

• The document mentions "blinded, independent review." It does not specify a formal adjudication method like "2+1" or "3+1" for discrepancies. It's implied that their assessment directly formed the basis for the primary endpoint.

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

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This study focuses solely on the performance of the PicoWay Laser System for tattoo and benign pigmented lesion removal.

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

• This is not applicable as the PicoWay Laser System is a physical medical device (laser system), not an AI algorithm. Its performance is directly tied to its physical operation and the human operator's use of it.

7. The Type of Ground Truth Used

• Expert Consensus/Clinical Assessment: The primary endpoint was determined by "blinded, independent review" of tattoo clearance, and a secondary endpoint was based on "investigator assessment." This indicates the ground truth was established through expert clinical evaluation.

8. The Sample Size for the Training Set

• The document does not mention a "training set" in the context of an algorithm or AI. This study is a clinical trial evaluating a physical medical device. The "training set" concept is not relevant here.

9. How the Ground Truth for the Training Set was established

• Not applicable, as there is no "training set" for this device.

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