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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The enlighten III laser system 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 enlighten III laser system is indicated for:

• treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI)
• 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 enlighten III laser system is indicated for:

• treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
• tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III

670 nm:
The 670 nm wavelength of the enlighten III laser system is indicated for treatment of benign pigments with Fitzpatrick skin types I-III.

The modified Cutera enlighten III laser system is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce multiple laser wavelengths and pulse widths (1064 and 532 nm: 750 ps and 2 ns; 670 nm: 660 ps and 2 ns).

The laser, power supplies, and control electronics are housed inside a console equipped with a touchscreen control panel. The laser treatment parameters are selected using the control panel. Laser emission is activated by depressing a footswitch. An articulated arm with rotational mirror knuckles delivers the laser beam from a laser head inside the console to a handpiece. The handpiece is equipped with an optical zoom assembly that determines the spot size of the laser beam on the treatment surface. The beam of a low-power diode laser is also transmitted through the arm to provide an aiming beam.

This document is an FDA 510(k) premarket notification for a modification to the Cutera enlighten III Laser System. It focuses on demonstrating substantial equivalence to a previously cleared device. Therefore, it does not contain the kind of detailed study data (like sample sizes, expert qualifications, or comparative effectiveness with human readers) that would be present in a clinical trial report for a new device.

Here's an analysis of what is and isn't provided based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it details modifications to the device's operational parameters and then asserts that these modifications do not introduce new risks or change the intended use, implying that the device, with these modifications, still meets the safety and effectiveness profile of its predicate.

However, the key performance data discussed relates to the device's technical specifications and compliance with safety standards.

• IEC 60601-1 (Edition 3.1, 2012)
• IEC 60601-1-6 (Edition 3.1, 2013)
• IEC 62366 (Edition 1.1, 2014)
• IEC 60601-2-22 (Edition 3.1, 2012)
• IEC 60825-1 (Edition 2.0, 2007)
• AAMI/ANSI ES60601-1:2005+A2 (R2012)+A1
• IEC 60601-1-2 (Edition 3, 2007) |
  | Maximum Delivered Energy | 1064 nm: Increased from 600 mJ to 800 mJ (maintaining 10 J/cm² max fluence)
  532 nm: Increased from 300 mJ to 400 mJ (maintaining 2.5 J/cm² max fluence) |
  | Maximum Treatment Fluence | 1064 nm: Maintained at 10 J/cm²
  532 nm: Maintained at 2.5 J/cm² |
  | Spot Sizes | Added 9 mm and 10 mm incremental spot sizes for 1064 nm and 532 nm wavelengths. |
  | Pulse Duration | Added 2 ns pulse duration for the 670 nm wavelength. |
  | No New Risks Introduced | Affirmed based on unchanged maximum treatment fluence and no changes to intended use or indications for use. |
  | Equivalence in Intended Use/Indications | Identical to predicate device. |
  | Equivalence in Technical Specifications | Similar or within range of predicate and reference devices in spot sizes, wavelengths, pulse widths, laser types, and repetition rates. |
  | Equivalence in Operating Performance | Similar to predicate and reference devices. |
  | Equivalence in General Design | Similar to predicate and reference devices. |

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

The document refers to a "Performance Data: enlighten III Software Verification and Validation Testing Report (V0140 rA1)". This report likely contains the details of the test set and data provenance for the software modifications. However, the FDA letter does not provide any specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for clinical or performance data related to the device's efficacy in treating patients.

The "testing" mentioned primarily concerns software verification and validation and compliance with electrical and safety standards, not a clinical study on human subjects with a "test set" in the context of diagnostic accuracy.

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

This information is not provided in the document. As this is a 510(k) for a laser system modification, the "ground truth" would likely refer to the physical output parameters of the laser, verified by engineering and metrology, rather than expert clinical consensus on patient outcomes, which is typical for AI diagnostic devices.

4. Adjudication method for the test set

This information is not provided. Given the nature of the device (a laser system for treatment), "adjudication method" in the context of reconciling expert opinions (as described by "2+1, 3+1") is not relevant here. The "testing" pertains to engineering standards and device performance specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done or described in this document. This type of study is relevant for evaluating the impact of AI algorithms on human reader performance, typically in diagnostic imaging, which is not the function of this laser system.

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

This concept is not applicable to this device. The Cutera enlighten III is a physical laser system, not a diagnostic algorithm. The "algorithm" here refers to the control software that dictates the laser's operational parameters, and its "performance" is judged by its ability to control the hardware within specified tolerances and safety limits.

7. The type of ground truth used

The implicit "ground truth" for this device's performance is its technical specifications and adherence to international safety and electrical standards (e.g., IEC 60601-1, IEC 60825-1, etc.), as well as the accurate output of laser parameters (energy, fluence, spot size, pulse duration). This is established through engineering measurements and metrology, not pathology, outcomes data, or expert clinical consensus on patient diagnosis.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device's "software modification" does not involve machine learning or AI models that require a "training set" in the typical sense of classifying data or predicting outcomes. The software is a set of control logic and algorithms to operate the laser system.

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

This information is not applicable for the same reasons as #8.

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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-IV.

The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm at short durations less than or equal to 900 picoseconds (ps) at repetition rates up to 5 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 spot size on the skin to be easily adjusted from 3 mm to 6 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 PicoWay Laser System was evaluated for its safety and effectiveness in the removal of benign pigmented lesions.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: 26 subjects (29 lesions)
• Data Provenance: Retrospective or prospective is not explicitly stated, but the study is described as a "single arm, prospective, self-controlled multicenter study," indicating a prospective design for data collection. The country of origin of the data is not specified.

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

• The document mentions "blinded, independent review" for assessing lesion clearance. However, the exact number of experts and their specific qualifications (e.g., radiologist with X years of experience) are not provided.

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

• The document states "blinded, independent review." It does not specify a particular adjudication method like 2+1 or 3+1.

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 human readers with and without AI assistance was not done. This study solely evaluated the performance of the PicoWay Laser System as a standalone treatment device.

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

• Yes, a standalone study was done. The clinical study evaluated the PicoWay Laser System's performance as a treatment device, not as an AI algorithm assisting human readers. The "algorithm" in this context refers to the laser system's operating parameters and its direct effect on the lesions.

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

• The ground truth for efficacy was primarily based on blinded, independent review of lesion clearance, which implies expert assessment.
• For safety, the ground truth was based on the occurrence and severity of adverse events and their resolution, which is outcomes data gathered from clinical observations.

8. The sample size for the training set:

• The document does not mention a training set as this is a clinical study for a medical device (laser system), not an AI algorithm requiring a machine learning training phase. The device itself is the "intervention" being tested.

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

• As there is no mention of a training set for an AI algorithm, this question is not applicable.

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