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The Clear + Brilliant Laser System is intended for dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.

The Clear + Brilliant™ Laser System is a non-ablative laser system designed for use in non-invasive dermatological procedures. The Clear + Brilliant Laser System has a laser source in the hand piece which is controlled by an embedded processor. The console is electrically connected to the facility power source. Laser energy produced by the unit is delivered to the tissue through the removable (disposable) contact treatment tips which attach to the hand piece. The original Clear + Brilliant Laser System has a single hand piece containing a 1440 nm diode laser. A second hand piece with a 1927 nm diode laser has been added to the system as a line extension which provides an additional laser wavelength option at the same low power settings of the predicate Clear + Brilliant Laser System.

The provided text describes a 510(k) summary for the Clear + Brilliant™ Laser System, which is a non-ablative laser system for dermatological procedures. This document aims to establish substantial equivalence to a predicate device.

However, the information provided does not contain details about specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other similar quantitative measures for an AI/algorithm-driven device.

Instead, the document focuses on:

• Safety and Effectiveness criteria by demonstrating compliance with electrical safety, EMI/EMC, laser safety, and biocompatibility standards.
• Substantial equivalence to a predicate device based on design specification, output energy, delivery system, and intended use.
• Verification and validation data showing the device meets "all product specifications" and functions "as intended."

Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance studies (sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance) as this information is not present in the provided text. The device described is a physical laser system, not an AI/algorithm-driven diagnostic or prognostic device that would typically have the performance metrics you've asked for.

The relevant section "7. Performance Data" states: "Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria." This is a general statement and does not provide specific quantitative acceptance criteria or detailed study results for metrics like those typically associated with AI performance.

Without further information that explicitly details acceptance criteria for an AI/algorithm's performance and a study proving it, I cannot fulfill the request as specified.

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Dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.

The CLEAR+BRILLIANT™ Laser System is a non-ablative laser system designed for use in non-invasive dermatological procedures. The CLEAR+BRILLIANT™ Laser System has a laser source in the hand piece which is controlled by an embedded processor. The console is electrically connected to the facility power source. Laser energy produced by the unit is delivered to the tissue through the removable (disposable) contact treatment tips which attach to the hand piece.

The provided 510(k) summary for the CLEAR+BRILLIANT™ Laser System (K110349) describes a non-ablative laser system for dermatological procedures. It primarily relies on demonstrating substantial equivalence to a predicate device (Fraxel IV SR Laser System, K063808) rather than presenting a traditional clinical study with defined acceptance criteria for device performance in terms of diagnostic accuracy or effect size in comparison to a gold standard.

Here's an analysis of the provided information concerning acceptance criteria and the study:

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

Since this is a submission for substantial equivalence based on technological performance and histological outcome mirroring the predicate device, the "acceptance criteria" are implied by compliance with standards and a comparative histological assessment, rather than specific performance metrics (e.g., sensitivity, specificity, accuracy) typical of diagnostic or decision-support AI devices.

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

The submission text does not specify a separate "test set" in the context of diagnostic or AI performance evaluation. Instead, it refers to:

• Histology: "Histology confirms the treatment skin response is the same as for the predicate Fraxel IV SR laser system when used at the same energy density settings."
  • Sample Size: Not explicitly stated. The number of subjects or tissue samples used for histological comparison is not provided.
  • Data Provenance: The provenance (e.g., country of origin, retrospective/prospective) for the histological data is not mentioned. It is implied to be from a scientific study or series of studies.

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

This information is not explicitly provided in the 510(k) summary. For histological assessments, it is standard practice to have pathologists interpret the tissue samples, but neither the number nor their qualifications are detailed.

4. Adjudication method for the test set

Not applicable/not specified. The document does not describe an adjudication method for the histological assessment, which is typical for such comparisons where a pathologist's interpretation is generally considered definitive for a given sample.

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 device is a laser system for dermatological procedures, not an AI-assisted diagnostic or decision-support tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

For the key performance claim related to clinical effect, the ground truth was histology (histological outcome/treatment skin response). This means that tissue samples were examined under a microscope to confirm the expected changes induced by the laser treatment, establishing the biological effect.

8. The sample size for the training set

Not applicable, as this is a medical device (laser system), not an AI device that requires a training set.

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

Not applicable, as this is not an AI device.

Summary of the Study:

The "study" presented in this 510(k) is primarily a comparative technological and biological assessment designed to demonstrate substantial equivalence to a legally marketed predicate device (Fraxel IV SR Laser System, K063808).

• Objective: To show that the CLEAR+BRILLIANT™ Laser System, despite having pre-determined energy settings (unlike the user-selectable settings of the predicate), performs equivalently to the predicate device in terms of safety standards, biocompatibility, and, crucially, histological outcome.
• Methodology:
  • Compliance Testing: The device underwent testing to confirm compliance with international standards for electrical safety (ISO 60601-1), EMI/EMC (IEC 60601-1-2), laser safety (ISO 60825), and biocompatibility of its treatment tips (ISO 10993-1).
  • Histological Comparison: Histological examination was conducted to compare the "treatment skin response" of the CLEAR+BRILLIANT™ system to that of the predicate device when both were operated at the same energy density settings.
• Key Finding: "Histology confirms the treatment skin response is the same as for the predicate Fraxel IV SR laser system when used at the same energy density settings." This was the primary evidence for the clinical equivalence of the device's effects on tissue, supporting its intended use.
• Conclusion for Equivalence: Based on the satisfactory results of safety and biocompatibility testing, and the confirmed histological equivalence to the predicate, the submission concluded that the CLEAR+BRILLIANT™ laser system is substantially equivalent to the Fraxel IV SR laser system and raises no new questions of safety and effectiveness.

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