(49 days)
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.