(45 days)
The Candela Fluorescent Pulsed Light System is indicated for the following uses:
Hair removal in all skin types to the Fitzpatrick scale. Permanent Hair Reduction.
Treatment of Vascular Lesions
Treatment of Inflammatory Acne (acne vulgaris)
Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae.
The Candela Fluorescent Pulsed Light System is designed for selective photothermolysis in aesthetic treatments. The technology is based on a unique combination of patented fluorescent filter technology, selected spectrums of light source emission; pulse forming and sapphire based skin cooling system. It operates through creation of a directed incoherent light beam of spectrally balanced light. The light is spectrally filtered to remove the shorter wavelength portions (UV) most likely to cause harm to the skin. A sapphire crystal light guide is used to transport the resultant longer wavelength light to a laser-dye impregnated polymer filter sheet, which absorbs the part of the lamp light spectrum below it's emission and emits the selected wavelength band (417- 1200 nm) to 615 - 1200 nm, and non fluorescent 650 nm - 1200 nm and 850 - 1200 nm.
A liquid-to-air cooling system, including a fluid pump, fluid reservoir, deionization filter, interlocks and forced convection liquid-to-air heat exchanger and a water to water ThermoElectrical cooler is used to maintain the hand piece components at the proper temperature. The electronic components of the system include multiple safety features to protect both the user and patient, and the pulsed-light system itself.
A microprocessor based system controller is used to monitor and direct all system functions. Users of the Candela Fluorescent Pulsed Light System select parameters such as desired energy density (fluence) level and filter wavelength and monitor operation via electronic controls and a display panel. The control panel is also used to enable or disable the triggering of the Candela Fluorescent Pulsed Light System, and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela Fluorescent Pulsed Light System supports 40mm x 20mm, 20mm x 20mm, 10mm x 20mm, 7mm x 15mm, 7mm x 7mm.
I am sorry, but based on the provided document, I cannot fulfill your request for detailed information regarding acceptance criteria and a study proving device performance in the way you've outlined. This document is a 510(k) summary for a Candela Fluorescent Pulsed Light System (K063800), which focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting the results of a primary clinical study with specific performance metrics against acceptance criteria.
The document states: "The Candela Fluorescent Pulsed Light System is substantial equivalent to the currently legally marketed Luxsano AB OmniLight Fluorescent Pulsed Light System, K032191 and the Palomar Medical Technologies, Inc. StarLux Pulsed Light System, K041086 predicate devices in intended use and technological features and therefore the risks and benefits are comparable to the predicate devices."
This means the FDA cleared the device based on its similarity to previously cleared devices, not necessarily on a new clinical study.
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance: This level of detail about specific performance metrics and acceptance thresholds for a new clinical study is not present.
- Sample size used for the test set and the data provenance: No new test set is described or analyzed in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of expert review or ground truth establishment for a new study.
- Adjudication method for the test set: Not applicable as no new test set is presented.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
- If a standalone performance study was done: The document does not describe a standalone study. Instead, it relies on substantial equivalence.
- The type of ground truth used: Not applicable.
- The sample size for the training set: No training set for an AI/algorithm is mentioned, as this device is not an AI-based system.
- How the ground truth for the training set was established: Not applicable.
The document's purpose is to establish substantial equivalence based on functional features, intended use, and technological features compared to existing devices. It does not contain the detailed reporting of a clinical study that would answer your specific questions about acceptance criteria and performance data from a new study.
§ 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.