(153 days)
The UTU series Medical Diode Laser are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and interdental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index,gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.
Whitening: The UTU series Medical Diode Laser are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy: The UTU series Medical Diode Laser are intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
The UTU series Medical Diode Laser (UTU3-F7B, UTU3-F7W, UTU3-G7B, UTU3-G7W, UTU-G20B and UTU-G20W) is a surgical and therapeutic device designated for a wide variety of oral soft tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain. The device utilizes a solid state diode as laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of a footswitch.
It is a portable medical device composed of a main unit, a laser delivery system, a footswitch, a power adapter and protective goggles. The main unit incorporates an LCD touchscreen for the device user to set output parameters and for control of the device, and a built-in large-capacity rechargeable lithium battery with longer time of endurance. The laser delivery system includes a fiber optic cable, handpiece and tips (disposable fiber tips, whitening tip, biostimulation tip or therapy tip) designed and optimized for different applications.
The UTU3-F7B and UTU3-F7W employ the diodes with wavelengths of 810nm, 650nm and 450nm, they only different in enclosure color, the enclosure color of UTU3-F7B is black and the enclosure color of UTU3-F7W is white. The UTU3-G7B and UTU3-G7W employ the diodes with wavelengths of 980nm, 650nm and 450nm, they only different in enclosure color, the enclosure color of UTU3-G7B is black and the enclosure color of UTU3-G7W is white. The UTU-G20B and UTU-G20W employ the diode with wavelength of 980nm, they only different in enclosure color, the enclosure color of UTU-G20B is black and the enclosure color of UTU-G20W is white. The device emits laser output energy in the infrared, red and blue spectra respectively.
The provided FDA 510(k) clearance letter and its associated 510(k) Summary for the Medical Diode Laser (K243764) indicate that this device is a laser surgical instrument. The document details the device's indications for use, technological characteristics, and a comparison to predicate devices, primarily focusing on non-clinical performance data such as biocompatibility, electrical safety, and general performance testing (bench testing).
Crucially, this document does not contain information about a study proving the device meets acceptance criteria related to a specific AI/algorithm performance evaluation that would involve concepts like sensitivity, specificity, or human reader improvement with AI assistance. The "Performance Data" section explicitly states "Clinical data: Not applicable" and then lists non-clinical data. The document does mention "Software Verification and Validation Testing," which is a standard requirement for devices with software, and the documentation level was assessed as "Basic Documentation Level," meaning it likely doesn't involve complex AI algorithms requiring deep learning performance evaluations against clinical ground truth.
Therefore, I cannot extract the information required for an AI-specific acceptance criteria table or study description from this document. The device in question is a physical medical device (laser) and its clearance is based on demonstrating substantial equivalence to existing laser devices, rather than on the performance of a diagnostic AI algorithm.
**Based on the provided document, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to AI/algorithm output (e.g., sensitivity, specificity).
- Sample sizes for test sets involving AI/algorithm performance.
- Number and qualifications of experts for AI ground truth.
- Adjudication methods for AI test sets.
- MRMC comparative effectiveness study results or effect sizes for AI assistance.
- Standalone algorithm performance.
- Type of ground truth for AI performance.
- Training set sample size for AI.
- How ground truth for AI training was established.**
This document describes the regulatory clearance of a hardware device (a medical diode laser), not a software-based AI diagnostic device. The performance data presented are for the physical properties and safety of the laser, not for an AI's ability to interpret medical images or data.
§ 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.