(65 days)
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. Indications for use are the following applications: marginal and interdental gingiva and epithelial lining of free gingiva, frenectomy frenotomy, biopsy, openculectomy, Implant recovery, gingivectomy, gingivoplasty, gingival troughing crown lengthening, hemostasis of donor site removal of granulation tissue, laser assisted flap surgery debridement of deseased 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, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy.
The SIROLaser is a Diode Laser System for dental soft tissue surgery. The system is comprised of the laser unit, laser fibers of different diameters hand pieces and tips of different angulations, a finger or a foot switch. The SIROLaser has the following basic functions - Ability to emit laser radiation either in continuous wave mode (cw) or . chopped mode (laser radiation is switched on and off with a presetable frequency and a duty cycle of 1:1) - Setup and display of treatment parameters: . - o power, - o treatment time, - chop frequency o - Selection of predetermined settings for different indications . - . Upgradeable firmware
The provided text describes the Sirona Dental Systems SIROLaser, a dental soft tissue laser. However, it does not include information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
The document primarily focuses on:
- Device Identification: Proprietary name, common name, classification, and predicate device.
- Intended Use: A comprehensive list of intra- and extra-oral surgical applications for soft tissue.
- Device Description: Basic functions, treatment parameters, and upgradeable firmware.
- Basis for Substantial Equivalence: It states that performance testing was conducted for electrical safety, electromagnetic compatibility, and validation of hardware and software functions, but it does not detail the results or specific acceptance criteria for these tests beyond stating they were sufficient for substantial equivalence.
- FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence to a predicate device.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or clinical study specifics (MRMC, standalone performance) because this information is not present in the provided text. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical trial results with specific performance metrics against pre-defined acceptance criteria.
§ 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.