(218 days)
The Sterling Diode Laser is indicated for: Dental soft tissue indications:
Dental, oral and soft tissue surgery including:
Sulcular debridement of diseased or fibrous tisue, excision and biopsy, gingivectory and gingivoplasty, lesion (tumor) removal, fibroma removal, tissue retraction (troughing), aphthous ulcers, gingival hyperplasia (excision and recontour), crown lengthening, operculectomy, frenectomy, and photocoagulation.
Laser periodontal procedures, including:
Laser soft tissue curettage; laser removal of diseased, infected and necrosed soft tissue within the periodontal pocket; removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.
The Sterling Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 10nm for a maximum of 5 watts of energy is delivered to the surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The target tissues absorb the laser energy converting it to heat. depending on the intensity or power output of the laser, the heat so generated can cell hemostasis, ablation, or vaporization. The device features some user definable settings, including a selectable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.
The optical fiber is stored within the device and dispensed to the desired length according to the clinician's need. A fiber is passed through a reusable, sterilizeable handpiece assembly and terminated with a single-use disposable tip. The operator uses the handpiece to position and direct the laser energy to the intended treatment site. The activation of the working beam diodes is accomplished by use of a foot-actuated switch.
The provided document is a 510(k) premarket notification for the Sterling Diode Laser, seeking substantial equivalence to a predicate device. This type of regulatory submission focuses on comparing a new device to an existing legally marketed one, rather than presenting a detailed study proving the device meets specific performance acceptance criteria in the manner described for an AI/ML medical device.
Therefore, the information requested, which is typically relevant to AI/ML device studies, cannot be fully extracted or is not applicable to this document.
However, I can provide the available information that aligns with your request categories:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly define "acceptance criteria" in the sense of quantitative performance metrics for a study to prove the device meets them. Instead, it demonstrates substantial equivalence to a predicate device by comparing technical specifications and performance characteristics.
| Criterion Type | CAO Group, Inc. Sterling Diode Laser Performance | Ivoclar Vivadent, Inc. Odyssey 2.4G Predicate Performance |
|---|---|---|
| Working Beam Wavelength | $810 \pm 10$ nm | $810 \pm 20$ nm |
| Working Beam Output Power | 0.5 - 5.0 watts | 0.1 - 5.0 watts |
| Aiming Beam Output Power |
§ 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.