(81 days)
The Sterling Supreme Diode Laser is indicated for dentistry and oral soft tissue procedures of:
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The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissues including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, gingivectomy, troughing, and removal of inflamed edematous tissue;
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Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
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Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
The Sterling Supreme Diode Laser is a device for delivering laser energy to human soft tissue for a variety of dental and oral procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to the surgical site by means of an optical fiber fully ensheathed within a coated steel coil terminated in a handpiece assembly, 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 cause hemostasis, ablation, or vaporization. The device features some user definable settings, including a selectable 650nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options. The device allows for selection of factoryestablished presets for common dental and oral care procedures, and allows for the operator to save desired settings for quick-reference.
Laser energy is transmitted through the fixed length of optical fiber to the distal end of the handpiece assembly. The handpiece assembly consists of a reusable, removable, sterilizable handpiece sleeve, and for surgical procedures is terminated with a single-use disposable tip. The operator uses the handpiece assembly 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 wireless foot-actuated switch.
The provided text is a 510(k) summary for the Sterling Supreme Diode Laser, a medical device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it does not contain the detailed acceptance criteria and study data typical of a clinical trial or a performance validation study for a new, non-substantially equivalent device.
The document's purpose is to establish substantial equivalence based on technological characteristics and performance specifications compared to a predicate device, not to provide a standalone clinical study proving the device meets specific acceptance criteria in the manner one might expect for a novel AI or diagnostic device.
Therefore, many of the requested sections (sample size for test/training set, ground truth methods, expert qualifications, MRMC studies, effect size, etc.) are not applicable or not provided in this type of regulatory submission for this specific device.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
The document defines "acceptance criteria" through conformance to standards and internal performance verification against labeled specifications. The predicate device's performance is used as a benchmark for "substantial equivalence" but not as formal "acceptance criteria" that the new device must meet to prove its own efficacy by objective performance metrics.
| Acceptance Criterion (Implicit, based on substantial equivalence & performance data) | Reported Device Performance (Sterling Supreme Diode Laser) | Predicate Device Performance (Precise SHP Diode Laser) |
|---|---|---|
| Technological Characteristics | ||
| Working Beam Output Wavelength | 810 ± 10 nm | 810 ± 10 nm |
| Working Beam Output Power | 0.1 - 3.0 watts | 0.5 - 3.0 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.