(30 days)
The Sapphire Plus STM 3W Diode Laser is intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fibre optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision; gingivectomy; gingivoplasty; incising and draining abscesses; operculectomy; oral papillectomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; and vestibuloplasty.
The Sapphire Plus STM Laser is a plug-in option for the Sapphire Plus Light Source Unit. The Sapphire Plus Light Source Unit contains a xenon arc lamp that, depending on which handpiece is attached, has been cleared for use as either a Curing/Whitening attachment (K081287) or as an adjunct for visual oral tissue examination (K073483). In both cases, these two attachments use different portions of the broad-spectrum xenon arc light's emissions to perform their clinical functions.
Like the other two attachments for the Sapphire Plus Light, the Sapphire Plus STM Laser also plugs into the Sapphire Plus Light. Unlike the other two attachments, however, when the Sapphire Plus STM Diode Laser is attached to the Sapphire Plus Light, only low-voltage DC current -not visible light -- is sent to the Laser. The Sapphire Plus STM Diode Laser is comprised of two basic parts: the control box ("control module") with microprocessor and user interface, and the Laser Handpiece containing the working and aiming beam laser diodes and the laser ON/OFF switch. The Control Module interface allows selection of mode (continuous wave or pulsed) and laser output, provides visual indications of power settings and of the unit's status, and features the unit's footswitch jack and operating key switch and the Emergency STOP button. The Laser Handpiece is found at the end of a six foot long power/communications cord that is plugged into the Control Module's light guide port. The Handpiece houses the 808 ± 5nm laser working beam diode and the 640 ± 10nm aiming beam diode and control board, optics and heat sink, on/off switch, and the disposable fiberoptic tip assembly. An optional footswitch is available that plugs into the control module and can be used to activate the laser working beam instead of the handpiece on/off actuator. The Sapphire Plus STM Laser is powered by a 15W, 5 VDC rechargeable lithium-ion battery that receives its energy from the Sapphire Plus Light Source Unit.
The information provided discusses the substantial equivalence of the Den-Mat Holdings Sapphire Plus STM 3W Diode Laser to predicate devices, focusing on non-clinical performance and a review of existing literature for similar devices. There isn't information present to fill all sections of the requested table.
Here's the information that can be extracted from the provided text:
1. Table of acceptance criteria and reported device performance
The acceptance criterion for laser output accuracy is that the output should vary by less than ± 20% of the setting, as per IEC 60601-2-22.
| Acceptance Criterion (IEC 60601-2-22) | Reported Device Performance (Den-Mat Holdings Sapphire Plus STM 3W Diode Laser) |
|---|---|
| Laser output varies by less than ± 20% of the setting | Average variance: 1.4% in Continuous Wave (CW), 0.5% in Pulsed (P) mode |
2. Sample size used for the test set and the data provenance
The document indicates that the Sapphire Plus STM Diode Laser was tested "side-by-side against one of the predicate devices". However, it does not specify the sample size for this comparison.
The data provenance is from non-clinical comparative performance testing conducted by Den-Mat Holdings, LLC, which would be considered prospective for the specific device being tested. No external data provenance like country of origin for a 'test set' in a clinical study is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
There is no mention of experts or ground truth establishment for the non-clinical comparative performance data presented. This section primarily focuses on technical specifications and output accuracy comparisons.
4. Adjudication method for the test set
No adjudication method is described as the available information pertains to non-clinical technical comparisons, not clinical trials requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was performed or mentioned. The device is a surgical laser, not an AI-powered diagnostic tool, so this type of study is not relevant to its evaluation in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone study of the device's technical performance was done. The "NON-CLINICAL COMPARISONS Comparative Performance Data" section describes measurements of the device's output accuracy (variance from set power), which is a standalone assessment of its functional precision.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the technical performance comparison, the "ground truth" used was the device's own set output parameters. The measured output was compared against these set values to determine accuracy, relative to the international standard IEC 60601-2-22.
The document also references a body of literature showing the safety and effectiveness of 808 nm diode lasers in general. This literature would consist of various study types (meta-reviews, clinical studies, in vitro studies, animal studies), implying diverse forms of "ground truth" (e.g., clinical outcomes, histological findings, expert assessment, etc.) but these are for the predicate devices and the general class of lasers, not specifically for establishing a ground truth for the new Sapphire Plus STM 3W Diode Laser's performance.
8. The sample size for the training set
No training set is mentioned. The document describes a medical device (laser), not an AI algorithm that requires training data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned for this device.
§ 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.