(14 days)
The Sapphire ST Portable 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 fiber optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision and excision; 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; vestibuloplasty, and light activation of bleaching materials for teeth whitening, laser-assisted bleaching /whitening of teeth.
The Sapphire ST Portable Diode Laser is comprised of three basic parts: the control box ("control module") with microprocessor and user interface for selection of mode (continuous wave or pulsed) and laser output to provide visual indications of power settings and of the unit's status, and features the unit's power ON/OFF switch, footswitch jack and key switch; the second component is the corded laser handpiece that houses the laser working beam and aiming beam diodes and control board, optics and harat 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. Electrical power is taken from the AC/DC Power Supply that plugs into a standard electrical outlet and charges a 15W, 5 VDC lithium-ion battery that generates 4 amps used to drive the diode laser.
The provided text describes the Den-Mat Holdings Sapphire ST Portable Diode Laser, a medical device. Here's an analysis of the acceptance criteria and study as requested:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (Sapphire ST Portable Diode Laser) |
|---|---|
| Laser Output Variability (IEC 60601-2-22 Standard): Laser output should vary from the device's setting by less than ± 20% of the setting. | Continuous Wave (CW) Mode: Average variance of only 1.4% from the unit's settings. |
| Pulsed (P) Mode: Average variance of only 0.5% from the unit's settings. | |
| (The predicate device had variances of 2.2% in CW and 2.7% in P) | |
| Wavelength | $808 \pm 5$ nm |
| Power | 0.1 – 3.0 W (CW) & 0.1 – 5.0 W (Pulse) |
| Aiming Beam | 640 nm ($\pm 10$ nm), maximum 2mW (adjustable) |
| Cooling System | Convection cooled |
| Pulse Control | Digital emission control |
| Laser Source | Solid-state diode |
| Power Requirements | 24W 5VDC supplied from 110 – 120 VAC @ 60 Hz or 220 – 240 VAC @ 50 Hz (switchable) |
| User Interface | Membrane touch pad, LCD Display, LED Indicators |
| Fiberoptic Tip | Disposable, 400 μm unit dose |
| Conformity to International Standards | Complies with 21 CFR 1040.10 and 1040.11, IEC 60601-1, IEC 60601-2-2, IEC 60825-1, and IEC 60601-2-22. |
Study Details:
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Sample size used for the test set and the data provenance:
- The document mentions "Measurements of the output of the subject device's working beam ranging from 0.1 to 3.0W output in Continuous Wave and Pulse modes were shown to vary..." However, it does not specify a numerical sample size for the test set (i.e., how many measurements were taken or how many devices were tested).
- The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective). It describes internal testing of the device against predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This study is a technical performance comparison of laser output accuracy against a predefined standard (IEC 60601-2-22), not a clinical study requiring expert ground truth in the traditional sense of medical image or diagnosis evaluation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2. The performance data is objective measurement of physical output, not subjective human assessment needing adjudication.
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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:
- Not applicable. This document is for a laser surgical instrument, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. See point 4.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance evaluation in this context is the international standard IEC 60601-2-22, which specifies that laser output should vary by less than ± 20% of the setting. The measurements taken from the device were compared against this objective standard.
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The sample size for the training set:
- Not applicable. This device is a hardware laser instrument, not a machine learning or AI model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 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.