(152 days)
The VIAX Dental Lab LUCERNA VDL980-1 is intended for use in dental intraoral soft tissue, general, oral maxillafacial and cosmetic surgery. It is intended for ablating, incising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. The following are the indications for which the device will be marketed:
- . 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
- . Photo initiation of gingival barriers and dams
- . Laser-assisted bleaching/whitening of teeth
The VIAX Dental Lab LUCERNA VDL980-1 Portable Diode Laser is comprised of three basic parts: The control box ("control module") with microprocessor and user interface for selection of modes: (a) Procedural (continuous wave or pulsed) 980mm laser output (b) Curing (dental photo initiated materials) at 450mm (+/-10mm) with timed outputs of 1.3, and 5 second(s) of output duration; and (c) Whitening procedures at 450nm (+/-10nm) timed to provide 15 minute durational output(s); A touch screen LCD display to provide visual indications of power settings and of the unit"s status, and accept inputs via the touch screen to select modes and operational parameters and adjust / set and features the units power ON/OFF functions, Application of user PIN number for operation and initialization, Selection of Language (English, Spanish, Portugese) and System settings (PIN/Password setting); the Second component is the laser handpiece that houses the laser working beam and aiming beam fiber optic component(s) and the disposable fiberoptic tip assemblies (Procedural, Curing, and Whitening). Two optional footswitches are available that can be used to activate the laser working beam: (a) Corded that plugs into the back of the system unit and (optional) wireless footswitch. Electrical power is taken from the AC/DC 12 vdc Power Supply that plugs into a standard electrical outlet and charges the L-ion 7.2VDC battery at 24W, a 7,2 VDC lithium-ion battery that generates 4 amps used to drive the diode laser(s) and system overhead.
The provided text is a 510(k) summary for the VIAX Dental Lab LUCERNA VDL980-1, which is a dental laser device. It focuses on demonstrating substantial equivalence to predicate devices, rather than an independent clinical study to establish novel performance criteria or effectiveness for a diagnostic or AI-based device. As such, many of the requested categories for acceptance criteria and study design (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) are not applicable or not detailed in this type of submission.
However, I can extract the information that is relevant to performance testing and acceptance criteria as presented in the document.
Acceptance Criteria and Reported Device Performance for VIAX Dental Lab LUCERNA VDL980-1
The submission primarily focuses on demonstrating that the device meets established international safety and performance standards for dental lasers and is substantially equivalent to predicate devices. The key performance criterion mentioned is the accuracy of the laser output relative to its setting.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (IEC 60601-2-22) | Reported Device Performance (VIAX Dental Lab LUCERNA VDL980-1) |
|---|---|
| Laser output should vary from the device's setting by less than ±20% | Average variance in Continuous Wave (CW) mode: 1.4% |
| Average variance in Pulse (P) mode: 0.5% |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical data for diagnostic performance. The comparative performance assessment was based on physical measurements of the device's output. Therefore, information on sample size, country of origin, or retrospective/prospective nature of a patient data test set is not applicable/not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the evaluation primarily involved physical performance measurements against a technical standard (IEC 60601-2-22), not a clinical diagnosis requiring expert consensus.
4. Adjudication Method
This information is not applicable for the type of performance testing described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted as this is a laser surgical instrument, not an imaging or diagnostic device requiring human reader interpretation with or without AI assistance. Therefore, an effect size for human reader improvement with AI is not applicable.
6. Standalone Performance Study
A standalone study, in the sense of an algorithm-only performance for AI, was not done. The "standalone" performance described refers to the device's physical output accuracy. It was tested against a predicate device.
7. Type of Ground Truth Used
The "ground truth" for the performance described was the technical standard IEC 60601-2-22, which specifies that laser output should be within ±20% of the device's setting.
8. Sample Size for the Training Set
This is not applicable. The device is not an AI/machine learning model that would require a training set in the conventional sense. The "training" here refers to the engineering and design process to meet specifications.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As a physical device, its design and calibration are based on engineering principles and regulatory standards, not a "ground truth" derived from a training dataset.
§ 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.