(78 days)
The SL3™ is intended to be used for oral soft tissue surgery, including: biopsies, hemostatic assistance; treatment of apthous ulcers; frenectomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining of abscesses; operculectomy; removal of fibromas; soft-tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) and tissue retraction for impressions.
The SL3 laser is to provide the ability to perform intraoral soft tissue dental, general, oral maxilla-facial and cosmetic surgery. The SL3 laser is intended for ablating, incising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.
The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharngeal indications for use 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 of 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
-Light activation of bleaching materials for teeth whitening
-Laser-assisted bleaching/whitening of teeth
The SL3™ is a Class IV soft-tissue diode laser that can be used for a wide variety of soft-tissue procedures. This device uses a Gallium, Aluminum, Arsenic (GaAIAS) diode for the active medium, producing laser energy at 810 nanometer wavelength. Laser technology has been steadily evolving, allowing doctors to provide less invasive treatment for many dental procedures, both preventative and restorative. The SL3™ is designed to be compact, portable, reliable and user friendly. It provides the practitioner with a versatile instrument for applications ranging from excisions to vaporization of tissues. The diode laser energy is delivered through optical fiber in the hand piece to the removable fiber tips. The system may be utilized for a wide variety of surgical and cosmetic procedures.
This document is a 510(k) Pre-market Notification for a medical device called SL3, a surgical laser system. It focuses on establishing substantial equivalence to previously cleared devices rather than primarily presenting a study to prove performance against acceptance criteria in the traditional sense of a clinical trial for diagnostic accuracy or treatment efficacy.
Therefore, many of the requested categories for a study proving device performance (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not explicitly detailed in this type of regulatory submission.
The acceptance criteria here are implicitly related to the technical specifications and safety profile being substantially equivalent to the predicate devices. The "study" proving this is essentially the comparison table and the demonstration that the SL3 meets similar performance characteristics and safety standards as the predicate devices.
Here's the information parsed from the document based on your request, with explanations for what is not applicable to this type of submission:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, "acceptance criteria" are not typically formal performance metrics in the way they would be for a diagnostic AI study. Instead, they are implicit in the substantial equivalence comparison - meaning the new device must perform comparably to the predicate devices and meet relevant safety and essential performance standards. The "reported device performance" is largely represented by its technical specifications.
| Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (SL3) |
|---|---|
| Type of laser: Diode laser | Diode laser |
| Wavelength: ~808 nm | $808 \pm 10$ nm |
| Max output power: Comparable to predicates (2.0W - 2.5W) | 3.0 Watt |
| Power requirements: Standard for medical devices | 100-240 VAC, @ 50-60 Hz, 1A |
| Battery operation option: Comparable to predicate with battery | Corded or battery operation |
| Operation mode: Continuous wave and pulsed | Continuous wave and pulsed |
| Delivery system: 400 µm core quartz fiber | 400 µm core quartz fiber |
| Fiber connection: FC connector to handpiece with disposable tip | FC connector to handpiece - Disposable tip magnetically attached to handpiece |
| Aiming beam: 5 mW diode laser, 650 nm | 5 mW diode laser, 650 nm |
| Activation means: Wireless foot switch | Wireless foot switch - takes 2 AA batteries |
| Interface: Color LCD touch-screen GUI with pre-set procedures or manual control | Color LCD touch-screen GUI on desk unit displays 8 pre-set procedures or manual control to set power and laser mode (continuous or pulse) |
| Diode Assembly: 2.0 - 2.5 watt single emitter diode | 3 watt single emitter diode lasing at 808 nm |
| Cooling system: Heat sink or fan | Heat sink |
| Laser diode power supply: External or internal | External |
| Intended Use / Indications for Use: Same as predicates | Matches and potentially expands slightly (implicit in higher power) what is listed for predicates. All listed indications are covered. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This is a 510(k) pre-market notification for a laser device, not an AI or diagnostic device requiring a "test set" in the context of clinical performance data. The submission relies on technical comparisons and safety data, not a patient-level data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: No "test set" or "ground truth" in this context as described for diagnostic or AI systems. The "ground truth" for a laser device would relate to engineering specifications, safety standards, and pre-clinical testing, which are performed by engineers and regulatory experts, not typically by medical experts establishing diagnostic ground truth from patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No test set requiring annotation 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
- Not Applicable: This is a surgical laser device; MRMC studies are used for diagnostic imaging systems, not for comparing human performance with and without a surgical instrument like a laser.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This device is a surgical instrument intended for human operation, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For this device, the "ground truth" is primarily based on engineering specifications, recognized national and international safety standards (e.g., laser safety standards), and the established performance and safety profiles of the predicate devices. Compliance with these technical and safety standards, along with successful pre-clinical testing (which would include electrical safety, EMC, laser emission measurements, etc.), forms the basis of "proof." There is no patient-level "ground truth" in the diagnostic sense.
8. The sample size for the training set
- Not Applicable: No "training set" as this is not an AI or machine learning device. Device development involves engineering design, prototyping, and testing, not data-driven training.
9. How the ground truth for the training set was established
- Not Applicable: No training set.
§ 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.