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Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue.
The GENTLEray 980 Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flan Singgry, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.

The GENTLEray 980 Diode Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system.

The KaVo GENTLEray 980 Diode Dental Laser System's acceptance criteria and the study proving it meets these criteria are outlined through a comparison to predicate devices, focusing on technical specifications and intended use rather than direct performance metrics like sensitivity or specificity. This is a 510(k) submission, which primarily establishes substantial equivalence.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are the specifications of the predicate devices. The "reported device performance" is the specifications of the proposed device, demonstrating equivalence. There are no explicit quantitative performance metrics like sensitivity, specificity, or AUC provided in this document as it's a laser device for surgical procedures, not a diagnostic tool.

Note: The table above primarily lists the Biolitec Smilepro 980 as a predicate for comparison, but the document also references ADT Diolase 980 D and Elexxion Claros. The Elexxion Claros had a different wavelength (810 nm) and significantly different output power, which makes the KaVo GENTLEray 980 more directly comparable to the other 980 nm predicate devices for wavelength.

2. Sample size used for the test set and the data provenance

The document indicates that "bench and user testing data" were analyzed. However, no specific sample sizes for test sets (e.g., number of procedures, number of patients) or the data provenance (e.g., country of origin, retrospective/prospective) are detailed in this summary. The comparison focuses on technical specifications to establish substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For device submissions based on substantial equivalence to existing technology, clinical efficacy is often inferred from the predicate device and the new device's adherence to relevant performance standards, rather than through a new clinical trial with expert-established ground truth.

4. Adjudication method for the test set

No adjudication method is mentioned as there is no specific clinical "test set" and outcome assessment detailed in this summary for the purpose of establishing efficacy or accuracy against a ground truth.

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 device is a laser surgical instrument, not an AI-assisted diagnostic or interpretative device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a surgical instrument that operates with human-in-the-loop (a dentist or surgeon). There is no "algorithm-only" performance for such a device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

No explicit "ground truth" of the type typically used for diagnostic or AI algorithm validation is mentioned. The basis for clearance is demonstrating that the device is "as safe and effective as the predicate device" through comparison of:

• Technical specifications: (e.g., wavelength, power, operating modes)
• Performance standards compliance: The device complies with 21 CFR §1010 and 21 CFR §1040.
• Validation testing: "electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions."
• Intended use: The intended use is identical to the predicate devices.

The "ground truth" for this type of submission is essentially the established safety and efficacy of the legally marketed predicate devices, combined with testing showing the proposed device meets manufacturing and performance standards relevant to its technical operation.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device, and thus does not involve a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML device, and thus does not involve a training set or its associated ground truth establishment.

Summary of the Study Proving Acceptance Criteria:

The study proving the KaVo GENTLEray 980 Diode Dental Laser System meets its "acceptance criteria" (defined as substantial equivalence to predicate devices) is a comparison study based on technical specifications, intended use, and compliance with performance standards.

The manufacturer, KaVo Dental Corporation, conducted:

• Bench testing: This would involve laboratory testing of the device's technical specifications (wavelength, power output, pulse characteristics, safety features, etc.) against design requirements and comparison to predicate device specifications.
• User testing: While not explicitly detailed, this would likely involve verification that the device functions as intended in a simulated or actual use environment, confirming operability and safety.
• Compliance testing: The device was tested to ensure compliance with the appropriate sections of 21 CFR §1010 and 21 CFR §1040 (performance standards for laser products).
• Validation testing of hardware and software functions: This ensures the device's components and control systems operate correctly and safely.
• Electromagnetic compatibility (EMC) testing.
• Electrical safety testing.

The conclusion drawn by KaVo, and subsequently accepted by the FDA, is that the GENTLEray 980 Diode Laser System is "as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device." This means the device met the "acceptance criteria" by demonstrating equivalence to devices already cleared for market.

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