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For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.

Examples:

Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Reduction of bacterial level (decontamination) and inflammation Soft tissue crown lengthening Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

Treatment of aphthous ulcers Vestibuloplasty Biopsy incision and excision Lesion (tumor) removal

For light activation for bleaching materials for teeth whitening For laser-assisted bleaching/whitening for teeth.

The laser source of the DioDent Micro 810/980 is a solid-state Gallium Aluminum Arsenide (GaAlAs) semiconductor diode. It produces invisible laser energy at the 810-nanometer or 980nm wavelength. The delivery system consists of an autoclavable flexible treatment fiber threaded through a lightweight, autoclavable hand piece. Activation occurs when the operator enables the laser and presses the footswitch. Releasing the footswitch suspends laser treatment. The footswitch can function as an on/off switch. A color touch-screen display panel allows the operator to adjust or set laser output level with minimal effort. The laser can operate in continuous wave or pulse mode.

The provided text is a 510(k) summary for the HOYA ConBio DioDent Micro 810/980 Dental Laser System. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this document.

Here's an analysis of the provided text in response to your questions:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria or reported device performance based on a dedicated study designed to meet specific metrics. The 510(k) pathway relies on demonstrating substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

There is no mention of a test set sample size or data provenance because no clinical or non-clinical performance study against specific acceptance criteria was conducted or necessary for this 510(k) submission. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None".

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, as no test set or ground truth establishment process is described for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no test set requiring adjudication is described.

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 dental laser, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

Not applicable. This device is a dental laser, not a standalone algorithm.

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

Not applicable, as no ground truth for performance evaluation was established in the context of this 510(k) summary. The submission relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable, as this device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as no training set was used.

Summary of Device Rationale from the Provided Text:

The basis for market clearance for the DioDent Micro 810/980 Dental Laser System is the demonstration of substantial equivalence to legally marketed predicate devices:

• SIROLaser by Sirona Dental Systems (K053161)
• DioDent II Dental Laser System by HOYA ConBio (K050274)
• Twilight Diode Laser System by BioLase Technologies (K991994)

The submission states that the DioDent Micro 810/980 is "equivalent in operating parameters, physical characteristics, and intended uses" to these predicate devices. The only noted difference among the equivalent devices is that the DioDent II (one of the predicates) is explicitly cleared for teeth whitening. The DioDent Micro 810/980's intended use also includes teeth whitening, implying it also aligns with the specified predicate for that particular indication.

Therefore, the "acceptance criteria" in this context are primarily regulatory – meeting the criteria for substantial equivalence under 21 CFR 878.4810 for a Class II medical device, which does not require new clinical performance studies if equivalence to a predicate device is adequately demonstrated.

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Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty Laser Periodontal procedures, including: Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

The EZLase™ dental diode laser system may be used to perform various soft tissue dental applications. The system uses advanced laser technology to incise, excise, vaporize, coagulate and ablate intra-oral soft tissues. A Gallium Aluminum Arsenide (GaAlAs) and/or an Indium Gallium Arsenide Phosphorous solid-state laser diode emit infrared laser energy to the various oral soft tissues targeted during procedure. This energy is transmitted via a flexible fiberoptic cable to the handpiece that emits the energy to the targeted tissue site. A visible light is emitted at the same time to visually pinpoint the treatment location. The power output and pulse width may be adjusted to specific user requirements.

This document is a 510(k) summary for the EZLase™ dental diode laser, which seeks substantial equivalence to already cleared devices. It does not contain a study demonstrating the device meets specific acceptance criteria in the way a clinical trial for a new therapeutic or diagnostic device would.

Instead, the submission for the EZLase™ dental diode laser relies on demonstrating substantial equivalence to predicate devices. This means that the device is shown to be as safe and effective as a legally marketed device that is not subject to PMA (Premarket Approval). The "acceptance criteria" here are met by proving this substantial equivalence, rather than by achieving specific performance metrics against a defined ground truth in a new clinical study.

Therefore, many of the requested sections (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, and how training set ground truth was established) are not applicable to this type of regulatory submission in the way they would be for a novel diagnostic AI algorithm.

Here's a breakdown based on the provided text, focusing on how substantial equivalence is demonstrated:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable in this context. This 510(k) submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices, not on a new clinical study with a test set of patient data to prove effectiveness. The "data provenance" would refer to the existing regulatory clearances for the predicate devices.

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

• Not Applicable. No new ground truth needed to be established for this submission as it relies on substantial equivalence.

4. Adjudication method for the test set

• Not Applicable. No new test set requiring adjudication was performed.

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 surgical laser, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant to its regulatory submission.

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

• Not Applicable. This is a hardware device (surgical laser), not an algorithm.

7. The type of ground truth used

• "Ground truth" here is embodied by the established safety and effectiveness of the predicate devices cleared by the FDA. The premise of a 510(k) is that if a new device is substantially equivalent to an already cleared device, then it is also safe and effective. The FDA's initial clearance of the predicate devices would have relied on various forms of evidence, potentially including clinical data, performance testing, and literature review, but not necessarily for this new device's submission.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. As per point 8.

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