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Dental Soft Tissue Indications
Incision, excision, vaporization, ablation 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
• · Tissue retraction for impression
• · Laser soft-tissue curettage
• · Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket

· Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility)

• · Reduction of bacterial level (decontamination) and inflammation
  • Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium

• · Lesion (tumor) removal

• · Removal of hyperplastic tissues

• · Laser assisted flap surgery

• · Removal of granulation tissue

Whitening

• · Light activation for bleaching materials for teeth whitening
• · Laser-assisted whitening/bleaching of teeth

Pain Therapy

· Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

The Epic 980 diode laser is a surgical and therapeutic device designated for a wide variety of oral soft-tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain.

The device uses a solid-state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the treatment site.

The laser is comprised of a base console, a wireless footswitch which activates the laser and a detachable delivery system consisting of a fiber optic cable, surgical handpiece and single-use disposable tips designed and optimized for different applications.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Biolase Epic 980 device.

This document describes a 510(k) premarket notification for the Biolase Epic 980, which is primarily a regulatory submission demonstrating substantial equivalence to already cleared predicate devices. As such, it relies heavily on the equivalence of the device's technical characteristics and previously cleared indications for use rather than new, extensive performance studies for the expanded indications.

Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with specific performance metrics is limited. Instead, the "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to the predicate devices, and the "study" is largely a comparison of specifications and previously cleared uses.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission, explicit "acceptance criteria" for the expanded indications are not defined in terms of performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the criterion for acceptance is that the device's technological characteristics and proposed expanded indications for use are substantially equivalent to those of legally marketed predicate devices, and these expanded indications have already been cleared.

The "reported device performance" is essentially that the Epic 980 shares the same core technological characteristics as the predicates and that, where parameters differ (like maximum power output), these differences do not lead to significantly different clinical performance for the specified indications.

2. Sample Size Used for the Test Set and the Data Provenance

The document explicitly states: "Since the expanded indications for use have been already cleared for equivalent devices, therefore any additional clinical and/or performance testing was not required."

This indicates that there was no new "test set" or study involving human subjects or specific performance data generated for this submission to prove the expanded indications. The "data provenance" for the original clearances of the predicate devices' expanded indications would be where this information implicitly lies, but it is not provided in this document. This submission relies on the existing clearances of the predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Given the statement in point 2, there was no new test set and therefore no new "ground truth" established for this specific submission. The reliance is on the regulatory history and clearances of the predicate devices, which would have had their own evidence for their respective indications.

4. Adjudication Method for the Test Set

As there was no new test set for this submission, there was no adjudication method applied.

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

This is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study was not applicable and not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The Epic 980 is a physical laser device operated by a human. It is not a standalone algorithm. Therefore, no standalone (algorithm only) performance study was conducted.

7. The Type of Ground Truth Used

For this specific 510(k) submission, the "ground truth" for the expanded indications relies on the prior regulatory clearances of the predicate devices for those indications. The FDA deemed those predicate devices safe and effective for those uses based on their own submissions, which may have included clinical data, pre-clinical studies, and expert consensus at the time of their clearance.

8. The Sample Size for the Training Set

This document does not describe the development or training of a software algorithm that would typically require a "training set." While the device has software, it's for control and functionality, not for "learning" or "decision-making" in the sense of AI. Therefore, a "training set" in the context of an AI/machine learning algorithm is not applicable to this submission. Software verification and validation were performed as per IEC 62304:2015.

9. How the Ground Truth for the Training Set Was Established

Given that a "training set" in the AI/ML context is not applicable, the method for establishing its "ground truth" is also not applicable. The software's performance was validated against its specifications and intended functions.

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1. Dental Soft Tissue Indications
   Incision, excision, vaporization, ablation 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
• · Tissue retraction for impression
• 2. Laser Periodontal Procedures
• · Laser soft-tissue curettage
• · Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket
  · Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility)
• 3. Whitening
• · Light activation for bleaching materials for teeth whitening
• · Laser-assisted whitening/bleaching of teeth
• 4. Pain Therapy
     · Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

The Epic 980 diode laser is a surgical and therapeutic device designated for a wide variety of oral soft-tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain.
The Epic 980 uses an Indium Gallium Arsenide (InGaAs) solid-state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the treatment site.
A visible light is emitted at the same time to visually identify the treatment location. The laser is comprised of a base console, a wireless footswitch which activates the laser and a detachable delivery system consisting of a fiber optic cable, surgical handpiece and single-use disposable tips designed and optimized for different applications.

The provided text describes the 510(k) premarket notification for the Biolase Epic 980 device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria and detailed performance of the subject device itself. Therefore, many of the requested data points (like sample size for test sets, ground truth establishment, MRMC study results, etc.) are not available in this document.

Here's an analysis based on the information provided:

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

The document does not explicitly define acceptance criteria as numerical targets for performance metrics in the way one might expect for an AI/ML device. Instead, the "acceptance criteria" are implied by the various tests and standards to which the device was found compliant, demonstrating safety and efficacy primarily through establishing equivalence to predicate devices. The "reported device performance" is mainly a statement of equivalency rather than specific numerical outcomes.

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

• Sample size for test set: Not specified for any of the tests.
• Data provenance: Not specified.

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 the document does not describe a study involving expert-established ground truth for a test set. The equivalency was based on objective technical standards and ex-vivo testing.

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

• Not applicable as the document does not describe a study involving adjudication for a test set.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a laser surgical instrument, not an AI diagnostic or assistance tool for human readers.

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

• No, this device is a physical laser instrument. The concept of "standalone algorithm only" is not applicable here. Performance was assessed through technical compliance and comparative ex-vivo testing.

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

• For biocompatibility, the ground truth is established through adherence to ISO 10993-1 biological evaluation methods.
• For electrical safety, EMC, laser safety, dental equipment safety, and usability, the ground truth is established by compliance with the specified IEC standards.
• For the ex-vivo bench testing, the "ground truth" was the performance of the predicate device, against which the subject device was compared for equivalency. The exact metrics for this comparison are not detailed beyond "the results demonstrate equivalency."

8. The sample size for the training set

• Not applicable. This device is a laser hardware system and not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As above, there is no "training set" for this type of device.

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