FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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
1. 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)
1. Whitening
· Light activation for bleaching materials for teeth whitening
· Laser-assisted whitening/bleaching of teeth
1. 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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1. Results demonstrate biocompatibility.
Electrical Safety	Compliance with IEC 60601-1-2.
EMC	Compliance with IEC 60601-1.
Laser Safety	Compliance with IEC 60601-2-22 and IEC 60825-1.
Dental Equipment Safety	Compliance with IEC 80601-2-60.
Usability	Compliance with IEC 60601-1-6.
Software Verification & Validation	Compliance with IEC 62304 and FDA guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices."
Clinical Performance (Equivalency)	Ex-vivo testing on soft tissue demonstrated performance equivalency to the predicate device leading to the conclusion that clinical testing was not necessary due to no change in intended use/indications.

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.

Summary

Regulation Number and Section

§ 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.