(90 days)
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)
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· 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
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· Removal of hyperplastic tissues
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· Laser assisted flap surgery
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· 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.
| Acceptance Criteria (Implicit for Substantial Equivalence to Predicates) | Reported Device Performance (Comparison with Predicates) |
|---|---|
| Same laser source type | Solid state diode laser |
| Same wavelength | 980 ± 10 nm |
| Same intended use area (oral soft tissue) | Incision, excision, vaporization, ablation, and coagulation of oral soft-tissues. |
| Same core indications for use (dental soft tissue, whitening, pain therapy) | Listed expanded indications are already cleared for predicate devices. |
| Similar design, delivery system, and control mechanism | Software-operated portable laser unit, footswitch activated, fiber optic cable, handpiece, single-use disposable tips. |
| Compliance with relevant electrical safety and EMC standards | Complies with IEC 60601-1-2:2014, IEC 60601-1:2012, IEC 60601-2-22:2007+A1:2012, IEC 60825-1:2014, IEC 80601-2-60:2012. |
| Software developed, tested, and documented per standards | Developed, tested, and documented in accordance with IEC 62304:2015 and FDA guidance. |
| Biocompatibility and sterilization unchanged from predicate | Patient-contacting accessories remain the same as previously cleared (K192430). |
| Maximum power settings for expanded indications do not exceed predicate device capabilities | Although Epic 980 capable of 10W, settings for expanded indications do not exceed 1W, which falls under maximum power of K103753 and K152032. |
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.
§ 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.