Search Results

· Excisional and incisional biopsies
· Exposure of unerupted teeth
Fibroma removal
· Gingivoplasty
· Hemostasis and coagulation
· Incision and drainage of abscess
· Operculectomy
· Pulpotomy
· Reduction of gingival hypertrophy
· Soft tissue crown lengthening
· Vestibuloplasty
· Laser Soft Tissue Curettage
· Tissue retraction
Frenectomy and Frenotomy
· Gingival troughing for crown impressions
· Gingivectomy
· Gingival incision and excision
· Implant recovery
· Leukoplakia
· Oral papillectomnies
Pulpotomy as an adjunct to root canal therapy
· Reduction of bacterial level (decontamination) and inflammation
Treatment of aphthous ulcers
· Lesion (tumor) removal
· Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
· Removal of Diseased, Inflamed and necrotic soft tissue within the periodontal pocket
Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium

· Sulcular debridement (removal of necrotic, 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)

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

Device Description

The ELUMI 810 + 980 Soft Tissue Laser, or ELUMI, is a battery-powered counter top surgical and therapeutic device designed for a wide variety of oral soft tissue procedures and dental teeth whitening.

The ELUMI comprises of five main assemblies; of a Laser Unit, a flexible fiber delivery system tethered to an anodized aluminum hand piece, disposable single-use fiber tips, a wireless footswitch, and an auxiliary power supply. Infrared laser energy is emitted from the fiber tips when the wireless footswitch is depressed. The ELUMI Laser Unit contains two single-emitter solid-state laser diodes of 10.0-watt peak output power each (Class IV laser), one lasing at 810nm and the other at 980nm wavelength. The laser diodes can simultaneously emit laser energy when ELUMI is set to Dual Wavelength mode. The laser diodes are directly coupled to the flexible fiber optic cable that connects the Laser Unit to the surgical hand piece and disposable fiber tip that emits the energy to the target area. The system also contains a 5mW power, 650nm laser diode coupled to the same fiber optic cable to produce the red aiming light. The laser's visible light is designed to aid the clinician in aiming the tip of the delivery fiber onto the target tissue. Additionally, a bright white light from two LEDs in the hand piece illuminates tarqet tissue during procedures through the translucent disposable laser tips. The auxiliary power supply connects to the Laser Unit and is used to charge the system battery and as a power source for the system in the event of low battery capacity.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ELUMI 810 + 980 Soft Tissue Laser, claiming substantial equivalence to a predicate device, the QuickLase DUAL+. As such, the study performed is a comparative effectiveness study against a predicate device rather than a standalone study establishing de novo acceptance criteria and performance thresholds.

The primary goal of the submission is to demonstrate that the new device is "as safe and as effective" as the predicate device. Therefore, the "acceptance criteria" can be implicitly understood as showing comparable performance to the predicate device in key functional and safety aspects.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission seeking substantial equivalence to a predicate device, the "acceptance criteria" are generally based on meeting or demonstrating comparable performance to the legally marketed predicate device (QuickLase DUAL+) and compliance with relevant international standards. The performance reported focuses on demonstrating this equivalence.

Acceptance Criteria (Implicit)	Reported Device Performance (ELUMI 810 + 980 Soft Tissue Laser)
Safety:
Adherence to Laser Safety Standards	Complied with 21 CFR 1040.10 & 1040.11 (except for deviations per laser notice 50), IEC 60601-2-22, and IEC 60825-1.
Adherence to Electrical Safety Standards	Complied with AAMI/ANSI ES60601-1 and IEC 60601-1-2.
Biocompatibility	Complied with AAMI/ANSI/ISO 10993-5:2009 (cytotoxicity).
Cleaning Validation (for reusable components)	Anodized Aluminum Surgical Hand Piece with Fiber Connector achieved 78.5% and 77.6% recoveries for protein and hemoglobin respectively. Cleaned devices contained < 5.4 μg/cm² protein and < 1.6 µg/cm² hemoglobin, validating the cleaning procedure.
Sterilization Validation (for reusable components)	Validated a 15-minute gravity steam sterilization cycle at 135°C for the Anodized Aluminum Hand Piece Shell, achieving a 10-6 sterility assurance level (SAL).
Effectiveness/Performance:
Comparable Average Power Output to Predicate (within limits)	Bench testing demonstrated that the ELUMI's average output power varied by less than ±20% of the setting, satisfying IEC 60601-2-22, similar to the Predicate Device.
Comparable Features and Functions to Predicate	Bench testing found ELUMI substantially equivalent to the Predicate Device by having identical features and functions as identified in 21 CFR 1040.10.
Comparable Histological Effects on Soft Tissue to Predicate	An animal study on pig liver soft tissue showed that the ELUMI 810+980 Soft Tissue Laser and the Predicate Device had "similar effects on soft tissue."
Equivalent Indications for Use to Predicate Device	Indications for use are explicitly stated as "identical to those of the previously cleared Predicate Device."
Equivalent Technological Characteristics to Predicate Device	Key technological characteristics (laser type, medium, wavelengths, max peak power, pulse type, delivery system, fiber diameter, aiming beam, activation) are largely identical or equivalent, as detailed in the "Technological Characteristics" table. Minor differences do "not alter the fundamental scientific technology."
Equivalent Functional Characteristics to Predicate Device	Functional characteristics (indications for use, operating principle, basic construction, shelf life, packaging) are identical or similar.

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

Bench Testing: The sample size for bench testing of power output, features, and functions is not explicitly stated. It implies multiple measurements to ensure compliance.
Animal Study: The sample size for the animal study is not specified in the provided text. It only states "an animal study was conducted."
Data Provenance: The data for bench testing and the animal study would be prospective experiments conducted by the manufacturer for this 510(k) submission. The country of origin for the data is not explicitly stated but is likely the location where Azena Medical, LLC operates or commissioned the tests.

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

N/A. This 510(k) submission primarily relies on bench test data, compliance with recognized standards, and animal study results to demonstrate substantial equivalence to a predicate device. There is no mention of human experts defining a "ground truth" for a specific test set in the context of diagnostic accuracy, which is where such experts would typically be involved.

4. Adjudication Method for the Test Set

N/A. As stated above, this submission relies on objective measurements in bench tests and observations from an animal study, not human interpretation of a test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

N/A. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This device is a surgical laser, and the "comparative effectiveness" is demonstrated through physical property measurements and biological effect studies against a predicate device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, in a sense. The bench testing and animal study represent "standalone" evaluations of the device's physical properties and biological effects without human intervention influencing the fundamental laser mechanism. The compliance with standards and the performance of the device itself (e.g., power output, histological effects) are assessed independently.

7. Type of Ground Truth Used

Bench Testing: The "ground truth" is defined by international and national standards (e.g., IEC 60601-2-22 for power output deviation) and direct comparison to the physical and functional characteristics of the predicate device.
Animal Study: The "ground truth" for histological effects would be derived from histopathological analysis of tissue samples, likely performed by veterinary pathologists, comparing the effects of the test device to the predicate device.

8. Sample Size for the Training Set

N/A. This device is a hardware laser system, not an AI/ML algorithm that requires a "training set" in the computational sense.

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

N/A. See point 8.

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