(150 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
- · Treatment of aphthous ulcers.
- · Vestibuloplasty
- · Tissue retraction for impression
- · Lesion (tumor) removal.
Laser Periodontal Procedures.
- · Laser soft tissue curettage.
- · Laser removal of diseased, Inflamed and necrosed 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 diseased, 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)
- · Reduction of bacterial level (decontamination) and inflammation
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 minor muscular back pain, the temporary increase in local blood circulation; the temporary relaxation of muscle.
Gemini is an 810nm + 980nm soft tissue laser is intended for the incision, ablation, vaporization, hemostasis and treatment of oral soft tissue and for pain relief using photobiomodulation. The Gemini laser operates at a wavelength of 810nm +/- 10nm or at 980 +/- 10nm or a combination of both 810nm + 980nm wavelengths, with a maximum average power of 2 watts +/- 20% and maximum peak pulse power of 20 watts +/- 20% when in dual wavelength mode. The dual wavelength diode laser radiation is delivered through a flexible optical fiber and the Photobiomodulation (PBM) Adapter. Infrared laser energy is emitted from the fiber tips and the PBM Adapter when the wireless footswitch is depressed. The laser diodes are directly coupled to the flexible fiber optic able that connects the laser unit to the surgical hand piece and to the disposable fiber tip and PBM Adapter that emits the energy to the target area. The laser diodes can simultaneously emit energy when Gemini is set to dual wavelength mode.
The Gemini unit comprises of six main assemblies: a Laser unit, a flexible fiber optic delivery svstem tethered to an anodized aluminum hand piece, disposable single-use fiber tips. PBM Adapter with spacers, a wireless footswitch, and an auxiliary power supply. The system also contains a 5mW 650nm laser diode coupled to the same fiber optic cable to produce the red aiming light. The laser system is contained within a compact lightweight impact resistant molded plastic housing that contains a laser diode assembly, a laser power controller PCB, an Electroluminescent Display connected to an interface PCB, a touch sensitive selection panel with status lights, and a rechargeable Lithium Battery. The hand piece used by the practitioner consists of an anodized aluminum cylindrical body which encloses the optics used to transfer the laser energy to the single-use fiber tips and the PBM Adapter. The LED illumination system for lighting the work area will be off for PBM Adapter.
The laser's visible light is designed to aid the clinician in aiming the tip of the delivery fiber into the target tissue. Additionally, a bright white light from the LEDS in the hand piece illuminates target work area during procedures through the translucent disposable laser tips.
The PBM Adapter is an accessory attachment to the Gemini laser system to increase the spot size of the laser beam, allowing the Gemini Laser to provide near-infrared laser energy to a tissue surface for the purpose of photobiomodulation. Affected muscles and/or joints must be exposed to an adequate level of laser energy over a period of time to provide effective results. The spot size of the PBM Adapter is 25 mm. The PBM Adapter operates at 810nm ± 10nm wavelength with a maximum average power of 1 watt ± 20%.
A PBM spacer is attached to the PBM Adapter. The spacer is a single-use disposable piece designed to ensure proper working distance to target tissues and limit the risk of cross contamination between patients. The PBM Adapter is designed to only work with the Gemini Laser System.
Gemini 810 + 980 Diode Laser utilizes non-volatile, preprogrammed firmware that cannot be modified by the user. During the development process, requirements are met, hazards are evaluated and mitiqated for the safety of the patient and /or the operator and the firmware. It does not capture any data related to patients. The Gemini software focuses on the functional and technical design for the Gemini laser. This includes the graphical user interface (GUI), the control of the laser drivers, sound, tip illumination and aiming light.
The provided text is a 510(k) summary for the Gemini 810+980 Diode Laser. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and non-clinical performance data.
Crucially, this document does not describe a study involving a "test set" with "ground truth established by experts" or a "multi-reader multi-case (MRMC) comparative effectiveness study" for an AI or imaging device. It is for a laser surgical instrument and pain therapy device.
Therefore, many of the requested items related to AI/imaging device validation (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test set and training set) are not applicable to this submission.
The document states: "No clinical data was submitted for this Traditional 510(k)." This further confirms that there were no human subject studies to evaluate the device's performance in a clinical setting in the way an AI/imaging device would be evaluated.
However, I can extract information related to the acceptance criteria and the studies that were performed to support the substantial equivalence claim for this specific type of device.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance:
Since this is a laser device and not an AI/imaging diagnostic tool, the "acceptance criteria" are compliance with various national and international standards, and "reported device performance" refers to the results of bench testing confirming these compliances and functional equivalence to predicate devices.
| Acceptance Criteria (Compliance with Standards/Functional Equivalence) | Reported Device Performance (Study Results) |
|---|---|
| Laser Safety & Performance Standards: | - 21 CFR 1040.10 & 1040.11: Found in compliance (except for deviations pursuant to laser notice 50 dated June 24, 2007). |
| - IEC 60601-2-22 Edition 3.1 2012-10 | - Conformed to IEC 60601-2-22 (Particular Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment). |
| - IEC 60825-1 Edition 2.0 2007-03 | - Conformed to IEC 60825-1 (Safety of laser products – Part 1: Equipment classification and requirements). |
| Electrical Safety & EMC Standards: | - AAMI/ANSI ES60601-1:2005/ (R) 2012 and A1:2012: Conformed to IEC 60601-1 (General requirements for basic safety and essential performance). |
| - IEC 60601-1-2 Edition 4.0 2014-02 | - Conformed to IEC 60601-1 -2 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic compatibility). |
| Cleaning & Sterilization Standards: | - AAMI/ANSI ST81:2004/(R)2016 |
| - AAMI/ANSI ST79:2017 | - Cleaning Validation (Anodized Aluminum Surgical Hand Piece with Fiber Connector): Achieved 78.5% protein recovery and 77.6% hemoglobin recovery. Cleaned devices contained |
§ 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.