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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
• 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 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.

The Gemini 2 810+980 Soft Tissue Laser is an 810+980nm soft tissue laser intended for the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue and for pain relief using Photobiomodulation. The Gemini 2 810+980 Soft Tissue Laser operates at a wavelength of 810±10nm or at 980±10nm or a combination of both 810+980nm, with a maximum average power output of 2.0 watts ± 20%. The system also contains a 2mW, 650nm laser diode coupled to the same fiber optic cable to produce a red aiming light for the infrared laser beams.

The laser energy is generated in an internal laser module and is then channeled through a flexible optical fiber that is permanently connected to a hand piece. Single-use disposable tips, or Photobiomodulation (PBM) adapters, become the laser aperture of the device when they are optically coupled to the fiber in the hand piece. The disposable tips and Photobiomodulation tips are interchangeable and provide a method of delivering laser energy to the target area.

The laser unit is comprised of a molded plastic housing that contains: the laser module, main PCB with integrated MCU and laser controller, an electroluminescent display connected to an interface PCB, a touch sensitive graphic user interface with status indicators, and a rechargeable lithium-ion battery.

The handpiece used by the practitioner consists of a cylindrical body of anodized aluminum which encloses the optics that transmit the laser energy to the disposable fiber tip or PBM adapters. The red aiming light is emitted directly from the aperture of the laser attached to the hand piece. Additionally, the handpiece illuminates the target work area with bright white LED lights during procedures through the translucent disposable tips.

The wireless footswitch provides hands-free laser activation. The switch utilized high band Bluetooth technology to wirelessly control the initiation and termination of laser power from the laser aperture. Haptic feedback is also incorporated into the foot pedal to provide a vibration upon laser activation which can be adjusted from low to medium, or high,

The single-use disposable fiber tip includes a translucent plastic tip body, stainless steel tube and a 400-micron polished optical fiber. The Gemini 2 810 + 980 Soft Tissue Laser was designed to utilize the same disposable tip as the Gemini 810+980 Soft Tissue Laser, previously cleared by FDA (K192617).

The PBM adapters are accessory attachments for the Gemini 2 810 + 980 Soft Tissue Laser which expand the diameter of the laser beams spot size to 25mm, 3mm or 7mm. The lager diameter laser beam is used for Photobiomodulation indications such as pain management. The PBM adapters are designed to be held in a fixed location for the duration of the treatment. The 25mm adapter is only intended for extraoral use directly on intact skin and is designed at a diameter for larger work areas. Single-use disposable spacers are intended to be used with the 25mm adapter to limit the risk of cross contamination between patients. Due to the extraoral use, and disposable spacers, the 25mm PBM adapter is not to be steam sterilized. The 3mm and 7mm PBM tips are intended to be used intraorally and are designed at an I angle for reaching the back of the mouth. Steam sterilization and cleaning are required for both the 3mm and 7mm PBM adapters before each use. Non-clinical testing was conducted on the 3mm and 7mm adapters to test that the adapters increased the intra oral tissue temperature to the FDA quidelines for the ILY product code. The results showed that even in the intraoral environment, the efficacy of the adapters was met and showed substantial equivalence to the previously cleared device. In addition, non-clinical testing was also conducted with the use of an FDA cleared barrier sleeve over the 3mm and 7mm Intra Oral adapters. The results show that the use of the sleeve did not affect the efficacy of the product.

The laser unit is controlled by a Main Control Unit (MCU) processor that is integrated into the main PCB. The PCB contains the software and hardware which requlates voltages and current and controls all the other functions and safety features. The PCB may be powered by either lithium-ion battery pack, or the included AC power supply. The PCB was designed to allow the power supply to provide power to the unit while simultaneously charging the battery pack.

The Gemini 2 810+980 Soft Tissue Laser utilizes non-volatile, preprogrammed firmware that cannot be modified by the user. Additionally, custom presets and individual user settings are stored in memory to be adjusted by users at any time. During the development process, regulations are recognized and applies to meet requirements, potential hazards are evaluated and mitigated for the safety of the patient and/or the operator. The Gemini 2 810 + 980 Soft Tissue Laser has software features that allows for access to training videos, user manuals and software updates.

The provided document is a 510(k) summary for the Azena Medical, LLC Gemini 2 810+980 Soft Tissue Laser. It does not describe a study involving human readers, AI, or the establishment of ground truth by expert consensus for diagnostic purposes.

Instead, this document details the device's technical specifications, its intended use (dental soft tissue procedures and pain therapy via topical heating), and demonstrates its substantial equivalence to previously cleared predicate devices (Gemini 810+980 Diode Laser and Epic Pro Diode Laser System).

The acceptance criteria and performance data discussed are related to:

• Compliance with international and national standards for medical electrical equipment, laser products, sterilization, and biocompatibility.
• Bench testing to verify performance characteristics like power output and tissue temperature elevation.
• Software validation according to IEC 62304.

Therefore, I cannot provide the information requested in terms of AI performance, human reader improvement, expert ground truth establishment, or data provenance relevant to an AI-assisted diagnostic study. The document explicitly states: "No clinical data was submitted for this Traditional 510(k)." This means there were no human subject studies to evaluate the device's performance in a clinical setting in the way you might find for an AI diagnostic device.

However, I can extract the acceptance criteria and demonstrated performance based on the type of evaluation conducted for this specific device, which is a medical laser for surgical and therapeutic use, not a diagnostic AI.

Here's a breakdown of the relevant information from the provided text, framed to address your questions where applicable, and noting where the information is not applicable (N/A) to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this laser device, the "acceptance criteria" are compliance with recognized safety and performance standards, and demonstrating equivalent performance to predicate devices through bench testing.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: N/A for human subject data. The "test set" here refers to physical devices, components, and software evaluated through bench testing and compliance verification. The document doesn't specify the number of units tested, which is common for this type of submission.
• Data Provenance: N/A. The data is generated from laboratory bench tests, sterilization validations, electrical safety, EMC, and software testing, performed by the manufacturer or contracted labs. It's not clinical data in terms of patient populations or geographical origin. This was a non-clinical submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. This device submission does not involve diagnostic ground truth established by medical experts (e.g., radiologists, pathologists). The "ground truth" for this laser device is based on objective measurements from engineering and performance testing against established standards and predicate device specifications.

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

• N/A. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments. The data presented here is from objective engineering and performance tests, not clinical adjudication.

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. An MRMC comparative effectiveness study was not done. This device is a surgical/therapeutic laser, not an AI-powered diagnostic tool for human readers. This type of study is not relevant to its clearance.

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

• N/A. This device is a physical laser system, not an algorithm. While it contains software, its "performance" is measured by its physical output (laser power, wavelength, impact on tissue temperature), not by its ability to perform a diagnostic task independently.

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

• The "ground truth" for this device, in terms of its regulatory submission, is based on:
  • Objective Engineering Specifications: Agreed-upon laser parameters (wavelength, power output, beam diameter).
  • Recognized National and International Standards: Established safety, performance, and sterilization criteria (e.g., IEC, ISO, AAMI/ANSI).
  • Predicate Device Specifications: The performance characteristics of legally marketed devices to which substantial equivalence is claimed.
  • In-vitro Bench Testing Results: Measurements of physical properties and effects (e.g., tissue heating).

8. The sample size for the training set:

• N/A. This submission does not involve a "training set" in the context of machine learning model development.

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

• N/A. As there is no training set mentioned in the context of an AI/ML model, this question is not applicable.

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