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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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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.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable in the context of an "AI/imaging test set": As stated, no clinical data was submitted. The testing involved bench testing of the device and its components, not a "test set" of patient data for diagnostic evaluation. Sample sizes for bench tests (e.g., number of units tested for electrical safety, cleaning/sterilization) are standard engineering and quality assurance practices and are not detailed in this summary.

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: No "ground truth" was established by medical experts for a test set of patient data, as this device is a laser surgical and pain therapy instrument, not an AI diagnostic tool.

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

• Not Applicable: No clinical test set requiring adjudication of findings was used.

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

• Not Applicable: This is not an AI-assisted diagnostic device. No MRMC study was performed.

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

• Not Applicable: This is a physical medical device, not an algorithm. Bench testing confirmed its standalone performance against engineering specifications and comparison with predicate devices.

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

• Not Applicable in the typical AI/imaging sense. For this device, "ground truth" for its performance is derived from:
  • Compliance with recognized industry standards: The standards themselves define acceptable parameters and measurement methodologies.
  • Bench test results: Physical measurements of power output, wavelength, temperature achieved, cleaning efficacy, sterilization efficacy, etc., verified by instruments and documented procedures.
  • Comparison to predicate device specifications/performance: Demonstrating that its physical and energy output characteristics are equivalent or superior to already cleared devices.

8. The sample size for the training set

• Not Applicable: This device does not use a "training set" in the context of machine learning.

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

• Not Applicable: No training set was used.

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The ELUMI 810+980 Soft Tissue Laser is intended for the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue.

The following are the oropharyngeal indications for use:

• · 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

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.

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.

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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