Search Results

The UTU series Medical Diode Laser are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and interdental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, infected, 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 inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.

Whitening: The UTU series Medical Diode Laser are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy: The UTU series Medical Diode Laser are intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

The UTU series Medical Diode Laser (UTU3-F7B, UTU3-F7W, UTU3-G7B, UTU3-G7W, UTU-G20B and UTU-G20W) 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 utilizes a solid state diode as laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of a footswitch.

It is a portable medical device composed of a main unit, a laser delivery system, a footswitch, a power adapter and protective goggles. The main unit incorporates an LCD touchscreen for the device user to set output parameters and for control of the device, and a built-in large-capacity rechargeable lithium battery with longer time of endurance. The laser delivery system includes a fiber optic cable, handpiece and tips (disposable fiber tips, whitening tip, biostimulation tip or therapy tip) designed and optimized for different applications.

The UTU3-F7B and UTU3-F7W employ the diodes with wavelengths of 810nm, 650nm and 450nm, they only different in enclosure color, the enclosure color of UTU3-F7B is black and the enclosure color of UTU3-F7W is white. The UTU3-G7B and UTU3-G7W employ the diodes with wavelengths of 980nm, 650nm and 450nm, they only different in enclosure color, the enclosure color of UTU3-G7B is black and the enclosure color of UTU3-G7W is white. The UTU-G20B and UTU-G20W employ the diode with wavelength of 980nm, they only different in enclosure color, the enclosure color of UTU-G20B is black and the enclosure color of UTU-G20W is white. The device emits laser output energy in the infrared, red and blue spectra respectively.

The provided FDA 510(k) clearance letter and its associated 510(k) Summary for the Medical Diode Laser (K243764) indicate that this device is a laser surgical instrument. The document details the device's indications for use, technological characteristics, and a comparison to predicate devices, primarily focusing on non-clinical performance data such as biocompatibility, electrical safety, and general performance testing (bench testing).

Crucially, this document does not contain information about a study proving the device meets acceptance criteria related to a specific AI/algorithm performance evaluation that would involve concepts like sensitivity, specificity, or human reader improvement with AI assistance. The "Performance Data" section explicitly states "Clinical data: Not applicable" and then lists non-clinical data. The document does mention "Software Verification and Validation Testing," which is a standard requirement for devices with software, and the documentation level was assessed as "Basic Documentation Level," meaning it likely doesn't involve complex AI algorithms requiring deep learning performance evaluations against clinical ground truth.

Therefore, I cannot extract the information required for an AI-specific acceptance criteria table or study description from this document. The device in question is a physical medical device (laser) and its clearance is based on demonstrating substantial equivalence to existing laser devices, rather than on the performance of a diagnostic AI algorithm.

**Based on the provided document, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to AI/algorithm output (e.g., sensitivity, specificity).
2. Sample sizes for test sets involving AI/algorithm performance.
3. Number and qualifications of experts for AI ground truth.
4. Adjudication methods for AI test sets.
5. MRMC comparative effectiveness study results or effect sizes for AI assistance.
6. Standalone algorithm performance.
7. Type of ground truth for AI performance.
8. Training set sample size for AI.
9. How ground truth for AI training was established.**

This document describes the regulatory clearance of a hardware device (a medical diode laser), not a software-based AI diagnostic device. The performance data presented are for the physical properties and safety of the laser, not for an AI's ability to interpret medical images or data.

Ask a specific question about this device

450 nm, 635 nm and 980 nm Diode Laser:
· Intended for intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tıssue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; 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 inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.

Whitening:
• Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy:
· Intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

810 nm Diode Laser in dentistry:
· Surgical applications requiring the ablation, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology
· Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue

• · Gingival troughing for crown impression
• · Gingivectomy
• · Gingivoplasty
• · Gingival incision and excision
• · Hemostasis and coagulation
• · Excisional and incisional biopsies
• · Fibroma removal
• · Frenectomy and frenotomy
• · Oral papillectomies
• · Soft tissue crown lengthening
• · Treatment of aphthous ulcers
• · Treatment of herpetic lesions
• · Periodontology;
• · Laser soft tissue curettage
• · Laser soft tissue curettage
• · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
• · Cosmetic Dentistry;
• · Laser-assisted bleaching/whitening of the teeth
• · Light activation for bleaching materials for teeth whitening
• · Implant recovery

810 nm Diode Laser in therapy:
· 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.

1064 nm Diode Laser in dentistry:

• · Excisional and incisional biopsies;
• · Excision and vaporization of herpes simplex I and II;
• · Frenectomy and frenotomy;
• · Gingivectomy;
• · Gingivoplasty;
• · Gingival incision and excision;
• · Hemostasis;
• · Implant recovery;
• · Operculectomy;
• · Pulpotomy and pulpotomy as an adjunct to root canal therapy;
• · Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy;
  · Sulcular debridement or soft tissue curettage (removal of 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):
  · Treatment of aphthous ulcers and herpetic lesions

The Dawn Diode Laser System manufactured by SWOT LASERS is a surgical device at the cutting edge of technology, designed for a wide variety of soft tissue procedures. The Dawn Diode Laser System utilizes a solid state diode as laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of footswitch.
This laser instrument consists of fiber connecting diode laser system, power supply system and microcomputer control system.
The Dawn Diode Laser System employs the diodes with wavelengths of 450nm, 635nm, 810nm, 980nm and 1064nm, and the device emits laser output energy in blue (450nm), red (635nm), orange (980nm) spectra respectively.

The provided text is a 510(k) summary for the "Dawn Diode Laser System." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in these documents. This is typical for a 510(k) submission where the primary goal is to show that a new device is as safe and effective as a legally marketed predicate device, often by demonstrating similar technological characteristics and performance through non-clinical testing.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the format requested. The document focuses on comparing the proposed device's technological characteristics to predicate devices. It states that "non-clinical tests" were performed to "verify the performance requirements" and that "the testing results do support substantial equivalence." However, it does not specify what those performance requirements (acceptance criteria) were or numerically report the device's performance against them.

The tables provided (Table 1 and Table 2) are comparison tables of technological characteristics between the proposed device and predicate devices, not performance against acceptance criteria.

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

Not applicable/Not provided. The document explicitly states: "No human clinical data is needed for Dawn Diode Laser System." The non-clinical tests mentioned are likely laboratory-based and do not involve human subjects or data provenance in the clinical sense.

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/Not provided. As no human clinical data was used, there was no "test set" requiring expert ground truth establishment in this context.

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

Not applicable/Not provided. Given the absence of a human clinical test set, no adjudication method 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/Not provided. This device is a laser system, not an AI diagnostic tool.

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

Not applicable/Not provided. This is a hardware device; the concept of "standalone performance" for an algorithm doesn't apply directly. The non-clinical tests assess the device's physical and functional properties.

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

Not applicable/Not provided. For non-clinical tests, "ground truth" would typically refer to established engineering standards or physical measurements, not clinical outcomes or expert consensus on patient data.

8. The sample size for the training set:

Not applicable/Not provided. There is no mention of a "training set," as this isn't an AI/machine learning device.

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

Not applicable/Not provided. No training set was used.

Summary of what is available regarding "acceptance criteria" and "study":

The document lists several non-clinical tests that were performed to demonstrate substantial equivalence and meet "performance requirements":

• Study Type: Non-clinical (laboratory/engineering) tests.
• Proof of Meeting Acceptance Criteria: The document states, "It shows that the testing results do support substantial equivalence." and "Demonstrated by the safety and performance tests, the characteristics of Dawn Diode Laser System are respectively equivalent to those of the predicate devices."
• Specific Standards/Tests Mentioned:
  • IEC 60601-1 Edition 3.2 2020-08: Medical electrical equipment - General requirements for basic safety and essential performance.
  • IEC 60601-1-2 Edition 4.1 2020-09: Electromagnetic disturbances.
  • IEC 60825-1 Edition 2.0 2007-03: Safety of laser products - Equipment classification, and requirements.
  • IEC 60601-2-22 Edition 3.1 2012-10: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
  • IEC 62366-1 Edition 1.1 2020-06: Application of usability engineering to medical devices.
  • IEC 62304 Edition 1.1 2015-06: Medical device software - Software life cycle processes.
  • ISO 10993-1 Fifth edition 2018-08: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
  • ISO 10993-5 Third edition 2009-06-01: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
  • ISO 10993-10 Fourth edition 2021-11: Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
  • ISO 10993-23 First edition 2021-01: Biological evaluation of medical devices - Part 23: Tests for irritation.
  • ISO 14971 Third Edition 2019-12: Medical devices - Application of risk management to medical devices.
  • IEC 60601-1-6 Edition 3.2 2020-07: Usability.
  • IEC 60601-1-9: Requirements for environmentally conscious design.
  • ISO 17664-1 First edition 2021-07: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.

The "acceptance criteria" can be inferred to be compliance with these international standards for safety, performance, EMC, biological compatibility, usability, and software. The "study" is the collection of tests performed according to these standards, which are stated to support substantial equivalence. No specific numeric performance results against these standards are detailed in this summary.

Ask a specific question about this device

D-Laser Blue and D-Laser 16 are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; implant recovery; gingivectomy; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining: incisions and draining of abscesses: tissue retraction for impressions: papillectory; vestibuloplasty ; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; 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 inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.

Whitening: D-Laser Blue and D-Laser 16 are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy: D-Laser Blue and D-Laser 16 are intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

The dental diode laser systems, D-Laser Blue and D-Laser 16, realize oral soft tissue surgery, periodontal disease, endodontic disease, pain treatment, soft laser therapy and other oral diseases by vaporizing, carbonizing and solidifying the tissue by laser. The device features include: Using a capacitive touch screen which has the clear display and is easy to operate; Builtin large-capacity rechargeable lithium battery with longer time of endurance; The handpiece sleeve and the fiber tip can be autoclaved to prevent from cross infection; Preset more than 20 treatment procedures to reduce the difficulty of use; A secure protection mechanism that automatically shuts down the device after 5 minutes of inactivity.

The D-Laser Blue and the D-Laser 16 respectively consist of a main unit, a laser transmission system and a power adapter. The main unit includes a semiconductor laser, a power supply system and a control device, a safety protection device and a display device.

The D-Laser Blue employs the diodes with wavelengths of 976nm, 650nm and 450nm, and the device emits laser output energy in the infrared, red and blue spectra respectively. The D-Laser 16 employs the diodes with wavelengths of 976nm and 650nm, and the device emits laser output energy in the infrared, red spectra respectively.

The provided text does not contain typical acceptance criteria and a study design for evaluating a medical device's performance in terms of diagnostic accuracy (e.g., sensitivity, specificity). Instead, this document is a 510(k) summary for laser surgical instruments (D-Laser Blue and D-Laser 16), primarily focusing on demonstrating substantial equivalence to legally marketed predicate devices.

The "acceptance criteria" presented are primarily comparisons of technological characteristics, indications for use, and a list of non-clinical tests confirming compliance with various electrical, safety, and biocompatibility standards. The study mentioned is a non-clinical comparison of cutting efficiency.

Therefore, many of the requested fields (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and training set ground truth establishment) are not applicable to the type of information presented in this 510(k) summary.

Here's an attempt to extract and format the available information according to your request, with "N/A" for criteria not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like the D-Laser Blue and D-Laser 16, substantial equivalence is often demonstrated by showing that the proposed device has the same intended use and similar technological characteristics to a predicate device, or that any differences do not raise new questions of safety or effectiveness. The "acceptance criteria" here are largely met by demonstrating these similarities and confirming compliance with relevant standards and functional tests.

Examples of comparisons and reported findings:

• Product Code: Matches GEX, ILY.
• Regulation Number & Classification: Matches 21 CFR 878.4810, Class II.
• Surgical IFU: Matches predicate devices.
• Laser Periodontic IFU: Matches predicate devices.
• Tooth Whitening IFU: Matches predicate devices.
• Low Level Laser Therapy IFU: Matches predicate devices.
• Application: Dental Laser (Matches).
• Laser Classification:
  • D-Laser Blue: 976 nm (Class IV), 650 nm (Class II), 450 nm (Class IV). Predicate: 970 nm (Class IV), 660 nm (Class II), 445 nm (Class IV). Accepted based on reference devices.
  • D-Laser 16: 976 nm (Class IV), 650 nm (Class II). Predicate: 970 nm (Class IV), 660 nm (Class II). Accepted based on reference devices.
• Laser Type: Solid state diode (Matches).
• Laser Wavelength:
  • D-Laser Blue: 976 nm (+/-20 nm), 650 nm (+/-20 nm), 450 nm (+/-20 nm). Accepted based on range compatibility with predicate/reference devices (e.g., K103753, K163128, K071687, K930210).
  • D-Laser 16: 976 nm (+/-20 nm), 650 nm (+/-20 nm). Accepted based on range compatibility with predicate/reference devices (e.g., K103753, K163128, K071687).
• Optical Power:
  • D-Laser Blue: 976 nm (0.2-4W CW, 7W peak), 650 nm (25-200 mW CW), 450 nm (0.2-3W CW, 4W peak). Accepted based on predicate/reference devices (e.g., K163128, K071687, K180044).
  • D-Laser 16: 976 nm (0.3-7W CW, 16W peak), 650 nm (25-200 mW CW). Accepted based on predicate/reference devices (e.g., K163128, K071687, K170500).
• Emission Modalities: Continuous Wave, Chopped (1 Hz - 20 kHz). Accepted based on reference device K163128.
• Pulse Duration: Chopped Mode (5 µsec - 0.9 sec). Accepted based on reference device K163128.
• Aiming Beam: 650±20 nm, Pmax

Ask a specific question about this device

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.

Ask a specific question about this device

1. 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
• 2. Laser Periodontal Procedures
• · 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)
• 3. Whitening
• · Light activation for bleaching materials for teeth whitening
• · Laser-assisted whitening/bleaching of teeth
• 4. Pain Therapy
     · Topical heating for the purpose of elevating tissue temperary 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 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 Epic 980 uses an Indium Gallium Arsenide (InGaAs) 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.
A visible light is emitted at the same time to visually identify the treatment location. 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.

The provided text describes the 510(k) premarket notification for the Biolase Epic 980 device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria and detailed performance of the subject device itself. Therefore, many of the requested data points (like sample size for test sets, ground truth establishment, MRMC study results, etc.) are not available in this document.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define acceptance criteria as numerical targets for performance metrics in the way one might expect for an AI/ML device. Instead, the "acceptance criteria" are implied by the various tests and standards to which the device was found compliant, demonstrating safety and efficacy primarily through establishing equivalence to predicate devices. The "reported device performance" is mainly a statement of equivalency rather than specific numerical outcomes.

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

• Sample size for test set: Not specified for any of the tests.
• Data provenance: Not specified.

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 as the document does not describe a study involving expert-established ground truth for a test set. The equivalency was based on objective technical standards and ex-vivo testing.

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

• Not applicable as the document does not describe a study involving adjudication for a test set.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a laser surgical instrument, not an AI diagnostic or assistance tool for human readers.

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

• No, this device is a physical laser instrument. The concept of "standalone algorithm only" is not applicable here. Performance was assessed through technical compliance and comparative ex-vivo testing.

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

• For biocompatibility, the ground truth is established through adherence to ISO 10993-1 biological evaluation methods.
• For electrical safety, EMC, laser safety, dental equipment safety, and usability, the ground truth is established by compliance with the specified IEC standards.
• For the ex-vivo bench testing, the "ground truth" was the performance of the predicate device, against which the subject device was compared for equivalency. The exact metrics for this comparison are not detailed beyond "the results demonstrate equivalency."

8. The sample size for the training set

• Not applicable. This device is a laser hardware system and not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As above, there is no "training set" for this type of device.

Ask a specific question about this device