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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.

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Medical Diode Laser Systems 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; biopsy; operculectomy; implant recovery; gingivoplasty; 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;papillectorny; 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: Medical Diode Laser Systems are indicated for light activation materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Low Level Laser Therapy: Medical Diode Laser Systems are intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffins pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

The Medical Diode Laser System is a compact, air-cooled unit. It is a complete self-contained instrument, which includes a high efficiency power supply, a microprocessor controlled, adjustable light output with automatic power stabilization, (fan cooled), as well as a switch panel and LCD screen display panel designed to be user friendly. The system includes high power lasers, safety features and an SMA fiber output connector. The system includes a Lithium battery, it can work 1hour when not external power input at maximum power output in pulse or CW but intermittent mode. The diodes are made from GaAlAs semiconductor material for high output and superior reliability. The diode lasers are enclosed in a rugged, factory-aligned, replaceable, environmentally protective module. High-capacity fans eliminate the need for water-cooling, and assure low maintenance and reliable laser operation. The diodes convert electric energy into coherent laser radiation with a wavelength of 810nm or 980nm+/-10nm (pilot beam: 650nm+/-10nm).

This document is a 510(k) premarket notification for a medical device (Medical Diode Laser Systems) and explicitly states that no clinical testing was performed. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully answered as it pertains to clinical performance and AI integration.

The provided document focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical testing (electrical safety, EMC, laser safety standards, and software verification). There is no mention of AI/ML, human-in-the-loop performance studies, or ground truth establishment based on expert consensus, pathology, or outcomes data, which are typical requirements for AI/ML device clearances.

Based on the provided text, here's what can be inferred/extracted and what cannot be answered:

1. Table of acceptance criteria and the reported device performance:

Since no clinical or AI performance study was presented, the "acceptance criteria" here refer to conformance with established safety and performance standards for laser medical devices.

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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.

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1. Dental Soft Tissue Indications
   incision, excision, vaporization and coagulation of oral soft-tissues including marginal and interdental gingival and epithelial lining of free gingiva and the following specific indications:

• Excisional and incisional biopsies
• Exposure of unerupted teeth
• Fibroma removal
• Frenectomy
• Frenotomv
• 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 adjunction 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
• Reduction of bacterial level (decontamination) and inflammation

2. Laser Periodontal Procedures

• Laser soft-tissue curettage
• Laser removal of diseased, inflamed and necrosed soft-tissue within periodontal pocket - Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue within 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 temperature for a temporary relief of minor muscle and joint pain and stiffness, minor 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.

Primo Dental Laser is a laser medical device with surgical and therapeutic effects mainly used in dental and oral care. It's a portable medical device composed by a console, the principal component of the device, connected to a handpiece through an optical fiber, which represent the applied parts.
Primo Dental Laser is a medical device used for a great variety of dental treatment including Surgery, Decontamination, Biostimulation and Therapy. All this due to the selection of protocols favourable through a wide spectrum of specialties.
Laser radiation is produced by a laser diode. This component, a semiconductor, is able to produce a laser radiation with a wavelength characteristic of the semiconductor itself.
Primo Dental Laser has the following characteristics: is transportable and equipped with an internal battery to be independent from the power supply. Laser emission occurs with a wireless pedal control, also powered by batteries.
The radiation emitted by the diode laser is delivered to the optical fiber or through the use of an accessory.

I am sorry, but the provided text focuses on the FDA's 510(k) clearance for the "Primo Dental Laser" and its substantial equivalence to predicate devices. It does not contain specific acceptance criteria, performance data, or details about a study designed to prove the device meets those criteria in the context of an AI/ML device.

The document is a regulatory submission for a medical device (a dental laser), not an AI/ML driven diagnostic or therapeutic device that would typically have the kind of acceptance criteria and performance study details you are requesting (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance).

Instead, it discusses:

• Device Description: The nature of the Primo Dental Laser (a portable laser device for dental and oral care).
• Indications for Use: A comprehensive list of dental procedures the laser is intended for.
• Predicate Devices: Comparison of the Primo Dental Laser to other legally marketed dental lasers (Epic 980, QuickLase, SIROLaser Blue, Epic Pro 940, ELUMI 810 + 980 Soft Tissue Laser) to establish substantial equivalence.
• Technological Comparison: Highlights similarities in laser medium, wavelengths, power, operation modes, delivery systems, and compliance with standards.
• Non-Clinical Testing: Mentions biocompatibility testing, electrical safety, electromagnetic compatibility (EMC), and software verification and validation.
• Clinical Testing: Explicitly states that "Clinical testing was not performed since there was no change to the intended use and indications for use and the performance characteristics between the subject device and its predicates."

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance study data as these are not present in the provided text for this particular device.

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The Solea system is indicated for the following:

• Ablation of hard tissue for caries removal and cavity prevention
• Incision, excision, vaporization, coagulation and hemostasis of soft tissue in the oral cavity
• Cutting, shaving, contouring and resection of oral osseous tissue (both)
• Aiding in the reduction of mineral loss in dental enamel

The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy for ablation of hard tissue for caries removal and cavity preparation; incision, excision, vaporization, coagulation, and hemostasis of soft tissue in the oral cavity; cutting, shaving, contouring and resection of oral osseous tissue (bone). The Solea system utilizes CO2 laser technology with a wavelength of 9.3 um.
The modification to the cleared Solea system is the introduction of the DR Handpiece which allows the system to deliver controlled sub-ablative energy necessary to heat the tooth surface mineral without ablation for the new treatment of aiding in the reduction of mineral loss in the tooth enamel.

The information provided describes the Solea laser system, which is intended for dental procedures, including a new indication for "aiding in the reduction of mineral loss in dental enamel."

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for the new indication ("aiding in the reduction of mineral loss in dental enamel") with corresponding reported performance values. Instead, it describes generic safety and performance testing for various aspects of the device and a specific finding from "bench testing" relating to the new indication.

Implicit Acceptance Criteria (for the new indication related to mineral loss in dental enamel):

General Safety and Performance Criteria (for the device as a whole):

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

The document states, "The in vitro studies found that the increase in pulpal temperature following the procedure was less than the maximum threshold of 5.5º C and there were no visually observed structural changes such as melting, charring or carbonization." It also mentions, "In vitro testing demonstrated a significant benefit of the Solea system in aiding in the reduction of mineral loss in dental enamel as measured by the relative mineral loss in depth and surface mineral loss, without significant damage to the enamel. Additionally, inhibition of surface softening and surface loss during pH cycling was observed."

• Sample Size for test set: Not specified.
• Data Provenance: The studies are described as "in vitro studies" and "bench testing," indicating laboratory-based studies. The country of origin of the data is not specified. The studies appear to be prospective to evaluate the device's performance under specific conditions.

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

This information is not provided in the document. The studies mentioned are in vitro/bench testing, which often relies on objective measurements rather than expert consensus on subjective interpretations (like image-based diagnoses). Thus, the concept of "ground truth established by experts" as typically seen in diagnostic AI is not directly applicable or reported here.

4. Adjudication method for the test set

This information is not provided in the document. Since the testing involves in vitro objective measurements and assessments of physical changes (pulpal temperature, structural changes, mineral loss), an adjudication method as typically used for subjective expert evaluations is unlikely to have been relevant or performed.

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 explicitly mentioned or implied. This device is a laser system for treatment, not a diagnostic AI tool, so an MRMC study comparing human reader performance with and without AI assistance is not applicable to its stated purpose.

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

The device is a laser system operated by a healthcare professional. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in the typical sense of a diagnostic AI algorithm. The performance mentioned ("significant benefit in aiding in the reduction of mineral loss," etc.) refers to the device's direct physical effect on dental enamel as tested in vitro, not an algorithmic output.

7. The type of ground truth used

For the specific new indication:

• The "ground truth" implicitly used for the effectiveness testing (reduction of mineral loss, inhibition of softening/loss) would be quantitative measurements of mineral content, depth, and surface characteristics of dental enamel, along with objective measurement of pulpal temperature and visual observation for structural damage. This falls under scientific measurement/bench testing data.

For other safety aspects (electrical, EMC, laser, sterilization):

• Compliance with established industry standards and regulatory requirements (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, AAMI TIR12, ANSI/AAMI ST79) serves as the "ground truth" for these safety parameters.

8. The sample size for the training set

The document describes this as a medical device (laser system), not an AI/machine learning algorithm that typically requires a training set. Therefore, information about a "training set sample size" is not applicable and not provided.

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

As described above, the device is a laser system, not an AI/machine learning algorithm requiring a training set, so this information is not applicable and not provided.

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Dental Soft Tissue Indications: Incision, excision, vaporization, ablation and coagulation 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, Leukoplakcia, 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. Laser Periodontal Procedures, including: Laser soft tissue curettage, 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 mobility).

Principle: The semiconductor laser diode is excited by the generation power supply to generate the laser, which is effectively transmitted to the treatment site through the optical fiber tip. Intended operator: Dental surgeon. Component part: It is composed of laser host (including internal power system, laser drive system, optical path system, LCD screen, emergency stop button, laser) and optic fiber tip. Sterile: The Fiber optic tip and the handpiece cover require sterilization prior to use.

This document is a 510(k) premarket notification for a Class II medical device, the Dental Diode Laser, SOGA Laser, ILaser II. It focuses on demonstrating substantial equivalence to a predicate device (iLase™ by Biolase Technology, Inc., K093852) rather than proving meeting specific acceptance criteria through a performance study against a defined ground truth.

Therefore, the requested information regarding acceptance criteria, device performance, sample size, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML-driven device performance studies) cannot be extracted from this document, as it describes a traditional medical device (a laser) and its regulatory submission based on substantial equivalence.

The document details the device's technical specifications and compares them to a predicate device to argue for substantial equivalence in safety and effectiveness, based primarily on non-clinical testing against recognized standards (e.g., IEC, ISO). Clinical testing was explicitly stated as not performed for this submission.

Here's what can be extracted based on the provided document, even though it doesn't align with the typical "acceptance criteria and study that proves the device meets the acceptance criteria" format for AI/ML devices:

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

This document does not present quantitative performance metrics against specific acceptance criteria for a "study" in the way an AI/ML device would. Instead, it compares technical specifications to a predicate device to demonstrate substantial equivalence. The "acceptance criteria" here are effectively "being substantially equivalent to the predicate device in terms of safety and effectiveness."

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

• Sample Size for Test Set: Not applicable. No clinical test set or data set for performance evaluation in the AI/ML sense was used. The submission relies on technical comparisons and non-clinical testing.
• Data Provenance: Not applicable for a "test set." The document refers to "literature referred [1]" for demonstrating efficiency equivalence but does not provide details of this literature.

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

• Not applicable. No ground truth establishment for a test set was performed, as it was a technical comparison for substantial equivalence.

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

• Not applicable. No adjudication was necessary as no test set requiring ground truth labeling 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:

• No MRMC study was done (or mentioned). This is a physical device (laser), not an AI-based diagnostic or assistive software.

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

• Not applicable. This is a physical laser device, not an algorithm.

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

• Not applicable. The basis for safety and effectiveness is "substantial equivalence" to a legally marketed predicate device, supported by compliance with international electrical, laser, and biocompatibility standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable.

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Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue; marginal and interdental gingival and epithelial lining of free gingiva; frenotomy; biopsy; operculectomy; Implant recovery; gingivectomy; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of deseased 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 index, 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:.

The semiconductor laser diode is excited by the generation power supply to generate the laser, which is effectively transmitted to the treatment site through the optical fiber tip. It is composed of laser host (including internal power system, laser drive system, optical path system, LCD screen, emergency stop button, laser) and optic fiber tip. The device mainframe not supplied sterile and do not require sterilization prior to use. The consumable component (Fiber optic tip) not supplied sterile but require sterilization prior to use.

This document describes the regulatory submission for the Shenzhen Soga Technology Co., Ltd. Dental Diode Laser (Model: ILaser I). It focuses on demonstrating substantial equivalence to a predicate device, SIROLaser Advance (Model: FonaLaser), rather than presenting a study to prove acceptance criteria with specific performance metrics.

Here's an analysis based on the provided text, addressing the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, it relies on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and adherence to recognized safety and performance standards. The "performance" reported is primarily that the device meets these safety and performance standards.

• Wavelength: 980nm ±20nm (vs. 970nm ±15nm for predicate). The document states this difference was verified for safety (IEC 60825-1, IEC 60601-2-22) and that the subject device's efficiency is better based on literature.
• Frequency: 1Hz to 100Hz (same as predicate).
• Output Power: 4.0 W Max CW / 8.0 W Peak Power (Pulse Mode) (vs. 4.0 W Max CW / 7.0 W Peak Power for predicate).
• Aiming Beam: Laser diode, 5 mW, 680nm±20nm, Class 1 (vs. max 1 mW, 635-650nm, Class 1 for predicate).
• Laser Class: IV (4) (same as predicate).
• N.O.H.D.: 3.03 meters (vs. 1.5 meters for predicate). Other characteristics (Principle of Operation, Environment of Use, Software) are also compared and deemed substantially equivalent. |
  | Safety and Performance Standards | Compliance with recognized international standards for medical electrical equipment safety, electromagnetic compatibility, and laser product safety. Expected standards include:
• IEC 60601-1 (Electrical Safety)
• IEC 60601-1-2 (Electromagnetic Compatibility)
• IEC 60825-1 (Safety of laser products - Part 1)
• IEC 60601-2-22 (Particular requirements for basic safety and essential performance of surgical laser equipment) | The device has been Verified to comply with:
• IEC 60601-1 (Electrical Safety)
• IEC 60601-1-2 (Electromagnetic Compatibility)
• IEC 60825-1 (Performance Safety and Effectiveness)
• IEC 60601-2-22 (Performance Safety and Effectiveness) |
  | Sterilization Conditions | Specific conditions for sterilization of consumable components. | Consumable component (Fiber optic tip) requires sterilization at 121℃ (250°F) for 30 minutes. |

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

• Sample Size: Not applicable. This submission is based on demonstrating substantial equivalence to a predicate device and adherence to recognized standards, not on a clinical trial with a "test set" of patients or data in the typical sense for performance evaluation (e.g., diagnostic accuracy).
• Data Provenance: The "data" provided relates to the technical specifications of the device and its predicate, and results from non-clinical testing performed in accordance with international standards. The country of origin for the subject device is China (Shenzhen, Guangdong).

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

• Number of Experts: Not applicable. There was no "test set" with ground truth established by experts in the context of this 510(k) submission for this type of device. The evaluation relies on engineering, safety, and performance testing against established standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there was no test set requiring expert 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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. This device is a laser surgical instrument, not an AI-assisted diagnostic tool for "human readers."

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

• Standalone Performance: Not applicable. This device is a hardware surgical instrument, not an algorithm. Its performance is evaluated through physical and electrical safety, and functional testing, not standalone algorithmic performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The "ground truth" in this context is the successful demonstration of compliance with established international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22). This relies on objective measurement and testing against the requirements set by these standards, rather than expert consensus on diagnostic images or pathology.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is a physical instrument, not an AI model requiring a training set of data.

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

• Ground Truth Establishment: Not applicable, as there is no training set for this device.

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The DEKA SmartPerio system is intended to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The device is intended to be used in dentistry. The following are the oropharyngeal indications for use: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.)

The DEKA SmartPerio is a Nd:YAG laser device for soft-tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip. The modification to the device consists in the increasing of the average output power from 6W to 10W.

The provided text describes a 510(k) premarket notification for a medical device called DEKA SmartPerio. This notification focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a study to prove acceptance criteria for a new, independent device performance claim. The key modification is an increase in average output power.

Therefore, the document does not contain the information requested for a detailed analysis of acceptance criteria, device performance studies (like MRMC or standalone performance), sample sizes, ground truth establishment, or expert involvement as would be typical for a new AI/algorithm-based device clearance or a device making novel performance claims.

Instead, the document focuses on demonstrating that the modified device, despite the power increase, remains equally safe and effective as its predicate by adhering to established electrical safety and laser equipment standards.

However, I can extract the information that is present and indicate where the requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modification to an existing device, the "acceptance criteria" are primarily related to safety and effectiveness compared to the predicate, as demonstrated by compliance with relevant standards. There are no specific performance metrics like sensitivity, specificity, or AUC provided in this document that would be typical for an AI/algorithm-driven diagnostic device.

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

Not applicable. This is not a study involving a test set of data (e.g., medical images or patient records) to evaluate an algorithm's performance. The "testing" refers to non-clinical bench testing for electrical, EMC, and laser safety standards.

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

Not applicable, as there is no test set with ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable, as there is no test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not describe an MRMC comparative effectiveness study. This type of study would be relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the scope of this 510(k) submission.

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

Not applicable. The DEKA SmartPerio is a laser device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. This document pertains to the safety and performance of a physical medical device (a laser) and its compliance with engineering standards, rather than the accuracy of an algorithm against a defined ground truth.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-driven device that requires a training set.

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

Not applicable.

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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

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Root Canal Hard Tissue Indications (for use on adult and pediatric patients)

• Root canal preparation including enlargement
• Root canal debridement and cleaning

Root Canal Disinfection (for use on adult and pediatric patients) - Laser root canal disinfection after endodontic treatment

EdgePro is an erbium, chromium: yttrium, scandium, gallium garnet (Er,Cr: YSGG)solid-state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2780 nm. The laser system consists of a top-table console which houses the laser head, power supply, cooling system, micro-processor and a removable tablet PC as a control panel. A flexible fiber cable, connected to the laser console, delivers laser energy to the treatment site through a laser tip attached to a Handpiece. A visible light emitted from the Handpiece head illuminates the area. The laser is activated by means of a wireless footswitch. Various laser tips are available for different clinical applications. EdgePro utilizes advanced laser and water atomization technologies to cut, shave, contour, roughen, etch and resect oral hard tissues, and direct laser energy, with or without water for cooling and hydration, to perform oral soft tissue removal, incision, excision, ablation and coagulation as well as specific endodontic and periodontal applications.

This 510(k) summary for the Biolase EdgePro laser system does not include a detailed study proving the device meets specific acceptance criteria for its intended clinical use. Instead, it relies on substantial equivalence to a predicate device (Waterlase Express) and non-clinical performance data.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., specific success rates for root canal preparation or disinfection) nor does it report specific clinical performance metrics for the EdgePro. The "performance" described is largely comparative to the predicate device in terms of technical characteristics and safety standards.

However, based on the "Comparison of EdgePro to Waterlase Express" table (Table 1) and the performance data section, we can infer some qualitative "acceptance criteria" through equivalence:

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

• Clinical Test Set: Not applicable. No clinical testing was performed for the EdgePro subject device. The device relies on equivalence to the predicate.
• Bench Testing: The document states "Testing was conducted to evaluate performance between the subject device and predicate device." However, it does not provide any details on the sample size (e.g., how many devices were tested, how many times each parameter was measured) or data provenance for this bench testing.
• Biocompatibility (for Predicate Device): Not specified.

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

Not applicable. No clinical test set with human subject data requiring expert ground truth establishment was conducted for the EdgePro in this submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical test data was collected from human subjects for the EdgePro subject device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "Clinical testing was not performed for the subject device since the indications for use are a subset of the predicate device and the performance characteristics are equivalent."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This device is not an AI/algorithm-only device. It is a laser surgical instrument. The software verification and validation would be considered a form of standalone performance assessment, but it's for the device's operational software, not an AI algorithm performing a diagnostic or prognostic task.

7. The Type of Ground Truth Used

• Biocompatibility: The ground truth would be accepted biological safety standards (e.g., ISO 10993-1) as demonstrated by laboratory tests for cytotoxicity, sensitization, intracutaneous reactivity, and systemic toxicity.
• Electrical Safety & EMC: Ground truth is defined by compliance with recognized international standards (IEC 60601 series).
• Software Verification & Validation: Ground truth is the device's functional specifications and FDA guidance for software in medical devices.
• Bench Testing: Ground truth is defined by the technical specifications of the device and comparative performance to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is a medical laser, not a machine learning model, so there is no "training set" in the context of AI.

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

Not applicable, as there is no training set for an AI/ML model.

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