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The Bluemoon is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photopolymerized in the 385~515nm waveband of visible light.

The Bluemoon Dental Curing Light is an instrument for photopolymerizing dental materials and starting agents by irradiating them with visible light between 385-515nm wavelength. It offers four modes (HYPER, TURBO, LOW, and SOFT START) depending on the output intensity and irradiation time.

The FDA 510(k) clearance letter for the Bluemoon Dental Curing Light provides information on several aspects of device testing, but it does not detail acceptance criteria for all performance metrics, nor does it present the study in a format that directly addresses the specific questions about AI/human-in-the-loop and ground truth establishment for AI models. This device is a dental curing light, a hardware device, not an AI/ML software. Therefore, the concepts of "AI assistance," "human readers," "test set," "training set," "ground truth" as typically defined for AI/ML performance studies are not directly applicable here.

However, I can extract and interpret the provided information to answer the relevant questions as best as possible for a hardware medical device.

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

The document lists "Performance Data" which includes various properties and their corresponding values. These values can be interpreted as the acceptance criteria for those specific properties, and the implicit reported performance is that the device meets these criteria, as stated in the conclusion.

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

The document describes "performance bench testing" but does not explicitly state the sample size (e.g., number of devices tested, number of dental material samples cured) for each test. Given it's a hardware device, the "test set" would refer to the units of the device and the materials it acts upon, rather than a dataset of clinical cases. The provenance of the data is not specified; however, the company is based in the Republic of Korea. The testing would be prospective (i.e., new tests conducted on the manufactured device) rather than retrospective clinical data.

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)

This question is not applicable to a hardware dental curing light. "Ground truth" for this device is established by objective physical measurements (e.g., wavelength, power output, temperature, polymerization depth and strength measured by calibrated instruments) rather than expert interpretation of images or clinical findings. Therefore, no experts in the sense of trained clinicians interpreting data were used for establishing ground truth for the performance tests.

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

This question is not applicable to a hardware dental curing light. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where expert consensus is required for ambiguous cases. The performance tests for this device involve objective measurements.

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

This question is not applicable. The Bluemoon is a dental curing light, not an AI-powered diagnostic or assistive tool. It does not involve "human readers" or "AI assistance."

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

This question is not applicable. The Bluemoon is a hardware device; there is no standalone algorithm to evaluate.

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

For the performance data listed (Irradiation time, Peak wavelength, Polymerization strength, Depth of cure, Light Probe temperature, Energy-saving mode, Auto power off), the "ground truth" is established through objective physical measurements using calibrated instruments and standardized test methods. For biocompatibility, the ground truth is established by the results of specific biocompatibility tests (Cytotoxicity, Skin Sensitization, Intracutaneous reactivity) conducted according to ISO 10993 standards.

8. The sample size for the training set

This question is not applicable. The Bluemoon is a hardware device and does not involve a "training set" in the context of machine learning or AI models. Its design and manufacturing process are validated through engineering principles and bench testing.

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

This question is not applicable as there is no training set for this hardware device.

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The Trust is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region. The Trust is restricted to usage with Dentium implant system, and the angle of the abutment must be maintained at 90° when in use.

This equipment measures the time between the healing abutment and the striking rod by mechanically striking the implanted abutment and quantifies the fluctuation between the implant abutment and the alveolar bone. It is a principle to measure the contact time according to the acceleration change at the moment of being hit by using the acceleration sensor mounted on the Attack Pole. The higher the number, the better the fixation between the implant fixture and the bone.

The provided text describes a 510(k) premarket notification for a medical device called "The Trust," which measures the stability of dental implants. To answer your request about acceptance criteria and the study proving the device meets them, I need to focus on the "Performance Data" section and the "Comparison Technological Characteristics with the Predicate Devices" table, as these are the most relevant parts.

Here's a breakdown based on the information provided and common expectations for such submissions:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table with specific pass/fail values. Instead, the document relies on demonstrating "similar performance" to a predicate device and meeting "established specifications." The key performance characteristic mentioned is the "Error of measurement value."

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

Based on the provided text, the study proving the device meets the acceptance criteria is primarily an equivalence test to the predicate device (AnyCheck IMT-100), rather than an independent clinical study with human subjects.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: The document does not explicitly state the sample size used for the performance comparison tests. It mentions "performance comparison tests with already licensed products" (refer to "002 Equivalence test to AnyCheck"). This often implies bench testing or testing on phantom models, rather than a large clinical test set with patient data.
   • Data Provenance: Not specified. Given it's a Korean manufacturer, it's likely the testing was conducted in South Korea. The type of study (retrospective or prospective) is not explicitly stated, but equivalence testing of this nature for dental handpieces typically involves prospective bench-top testing.

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

   • Not applicable/Not specified. For this type of device and performance testing, ground truth would likely be established by controlled experimental setups and direct measurement by engineers/technicians, rather than expert review of images or clinical outcomes.

3. Adjudication Method for the Test Set:

   • Not applicable/Not specified. As the "ground truth" is likely derived from calibrated measurements in a controlled environment, there wouldn't typically be a need for expert adjudication in the way it's used for AI diagnostic studies.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. An MRMC study is typically performed for AI-driven diagnostic devices where human readers interpret medical images. This device measures implant stability mechanically. There is no indication of such a study being conducted or required.
   • Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.

5. Standalone (Algorithm Only) Performance:

   • Yes, implicitly. The "Performance Data" section refers to tests to ensure the device met "established specifications" and "consistent performance for the intended use." This strongly suggests bench testing or in vitro (non-human) testing of the device's measurement capabilities, which would be considered standalone performance. The "±3 ISV" error of measurement is a standalone performance metric.

6. Type of Ground Truth Used:

   • Likely bench-top measurements / calibrated experimental setup. The device measures a physical property (time between abutment and striking rod, quantified as ISV). The "ground truth" for evaluating its accuracy would come from highly controlled conditions where the "true" stability or a reference value is known (e.g., using standardized implant models with predefined stability levels or comparing to a gold standard measurement technique). It is not pathology, expert consensus, or outcomes data.

7. Sample Size for the Training Set:

   • Not applicable/Not specified. This device is described as a mechanical measurement device using an acceleration sensor, not an AI/machine learning device that requires a "training set" in the conventional sense. The "principle to measure the contact time according to the acceleration change... by using the acceleration sensor mounted on the Attack Pole" suggests a direct physical measurement.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there's no indication of a "training set" for an AI algorithm.

Summary of Device Performance Test and Conclusion:

The performance evaluation for "The Trust" appears to have focused on demonstrating its technical accuracy and equivalence to a legally marketed predicate device (AnyCheck IMT-100). The key performance metric highlighted is the "Error of measurement value" of ±3 ISV, which matches that of the predicate. The submission argues that similarities in operational principles and biological safety, despite minor design differences (e.g., how the calibrator is integrated, magnetic vs. screw connection for the attack pole), do not raise new questions of safety or effectiveness. Biocompatibility testing was also conducted according to ISO 10993 standards and found the materials to be non-toxic and non-sensitizing.

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rainbow Paste Stain SE is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.

rainbow™ Paste Stain SE is a dental veneering material in paste form used for color staining and glazing of the surfaces of restorations such as porcelain-fused zirconia, full-contoured zirconia, or lithium disilicate. The intended use of general porcelain is to make artificial teeth (dental prosthesis) more similar with natural teeth. The subject device is pre-mixed paste form, which can help dental technicians exclude mixing process of porcelain powder and liquid.

Given the provided text, there is no information about a study involving AI, human readers, or a medical device that diagnoses or analyzes conditions. The document is a 510(k) summary for a dental product called "rainbow Paste Stain SE," which is a veneering material for fixed prosthetics. The performance data presented refers to the physical and chemical properties of the material itself, not the performance of an AI algorithm or human readers.

Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets them in the context of AI assistance, human reader improvement, or ground truth establishment for a diagnostic device.

The provided document discusses:

• Device Name: rainbow™ Paste Stain SE
• Intended Use: As a veneering material for fixed prosthesis in crowns and bridges.
• Acceptance Criteria for the material's properties: These are physical and chemical metrics like flexural strength, chemical solubility, appearance, and biocompatibility.
• Performance Data: Results of tests against these material-specific criteria.

There is no mention of:

• AI or software.
• Diagnostic capabilities.
• Human-in-the-loop performance studies.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Ground truth established by experts, pathology, or outcomes data in a diagnostic context.
• Training or test sets in the machine learning sense.

The acceptance criteria and performance data provided in the document relate to the physical and chemical properties of the dental paste itself, demonstrating its suitability as a dental material compared to a predicate device.

If you have a different document that details an AI medical device study, please provide that.

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rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono is used in the manufacture of a dental core through milling by machine followed by sintering.

rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is milled into core (zirconia substructure) of artificial teeth and then is finally sintered in a furnace to harden the ZrO2.

rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is fabricated by CAD/CAM or MAD/MAM machining processes. At the dental lab, the blanks are held to the milling machine which is used to machine to the final dental restoration. After machining steps, the dental restoration is fully sintered in the furnace to harden the ZrO2, and fitted to the patients as crowns and bridges.

rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is available in numerous shapes and sizes in order to be compatible with multiple milling machines. According to the shapes, they are used for fabricating of each intended dental restoration, such as anterior crowns, posterior crowns, bridges

rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is not for use or intended for use to fabricate the top-half of an abutment/titanium base and is for the fabrication of dental restorations only.

The provided text describes the 510(k) premarket notification for the "rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono" dental ceramic. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a legally marketed predicate device.

The information provided in the document focuses on the bench testing and biocompatibility testing performed on the device to establish its safety and performance characteristics, comparing it to a predicate device. It does not present a study related to AI or human reader performance/improvement, nor does it describe a ground truth establishment process involving experts or pathology for a test set. This is because the device is a dental material (porcelain powder for clinical use), not an AI-powered diagnostic or assistive tool.

Therefore, for the aspects related to AI/human reader studies, ground truth establishment, or MRMC studies, the requested information is not applicable to this specific device and the provided document.

Here's the breakdown of the information that is available in the document, framed by the acceptance criteria provided in your prompt, and noting where the requested information is not relevant to this type of device submission:

Device: rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono (Dental Ceramic)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance tests, primarily mechanical and chemical, with their acceptance criteria and results.

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

• Sample Size: The exact sample size for each bench test (e.g., number of blocks tested for flexural strength) is not explicitly stated in the summary document. It states that "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono met the established specifications."
• Data Provenance: The tests were conducted to support a submission to the U.S. FDA by Genoss Co., Ltd. from South Korea. The type of data is bench test data and biocompatibility test data, performed on the device material itself. This is not a human clinical study in the sense of retrospective or prospective patient data, but rather laboratory testing of a material.

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

• Not Applicable. As this is a dental material, the "ground truth" for its performance is established through standardized laboratory testing (e.g., ISO 6872 for dental ceramics, ISO 10993 for biocompatibility) and direct physical/chemical measurements by qualified lab personnel. There is no concept of "experts establishing ground truth" in the diagnostic imaging sense for this device.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reviewing images). For physical and chemical material testing, the results are typically quantitative measurements or qualitative observations by laboratory technicians/scientists following established protocols, not subjective assessment requiring 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

• Not Applicable. This is a dental ceramic block, not an AI-powered device or software. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

• Not Applicable. Again, this is a physical dental material, not an algorithm or software. As such, the concept of "standalone algorithm performance" does not apply. The device's "performance" is its material properties and safety.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by international standards (e.g., ISO 6872 for dental ceramics, ISO 10993 for biological evaluation of medical devices). These standards define the accepted methodologies and criteria for testing the material's physical, chemical, and biological properties. The results of these tests, conducted according to the standards, serve as the evidence of the device's performance and safety.

8. The Sample Size for the Training Set

• Not Applicable. As this is a physical medical device (dental ceramic) and not an AI/Machine Learning model, there is no concept of a "training set" in the computational sense. The product development and manufacturing process involve R&D and quality control, but not data-driven machine learning training.

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

• Not Applicable. There is no "training set" for this device, as it is not an AI/ML product.

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Bright MTA Sealer Plus is used for filling root canals.

Bright MTA Sealer Plus is a ready-to-use, injectable paste-like material for root canal filling, which is hardened and obturated after being injected into the root canal space. The product based on calcium silicate exhibits excellent biocompatibility as well as a low film thickness suitable for easy penetration of lateral and accessory canals.

The provided text describes the acceptance criteria and performance data for a medical device called "Bright MTA Sealer Plus." However, it is not an AI-driven device; it is a root canal filling material. Therefore, some of the requested information, such as details on AI acceptance criteria, expert ground truthing, MRMC studies, or training/test sets for an AI model, are not applicable and thus not present in the document.

The document primarily focuses on the biocompatibility and mechanical performance of the "Bright MTA Sealer Plus" in comparison to a predicate device.

Here's a breakdown of the available information based on your request, with an explanation for elements that are not applicable:

Device Name: Bright MTA Sealer Plus

Device Type: Root canal filling material (Non-AI device)

1. Table of Acceptance Criteria and Reported Device Performance

The closest information available is in the "Mechanical testing" section:

In addition, Biocompatibility testing was performed with the following acceptance criteria and evaluation:

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

• Sample Size: Not explicitly stated in terms of number of samples/units tested for each mechanical or biocompatibility test, but the tests were performed on the device itself.
• Data Provenance: The document implies in-house testing performed by or for Genoss Co., Ltd. The country of origin for the company is South Korea. The studies are assumed to be prospective tests on newly manufactured samples of the device.

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

• Not Applicable. This is not an AI device that requires expert-established ground truth for image interpretation or diagnosis. The ground truth for this device's performance is derived from standardized physical and biological material testing.

4. Adjudication method for the test set

• Not Applicable. As this is not an AI device involving human interpretation, there is no need for an adjudication method for a test set. The results are based on objective measurements from standardized tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. An MRMC study is relevant for AI systems that assist human readers in tasks like radiological interpretation. This device is a material, not an AI system, so an MRMC study would not be performed.

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

• Not Applicable. This is not an algorithm or AI system. Its performance is inherent to its physical and chemical properties.

7. The type of ground truth used

• The ground truth for this device's performance is based on objective measurements from internationally recognized standards (ISO and EN ISO) for dental materials and biocompatibility. For example, specific diameters for flow, time limits for setting, weight differences, and qualitative assessments of physical appearance and biological reactions are used as the "ground truth" against which the device's performance is measured. It's not expert consensus, pathology, or outcomes data in the traditional sense of diagnostic AI.

8. The sample size for the training set

• Not Applicable. This is not an AI device that undergoes machine learning training.

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

• Not Applicable. As it's not an AI device, there is no training set or associated ground truth establishment process.

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Impression of inlay, onlay crown, and bridge preparation

• Crown, bridge impression
• Inlay and onlay impression
• Functional impression
• Denture impression
• Study model impression

Bright Impress impression material is a fast-set of addition-reaction silicone elastomer (Vinyl polysiloxane)-based material for dental professionals, consisting of five types (Light, Medium, Heavy, Bite and Putty) with superior hydrophilicity, dimensional accuracy, high tensile strength, and resistant to deformation. It is designed for versatile impression techniques of crowns, bridges, orthodontics and implants.

The document is a 510(k) Summary for the dental impression material "Bright Impress" by Genoss Co., Ltd. It compares the characteristics of Bright Impress to a predicate device, HySil Impression Materials, and presents performance and biocompatibility data.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document provides extensive tables for both biocompatibility and performance for each variant of "Bright Impress" (Light, Medium, Heavy, Putty, Bite). I will consolidate and present a representative sample, focusing on the "Performance Data" which directly addresses how the device meets physical/mechanical acceptance criteria. The "Biocompatibility Data" also uses "Acceptance Criteria" and "P/F" (Pass/Fail) results.

Comprehensive Table of Acceptance Criteria and Reported Device Performance

Important Note: The document often states "Pass" for certain criteria in the performance tables where a specific numerical result might be expected (e.g., Working Time for Bright Impress - Bite, Flexural Strength for Bright Impress - Bite). This indicates that the device met the specified quantitative acceptance criteria, even if the exact number isn't explicitly shown in that particular table. The "Technological Characteristics" section comparing to the predicate does provide specific numbers for some of these.

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

• Sample Size: The document does not explicitly state the sample sizes used for the performance and biocompatibility tests. It lists "Report No." for biocompatibility tests, suggesting external lab reports, but these reports are not provided. For performance, it lists Method (e.g., ISO 4823, DIN 13903) which implies standardized testing procedures that would define sample sizes, but the actual numbers of samples tested are not given.
• Data Provenance: The manufacturer is Genoss Co., Ltd., located in Suwon-si, Gyeonggi-do, Korea, South. The document doesn't specify if the testing was done in Korea or elsewhere. The studies appear to be prospective bench tests and biocompatibility assessments conducted to demonstrate equivalency for regulatory clearance, rather than retrospective or prospective clinical studies on human subjects.

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

This information is not applicable to the type of study described. The document outlines bench testing (physical and mechanical properties) and biocompatibility testing of a medical device material. The "ground truth" here is established by adherence to international standards (ISO, DIN) and objective measurements using laboratory equipment, not by human expert consensus on clinical data.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for image interpretation or diagnosis where multiple readers provide opinions, and a consensus process is needed to establish ground truth. The studies described are bench tests and biocompatibility assessments, which rely on objective measurements and established protocols.

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

This is not applicable. This document describes the clearance of a dental impression material, not an AI-powered diagnostic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.

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

This is not applicable. This device is a material, not software or an algorithm.

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

The "ground truth" for the tests performed is based on:

• International Standards: Adherence to established ISO (International Organization for Standardization) and DIN (Deutsches Institut für Normung) standards for dental materials, which define methods and acceptance criteria for properties like consistency, working time, dimensional change, elastic recovery, and detail reproduction.
• Objective Laboratory Measurements: Data obtained from quantitative measurements in a laboratory setting (e.g., electronic scale for volume, specific instruments for consistency, hardness, flexural strength).
• Biocompatibility Protocol Compliance: Results from standardized biological tests (e.g., Cytotoxicity, Sensitization, Irritation) following ISO 10993 guidelines, indicating the material's interaction with biological systems.

Essentially, the ground truth is objective scientific measurement and compliance with established performance and safety standards.

8. The sample size for the training set

This is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

This is not applicable as there is no training set for this type of device.

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1. Base/liner
2. Pit & Fissure sealant

Bright Flow is a light-cured flowable composite resin. It comprises two different types of flowability (Low Flow and High Flow) and 9 shades depending on the intended use, which enables aesthetic and durable outcomes for anterior and posterior composite restorations.

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

Device Name: Bright High Flow
Manufacturer: GENOSS Co., Ltd.

The provided document describes the performance bench testing and biocompatibility testing conducted to demonstrate that the Bright High Flow device meets its acceptance criteria. No clinical study or MRMC effectiveness study is mentioned, as this device appears to be a dental material.

1. Table of Acceptance Criteria and Reported Device Performance

Biocompatibility Testing

Performance Bench Testing

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

The document does not explicitly state the sample sizes used for each test. The tests are bench tests and biocompatibility tests, not studies involving human subjects or patient data. The provenance of the data (country of origin, retrospective/prospective) is not specified beyond the fact that the manufacturer is based in Korea and the testing was conducted according to international standards (ISO).

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

This information is not applicable. The evaluations are based on standardized laboratory tests (ISO standards) rather than expert interpretation of clinical data. There is no mention of experts establishing ground truth for a test set in the context of this device's evaluation.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments, which are not detailed for this device. The evaluation relies on objective measurements against defined standards.

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 comparative effectiveness study was done. This device is a dental material (flowable composite resin) and its evaluation is based on material properties and biocompatibility, not AI assistance for human readers.

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

This information is not applicable. The device is a dental material, not an algorithm, so "standalone performance" in the context of AI is irrelevant. Its performance is measured directly through physical and chemical property tests.

7. The type of ground truth used

The ground truth used for the performance evaluations are international consensus standards (ISO 10993 for biocompatibility and ISO 4049 for dental polymer-based restorative materials). These standards define the acceptable range or threshold for specific material properties.

8. The sample size for the training set

This information is not applicable. As the device is a material, there is no "training set" in the context of machine learning. The manufacturing process and material formulation are developed based on established dental material science principles.

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

This information is not applicable, as there is no "training set" for this type of device. The "ground truth" for developing the material is derived from scientific knowledge, material engineering, and performance requirements for dental restorative materials, as codified in relevant ISO standards.

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1. Direct bonding for light-cured composites to tooth surface
2. Bonding of dual-cured core build up composites to tooth surface
3. Intraoral repair of composite, PFM and ceramic restoration using cements
4. Sealing of tooth preparation for indirect restoration

Bright Bond Universal is a light-cured dental adhesive that combines etching, priming, and bonding functions in a single bottle solution. It provides strong and durable bonds between dentin/enamel and light-curable direct/indirect restorative materials.

The provided text describes the acceptance criteria and performance data for a dental bonding agent, "Bright Bond Universal," in the context of its 510(k) premarket notification to the FDA. The study presented here is a bench testing study, not a clinical study involving human patients or multi-reader studies. Therefore, many of the requested details about human expert involvement, MRMC studies, and patient data provenance are not applicable to the information contained in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against a set of physical and chemical specifications for a dental bonding agent and biocompatibility standards.

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

• Sample Size: The document does not specify exact sample sizes for each bench test. However, these tests are typically conducted on a sufficient number of material samples to ensure statistical validity for the specific test (e.g., multiple specimens for bonding strength, multiple replicates for biocompatibility assays).
• Data Provenance: The tests were conducted by GENOSS Co., Ltd. (South Korea). The data is from laboratory bench testing of the physical properties and biocompatibility of the bonding agent. It is inherently "prospective" in the sense that the tests were specifically performed to demonstrate the device's characteristics for regulatory submission. It does not involve patient data.

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

This information is not applicable. The "ground truth" for these tests is established by industry-standardized test methods (e.g., ISO standards) and measurable physical/chemical properties, not by human expert opinion or interpretation of images. The results are quantitative measurements.

4. Adjudication Method for the Test Set

This is not applicable. The tests involve objective measurements (e.g., weight difference, film thickness, bonding strength in MPa, observation of cell viability or tissue reaction), rather than subjective interpretations requiring adjudication.

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

No, an MRMC study was not done. This type of study is relevant for AI/radiology devices where human readers interpret medical images. This document describes a dental material, not an imaging device or an AI algorithm for image interpretation.

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

This is not applicable. This is not an AI algorithm. The performance described is the inherent performance of the dental bonding material itself.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on:

• Standardized Test Methods: Specific ISO standards (e.g., ISO 10993 for biocompatibility, ISO 4049 and ISO 29022 for physical properties) define how the tests are performed and how results are interpreted.
• Quantitative Measurements: Performance is measured against predetermined quantifiable thresholds (e.g., MPa for bonding strength, µm for film thickness, visual assessment of impurities).
• Biocompatibility Endpoints: For biocompatibility, the ground truth is established by the absence of adverse biological responses as defined by the ISO 10993 series of standards.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning model. The device's formulation and manufacturing processes are likely developed through research and development, but there isn't a "training set" of data in the AI sense.

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

This is not applicable, as there is no training set.

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1. Class I, III, V (non-stress area, minimally invasive restoration)
2. Composite resin repair

Bright Flow is a light-cured flowable composite resin. It comprises two different types of flowability (Low Flow and High Flow) and 9 shades depending on the intended use, which enables aesthetic and durable outcomes for anterior and posterior composite restorations.

This document is a 510(k) summary for the medical device "Bright Low Flow", a light-cured flowable composite resin manufactured by GENOSS Co., Ltd. It declares that the device is substantially equivalent to a predicate device (K091388 G-aenial Universal Flo) and provides performance data to support this claim.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document presents two tables related to performance criteria: Biocompatibility and Performance Bench Testing.

Biocompatibility Acceptance Criteria and Performance:

Performance Bench Testing Acceptance Criteria and Performance:

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

The document does not explicitly state the sample sizes used for each of the biocompatibility and performance bench tests. However, the tests are identified by their ISO standard methods (e.g., ISO 10993-5, ISO 4049), implying that the testing was conducted according to these internationally recognized standards, which typically define appropriate sample sizes.

Data Provenance: The document indicates that the submitter is "GENOSS Co., Ltd." located in "Suwon-si, Gyeonggi-do, Korea." This suggests the data was generated in South Korea, or at least commissioned by a South Korean company. The tests are referred to as "Biocompatibility testing on the proposed Bright Low Flow has been completed" and "The proposed Bright Low Flow was evaluated using the following performance bench testing," implying these are prospective tests performed on the device itself for this submission.

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

This information is not provided in the document. The tests performed are laboratory-based physical and chemical property evaluations or biological assays (biocompatibility) rather than interpretations requiring human expert consensus on a test set.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective, laboratory-based measurements or biological assays, not interpretations requiring 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

This information is not applicable. The device is a "light-cured flowable composite resin" (dental material), not an AI diagnostic or assistive tool.

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

This information is not applicable. The device is a dental material, not an algorithm.

7. The Type of Ground Truth Used

For the biocompatibility tests, the "ground truth" is based on the biological response observed in the specific assays according to the ISO 10993 standards (e.g., cell viability for cytotoxicity, skin reaction for irritation, systemic effects for acute systemic toxicity).

For the performance bench tests, the "ground truth" is the quantitative measurement of the physical/chemical properties of the material (e.g., depth of cure in mm, flexural strength in MPa, water sorption in µg/mm3) as determined by the specified ISO 4049 standard methods. This represents direct measurement of inherent material properties.

8. The Sample Size for the Training Set

This information is not applicable. As a dental material, there is no "training set" in the context of machine learning or AI models. The device's properties are inherent to its formulation and manufacturing process, evaluated through scientific testing.

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

This information is not applicable for the reasons stated in point 8.

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TN-Brush is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium implant surfaces in bone defects caused by peri-implantitis.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets acceptance criteria for the "TN-Brush." The document is an FDA 510(k) clearance letter for the device, which primarily addresses its substantial equivalence to a predicate device and general regulatory compliance.

The document does not contain details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance for any studies.
• The number or qualifications of experts used for ground truth.
• Adjudication methods for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect sizes related to human reader improvement with AI assistance.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for a training set.
• How ground truth for a training set was established.

The provided text focuses on the regulatory clearance process for a dental device (TN-Brush) and its indicated use for debridement of titanium dental implants. It does not delve into the specifics of performance studies or acceptance criteria that would fall under the scope of AI/ML device validation.

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