Search Results

1. Direct restorative for Class I, II, III, IV, and V cavities
2. Fissure sealant
3. Sealing hypersensitive areas
4. Repair of (in)direct aesthetic restorations, temporary crown & bridge, defect margins when margins are in enamel
5. Blocking out undercuts
6. Liner or base
7. Core build-up
8. Adhesive cementation of ceramic and composite veneers, inlays and onlays with a thickness (

G-ænial Universal Injectable II is a light-cured, nano-filled radiopaque composite resin filled in syringe. The device is used for the restoration of both anterior and posterior teeth, core build-up, adhesive cementation of ceramic and composite veneer, inlays and onlays, and build-up for transparent removable orthodontic retainers. The device is available in 9 shades.

This document is an FDA 510(k) clearance letter for a dental resin material, G-ænial Universal Injectable II. It is important to note that this is NOT an AI/ML medical device submission. Therefore, the information provided in the document focuses on the material's physical and chemical properties and biocompatibility, as compared to predicate dental materials.

The request asks for information typically found in submissions for AI/ML medical devices, such as acceptance criteria based on diagnostic performance metrics (e.g., sensitivity, specificity, AUC), details about test and training sets, expert consensus for ground truth, MRMC studies, and effect sizes of AI assistance. Since this is a dental material, these types of studies are not relevant and are not present in the provided document.

Therefore, the following response will adapt the requested sections to the context of this dental material, explaining what information is available and what is not, given the nature of the device.

Acceptance Criteria and Device Performance for G-ænial Universal Injectable II

The acceptance criteria for G-ænial Universal Injectable II are based on established ISO standards for dental materials and FDA guidance for composite resin devices. The "study that proves the device meets the acceptance criteria" refers to the Performance Bench Tests and Non-Clinical Performance Testing detailed in Section 7 and 8 of the 510(k) summary. These tests assess the physical, chemical, and biological properties of the material.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "Complies" with specific quantitative or qualitative thresholds defined by the standards (e.g., ISO 4049, ISO 6874). The document reports that the device Complies with all listed requirements.

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

For a dental material, the "test set" refers to the samples of the material manufactured and subjected to the performance bench tests and biocompatibility assessments.

• Sample Size: The document does not specify the exact number of samples (e.g., number of specimens for flexural strength, number of animals for biocompatibility tests). It simply states that "Performance testing includes" and "A biocompatibility assessment was completed."
• Data Provenance: The data provenance is internal to the manufacturer (GC America, Inc.) and derived from laboratory testing of the material according to international ISO standards and FDA guidance documents. There is no indication of "country of origin of the data" in the sense of patient data, nor is it a retrospective or prospective study in the clinical trial sense. These are laboratory-based material characterization tests.

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

This question is not applicable to a dental material submission. The "ground truth" for material properties is established by the standardized test methods themselves (e.g., ISO 4049 defines how depth of cure is measured). There are no "experts" establishing ground truth in the sense of clinical interpretations or diagnoses. The expertise lies in adhering to the established test protocols and analyzing results accurately by qualified laboratory personnel.

4. Adjudication Method for the Test Set

This concept is not applicable for dental material performance testing. Adjudication methods (like 2+1, 3+1 consensus) are used in studies involving human interpretation of images or clinical outcomes, typically for AI/ML device validation. Here, tests are quantitative measurements of physical/chemical properties or biological responses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improving with AI vs Without AI Assistance

This question is not applicable. G-ænial Universal Injectable II is a dental restorative material, not an AI-assisted diagnostic or therapeutic device. There are no "human readers" involved in interpreting its performance, nor does it assist human readers. Therefore, no MRMC study was performed, and no effect size on human reader improvement with AI assistance can be reported.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable. G-ænial Universal Injectable II is a physical dental material, not an algorithm. There is no "standalone performance" of an algorithm. Its performance is measured directly through laboratory tests of its inherent material properties.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For dental materials, the "ground truth" is based on:

• Standardized Test Methods: Adherence to established ISO standards (e.g., ISO 4049, ISO 6874, ISO 10993) defines the "truth" for material properties like flexural strength, depth of cure, water sorption, and biocompatibility.
• Predicate Device Comparison: Performance is also evaluated in comparison to predicate devices, where "equivalence" often serves as a benchmark for acceptance.

There is no "expert consensus," "pathology," or "outcomes data" in the sense of human diagnostic performance or clinical trial results, as this is a pre-market notification for a material.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" for a dental material in the context of machine learning. The material itself is manufactured, and specific properties are tested for quality control and regulatory submission.

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

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

Ask a specific question about this device

1. Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges.
2. Cementation of metal, ceramic, fiber posts, and cast post and cores.
3. Cementation of all ceramic and composite veneers.
4. Final cementation of crowns and bridges on implant abutments.

G-CEM ONE is a dual-cured self-adhesive resin cement with a tooth primer, G-CEM ONE ADHESIVE ENHANCING PRIMER. The mixed cement hardens through polymerization. The adhesive component is an acidic monomer which also can polymerize with frame-forming monomers. This copolymerizing reaction provides higher physical strength than resin-modified glass ionomer cements. Using the primer on the prepared tooth, surface modification and cement polymerization are promoted and hardened along with the cement. The cement syringe consists of Paste A and B, which are filled in a one-body/two chamber syringe. Both pastes are automixed with a mixing tip and applied directly to restorations or prepared cavity.

I am sorry, but the provided text is a 510(k) premarket notification for a dental cement (G-CEM ONE) and does not contain information about an AI/ML device.

Therefore, I cannot extract the acceptance criteria or study details regarding AI performance as requested in your prompt. The document focuses on the physical and chemical properties of the dental cement and its biocompatibility, comparing it to predicate dental cements.

Specifically, the document includes:

• Acceptance Criteria and Reported Device Performance (for the dental cement): This is presented in the tables under "9. Performance Bench Tests" for G-CEM ONE and "G-CEM ONE ADHESIVE ENHANCING PRIMER" on pages 4 and 5. These criteria relate to properties like film thickness, working time, setting time, flexural strength, water sorption, solubility, radiopacity, appearance, coatability, color tone, and refractive index.
• Sample Size for Test Set and Data Provenance: Not specified for any AI/ML context. The performance tests are laboratory bench tests, not clinical studies with human subjects.
• Number of Experts and Qualifications: Not applicable as it's not an AI/ML device requiring expert ground truth for interpretation.
• Adjudication Method: Not applicable.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned as it's not an AI/ML device.
• Standalone Performance: Not applicable for an AI/ML device.
• Type of Ground Truth Used: Not applicable for an AI/ML device.
• Sample Size for Training Set & How Ground Truth for Training Set Was Established: Not applicable as it's not an AI/ML device.

Please provide a document related to an AI/ML device if you wish for me to extract information on its acceptance criteria and study data.

Ask a specific question about this device

BZF-29 is a two component (PRIMER and ADHESIVE), light-cured bonding agent suitable for:

• Bonding of light cured composites and acid modified composites (compomers) to tooth structure.
• Bonding of dual cured luting and core build up composites to tooth structure as long as these materials are light cured.
• Intraoral repairs of porcelain fused to metal crowns and composite veneer crowns with metal backing.
• . Intraoral repairs of all ceramic crowns (except zirconia and alumina), hybrid resin jacket crowns, CAD/CAM hybrid resin crowns and composites.
• . Intraoral repairs of porcelain fused to zirconia crowns, porcelain fused to alumina crowns and full zirconia crowns.
• . Treatment of hypersensitive teeth.

BZF-29 is a two component, light-cured bonding agent to bond light-cured composite resins to tooth structure, composites, hybrid ceramics, ceramics and metal surfaces, and for the treatment of hypersensitive teeth.

The provided document is a 510(k) premarket notification for a dental bonding agent, BZF-29, seeking substantial equivalence to a predicate device, G-Premio BOND. The document details performance bench tests and comparisons to establish this equivalency, but it does not describe a study involving human subjects or AI assistance. Instead, the "performance" described refers to material properties and bond strengths as mechanical measures.

Therefore, many of the requested criteria regarding human readers, AI assistance, ground truth establishment methods for training, and detailed study specifics are not applicable or cannot be extracted from this document, as it focuses on demonstrating product characteristics through bench and biocompatibility testing against a predicate device.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on the Table:

• For "Appearance," "Curing property," "Application characteristics," "Color," "pH," and "Refraction index," the document states that the applicant device complies with all the requirements of 1AB-1500-3-10706 (Company specification) and then lists the specific requirements. The predicate device's performance against these specific criteria is not individually detailed but is implied to be "Conformed" for overall comparison purposes to establish substantial equivalence.
• The acceptance criteria for bond strength are stated as ">10MPa" for all categories.

2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size (number of teeth/samples tested) for each specific bench test (e.g., bond strength measurements). It refers to the results as statistical averages with standard deviations, implying multiple samples were used for each measurement.
The data provenance is not specified beyond "bench tests" conducted by the manufacturer, presumably in a laboratory setting. There is no information on country of origin or whether it was retrospective or prospective, as these terms are typically used for clinical studies involving patients, which is not the case here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The "ground truth" for the test set is established by objective physical and chemical measurements (e.g., MPa for bond strength, pH values, visual checks for homogeneity, SEM for dentin tubules) and adherence to ISO standards for biocompatibility, not by expert consensus or interpretation of images.

4. Adjudication method for the test set
Not applicable. The tests are based on objective, quantifiable measurements against pre-defined specifications and ISO standards, not on subjective assessment requiring adjudication among experts.

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 material science study of a dental bonding agent, not a diagnostic device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material science study, not an AI algorithm.

7. The type of ground truth used
The ground truth is based on:

• Company specifications (1AB-1500-3-10706): For properties like appearance, curing, application characteristics, color, pH, and refraction index.
• Quantitative measurements: For bond strength (measured in MPa).
• Microscopic observation: For sealing property of dentin tubules (using SEM).
• International Standards (ISO 10993 series): For biocompatibility, specifically ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitivity, irritation).

8. The sample size for the training set
Not applicable. This document describes performance validation against a predicate device and established standards, not the training of a machine learning model.

9. How the ground truth for the training set was established
Not applicable, as no training set for an algorithm is mentioned or implied.

Ask a specific question about this device

-Augmentation or reconstructive treatment of the alveolar ridge.
-Filling of periodontal defects.
-Filling of defects after root resection, apicocetomy, and cystectomy.
-Filling of extraction sockets to enhance preservation of the alveolar ridge.
-Elevation of the maxillary sinus floor.
-Filling of periodontal defects in conjunction with products intended Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
-Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Cytrans Granules is composed of carbonate apatite. The material of Cytrans Granules has been formulated in terms of carbonate apatite content to the mineral content of natural bone. As Cytrans Granules is completely synthetic, there are no animal derived ingredients in the formula. Cytrans Granules is gradually resorbed and eventually replaced with new bone. Resorption is by osteoclasts under acidic conditions. Cytrans Granules is manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. It is sterilized via gamma irradiation and will be marketed/sold in sterile vials for single use.

The provided text describes the 510(k) submission for Cytrans Granules, a bone grafting material. While it discusses performance testing, it does not explicitly state acceptance criteria in a quantitative table or directly link numerical performance results to specific criteria. The document focuses on demonstrating substantial equivalence to a predicate device rather than meeting predefined acceptance criteria for a novel performance claim.

However, based on the information provided, we can infer the aspects of performance that were evaluated and deemed acceptable for the device to be considered substantially equivalent.

Here's an attempt to structure the information according to your request, acknowledging the limitations of the provided text:

Acceptance Criteria and Device Performance for Cytrans Granules

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative "acceptance criteria" for the device's clinical performance are not explicitly stated in the document (which is common for 510(k) submissions focusing on substantial equivalence), the table below infers the performance aspects that were evaluated and found acceptable relative to the predicate devices and general expectations for bone grafting materials. The "Reported Device Performance" column reflects the findings from the non-clinical and clinical studies.

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

• Test Set (Clinical Study):

  • Sample Size: 22 cases (patients) for sinus floor augmentation (excluding 6 cases due to exclusion criteria).
  • Data Provenance: Japan (stated as "three institutions in Japan"). The study was prospective clinical testing.

• Test Set (Animal Studies):

  • Sample Size: Not explicitly stated beyond "a beagle dog model" where "three commercially available bone substitutes" were compared. It implies multiple animals were used, but the exact number is not provided.
  • Data Provenance: Not specified, but generally animal studies typically involve institutional animal care and use committee approval from the research facility.

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

• The document does not explicitly state the number of experts used or their detailed qualifications for establishing ground truth in the clinical study.
• For a clinical study involving sinus floor augmentation and dental implants, it is implicitly understood that the "ground truth" (e.g., successful implant placement, bone formation assessment, complication rates) would be established by qualified dental surgeons and potentially radiologists/pathologists involved in patient follow-up and evaluation (panoramic X-ray, CT imaging, tissue biopsy).
• The study was conducted across "three institutions in Japan," suggesting that multiple clinical professionals were involved in the evaluations.

4. Adjudication Method for the Test Set

• The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1).
• Clinical trials typically involve standardized protocols for evaluation and data collection, and any discrepancies might be resolved by consensus or a senior investigator, but a formal adjudication process beyond standard clinical practice is not mentioned. Outcomes like "success rate...exceeded the level deemed to be effective" suggest a predefined standard, but not a specific adjudication protocol.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done in the context of comparing human readers' performance with and without AI assistance. This document describes a medical device (bone grafting material), not an AI-powered diagnostic or assistive tool.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Not applicable. This device is a bone grafting material, not an algorithm or AI system. Its performance is evaluated through its biological interaction within the patient's body, not as a standalone software algorithm.

7. Type of Ground Truth Used

• Clinical Study (Sinus Floor Augmentation):
  • Clinical Outcomes Data: Successful implant placement, lack of rotation/movement, implant placement torque, absence of complications.
  • Imaging Data: Opacity on panoramic X-ray and vertical residual bone on CT imaging confirming new bone formation.
  • Pathology/Histology: Tissue biopsy confirming new bone formation in all cases of the two-stage group.
• Animal Studies: New bone formation, bone-to-implant contact ratio (likely assessed histologically and/or with imaging).
• Biocompatibility Testing: Lab-based tests (Cytotoxicity, Sensitization, Genotoxicity, etc.) with established assay endpoints and interpretations.

8. Sample Size for the Training Set

• Not applicable. This is a medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The device's development involved material science, preclinical, and clinical testing, but not an ML training paradigm.

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

• Not applicable. As there is no training set (for AI/ML), there is no ground truth established for it. The "ground truth" equivalent in medical device development would be the scientific and clinical validation of its material properties, biological interactions, and clinical efficacy through established testing methods and clinical trials.

Ask a specific question about this device

1. Fabrication of temporary crowns, bridges, inlays, onlays and veneers
2. Fabrication of long-term temporary restorations

GC Temp PRINT is 3D printable light curing composite for temporary crown and bridge. The device consists of a paste delivered in a bottle. GC Temp PRINT is fabricated with certain Digital Light Processing/Stereolithography Apparatus (DLP/SLA)a` 3D printers and post cured with light curing device into dental restorations, which are then bonded to tooth structure with adhesive temporary cement.

The provided text is a 510(k) summary for a dental device called "GC Temp PRINT". This document primarily focuses on establishing substantial equivalence to predicate devices, rather than describing a study proving the device meets specific acceptance criteria in the context of AI/ML performance.

Therefore, the requested information regarding acceptance criteria and performance study for AI/ML aspects cannot be fully provided from the given document as it refers to material properties and biocompatibility, not AI/ML performance.

However, I can extract the acceptance criteria and the bench test results for the physical properties of the GC Temp PRINT device as described in Section 6, "Performance Bench Tests".

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

1. Pit & Fissure Sealant and Root Surface Sealant
2. Hypersensitivity due to abrasion and early non-cavitated lesions
3. Protection immature enamel
4. Temporary filling including endodontic access

GC Fuji Triage EP is a bioactive glass ionomer for temporary restorative material. The device consists of powder and liquid filled in a capsule and is mixed with a capsule mixer. Then, the mixture is applied directly to a cavity with a capsule applier. As an additional improvement, a proprietary elongation tip can be attached to the capsule nozzle which enables access to small or deep cavities. GC Fuji Triage EP contains CPP-ACP (casein phosphopeptide - amorphous calcium phosphate) in the formulation. CPP-ACP was added to moderate the strength of cement for its use and provide a source of Ca+ and HP04-2. CPP-ACP was chosen as the additive for regulating the strength because it does not interfere with the setting reaction of the material.

The provided document is a 510(k) summary for the GC Fuji Triage EP dental cement. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information typically found in a clinical study report that would outline acceptance criteria, study design, and results for a medical device with an algorithmic component.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they are not present in the provided text. The document describes a non-clinical performance testing for a dental cement, not a study involving human readers or AI algorithms.

Here's why each point of your request cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance: While there is a table of "Property" and "Requirements" for non-clinical performance (e.g., Net setting time, Compressive strength), this is for the physical properties of the dental cement, not the performance of an AI device. The document explicitly states "No clinical testing has been performed on this device."
2. Sample size used for the test set and the data provenance: Not applicable. There is no test set in the context of an AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no test set for an AI device, and thus no ground truth established by experts in that context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. No MRMC study was performed as this is a dental cement, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI device. The ground truth for the dental cement is based on laboratory-measured physical properties against ISO standards.
8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable.

The document pertains to the regulatory submission for a dental cement, GC Fuji Triage EP, and focuses on demonstrating its safety and efficacy through biocompatibility testing (ISO 10993-1:2018, ISO 10993-5, ISO 10993-10) and physical property testing against ISO 9917-1:2007 for water-based cements, as well as comparison to a predicate device for substantial equivalence.

Ask a specific question about this device

everX Flow is a reinforcing dentin replacement material suitable for:

• 1. All direct composite restorations including large posterior cavities.
• 2. Deep cavities and endo-treated teeth.
• 3. Cavities with missing cusps or after amalgam removal and cavities where inlays would also be recommended.
• 4. Core build-up

everX Flow is a light cured, short-fiber-reinforced composite for dentin replacement for the restoration of posterior and anterior teeth. EverX Flow is filled in a syringe. The material is available in two shades, Bulk shade and Dentin shade.

The provided document pertains to a 510(k) premarket notification for a dental device named "everX Flow," a tooth shade resin material. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through bench testing (performance testing) and biocompatibility assessment, rather than clinical performance testing involving human subjects or AI-assisted diagnostic studies.

Therefore, many of the requested details regarding acceptance criteria, study methodologies (like sample size for test sets, number of experts, adjudication, MRMC studies, standalone AI performance), and ground truth establishment for a diagnostic AI device are not applicable to this submission. This is a material science and dental product regulatory submission, not a medical AI/software as a medical device (SaMD) submission.

However, I can extract and present the acceptance criteria and performance data that are relevant to this type of device, which is primarily laboratory bench testing.

Acceptance Criteria and Reported Device Performance for everX Flow (Dental Resin Material)

This device, "everX Flow," is a dental restorative material, not an AI or diagnostic device. Therefore, the "acceptance criteria" refer to the physical, chemical, and biological properties of the material itself, as tested in a laboratory setting according to international standards (ISO 4049:2009 and ISO 10993-1:2009 for biocompatibility).

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

• -Cementation of metal-based inlays, onlays, crowns and bridges
• -Cementation of resin inlays, onlays, crowns and bridges
• Cementation of all ceramic inlays -
• -Cementation of high strength (e.g. zirconia based, lithium disilicate) ceramic onlays, crowns and bridges
• Cementation of metal, ceramic and fiber posts -

GC FujiCEM 2 (Improved) is a resin modified glass ionomer luting cement. The device is composed of the two pastes, Paste A and Paste B, packaged in an automix dual barrel syringe.

The provided document is a 510(k) summary for a dental cement (GC FujiCEM 2 (Improved)). It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about software or AI-based devices. Therefore, a table of acceptance criteria and reported device performance for an AI/software device cannot be generated from this text.

The document discusses the physical and chemical properties of the dental cement through performance bench tests and biocompatibility assessments against established ISO standards.

Here's an analysis of the available information regarding the device's evaluation, although it's for a physical dental cement product, not an AI device:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Software):

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

• Not applicable for AI/Software. The document describes non-clinical bench testing. The sample sizes for each specific test (e.g., number of specimens for flexural strength) are not explicitly stated within this summary. Data provenance is implied to be from the manufacturer's own testing.

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

• Not applicable for AI/Software. Ground truth for dental cement properties is established through standardized physical and chemical testing methods, not expert consensus in the way it's used for AI diagnostic outputs.

4. Adjudication method for the test set:

• Not applicable for AI/Software. The performance criteria for the dental cement are objective metrics measured by equipment and standardized procedures, not subjective 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:

• Not applicable. This document is for a dental cement, not an AI or software device.

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

• Not applicable. This is a physical medical device (dental cement), not an algorithm or software. No standalone algorithm performance was assessed.

7. The type of ground truth used:

• For biocompatibility: Ground truth is defined by the criteria and methods outlined in ISO 10993 series standards.
• For performance bench tests: Ground truth is defined by the specifications and methods in ISO 9917-2: 2017 (Dentistry - Water-based cements - Part 2: Resin-modified cements) and the company's internal standards. These are objective, measurable physical and chemical properties.

8. The sample size for the training set:

• Not applicable. This is a physical medical device. There is no training set in the context of AI/machine learning.

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

• Not applicable. See point 8.

Ask a specific question about this device

Increases the adhesiveness of light-curing composites to conventional acrylic resins used in dental laboratory procedures (e.g., modification of denture teeth/denture base resins)

GC ACRYLIC PRIMER is a primer which raises the adhesiveness to acrylic resin and composite resin. GC ACRYLIC PRIMER is intended to use for bonding acrylics to acrylic resin, composite to composite resin, and acrylics to composite resin respectively.

The device in question is GC ACRYLIC PRIMER, a resin tooth bonding agent.

Here's a breakdown of the acceptance criteria and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical or performance testing with human subjects or a defined dataset for AI. The performance bench tests appear to be conducted on the device itself.

• Sample Size for Test Set: Not explicitly stated for performance bench tests, but implied to be sufficient to demonstrate conformity to specifications.
• Data Provenance: Not applicable in the context of a "test set" as typically understood for AI/clinical studies. The performance data is generated from laboratory bench testing 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. The performance testing involves laboratory measurements and assessments against predefined physical and chemical specifications, not expert-derived ground truth on clinical data.

4. Adjudication method for the test set

Not applicable. The performance testing involves objective measurements rather than 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

No MRMC comparative effectiveness study was conducted. This device is a dental material (primer) and not an AI-powered diagnostic tool.

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

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

7. The type of ground truth used

The "ground truth" for the performance criteria is based on:

• Predefined physical and chemical specifications: For appearance, application characteristics, refractive index, and bond strength. These are objective laboratory measurements.
• Biocompatibility standards: ISO 10993-5 guidelines for cytotoxicity.

8. The sample size for the training set

Not applicable. This device is a dental material, not an AI model, and therefore does not have a training set.

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

Not applicable. This device is a dental material, not an AI model, and therefore does not have a training set or associated ground truth establishment.

Ask a specific question about this device

AIM2 is a silicone impression material for taking oral impressions.

AIM2 is a VPS silicone impression material. The components consist of the base silicone paste and the catalyst silicone paste that are extruded from a cartridge and are automixed with a mixing tip. AIM2 is available in one viscosity. The cartridge is made of high density polyethylene and the cap is made of polypropylene. The mixing tip is made of polypropylene.

This document describes the premarket notification (510(k)) for the dental impression material AIM2. It focuses on demonstrating that AIM2 is substantially equivalent to a predicate device, EXAFLEX/EXAMIX Impression Material (K955932).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria mentioned are the specifications outlined in ISO 4823. The document states that the device conforms to these required specifications.

Note: The document explicitly states: "Results of benchtop testing indicate the physical properties such as linear dimensional change, elastic recover and strain-in compression met the specification set in ISO 4823." This is the direct evidence of meeting the acceptance criteria.

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

• Sample Size for Test Set: The document does not specify the sample size used for the benchtop tests.
• Data Provenance: The tests were "benchtop testing," which implies laboratory testing. The country of origin of the data is not specified, but the manufacturer is GC Corporation. The study is not a clinical trial, so the terms "retrospective" or "prospective" are not applicable in this context.

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

This information is not applicable as the study is a benchtop performance test against international standards (ISO 4823), not a study requiring expert interpretation of clinical data or images to establish ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for a benchtop performance test.

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 an impression material, not an AI-powered diagnostic or assistive tool 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 physical impression material, not an algorithm.

7. The Type of Ground Truth Used:

For the performance tests, the "ground truth" or reference standard was the specifications outlined in ISO 4823. For biocompatibility, the document refers to the biological safety test data of the predicate device.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical material and not an AI/ML algorithm that requires a training set.

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

This information is not applicable as the device does not involve a training set.

Ask a specific question about this device