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1. Direct bonding of restorative materials
2. Bonding of dual-cured core build up composites
3. Adhesive cementation of indirect restorations
4. Priming of adherent surface of indirect restorations
5. Intraoral repair of fractured restorations
6. Treatment of hypersensitive teeth
7. Sealing of tooth preparation (cavity or abutment) for indirect restorations
8. Treatment of exposed root surfaces
9. Micro-invasive treatment and infiltration of non-cavitated non-carious enamel lesions
10. Post cementation

G-BOND Universal is a one component, light-cured bonding agent, which can also be used for micro-invasive treatment and infiltration of non-cavitated non-carious enamel lesions, available in a 5 mL liquid bottle or 0.1 mL unit dose.

N/A

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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 (<2.0 mm) and translucency that enables the complete light curing of the cement
9. Retention of aligner e.g. by fabrication of aligner attachments

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.

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-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.

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G-Cem LinkForce

• 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 (up to 2 teeth)
• 4. Permanent cementation of crowns and bridges on implant abutments.

GC DUAL CURE ACTIVATOR

1. Cementation of indirect restorations.
2. Bonding of core build-ups made of light-curing composite or core build-up materials to tooth structure.
3. Bonding of resin cements and core build-up materials and self-cure composites to tooth structure.

TRY-IN PASTE
To evaluate the shade and the fitting of the restoration prior to permanent cementation.

MULTI PRIMER

• 1. Priming of the adherend surfaces of indirect restorations made of glass ceramics, oxide ceramics, hybrid ceramics, composite and metal before luting procedures.
• 2. Intra-oral and extra-oral repair of fractured indirect restorations made of ceramics, hybrid ceramics and composites.

G-CEM LinkForce is a dual-cured resin cement. The components consists of Paste A and B, which are filled in a one-body syringe. Both pastes are automixed with a mixing tip. G-CEM LinkForce is available in 4 shades: Translucent, A2, Opaque, Bleach.

GC DUAL CURE ACTIVATOR is a primer to a tooth abutment. It must be used with G-Premio BOND (510(k) No. K143140).

TRY-IN PASTE is a hue-conformity verification material. The product is placed into a dental restoration and set on an abutment tooth to verify hue and conformity. The product has a same color as G-CEM LinkForce.

MULTI PRIMER is a priming agent designed to treat the adherend surface of glass ceramic, oxide ceramic, hybrid ceramic, composite and metal restorations to promote a strong bond to resin-based materials as resin-based cements in case of luting procedures or direct composites in case of repairs.

Here's a breakdown of the acceptance criteria and the study information for the G-Cem LinkForce, GC Dual Cure Activator, Try-In Paste, and Multi Primer devices, based on the provided text.

Note: The provided document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a standalone clinical study for the new device. Therefore, much of the requested information regarding detailed clinical study design (sample size, ground truth, experts, MRMC studies, training set details) is not present. The studies mentioned are primarily in vitro performance bench tests against ISO standards.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by ISO standards and internal company specifications. The document states that the applicant device conforms to these required specifications.

Table of Acceptance Criteria and Reported Device Performance (Summary from Tables 5.2, 5.3, 5.4, 5.5)

Biocompatibility for all devices (G-CEM LinkForce, GC DUAL CURE ACTIVATOR, TRY-IN PASTE, MULTI PRIMER):

• Cytotoxicity (ISO 10993-5): No cytotoxic effect.
• Sensitization (ISO 10993-10): 0% sensitization rate, non-irritant to buccal tissues.

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

The document describes performance bench tests according to ISO standards, not a clinical test set with human subjects.

• Sample Size: Not explicitly stated for each specific test, but ISO standards typically involve a defined number of specimens for mechanical and physical property testing.
• Data Provenance: In-vitro laboratory testing, likely conducted by the manufacturer, GC America Inc. Country of origin not specified, but the submission is to the US FDA. The data is retrospective in the sense that it's reported on already conducted tests.

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

Not applicable. The ground truth for performance bench tests is the objective measurement of physical and mechanical properties against pre-defined engineering and material standards (ISO standards, company specifications). There's no "expert ground truth consensus" involved in this type of testing.

4. Adjudication Method for the Test Set

Not applicable. This type of performance testing involves direct physical measurements, not interpretation or adjudication by 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 submission is for dental cements and primers, which are materials, not AI-powered diagnostic or assistive devices that would involve human readers or AI assistance.

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

Not applicable. These are physical dental materials, not algorithms.

7. The Type of Ground Truth Used

The ground truth used for these performance bench tests are:

• Established ISO standards for dental materials (ISO 4049:2009, ISO 11405:2015, ISO 10993-5, ISO 10993-10). These standards define the methodology and acceptable ranges for various physical, mechanical, and biological properties.
• Company Specifications for properties like film thickness (Try-in Paste) and tensile bond strength to various restorative materials (Multi Primer).

8. The Sample Size for the Training Set

Not applicable. These are dental materials tested against standards, not AI algorithms requiring a training set.

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

Not applicable, as there is no training set for an AI algorithm.

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GC RELINE II is a resilient material for making soft relining of dentures.

GC RELINE II is a VPS silicone for relining of dentures. 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. GC Reline II is available in the following viscosities: Soft, Extra Soft, and Extra Extra Soft.

The cartridge is made of high density polyethylene and the cap is made of polypropylene. The mixing tip is made of polypropylene.

GC Reline Primer for Resin is a resin adhesive that is packaged in a glass bottle.

GC Reline Modifier is available in Liquid A and Liquid B and is similar to the Base and Catalyst of the subject device. Liquid A and Liquid B are dispensed in equal amounts onto the mixing pad and mixed together. It is used to modify (activate) the existing reline surface to accept additional Reline II material.

The provided document describes the FDA 510(k) clearance for the GC Reline II, a denture relining material. This document does not detail a study involving AI or human readers, but rather a non-clinical benchtop study to demonstrate substantial equivalence to a predicate device. Therefore, information regarding human readers, AI assistance, multi-reader multi-case studies, or detailed AI algorithm performance metrics (like sample sizes for training/test sets for AI, data provenance for AI, ground truth for AI, adjudication methods for AI) is not applicable or available in this document.

The acceptance criteria and reported device performance are based on physical properties and biocompatibility in accordance with established ISO standards, comparing the new device (GC Reline II) to a legally marketed predicate device (GC Reline Soft/Extra Soft).

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "Bench top testing indicates that even with different formula, applicant device and predicate devices, meet specifications listed in ISO 10139-2. Therefore, the applicant and predicate device are substantially equivalent. There are no statistically significant differences between GC RELINE II and GC RELINE when comparing performance data."

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

• Sample Size: The document does not specify a numerical sample size for the benchtop tests (e.g., number of denture material samples tested for hardness, bond strength, etc.). It refers to testing being done "in accordance with ISO 10139-2," which implies that the material property tests were conducted on batches or samples as prescribed by the standard.
• Data Provenance: The data is from non-clinical benchtop testing. No information is provided regarding the country of origin, but the testing was conducted by GC America, Inc. or contractors on their behalf. The data is prospective in the sense that it was generated specifically for this 510(k) submission.

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

• Not Applicable. This was a non-clinical benchtop study evaluating material properties and biocompatibility against ISO standards, not a study involving medical image interpretation or diagnosis requiring human expert consensus. The "ground truth" for material properties is determined by the physical and chemical measurements themselves, compared against the predefined thresholds in the ISO standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this was a non-clinical benchtop study, there was no need for adjudication involving human readers or experts to determine a "ground truth" based on consensus. The results are objective measurements.

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

• No. An MRMC study was not done. This submission is for a medical device (denture relining material), not an AI diagnostic tool.

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

• Not Applicable. This document pertains to a physical dental material, not an algorithm or AI system.

7. Type of Ground Truth Used

• The ground truth used was objective measurements of physical properties and biological responses (biocompatibility) compared against established International Organization for Standardization (ISO) standards:
  • ISO 10139-2:2009 (Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use) for physical properties.
  • ISO 10993 series (Biological evaluation of medical devices) for biocompatibility.

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of this device and study, as it is not an AI/machine learning device. The device's formula and manufacturing processes are developed and optimized by the manufacturer, but this doesn't constitute a "training set" in the AI sense.

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

• Not Applicable. As there is no AI training set, this question is not relevant to this submission.

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• 1. 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 2. are light cured.
• 3. 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, 4. CAD/CAM hybrid resin crowns and composites.
• 5. Intraoral repairs of porcelain fused to zirconia crowns, porcelain fused to alumina crowns and full zirconia crowns.
• Treatment of hypersensitive teeth. 6.

G-Premio BOND is a one component, light-cured bonding agent available in a 5 mL liquid bottle or unit dose.

Here's an analysis of the provided text regarding the acceptance criteria and study for the G-Premio BOND device, organized according to your requested points:

Note: The provided document is a 510(k) premarket notification summary. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed report of a device's standalone performance or clinical trials as might be found in a full scientific publication. Therefore, some of your requested information, particularly regarding "study" details like sample sizes for training sets, adjudication methods, or MRMC studies, is not present in this regulatory submission. The "study" described here is primarily a bench test to show compliance with internal specifications and substantial equivalence, not a clinical trial.

Acceptance Criteria and Reported Device Performance

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

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

• Sample Size for Test Set: Not explicitly stated in the document for the bench tests.
• Data Provenance: The document implies that the testing was conducted by GC America Inc. or its parent company (GC Corporation), likely in a laboratory setting. There is no information regarding the country of origin of data or if it was retrospective or prospective in a clinical sense. These are bench test results, not clinical data.

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 acceptance criteria were established by the company (GC America Inc. specification AB-15-Q-301-631(1)), and the performance was measured against these internal specifications and compared to a predicate device. There is no indication of external experts establishing a "ground truth" for the test set in the conventional sense of a clinical study.

4. Adjudication method for the test set

• This information is not applicable/not provided for these types of bench tests. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of results (e.g., imaging) by multiple readers, which is not the nature of the performance tests described here (e.g., bond strength, curing properties, appearance).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This device is a dental bonding agent, a physical product, not an AI-powered diagnostic or assistive tool. Therefore, this question is not applicable to the device described.

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

• No, this question is not applicable. The device is a dental bonding agent, and there is no algorithm involved. The performance tests are for the physical properties of the bonding agent itself.

7. The type of ground truth used

• For physical properties like bond strength, curing, appearance, pH, etc., the "ground truth" is defined by established scientific and engineering measurement standards and internal company specifications. For the sealing property of dentin tubules, the "ground truth" was visual confirmation via Scanning Electron Microscopy (SEM) images (implied to be assessed as "sealed").
• For the purpose of the 510(k) submission, the ultimate "ground truth" for demonstrating substantial equivalence was showing that the device performed similarly to or better than the predicate device across key technical characteristics, and met its own predefined specifications.

8. The sample size for the training set

• This information is not applicable/not provided. There is no "training set" in the context of this device, as it is a physical product and not a machine learning model.

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

• This information is not applicable/not provided. As above, there is no "training set" for this type of device.

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

MSN-006 is a dual-cured, temporary crown and bridge resin. The components consists of Paste A and B, which are filled in a cartridge. Both pastes are automixed with a mixing tip.

This is a 510(k) summary for a dental device, MSN-006, a temporary crown and bridge resin. The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through bench testing against an international standard. As such, it does not involve AI or algorithms, human readers, or clinical studies with ground truth established by experts or pathology.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the information provided in this document.

However, I can provide the acceptance criteria and performance based on the bench testing described.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by the international standard ISO 10477: 2004 (Dentistry - Polymer-based crown and bridge materials). The document states that the applicant device (MSN-006) complies with all the requirements of this standard. While specific numerical acceptance criteria from ISO 10477 are not explicitly listed in the document, it broadly states that "Differences in bench top performance tests meet or exceed requirements as outlined in ISO 10477". It also notes "Differences in Flexural Strength, Water Sorption and Solubility are noted" but still confirms compliance with ISO 10477.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a bench top testing regimen. The document explicitly states: "Bench top testing indicates that even with different formulas, applicant device and predicate devices previously mentioned, meet specifications listed in ISO 10477 (Section 18)." and "In summary, indications for previously mentioned predicate devices and applicant device are the same. Differences in bench top performance tests meet or exceed requirements as outlined in ISO 10477 (Section 18)."

Remaining Information (Not Applicable to this Document):

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to bench testing, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant here.

4. Adjudication method 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. This is not an AI/algorithm-based device.

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

7. The type of ground truth used: Not applicable. For bench testing, the "ground truth" is adherence to the scientific and technical specifications of the ISO standard.

8. The sample size for the training set: Not applicable. This is not an AI/algorithm-based device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/algorithm-based device.

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1. Liner or base
2. Blocking out undercuts
3. Repair of direct and indirect aesthetic restorations: composites, veneers, crowns and bridges (including temporary crowns and bridges), defect margins when margins are in enamel
4. Sealing hypersensitive areas
5. Fissure sealant
6. Direct restorative for small Class I, II, III, IV, and V cavities

HTFX-222 is a light cured nano-filled radiopaque composite resin filled in a syringe. The device is a universal type. The material is available in 8 shades: A1, A2, A3, A3.5, A4, A02, AO3 and CV

The provided document is a 510(k) summary for a dental resin material, HTFX-222. It focuses on demonstrating substantial equivalence to predicate devices rather than describing a performance study of an AI-powered diagnostic device. Therefore, the specific information requested about acceptance criteria, study design, expert involvement, and AI performance metrics is not applicable to this document.

However, I can extract the information that is present regarding the device's technical specifications and how its performance was verified against an industry standard.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the international standard ISO 4049:2009 (Dentistry - Polymer-based restorative materials). The document states that the device was tested and confirmed to meet these requirements.

Note: The document explicitly states, "It is confirmed that the device conforms to the required specifications of ISO 4049:2009 and is suitable for its intended use." Differences in Depth of Cure, Flexural Strength, and Water Sorption are noted when compared to predicate devices, but the implication is that these still fall within the acceptable parameters of ISO 4049.

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

Not applicable. This is a material science study, not a study involving patient data or a "test set" in the context of an AI device. The tests are performed on material specimens.

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

Not applicable. Ground truth for material properties is established through standardized laboratory testing methods defined by ISO 4049:2009, not by expert consensus in the typical sense of medical image interpretation.

4. Adjudication Method for the Test Set

Not applicable. Material property tests are objective measurements, not subject to adjudication by multiple parties.

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

No. This is not an AI-powered diagnostic device, so an MRMC study is not relevant.

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

No. This is a material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of HTFX-222 is based on standardized laboratory measurements and accepted industry specifications as defined by ISO 4049:2009. These are objective physical and chemical properties of the material.

8. The Sample Size for the Training Set

Not applicable. This is a material testing document, not a machine learning study. There is no "training set."

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

Not applicable. As there's no training set, this question is not relevant.

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The product is indicated for inlays, onlays, veneers and full crown restorations, including crowns on implants.

CERASMART is a pre-cured composite block for milling CAD/CAM indirect restorations. The milled device is used for the restorations of both anterior and posterior teeth.

The provided document describes the 510(k) summary for CERASMART, a pre-cured composite block for milling CAD/CAM indirect dental restorations. The submission focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study with acceptance criteria and a detailed study report. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not available in this document.

Here's a breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds that were met by a study. Instead, it presents performance testing results for the applicant device (CERASMART) and compares them with predicate devices, implying that equivalent or improved performance is desired. The comparison in the table below is qualitative, based on the provided data.

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

This information is not provided in the 510(k) summary. The document focuses on material properties and comparison to predicate devices, not on a clinical trial or a test set of patient data.

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

This information is not provided as there is no mention of a test set requiring expert ground truth establishment for a diagnostic or AI-driven device. This submission is for a dental restorative material, not a diagnostic tool.

4. Adjudication Method for the Test Set

This information is not provided for the same reasons as above.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI algorithms that assist human readers. CERASMART is a dental restorative material.

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

No, a standalone performance study was not done. This is not an AI or algorithm-driven device.

7. The Type of Ground Truth Used

This information is not applicable as there is no diagnostic or AI component requiring a ground truth. The "ground truth" in this context would generally refer to the established physical and chemical properties measured during bench testing of the material itself.

8. The Sample Size for the Training Set

This information is not applicable as there is no AI algorithm being trained.

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

This information is not applicable as there is no AI algorithm being trained.

Summary of Device and Study Focus:

The K133824 submission for CERASMART is a substantial equivalence (SE) application for a Class II dental restorative material. The "study" referenced in the document is primarily bench testing to demonstrate the material's physical and chemical properties (e.g., flexural strength, water sorption, solubility, radiopacity) and comparing them to legally marketed predicate devices. The "acceptance criteria" are implicitly met by demonstrating that CERASMART is "substantially equivalent" to the predicate devices in terms of function, composition, and intended use, with comparable or improved performance in relevant material properties.

The document highlights:

• Predicate Devices: 3M ESPE Dental Products LAVA Ultimate (K110131), GC America Inc. MFP-051 (K123631), and GC America Inc. GRADIA CORE (K082171).
• Technological Characteristics: All components of CERASMART have been previously used in MFP-051 and GRADIA CORE.
• Differences Noted: CERASMART has lower water sorption than 3M Lava Ultimate. MFP-051 and Gradia Core are not pre-cured, unlike CERASMART.
• Conclusion: The submission concludes that CERASMART is substantially equivalent to the predicate devices based on its function, composition, and intended use, supported by performance testing data (though specific numerical results are not detailed in this summary).

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1. Direct restorative for class I, II, III, IV, V cavities.
2. Direct restorative for wedge-shaped defects and root surface cavities.
3. Direct restorative for veneers and diastema closure.

MFP-051 is a light-cured, nano-filled radiopaque composite resin filled in either a syringe or unitip. The device is a universal type. The material is available in 17 shades. The device is used for the restorations of both anterior and posterior teeth.

The provided document is a 510(k) summary for a dental restorative material (MFP-051). It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific acceptance criteria in a clinical or simulated clinical setting. As such, most of the requested information regarding acceptance criteria and performance studies is not available in this document.

Here is a breakdown of the information that can be extracted or deduced from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not explicitly stated in the document. The document refers to meeting ISO standards and equivalence, implying testing was done, but details about the sample size, test methods, or data provenance (e.g., country of origin, retrospective/prospective) are not provided for specific performance tests. This submission relies on demonstrating compositional and functional similarity to already cleared devices and compliance with an international standard.

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

• Not applicable. This document does not describe a study involving expert assessment or "ground truth" establishment in the context of clinical or diagnostic performance. The evaluation is based on material properties and regulatory standards.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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 device is a dental restorative material, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

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

7. The type of ground truth used:

• For the material properties (flexural strength, water sorption, solubility), the "ground truth" would be established by validated laboratory testing methods against the requirements of ISO 4049:2009.
• For the claim of "substantial equivalence" of components and indications, the ground truth is the characterization of the predicate devices and their established safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a "training set."

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

• Not applicable. See point 8.

In summary:

This 510(k) submission for MFP-051 demonstrates substantial equivalence by showing that the device complies with ISO 4049:2009, contains components already used in predicate devices, and shows equivalence in key material properties (flexural strength, water sorption, solubility) to similar legally marketed devices. It does not contain details of specific clinical performance studies with acceptance criteria, sample sizes, or expert adjudication as would be relevant for a diagnostic or AI device. The "acceptance criteria" primarily revolve around meeting an international standard (ISO 4049) and demonstrating technical and functional similarity to predicate devices.

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