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It is intended for the permanent cementation of ceramic (including zirconia), composite and metal-based posts, crowns, bridges, veneers, inlays and onlays.

TotalC-Ram is permanent, radio-opaque dual cured (auto/photopolymerizable) self-etch and self-adhesive resin cement.

The provided document is a 510(k) premarket notification for a dental cement called "TotalC-RAM." It outlines the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence to legally marketed devices.

This document does not describe a study involving AI/ML medical devices based on imaging data or other complex data types that would require acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance. Therefore, most of the requested information (points 1-9) about acceptance criteria, test sets, expert ground truth, MRMC studies, standalone performance, and training sets is not applicable to this document.

Here's why and what information can be extracted:

• This is a review for a dental cement (TotalC-RAM), which is a physical material used in dental procedures.
• The comparison is based on physical and mechanical properties (e.g., shear bond strength, flexural strength, solubility, working time, setting time, film thickness, shelf life) and chemical composition.
• Section 11, "Brief Description of Performance and Biocompatibility Testing," explicitly states that the submission is an Abbreviated 510(k) and relies on conformity with guidance documents and recognized consensus standards (like ISO standards for dental materials).
• Section 12, "Clinical Performance Data," explicitly states: "Not applicable. Clinical performance testing has not been performed for the subject device." This confirms that there was no human reader study, no ground truth established by experts interpreting imaging, and no AI performance metrics.

Therefore, it is impossible to populate the requested table and answer the specific questions (1-9) as they pertain to the evaluation of an AI-based system's performance. The information requested is relevant for software-based medical devices, especially those that analyze medical images or other clinical data to provide diagnostic or prognostic insights.

To directly address your request, here's what can be inferred or stated based on the document's content, acknowledging the mismatch in context:

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

The "acceptance criteria" here are not in terms of AI performance metrics (like sensitivity/specificity) but rather the physical and mechanical properties being comparable to predicate devices or meeting ISO standards. The document doesn't explicitly state quantitative acceptance criteria for each property for the purpose of a performance study, but rather lists the measured performance of the device and compares it to predicates. The "acceptance" is that these values are within a range considered safe and effective, and contribute to substantial equivalence.

Note: The "acceptance criteria" for a physical dental cement are primarily whether its properties fall within established ranges defined by international standards (e.g., ISO 4049, ISO 9917-1) and whether it is "substantially equivalent" to predicate devices, meaning it performs similarly and does not raise new questions of safety or effectiveness. The increased shear bond strength for zirconia is highlighted as a performance advantage, but not as a strict "acceptance criterion" that it must surpass predicates.

2. Sample size used for the test set and the data provenance: Not Applicable. This is a material properties comparison, not a data-driven AI study. Laboratory tests are performed on material specimens.

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 material properties is established through standardized laboratory testing, not expert consensus on interpretations.

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 human readers or AI assistance involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not Applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for material properties is established through standardized laboratory testing methods as outlined by ISO standards (e.g., measuring flexural strength, solubility, bond strength under controlled laboratory conditions).

8. The sample size for the training set: Not Applicable. This product is not an AI/ML device.

9. How the ground truth for the training set was established: Not Applicable. This product is not an AI/ML device.

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Prevent Seal is used by dental profesionnals primarily in young children :

• . To fill and seal pit and fissure depressions (faults in the enamel) of teeth to prevent cavities :
• . Covering layer or " initial layer " in the fabrication of esthetically demanding composite restorations ; and
• . For repairs of composite restorations (in particular filling of voids, leveling out of porosities and minor chips).

Prevent Seal is a fluoride releasing, white, light-cured acrylate resin. Not manufactured with Bisphenol A.

Here's the analysis of the provided text regarding the acceptance criteria and study for the Prevent Seal device, formatted as requested:

1. Table of acceptance criteria and the reported device performance

Note: The document lists "Summary of Performance Testing" which includes these metrics and their corresponding values. It does not explicitly state "acceptance criteria" with specific thresholds that the device had to meet. The provided values are the reported performance of the device based on the laboratory testing. This submission appears to rely on demonstrating performance comparable to predicate devices rather than meeting pre-defined specific numerical acceptance criteria.

Regarding the study that proves the device meets the acceptance criteria, based on the provided text, the following information is available:

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

• Sample size for the test set: Not specified in the provided text.
• Data provenance: "laboratory results". No specific country of origin is mentioned, but the submitter is based in France and the contact person in Canada. The testing explicitly states "laboratory results", implying prospective testing for this device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable/Not specified. The performance testing appears to be objective, quantitative laboratory measurements of physical and mechanical properties, not subjective expert evaluation requiring ground truth establishment through consensus.

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

• Not applicable. The reported performance metrics are results of laboratory tests (e.g., strength, curing time) and do not involve human adjudication for a test set.

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

• No, an MRMC comparative effectiveness study was not done. The device is a pit and fissure sealant, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This is a medical device (a sealant material), not an algorithm or AI system. The performance documented is of the material itself.

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

• Objective laboratory measurements: The "ground truth" for the reported performance metrics (Flexural Strength, Compressive Strength, etc.) is the direct measurement obtained from standardized laboratory tests. There is no human-interpreted "ground truth" in the traditional sense for these material properties.

8. The sample size for the training set:

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

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

• Not applicable. This device is not an AI model, so there is no training set or associated ground truth.

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It is intended for: 1) quick temporary cementation of temporary crowns and bridges; 2) rebasing of crowns; and 3) permanent cementation of implant-retained crowns and bridges while maintaining retrievability, when desired. DentoTemp is fully compatible with both acrylic and composite (bis-acryl) temporary materials and as a result, is indicated on both natural and metal implants abutments.

DentoTemp is a dental long term acrylic-urethane polymer based temporary cement. It does not contain eugenol or zinc oxyde. It is a unique 2-stage polymerization composition which does not harm temporary crowns and does not interfere with permanent cements.

This K122549 510(k) summary describes a dental device called DentoTemp. The submission is an Abbreviated 510(k), which relies on conformity with FDA guidance documents and international standards. This type of submission is typically used for devices that are well-understood and for which performance standards and test methods are well-established.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for DentoTemp are directly aligned with its technological characteristics and intended uses, compared against a predicate device (Premier Implant Cement K033309) and relevant standards.

Table of Acceptance Criteria and Reported Device Performance:

2. Rebasing of crowns;
3. Permanent cementation of implant-retained crowns and bridges while maintaining retrievability, when desired. | 1. Quick temporary cementation of temporary crowns and bridges;
4. Rebasing of crowns;
5. Permanent cementation of implant-retained crowns and bridges while maintaining retrievability, when desired. |
   | Working time (sec) | Approximately 90s | 90-120s |
   | Solubility (µg/mm³) | Low | Low |
   | Setting time at 37 °C (min) | Approximately 4-5 min | 2.5-3 min |
   | Film thickness (µg/mm³) | 15 µg/mm³ | 15 µg/mm³ |
   | Shelf life (Years) | 2 years | 2 years |
   | Linear Shrinkage (%) | 2.5% | 2.5% |

Note on "Acceptance Criteria" for Functional Properties: The document implies that meeting or improving upon the predicate device's performance, as well as conforming to relevant standards (ISO 4049 and FDA guidance), constitutes the acceptance criteria. For quantitative metrics like working time, setting time, film thickness, and linear shrinkage, the values of the predicate device serve as benchmarks. For qualities like "low solubility," the standard or common understanding within the industry for temporary dental cements determines acceptance.

Study Information

The provided document describes an Abbreviated 510(k) submission. This means that extensive, novel clinical trials demonstrating effectiveness may not have been performed in the same way as for a completely new technology. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Premier Implant Cement, K033309) by adhering to established performance standards and guidance documents.

Here's what can be inferred or directly stated about the "study" based on the provided information:

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

   • The document does not provide details on specific sample sizes for particular tests. As an Abbreviated 510(k), it relies on conformity with established standards (ISO 4049) and FDA guidance for dental cements. These standards dictate specific test methods and often include requirements for sample sizes, but these are not explicitly presented here as "test set" samples for a novel study.
   • The data provenance is not specified beyond "Itena Clinical has provided information to demonstrate conformity." It's likely these tests were performed in a lab setting to ISO standards, but the location is not further detailed. The submission came from France.

2. 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 in the context of this submission. The "ground truth" for the performance characteristics of a dental cement like DentoTemp is established by universally recognized physical and chemical testing methods outlined in standards such as ISO 4049, not by expert consensus on clinical cases.

3. 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 typically used in clinical studies involving interpretation of medical images or patient outcomes where an expert panel provides a gold standard. For material property testing of a dental cement, the "adjudication" is inherent in the standardized test methods and measurement protocols.

4. 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. MRMC studies and the concept of "human readers improving with AI assistance" are relevant to diagnostic AI devices, particularly in medical imaging. DentoTemp is a dental cement, a material device, and does not involve AI or human interpretation in this manner.

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

   • This is not applicable. This question pertains to AI/algorithm performance. DentoTemp is a material device.

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

   • The "ground truth" for the performance characteristics (e.g., working time, setting time, film thickness, solubility, linear shrinkage, shelf life) is established through standardized laboratory testing methods as specified in ISO 4049 and likely FDA guidance documents for dental cements. The results of these tests (e.g., a measured working time of 90-120 seconds) directly represent the "truth" of the material's properties under specified conditions.

7. The sample size for the training set:

   • This is not applicable. "Training set" refers to data used to train machine learning models. As DentoTemp is a material device, there is no AI or machine learning involved, and thus no training set in this context.

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

   • This is not applicable for the same reasons as #7.

In summary, the "study" for K122549 is a non-clinical performance evaluation demonstrating that DentoTemp's physical and chemical properties conform to recognized industry standards (ISO 4049) and FDA guidance for dental cements, and that these properties are substantially equivalent to those of the predicate device. This approach is standard for Abbreviated 510(k) submissions for well-understood material devices like dental cements.

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TotalCem
The device is intended for the cementation of posts, crowns, bridges, inlays and onlays.

DentoCem
The device is intended for permanent cementation of:

• crowns and bridges, inlays, onlays, posts and cores, ceramic crowns, Maryland . bridges and veneers;
• . implant prosthesis:
• orthodontic attachments:
• amalgam restorations:
• veneering of alloys: and ●
• composite restorations. .

TotalCem: TotalCem is a permanent, radio-opaque dual cured (auto/photopolymerizable) self-etch and self-adhesive resin cement.
DentoCem: DentoCem is a chemical-curing, multi-purpose, dual-cured (auto/photopolymerizable), radio opaque permanent adhesive resin cement comprised of two easy-to-mix components.

The provided text is a 510(k) summary for dental cements (TotalCem and DentoCem). It details the device's technical characteristics, intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in reports for AI/ML-driven medical devices.

Instead, the documentation focuses on demonstrating substantial equivalence based on:

• Indications for Use: Comparing the intended uses of TotalCem and DentoCem with their respective predicate devices.
• Technological Characteristics: Comparing the matrix, fillers, delivery method, curing method, and radiopacity of the subject devices with their predicates.
• Biocompatibility Testing: Mentioned as being combined with the above comparisons to draw conclusions.
• Conformity with Guidance Documents and Standards: Reference to "FDA's guidance document entitled Dental Cements - Premarket Notification, August 1998" and "ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials."

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is not present in the provided 510(k) summary.

The document concludes that "the subject devices have been shown to be safe and effective for their intended use" and "substantially equivalent to their respective predicates" based on the comparisons outlined above and biocompatibility testing. This is a common approach for conventional medical devices demonstrating substantial equivalence, rather than providing detailed performance metrics against pre-defined acceptance criteria through a specific clinical study as might be expected for an AI-powered device.

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DentoEtch: It is intended used for etching tooth enamel and dentine when preparing surfaces for application of composites.
Quickbond: It is intended for: Bonding composite to enamel and/or dentin; Bonding veneers, crowns & bridges, onlays and inlays; Bonding composite core built-up material; Bonding of composite to metal, Intraoral repairs (i.e. composite, fractured crowns & bridges, inlays & onlays and veneers); Treatment of hypersensitive teeth or exposed root surfaces; and Cavity sealing under amalgam restorations
Bond Activator: It is intended for use to enable the practitioner to use self-cure techniques for the indications where dual-cured adhesive may be desired.

DentoEtch: DentoEtch is an etching gel phosphoric acid 37%.
Quickbond: Simple to use, two-bottle, two step self-etching bonding system, with a first bottle containing the primer and a second one containing the bonding agent. This subject device may also be used with a self-curing activator

The provided text is related to a 510(k) summary for dental devices (DentoEtch, Quickbond, and Bond Activator) and does not contain information about a study proving that a device meets specific acceptance criteria in the context of AI/ML performance testing for medical image analysis or similar diagnostic tools. The document describes the devices, their classification, predicate devices, and indications for use, as well as the FDA's clearance of the devices based on substantial equivalence to existing products.

Therefore, for almost all points requested, the information is not present in the provided text, as the context is a traditional medical device clearance, not an AI/ML diagnostic tool.

Here's how the information maps to the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The 510(k) summary focuses on substantial equivalence based on indications for use and technological characteristics, not on quantifiable performance metrics of an AI/ML system.
2. Sample sizes used for the test set and the data provenance: Not present. This type of detail is not typically included in a 510(k) summary for these types of dental devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. Ground truth establishment for AI/ML models is not relevant to this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not present.
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 present. This type of study is relevant for AI/ML-assisted diagnostic tools, not for dental bonding agents and etchants.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. Not applicable to these devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The only "performance" or "test" information mentioned is:

• "cell reactions that have been interpreted as Moderate-severe and none, respectively, validating the test." This is a very brief and high-level statement, likely referring to biocompatibility testing, which is standard for medical devices, but it does not provide acceptance criteria or detailed performance data in the way an AI/ML study would. It serves only to state that a test was performed and validated the product.

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The subject devices are intended to serve for the fabrication of core build-ups. They are also intended to serve as a base cement to affix pins and posts. They may be used with any Bis-GMA compatible bonding agent.

The subject devices are dual-cure (auto and photo), nanofilled resin composite materials. They are stackable for easy setting, with no condensation, radio opaque and fluoride releasing. The subject devices are presented in an Automix syringe and a Cartridge used with a gun. Dentocore and Dentocore Body have the same intended use; the former possessing a relatively higher viscosity. This quality is a selection for practitioners choosing this type of material. The subject devices present numerous advantages, notably the following: Good compressive strength, Low polymerization shrinkage, Fluorure release, Very high radio opacity properties.

This 510(k) summary describes an Abbreviated 510(k) submission for a dental material, not an AI/ML medical device. Therefore, much of the requested information about device performance, study design, and ground truth establishment, which are specific to AI/ML device evaluations, is not applicable or available in this document.

However, I can extract the relevant information provided for this device based on the submission type and available details:

1. Table of Acceptance Criteria and Reported Device Performance

As this is an Abbreviated 510(k) for a dental material, the "acceptance criteria" are related to conformity with recognized standards and demonstrating non-inferiority to a predicate device. Performance is primarily reported in relation to these standards and general material properties.

Study Information (as applicable to a dental material 510(k)):

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

• Test Set Sample Size: The document mentions "in vitro Cytotoxicity assay" and general material characteristic testing. Specific sample sizes for these tests are not provided in this summary.
• Data Provenance: The studies were in-vitro (laboratory-based) as per the cytotoxicity assay and material property evaluations. The country of origin for the data is not specified, though the submitter is Itena Clinical from Paris, France. The studies are by definition prospective in the context of generating data for this specific submission.

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

• Not applicable / Not specified. For dental material testing (e.g., cytotoxicity, mechanical properties), "experts" are typically involved in designing and interpreting the scientific experiments, following established protocols. The concept of "ground truth" established by a panel of human experts is not relevant here as the performance metrics are objective physical or biological measurements.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (like 2+1, 3+1) are for human rater discrepancies in diagnostic image interpretation or similar tasks. This is not relevant for in-vitro material testing.

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. This is a dental material, not an AI-assisted diagnostic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is applicable.

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

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

7. The type of ground truth used

• For the cytotoxicity assay, the "ground truth" was established by standardized biological assay protocols (ISO 7405:1997 and ISO 10993) using a well-characterized mouse cell line (L929). The reaction of positive and negative controls validated the test.
• For other material properties (compressive strength, polymerization shrinkage, fluoride release, radio opacity), the "ground truth" is based on objective scientific measurements and adherence to recognized material testing standards (like ISO 4049).

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of evaluating a dental material as it's not a machine learning model.

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

• Not applicable. As there is no training set for an AI/ML model, this question is not relevant.

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