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TempoCem Clear is indicated for:

• · Temporary or semipermanent luting of temporary and permanent crowns, bridges, inlays and onlays.
• · Temporary luting of temporary veneers.
• · Temporary or semipermanent luting of implant-borne dental prosthesis.

TempoCem Clear is a transparent, dual-curing, resin-based dental cement for the temporary or semipermanent cementing of provisional resin-based composite restorations (crowns, bridges, inlays, onlays, veneers) to a tooth and for temporary or semipermanent luting to an implant abutment. The cement consists of two pastes (base and catalyst) packaged in a double-barreled plastic syringe. The pastes are automatically mixed when dispensed through the single-use mixing tips supplied with the device.

The provided document is a 510(k) summary for a dental cement called TempoCem Clear. It does not contain information about a study proving the device meets specific acceptance criteria in the manner of a clinical efficacy trial with established benchmarks. Instead, it demonstrates substantial equivalence to a predicate device based on non-clinical performance data.

Here's an analysis based on the information provided, attempting to address your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" against which the device performance is measured in a pass/fail manner. Instead, it compares the performance of TempoCem Clear to a predicate device (Telio CS Link) and references relevant ISO standards and FDA guidance. The "acceptance criteria" here are implied to be "comparable to the predicate device" or "within acceptable ranges for dental cements" as defined by the mentioned standards and guidance.

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

The document does not provide specific sample sizes (e.g., number of test specimens) for each of the physical and mechanical property tests. It states that "Physical and mechanical properties of TempoCem Clear were investigated and compared to the predicate device in accordance with FDA's 1998 Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (chemistry of the setting reaction, working and setting times, solubility, dimensional change, bonding strength, film thickness, heat generated during setting and biocompatibility)." This implies the tests were conducted in a laboratory setting, likely following standard test methodologies but the country of origin of the data is not specified (though the submitter information lists "DMG USA, Inc." in Massachusetts, USA). The data is by nature retrospective for the predicate device and newly generated for the proposed device.

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

This information is not applicable to the type of testing described. The "ground truth" for physical and mechanical properties is established by standardized laboratory measurements rather than expert human interpretation. Biocompatibility "ground truth" is established via cytotoxic assays, not expert panels.

4. Adjudication Method for the Test Set

Not applicable. There is no human adjudication for these types of non-clinical, quantitative tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a dental cement, not an AI-assisted diagnostic device. No MRMC study was performed.

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

Not applicable. This is a dental cement, not an algorithm.

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

For the physical and mechanical properties, the "ground truth" is derived from direct measurements using established laboratory test methods (e.g., measuring solubility, strength, etc.) as outlined in the FDA guidance and ISO standards (e.g., ISO Standard 7405).
For biocompatibility, the ground truth is established through cytotoxicity studies, not expert consensus or pathology in a clinical setting.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study, so there is no training set in that context.

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

Not applicable, as there is no training set for this type of device submission.

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TempoCem is a dental luting agent indicated for:

• . temporary cementation of provisional crowns and bridges
• cementing of semi-permanent implants .

TempoCem is a temporary cement based on zinc oxide / eugenol for automatic mixing. Its low film thickness provides an exceptional fit. TempoCem combines reliable adhesion with easy and clean removal. Excess can be removed easily. TempoCem is offered in different varieties.

The provided text describes a 510(k) premarket notification for a dental temporary cement called TempoCem. The information focuses on regulatory approval based on substantial equivalence to predicate devices and adherence to an international standard.

Based on the provided text, the following information regarding acceptance criteria and a study proving the device meets these criteria can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for TempoCem, as stated, is that it "meets the requirements of ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition." The text does not provide a table with specific numerical acceptance criteria from this ISO standard nor specific reported performance values for TempoCem against these criteria.

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

The document mentions that the submission is an "Abbreviated 510(k) as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.'" This typically means that new clinical data or extensive performance data might not be required if the device is substantially equivalent to a legally marketed predicate and adheres to recognized standards.

• Sample Size for Test Set: Not specified. The document implies compliance with an ISO standard rather than a specific clinical trial with a defined test set sample size.
• Data Provenance: Not specified. The compliance is with an "ISO" standard, which is an international standard, but the location where the tests were conducted or the origin of any data (if external to the standard's methodology) is not mentioned. It is highly likely the data is from in vitro laboratory testing to demonstrate compliance with the standard. The study is not a retrospective or prospective clinical study in the traditional sense described in the context of device performance in humans.

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

This information is not applicable and not provided. The device's substantial equivalence is based on meeting an ISO standard for dental cements and comparison to predicate devices, not on expert-adjudicated ground truth from a test set of patient data.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As above, the evaluation is based on compliance with an ISO standard, not a human reader or expert adjudication process.

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

An MRMC study was not done. The approval is for a dental cement, not an imaging or diagnostic device that would typically involve human readers.

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

This concept is not applicable to this device. TempoCem is a physical dental cement, not an algorithm or AI system. Its performance is intrinsic to the material properties.

7. Type of Ground Truth Used:

The "ground truth" here is compliance with an international standard (ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition). This standard likely sets forth methodologies and acceptable ranges for various physical and chemical properties of dental cements.

8. Sample Size for the Training Set:

This information is not applicable and not provided. As TempoCem is a manufactured product and not an AI/ML algorithm, there is no "training set" in the context of data science or machine learning.

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

This information is not applicable and not provided. There is no ground truth for a training set in this context.

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TempoCem N/E is a dental luting agent for the temporary cementation of crowns and bridges.

Not Found

The document provided is a 510(k) premarket notification letter from the FDA for a dental luting agent called TempoCem N/E. It does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is not a medical imaging or AI-driven device.

Therefore, I cannot fulfill your request using the provided text. The document is about a dental cement and its regulatory approval process, not about a device that undergoes performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

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