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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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