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FixTemp ™ Cement is a dental luting agent indicated for:

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

The Fixtemp Cement is designed as a luting cement for temporary dental applications. This dental cement having the active ingredients of zinc oxide does not include Eugenol. This lack of Eugenol does not reduce structural properties but allows a choice among healthcare professionals where Eugenol can cause objectionable results.

The provided text is for a 510(k) premarket notification for a dental cement called FixTemp Cement. This document primarily focuses on establishing substantial equivalence to a predicate device, not on presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria in a medical AI context. Therefore, much of the requested information regarding AI device studies (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC studies) is not applicable to this document.

However, the document does contain "acceptance criteria" in the form of performance characteristics used to demonstrate substantial equivalence to a predicate device.

Here's the information that can be extracted or inferred from the provided text, adapted to the request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are the performance characteristics of the predicate device, which the FixTemp Cement aims to match or exceed.

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

• Sample Size: Not specified. The document refers to "a series of factory tests" and "testing has confirmed this device meets its product specification," but does not provide details on sample sizes for these tests.
• Data Provenance: The tests are referred to as "factory tests," implying they were conducted by the manufacturer, Exacta Dental Direct, Inc. No information regarding country of origin of the data or whether it was retrospective/prospective is provided.

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

• Not applicable. This document describes performance testing of a dental cement, not an AI device requiring expert-established ground truth from images or other medical data. The ground truth for physical properties (like film thickness, setting time) would be based on standardized laboratory measurements.

4. Adjudication method for the test set

• Not applicable. See point 3. Performance is based on direct physical measurements against a standard (ISO 3107), not on human adjudication of classification or detection tasks.

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 medical device.

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

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

7. The type of ground truth used

• The ground truth for the performance characteristics (e.g., film thickness, setting time, compressive strength, working time) is established by physical measurements based on recognized international standards (ISO 3107). These are objective, quantitative measurements.

8. The sample size for the training set

• Not applicable. This document does not describe the development of an AI model; therefore, there is no training set in the context of machine learning.

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

• Not applicable. See point 8.

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