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Final cementation of ceramic, composite or metal inlays, onlays, crowns, bridges, 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis); Final cementation of post and screws; Final cementation of ceramic, composite or metal restorations on implant abutments; Cementation of abutments made of Lava™ zirconium oxide ceramic.

Unicem HM in the Clicker™ dispenser is a dual-curing, self-adhesive resin cement for hand mixing. It contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 70% by weight; the grain size (D 90%) is about 12.5 um. The mixing ratio; based on volume, is 1 part base paste : 1 part catalyst. The cement is available in various shades.

Here's a breakdown of the acceptance criteria and the study details for the Unicem HM device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The device, Unicem HM, was compared to its predicate device, Unicem Aplicap, across several performance metrics. The acceptance criteria were established by relevant ISO and DIN standards.

Table 1: Acceptance Criteria and Reported Device Performance for Unicem HM

Summary of Device Performance against Acceptance Criteria:

Based on the table above, Unicem HM met all the specified limits for film thickness, working time, setting time, radiopacity, flexural strength (both dark and light cured), and compressive strength (both dark and light cured). For surface hardness, which had no specified numerical limit ("n.a."), the values are provided for comparison. The study concluded that Unicem HM is "safe and effective as as the predicate devices."

Study Details

The provided document describes a bench testing study comparing Unicem HM to a predicate device, Unicem Aplicap, and other predicate devices (Panavia F 2.0, Maxcem 2) were also referenced for substantial equivalence. This is not a clinical study involving human patients.

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

   • The document does not explicitly state the sample sizes (number of specimens tested) for each performance metric. It provides mean values and standard deviations (± values), which implies multiple samples were tested for each metric to calculate these statistics.
   • Data Provenance: The company submitting the 510(k) is 3M ESPE AG, based in Germany. Therefore, the data likely originated from Germany. The study is retrospective in the sense that the data appears to be from laboratory tests conducted to demonstrate compliance with standards for the premarket notification.

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

   • This question is not applicable (N/A) to this type of study. Ground truth, in the context of expert consensus, refers to clinical assessments or interpretations. As this is a bench testing study evaluating material properties against established standards, it does not involve expert readers establishing ground truth. The "ground truth" here is objective physical and chemical properties measured according to standardized methods.

3. Adjudication method for the test set:

   • N/A. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts in clinical studies or image interpretation. This study involves objective measurements of material properties, not human interpretation, so no adjudication method was used.

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:

   • No. This is not an MRMC study. It is a bench testing study for a dental cement, not a diagnostic device involving human readers or AI assistance.

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

   • No. This is not an algorithm or AI device. It is a material science study.

6. The type of ground truth used:

   • The "ground truth" in this context is based on established international standards (ISO and DIN) for dental materials. The device's performance was measured against these objective standards. Additionally, the performance of the predicate device serves as a benchmark for comparison to demonstrate substantial equivalence.

7. The sample size for the training set:

   • N/A. This is a material testing study, not a machine learning study, so there is no concept of a "training set."

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

   • N/A. As there is no training set for this type of study, this question is not applicable.

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