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510(k) Data Aggregation
(74 days)
AMANN GIRRBACH AMERICA, INC.
Amann Girrbach America, Inc. Ceramill Zi blanks are used in the manufacture of dental prosthetics.
The Ceramill Zi Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics
The provided text describes a 510(k) summary for the "Ceramill Zi Blank" dental material.
Based on the provided information, the device is claiming substantial equivalence to predicate devices based on comparisons of formulations, mechanical characteristics, and intended uses.
Therefore, there is no acceptance criteria based on performance metrics for the device, and no study that demonstrates the device meets such criteria. The FDA cleared the device based on its substantial equivalence to legally marketed predicate devices without requiring performance data.
The sections below are filled out as "N/A" (Not Applicable) because the submitted document explicitly states "Performance Data: None required."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| N/A | N/A | Performance data was not required for this 510(k) submission. Substantial equivalence was based on formulations, mechanical characteristics, and intended uses compared to predicate devices. |
2. Sample size used for the test set and the data provenance
N/A - No performance test set or data provenance is mentioned as performance data was not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - No ground truth or experts were involved in establishing performance for this device, as performance data was not required.
4. Adjudication method for the test set
N/A - No test set or adjudication method is mentioned as performance data was not required.
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
N/A - This device is a dental material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A - This device is a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A - No ground truth information related to performance is provided, as performance data was not required.
8. The sample size for the training set
N/A - No training set is mentioned as performance data was not required.
9. How the ground truth for the training set was established
N/A - No training set or ground truth establishment is mentioned as performance data was not required.
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