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510(k) Data Aggregation
(5 days)
This product is indicated for use as a substructure for Porcelain fused to ceramic fixed dental restorations; namely crowns and bridges. Foundation Milling Center Z-Blocks are machined using CAD/CAM technology.
This product is a ceramic block made out of ZrO2 (Zirconia Oxide). There is a metal chuck glued on the end of the block that holds the block into the CAD/CAM machine. The block is milled into cores for teeth and then is fired in an oven to harden the ZrO2. Then the core is layered with ceramic porcelain to make a finished tooth.
The provided text is a 510(k) summary for a dental device called "Foundation Milling Center Z-Blocks." This submission asserts substantial equivalence to a predicate device and does not involve a study demonstrating the device meets specific acceptance criteria in the manner typically seen for algorithm-driven medical devices.
Instead, the submission focuses on the technological characteristics and intended use to establish equivalence. Therefore, many of the requested data points (like sample size, ground truth, MRMC studies, etc.) are not applicable to this type of regulatory submission.
However, based on the provided text, I can extract and infer some information, particularly regarding the equivalence argument.
Here's an attempt to answer your request based on the provided document, noting where information is not present or applicable:
1. A table of acceptance criteria and the reported device performance
For this device, the "acceptance criteria" are implied by the requirements for substantial equivalence to the predicate device. The performance is then deemed "equivalent" if these criteria are met.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated by sponsor) |
|---|---|
| Same Intended Use as Predicate Device | "This product is indicated for use as a substructure for porcelain fused to ceramic fixed dental restorations; namely crowns and bridges." This matches the intended use of the legally marketed predicate devices. |
| Same Technological Characteristics as Predicate Device | "The technological characteristics between the predicate and proposed devices are identical. There is no difference in fundamental scientific technology. They are made from the same materials and have the same intended use." |
| No significant differences raising questions about safety and effectiveness | "There are no significant differences between the Foundation Milling Center Z-Blocks and the predicate devices and therefore, the Foundation Milling Center Z-Blocks do not raise any questions regarding safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on an equivalency argument based on material composition, manufacturing process, and intended use, rather than a clinical performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical or diagnostic data was evaluated for "ground truth" establishment in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication was described.
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 device is a dental ceramic block, not an AI-driven or diagnostic system that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical dental material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is essentially the well-established performance and safety profile of the predicate device based on its design, materials, and intended use. The new device claims to be identical in these aspects.
8. The sample size for the training set
Not applicable. This device is a dental ceramic block, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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