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Found 3 results
510(k) Data Aggregation
(56 days)
Indirect cementation of ceramic, composite and metal inlays, onlays, crowns, bridges, posts, screws and veneers.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter for a dental cement (trade name "seT"). It does not contain any information about acceptance criteria or a study that proves the device meets those criteria for an AI or medical device that would have such a study.
The document is a regulatory approval notice, confirming that the dental cement "seT" is substantially equivalent to a legally marketed predicate device. This type of clearance does not typically involve the detailed performance studies or AI-specific evaluation metrics you've requested.
Therefore, I cannot extract the information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment from this document.
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(77 days)
High density restorative for cavity preparation in posterior teeth. May be used as an indirect restorative for inlays and onlays.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental device called "ROK." It primarily confirms the device's substantial equivalence to a legally marketed predicate device and does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria.
Therefore, I cannot provide the requested information based on the input text. The document focuses on regulatory approval based on equivalence, not on a detailed performance study with acceptance criteria.
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(77 days)
Microfil hybrid restorative for all cavity classes, veneers and diastema closures.
Not Found
I am sorry, but the provided text from the FDA document (K012528) does not contain any information regarding acceptance criteria, device performance studies, or details about artificial intelligence (AI) performance.
This document is a 510(k) clearance letter for a dental composite product called "ICE." It primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance information.
Therefore, I cannot provide the requested table and study details as they are not present in the input text.
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