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For use as an intra-bony, supporting component in the oral cavity to support crowns, badges, and overdentures when replacing missing teeth.

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This document is a 510(k) clearance letter from the FDA for a dental implant. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement. The letter is a regulatory approval document and not a scientific study report.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study that proves the device meets acceptance criteria, as none of that data is present in the input.

The document only states the "Indications for use" which are: "For use as an intra-bony, supporting component in the oral cavity to support crowns, badges, and overdentures when replacing missing teeth." This describes what the device is intended for, but not its performance metrics or acceptance criteria.

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For use as an intra-bony, supporting component in the oral cavity to support crowns, bridges, and overdentures when replacing missing teeth.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental implant. This type of document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or effects of AI assistance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input. The letter simply states that the FDA has reviewed the submission and determined that the device is substantially equivalent to a legally marketed predicate device.

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For use as an intra-bony, supporting component in the oral cavity to support crowns, bridges, and overdentures when replacing missing teeth.

4.0 mm Simpler One Threaded Dental Implant

The provided text is a 510(k) clearance letter from the FDA for a dental implant. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt.

Therefore, I cannot provide the requested table and study details based on the given input.

Ask a specific question about this device

For use as an intra-bony, supporting component in the oral cavity to support crowns, bridges, and overdentures when replacing missing teeth.

3.2.5 mm Simpler One Pushin Dental Implant

This document is a 510(k) clearance letter from the FDA for a dental implant. It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information based on the provided text. The letter only confirms the regulatory clearance of the 3.25mm Simpler One Pushin Dental Implant.

Ask a specific question about this device

For use as an intra-bony, supporting component in the oral cavity to support crowns, bridges, and overdentures when replacing missing teeth.

4.0mm Simpler One Pushin Dental Implant

This document is a 510(k) clearance letter from the FDA for a dental implant and does not contain detailed information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information about experts used for ground truth or adjudication methods.
4. Details of a multi-reader multi-case comparative effectiveness study or an effect size.
5. Results of a standalone algorithm performance study.
6. The type of ground truth used.
7. Sample size for the training set or how ground truth for the training set was established.

Ask a specific question about this device

For use as an intra-bony, supporting component in the oral cavity to support crowns, bridges, and overdentures when replacing missing teeth.

3.25mm Simpler One Threaded Dental Implant

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a 510(k) clearance letter from the FDA for a dental implant, which indicates that the device is substantially equivalent to a previously marketed device. It does not include details on specific performance metrics, study design, or results.

Ask a specific question about this device