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The UF(II) Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:

• The intended use for the 3.0mm, 3.3mm diameter UF(II) Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.
• Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
• It is intended for delayed loading.

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The provided text is an FDA 510(k) clearance letter for the UF(II) Narrow Implant System. It primarily addresses the regulatory approval of the device based on substantial equivalence to predicate devices and outlines general regulatory requirements. Crucially, it does not contain the detailed information about acceptance criteria or specific studies proving the device meets those criteria.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document is a regulatory approval notice, not a detailed technical report or clinical study summary. To obtain the information you're looking for, you would generally need to consult the company's 510(k) submission summary, premarket approval (PMA) application documents, or scientific publications from studies conducted on the device.

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