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The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

The Tapered Screw-Vent Implant, 4.1mm is an endosseous dental implant. The implant is composed of titanium alloy. The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with double-lead threads.

I am sorry, but the provided text describes a 510(k) summary for a dental implant (Tapered Screw-Vent Implant, 4.1mmD) and does not contain information about studies related to acceptance criteria or performance of an AI/ML device.

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 data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study
6. Standalone performance study
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document focuses on the substantial equivalence of a modified dental implant to a predicate device, as required for a 510(k) submission to the FDA.

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