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The ScrewPlus Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system that is to be used for single-stage or two-stage surgical procedures. The ScrewPlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The ScrewPlus Implant system consists of tapered screw-type endosseous implants with the same standard "V" thread configuration, the same 2mm of minithreads near the top of each implant, are manufactured using the same medical grade titanium alloy material and are coated with the same soluble blast media (SBM) blasted surface treatment or HA plasma sprayed. The HA coated variety of these implants are the subject of this submission.

This document is a 510(k) summary for a dental implant system (K073049). It does NOT contain information about acceptance criteria or a study proving that a device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on:

• Identical intended use: The ScrewPlus System Implants with HA Coating have the same intended use as the predicate implants (Zimmer Dental AdVent Dental Implant System and Implant Direct's Spectra-System).
• Nearly identical technological characteristics and materials: The new device shares the same screw-type design, thread configuration, minithreads, medical-grade titanium alloy, and surface treatment (SBM blasted or HA plasma sprayed) as the predicate devices.

The FDA's review concludes that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. This is a regulatory pathway that primarily compares a new device to existing ones rather than detailing performance studies with specific acceptance criteria in the way you've outlined.

Therefore, I cannot populate your requested table and information points as the provided text does not contain that type of data. The document does not describe:

• A table of acceptance criteria and reported device performance (e.g., accuracy, sensitivity, specificity).
• Sample sizes for test sets or their data provenance.
• Number/qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for training sets.
• How ground truth for training sets was established.

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