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The RePlus Dental Implants with HA coating are dental implant fixtures that are a part of a two-piece implant system. The RePlus 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 loading for support of single tooth and/or multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

The RePlus Implant system consists of tapered screw-type endosseous implants with the same standard "V" thread configuration, the same 2mm of mini-threads 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.

The provided document is a 510(k) summary for the RePlus Dental Implants With HA Coating. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document focuses on:

• Device Description: Tapered screw-type endosseous implants with specific thread configurations, materials (medical grade titanium alloy), and surface treatments (SBM blasted or HA plasma sprayed).
• Intended Use: For use in mandible and maxilla to support single or multiple-unit restorations and for retention/support of overdentures, including immediate loading under specific conditions.
• Device Comparison: States that the device compares favorably to predicate devices (Zimmer Dental Tapered Screw-Vent, Nobel Biocare Tapered Groovy Implants, and Implant Direct's Spectra-System) in function, technological characteristics, intended use, and materials.
• Substantial Equivalence: The FDA's letter confirms substantial equivalence to legally marketed predicate devices, which allows the device to be marketed.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment as this information is not present in the provided text.

To answer your specific questions, if such a study were to be described, it would typically include details like:

1. A table of acceptance criteria and the reported device performance: This would list specific quantitative or qualitative targets (e.g., bone-to-implant contact percentage > X%, maximum torque value > Y Ncm) and the results obtained from testing.
2. Sample size used for the test set and the data provenance: How many implants were tested, where were they tested (e.g., specific clinics, animal models), and was the data collected retrospectively from existing records or prospectively through a new study?
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would apply more to image-based diagnostic devices, not typically for dental implants.
4. Adjudication method: Again, more relevant to diagnostic interpretations.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not typically applicable for dental implants, which are hardware devices.
6. Standalone performance: Also not applicable as this relates to an algorithm's performance without human interaction.
7. Type of ground truth used: For dental implants, ground truth often relates to histological measurements of bone integration, mechanical stability testing, or clinical follow-up data on success rates.
8. Sample size for the training set: Not applicable for a device like a dental implant; this refers to AI/machine learning models.
9. How the ground truth for the training set was established: Not applicable for a dental implant.

Based on the provided text, the RePlus Dental Implants With HA Coating achieved market clearance through a 510(k) submission by demonstrating substantial equivalence to existing predicate devices, rather than through a study proving it met specific novel acceptance criteria. Substantial equivalence means the device is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).

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