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The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems: BioHorizons The Prodigy System™ Dental Implants 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants and BioHorizons The Maestro™ System Implants RBM and HA coated 3.5mm, 4.0mm and 5.0mm Implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

The Atlantis™ Abutments in Zirconia for BioHorizons Implant and abutment screws are made from biocompatible vttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356. The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with BioHorizons Prodigy System™ 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants and BioHorizons The Maestro™ System Implants RBM and HA coated 3.5mm, 4.0mm and 5.0mm Implants.

The provided text is a 510(k) summary for a pre-market notification of a dental implant abutment. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document focuses on establishing substantial equivalence to a predicate device, as required for 510(k) submissions. This typically involves demonstrating that the new device has the same intended use, technological characteristics (materials, design), and performs similarly to a legally marketed device, often through a comparison of engineering specifications and materials rather than extensive clinical efficacy studies with specific performance metrics.

Therefore, I cannot fulfill your request for details on acceptance criteria and a study to prove they are met from the provided input. The document explicitly states:

• "The Atlantis™ Abutments in Zirconia for BioHorizons Implants are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments for Zimmer Interface cleared under K053373 and BioHorizons Prodigy System™ Dental Implants cleared under K042429."

This highlights that the basis for approval is substantial equivalence, not a standalone study demonstrating performance against a set of predefined acceptance criteria for the new device itself.

To answer your specific points based on the absence of information:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or related performance data is described in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This document pertains to a dental abutment, not an AI-assisted diagnostic tool, so an MRMC study is not relevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study requiring ground truth is described.
8. The sample size for the training set: Not applicable, as no algorithm training is described.
9. How the ground truth for the training set was established: Not applicable, as no algorithm training is described.

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