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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 cemented or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Atlantis™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration. in partially or completely edentulous patients. The abutment screw is intended to secure the crown abutment to the endosseous implant.

Atlantis™ Straumann Bone Level Abutment in Zirconia is compatible with the Ø3.3 mm Straumann Bone Level Implant.

Atlantis Straumann Bone Level Abutment is a patient specific dental implant abutment for screw-retained, cement-retained or friction fit restorations. Atlantis Straumann Bone Level Abutment is provided in one diameter (03.3 mm) and two designs: Atlantis Straumann Bone Level Abutment and Atlantis Straumann Bone Level Crown Abutment. The coronal portion of Atlantis Abutment is fabricated as a patient specific abutment for prosthesis attachment. The coronal portion of Atlantis Crown Abutment is fabricated as a single tooth final restoration and is shaped in the design of the final prosthesis onto which porcelain is added. Both designs are compatible with the Straumann Bone Level implant Ø3.3 mm. Atlantis abutments are made from yttria-stabilized zirconia (Y-TZP) conforming to ISO 13356 Implants for surgery-ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and are used with a titanium alloy abutment screw.

The provided text is a 510(k) summary for the Atlantis™ Straumann Bone Level Abutment, which is a dental implant abutment. This document does not describe a study involving acceptance criteria related to software performance, AI algorithms, or human reader effectiveness. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing for a physical medical device.

Therefore, the requested information cannot be extracted from the provided text as it does not contain details about:

• Acceptance criteria for a software/AI device.
• A study proving a device meets such acceptance criteria.
• Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for AI/software development.

The "studies" mentioned in the document are:

• Non-clinical testing data: engineering analysis, dimensional analysis.
• Static and dynamic compression-bending testing: according to ISO 14801 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants.

These tests are designed to demonstrate the physical performance and safety of the dental abutment, ensuring it meets established engineering standards for medical devices of its type, rather than evaluating interpretive or diagnostic capabilities of an algorithm.

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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.

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™ Straumann Bone Level Abutment and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.3mm, 4.1mm and 4.8mm sizes. In addition, the Atlantis™ Straumann Bone Level Abutment for the 4.1mm and 4.8mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6072 & 13356). The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

This 510(k) premarket notification (K083871) for the Atlantis™ Straumann Bone Level Abutment describes a dental abutment intended to support prosthetic restorations on dental implants. As a Class II medical device, it primarily relies on substantial equivalence to predicate devices rather than extensive clinical studies demonstrating novel performance. The provided text does not contain information about specific acceptance criteria and a study proving the device meets those criteria in the way a diagnostic AI device submission would.

Therefore, I cannot populate the requested table and sections with specific performance metrics, sample sizes for test sets, expert qualifications, or details of standalone performance studies for this device. The submission focuses on functional equivalence, material specifications, and compatibility with existing implant systems.

However, based on the provided text, I can infer the "acceptance criteria" and "study" in the context of a 510(k) for a dental abutment:

Inferred Acceptance Criteria (for the 510(k) process):

• Substantial Equivalence: The primary acceptance criterion for a 510(k) device is that it is substantially equivalent to a legally marketed predicate device. This involves demonstrating equivalence in intended use, technological characteristics (materials, design), and performance.
• Material Compliance: The materials used (Titanium grade Ti-6Al-4V ELI and Yttria-stabilized tetragonal zirconia polycrystals (Y-TZP)) must meet established ASTM and ISO standards, respectively.
• Biocompatibility: Implied by the use of established medical-grade materials.
• Functional Compatibility: The abutments must be compatible with specified Straumann implant systems.
• Mechanical Integrity/Performance: While not explicitly detailed as acceptance criteria with specific thresholds in this excerpt, the "performance" aspect of substantial equivalence typically includes mechanical testing (e.g., fatigue, fracture strength) to ensure the device performs at least as well as the predicate device when subjected to relevant forces.

Inferred "Study" Proving Acceptance Criteria are Met:

For a dental abutment like this, the "study" proving it meets acceptance criteria (i.e., is substantially equivalent) would involve a combination of:

• Engineering/Bench Testing: Mechanical tests to compare the performance characteristics (e.g., strength, fatigue resistance) of the new abutment to the predicate devices. This would demonstrate that the new device's performance is at least equivalent.
• Material Characterization: Verification that the materials meet the specified ASTM and ISO standards.
• Design and Intended Use Comparison: A detailed comparison of the new device's design features and intended use with those of the predicate devices.

Given that this 510(k) is for a physical medical device (dental abutment) and not an AI/diagnostic software, the conventional structure of AI device performance studies is not applicable. The document does not contain information on:

• A table of acceptance criteria with reported device performance metrics in the context of diagnostic accuracy (e.g., sensitivity, specificity).
• Sample sizes for specific test sets in a diagnostic context.
• Data provenance for diagnostic images.
• Number of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth (pathology, outcomes data) for diagnostic purposes.
• Sample size for training sets.
• How ground truth for training sets was established.

The provided text from the 510(k) summary focuses on demonstrating substantial equivalence through comparison of materials, design, and intended use with predicate devices, which is the standard regulatory pathway for many physical medical devices. This is not the type of submission that would include the detailed performance study information typically requested for AI/software as a medical device.

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