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NeoConvert Solution: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The NeoConvert Solution may be used with single-stage or two-stage procedures, for temporary multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Direct Screw to MUA: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. All digitally designed personalized copings to be used with the Direct to Multi Unit Abutment Screw are intended to be sent to Straumann for manufacture at a validated milling center.

GM Attachment TiN 30°: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The GM Attachment TiN 30° may be used with single-stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

This premarket notification includes the following additions to the Neodent Implant System: NeoConvert Solution, Direct Screw to MUA, GM Attachment TiN 30°. The Neodent Multi-Unit Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System, according to predicate devices described above. This submission intends to expand the portfolio of Neodent Abutments with these new solutions for multi-unit restorations, to provide more treatment options to customers. The NeoConvert Solution is a technique comprised by some abutments (not subject of this submission) used for converting removable temporary prosthesis into a screw-retained fixed temporary prosthesis. The Direct Screw to MUA is a prosthetic component designed to fix planned and digitally designed multi-unit milled restorations directly onto mini or micro abutments, eliminating the need for using the passive seating cylinder to restore chewing function. The GM Attachment TiN 30° is a prosthetic component used to stabilize implant-mucosa-supported removable full prosthesis (retained on the implant and supported on the mucosa), on implants installed in the maxilla or mandible. Although all these three new solutions are compatible with the same implants and components of Neodent Implant System and used for multiple unit rehabilitation, they are not used in conjunction with each other.

The provided text describes a 510(k) premarket notification for the "Neodent Implant System," focusing on the NeoConvert Solution, Direct Screw to MUA, and GM Attachment TiN 30°. This document details the device's technical characteristics, intended use, and its substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device submission. The document is a traditional 510(k) submission for dental implants and abutments, which are physical medical devices, not AI/ML software. Therefore, the specific requirements for an AI/ML device study (such as sample sizes for test and training sets, expert qualifications for ground truth, MRMC studies, or standalone performance) are not applicable or present in this document.

The "Performance Testing" section (pages 15-16) describes bench testing (dynamic fatigue, torsion, SEM images), MRI compatibility testing, biocompatibility testing, sterilization validation, and shelf-life testing for the physical dental implant components. These are standard performance tests for this type of physical device, not AI/ML algorithm validation.

Therefore, I cannot provide a table of acceptance criteria and a study proving the device meets acceptance criteria as typically outlined for an AI/ML medical device, as this information is not present in the provided document. The document focuses on demonstrating substantial equivalence of a physical dental device to predicate devices through engineering and material testing.

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NobelProcera Zirconia Implant Bridge (previously cleared per K202452) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.

TiUltra Implants and Xeal Abutments (previously cleared per K202344) NobelActive TiUltra NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early of delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with

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This document is a 510(k) premarket notification decision letter from the FDA to Nobel Biocare AG regarding their Dental Implant Systems Portfolio - MR Conditional. It explicitly states that the letter covers indications for use and general controls, but does not contain information about acceptance criteria or performance studies for the device itself.

Therefore, I cannot provide the requested information for the following reasons:

1. Acceptance Criteria and Performance Data: The document is a regulatory clearance letter, not a clinical study report. It does not contain acceptance criteria for device performance, nor does it present any data from studies proving the device meets particular criteria. The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined the device is as safe and effective as a previously cleared device, not that specific performance metrics were tested and met in a new study.
2. Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no performance study data is included in this FDA 510(k) clearance letter, none of these details can be extracted. The document refers to various previously cleared predicate devices (e.g., K202452, K202344, K181869), but it doesn't describe the studies that led to their clearance.

In summary, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria.

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