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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. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. Healing,

The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement- or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.

The PEEK CR Abutment is indicated to be used on Neodent Implants to provide support for prosthetic structures for up to 6 months. They can be used in single- or two-stage procedures and they are intended to be placed out of occlusion.

The Zirconia Abutments subject of this submission are similar to devices already approved in previous submissions of Zirconia Implant System, according to predicate devices described above. This submission intends to expand the portfolio of Zirconia Abutments with new dimensions of gingival height for Zirconia Healing Abutments, Zirconia Bases, CR Abutments for Zirconia and PEEK CR Abutments for Zirconia, to provide more treatment options to the customers. All these abutments have an internal connection with the implants (ZiLock) and the prosthetic platform is identical for all subject devices described in this submission. They are intended for single use and provided sterile via Ethylene Oxide method. The new transmucosal heights are 3.5mm and 4.5mm.

The restorative materials Polycon ae, N!ce and IPS e.max CAD LT were not presented in previous submissions of Zirconia Implant System and are being included in the scope of Zirconia Bases indication.

The provided document is a 510(k) summary for the Neodent Implant System - Zirconia Implant System. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with defined performance metrics, sample sizes, and expert adjudication as might be seen for novel AI/software as a medical device (SaMD) products.

Therefore, the document does not contain the information requested regarding acceptance criteria related to a study proving performance, sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment methods for training sets.

The performance testing section (pages 14-15) describes:

• Bench Testing:
  • Dynamic fatigue testing: Conducted according to FDA guidance and ISO 14801. The results demonstrated the subject devices do not introduce a new worst case compared to predicate and reference devices.
  • Torsion tests: Performed to evaluate screw strength, and results proved adequate torsion strength according to installation torque.
• Biocompatibility Testing:
  • Assessment performed according to ISO 10993-1 and FDA guidance. No new issues were raised and no additional testing was required because the subject devices are identical in material and manufacturing processes to predicate and reference devices.
• Sterilization Validation and Packaging:
  • Ethylene Oxide (EO) sterilization validated to SAL of 10-6 per ISO 11135:2014. EO residuals verified per ISO 10993-7. The packaging and sterilization are identical to predicate devices.
  • Steam sterilization validated per ISO 17665-1, using parameters identical to predicate devices.
  • Pyrogen limit specifications met via LAL Endotoxin Analysis (testing limit 20 EU/device) for blood contacting and implanted devices.

In essence, the study presented is a non-inferiority or equivalence-based assessment against previously cleared devices, focusing on engineering and biocompatibility characteristics, not clinical performance metrics or AI algorithm validation metrics.

Therefore, I cannot provide the requested table and details because the information is not present in the provided text. The document describes a traditional medical device (dental implants and abutments) clearance, not a software or AI device that would have the specific performance study criteria outlined in your request.

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