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Straumann Narrow Neck implants are intended for single-stage or two-stage surqical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Straumann Narrow Neck implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

The Straumann Narrow Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants have an SLA or SLActive surface and have the same design and dimensions as the predicate device.

The provided text is a 510(k) Summary and FDA clearance letter for a medical device, specifically dental implants. It does not contain information about acceptance criteria, device performance metrics, or details of a study that proves the device meets such criteria.

The 510(k) summary focuses on establishing substantial equivalence to previously cleared predicate devices. This type of submission generally does not require new clinical studies with defined acceptance criteria and performance metrics in the same way a PMA (Pre-Market Approval) or de novo submission would. Instead, the focus is on demonstrating that the new device is as safe and effective as a legally marketed device.

Therefore, I cannot fulfill your request for the tables and study details based on the provided text. The document explicitly states:

• "The subject Narrow Neck implants are substantially equivalent to the previously cleared Straumann implants, K010291, K03007 and K053088. There is no change to the implant design or dimensions. The intended use is identical to predicate devices."
• The FDA letter confirms "determined the device is substantially equivalent... to legally marketed predicate devices."

This indicates that the clearance was based on similarity to existing devices, not on a new study with the type of rigorous performance testing and acceptance criteria you've asked for.

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