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Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

The subject devices are part of the BLX implant line, a fully tapered implant manufactured out of Roxolid and having the SLActive or SLA surface. The connection is identified as conical fitting with the Torx style engaging feature. The subject BLX implants have endosteal implant diameters of Ø5.0mm and lengths of 18 mm and diameters of Ø5.5mm and Ø6.5mm and lengths of 14 mm and 16 mm. The subject devices are presented with the WB (Wide Base) prosthetic platform. The internal connection and the prosthetic platform are identical for all subject devices.

This document, a 510(k) summary for the BLX WB dental implants, does not contain the specific information requested about acceptance criteria and the study proving the device meets them in the format of AI/ML device performance. This is because the device described is a traditional medical device (dental implants), not a software as a medical device (SaMD) or an AI/ML-driven diagnostic tool.

Therefore, there is no discussion of:

• A table of acceptance criteria and reported device performance related to AI/ML metrics.
• Sample size used for test set or data provenance in the context of algorithm evaluation.
• Number and qualifications of experts for establishing ground truth for a test set.
• Adjudication methods for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data in the context of AI/ML).
• Sample size for training set or how ground truth was established for a training set.

Instead, the document focuses on:

• Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This is shown by comparing indications for use, technological characteristics (materials, surface treatment, connection, dimensions, design), and performance testing.
• Performance Bench Testing:
  • Dynamic fatigue testing: Conducted according to FDA guidance (Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments). The testing was leveraged from a reference device (K173961), indicating that the new device does not introduce a new worst-case scenario. This implies the acceptance criteria for fatigue are met by demonstrating equivalence to a device that already meets them.
  • Insertion tests: Performed for the subject implants, showing "adequate insertion torque in different bone classes" and results "equivalent to the primary predicate device." This implicitly sets acceptance criteria as "adequate" and "equivalent to predicate."
• Biocompatibility Testing: Assessed according to ISO 10993-1:2009 and FDA guidance. The conclusion is that "No new issues of biocompatibility are raised for the subject devices," meaning existing biocompatibility standards for similar devices are met.
• Sterilization Validation and Packaging:
  • Validated to a sterility assurance level (SAL) of 10-6 in accordance with ISO 11137-1:2006 and ISO 11137-2:2013.
  • Shelf life: 5 years (identical to predicate).
  • Pyrogenicity: Met limit specifications (20 EU/device) via LAL Endotoxin Analysis.

In summary, the "acceptance criteria" for this traditional medical device are largely defined by equivalence to predicate devices and adherence to recognized international standards (ISO) and FDA guidance documents for mechanical performance, biocompatibility, and sterilization. The "study that proves the device meets the acceptance criteria" refers to the bench testing and validation efforts described above, not to clinical trials or AI/ML performance studies.

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