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Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.

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 Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCl). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments.

The purpose of this premarket notification is to extend the BLC and TLC Implants portfolio by including new sizes of implants, more specifically:

BLC implants:

• L 16 mm for diameter Ø 6.5 mm, presented with WB (Wide Base) prosthetic platform.
  TLC implants:
• L 14 mm and L 16 mm for diameter Ø 5.5 mm, with both implant neck options Standard (2.8 mm height) and Standard Plus (1.8 mm height)
• L 8 mm and L 10 mm for diameter Ø 6.5 mm and implant neck Standard (2.8 mm height)
• L 12 mm to L 16 mm for diameter Ø 6.5 mm, with both implant neck options Standard (2.8 mm height)

and presented with WT (Wide TorcFit) prosthetic platform.

The submission also introduces a new sterilization method using X-ray irradiation which was validated on worst-case test articles representative of the BLC and TLC implant systems.

This is a 510(k) summary for a medical device that is cleared based on substantial equivalence to predicate devices, not on meeting specific performance acceptance criteria in the same way an AI/ML device might. Therefore, many of the requested categories are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

Device Type: This document is for an Endosseous Dental Implant, not a software or AI/ML device. The acceptance criteria and performance study described are focused on hardware aspects (sterilization, biocompatibility, mechanical performance) rather than algorithmic performance.

Applicable Information from the document:

Since this is a dental implant and not an AI/ML device, concepts like "test set," "training set," "experts to establish ground truth," and "MRMC study" are not relevant in the context of the device's technical clearance. The document focuses on showing the new implants are substantially equivalent to previously cleared implants.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sterilization Validation: The document mentions "worst-case test articles representative of the BLC and TLC implant systems" for X-ray sterilization validation. It does not provide a specific sample size. The methods (VDmax25) are standard for radiation sterilization validation.
• Biocompatibility Testing: The document refers to "assessed devices" and "conducted tests" (e.g., at T0, T3, T5 for X-ray sterilization impact). Specific sample sizes are not provided, but the testing followed ISO 10993-1.
• Mechanical Testing (Insertion Torque): "Insertion tests were performed for the subject implants." No specific sample size is given.
• Data Provenance: The studies appear to be internal validation studies conducted by the manufacturer, not patient data from specific countries. They are prospective in the sense of being planned validation tests for the device changes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This concept is not applicable as the studies described are bench and lab validations against industry standards (ISO, FDA guidance), not expert-interpreted clinical data. The "ground truth" is defined by the technical specifications and performance against those standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable for these types of technical validation studies. Adjudication methods are typically used in clinical trials or studies involving human interpretation of medical images or data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI/ML device, nor does it involve human readers interpreting data assisted by the device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device (dental implant).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" in this context is defined by established international standards (e.g., ISO 11137 for sterilization, ISO 10993-1 for biocompatibility, FDA guidance for MR Conditional status) and the engineering specifications/performance achieved by the device. It's essentially performance against predefined engineering and safety standards.

8. The sample size for the training set

• Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established

• Not applicable, as this is not an AI/ML device.

Conclusion based on the document:

The device is an extension of existing dental implants, and its clearance relies on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" are implied by the need to conform to generally recognized standards and to demonstrate that the new sizes and sterilization method do not introduce new safety or effectiveness concerns compared to the predicates. The studies performed are primarily bench testing and validation studies to confirm the physical and biological characteristics of the implants meet these standards.

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