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The Bonafix TWO Dental Implant System is indicated for delayed loading in surgical and restorative applications placement in the upper or lower jaw and to provide support for prosthetic devices such as artificial teeth with the goal of restoring the patient's chewing function.

Bonafix TWO Implant is a bone level type implant indicated for delayed loading only, built in Grade 5 ELI Titanium Alloy and treated with RBM technology. To prevent unnecessary rotations between the implant and the abutment, the implant has an internal hex connection style. The body of the implant is tapered, the implant neck is straight and has micro-rings; and the apex of the implant has a dome shape. Was designed with a double-thread that has a constant depth and thickness. Has two-spiral channel at the apical end of the implant that provide self-tapping properties to the implant. This system has 3.35, 3.75, 4.20, 5.00, 6.00 diameter distributed in three (3) platform (Narrow, Standard and Wide) and 8, 10, 11.5, 13 and 15 mm lengths. The 3.35 mm diameter excludes the 8 mm length, and the 6.00 mm diameter excludes the 15 mm length. The implants are provided sterile and are ready to be implanted. The system includes various prosthetic device such as, Cover screw, Healing caps, and two (2) abutments, Straight abutments and Angle abutments are connected to implant through the hex and secured by retained screw. The Straight abutment has 2 to 3 emergence profiles depending on platform. The Angle abutments has a single emergence profile by platform. The angle abutment has axis inclined of 20° compared to the implant's axis. The abutments are provided non-sterile and are intended to be sterilized before use. All prosthetic device are made in Grade 5 ELI Titanium Alloy.

This document describes the Bonafix TWO - Dental Implant System. Here's a breakdown of the acceptance criteria and study information provided, focusing on what is present and what is not mentioned in the text.

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

The document does not explicitly state a table of "acceptance criteria" against which a direct performance measure is reported in a pass/fail manner. Instead, it details various performance tests and their outcomes, indicating that the device's performance was found to be "comparable" or "demonstrated."

Here's an attempt to extract the relevant information into a table format based on the "Performance Data" section:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "laboratory testing," but does not provide any details regarding sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the studies described are non-clinical (laboratory) tests and do not involve human expert review for establishing ground truth.

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

This information is not provided as the studies described are non-clinical (laboratory) tests and do not involve human review with adjudication.

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

There is no mention of an MRMC study, AI assistance, or human reader improvement in this document. The device is a physical dental implant system, not an AI software.

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

This is not applicable as the device is a physical dental implant system, not an algorithm.

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

For the non-clinical tests, the "ground truth" is established by adherence to recognized international standards for laboratory testing (e.g., ISO 10993-5, USP , ISO 14801, ISO 11137, ISO 17665). The outcomes are objective measurements against these standards. There is no mention of expert consensus, pathology, or outcomes data in the context of these specific performance tests.

8. The sample size for the training set

This is not applicable/not provided. The document describes a physical medical device and non-clinical performance testing, not a machine learning model that would require a training set.

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

This is not applicable/not provided as there is no training set for a machine learning model.

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