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Bonafix 2 Plus Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Bonafix 2 Plus implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading.

The current submission requests clearance for the Class II Bonafix 2 Plus implant system. The Bonafix 2 Plus Implant is a bone level type implant, built in Grade 5 ELI Titanium Alloy and treated with RBM technology. The implant has a conventional internal hex connection style. The crestal zone of implant have micro-rings. The design crestal zone (straight or tapered) depends on Implant diameter because the implant system has only one platform. The body of the implant is tapered, designed with a double progressive thread with a small internal channel at the bottom of the thread; and the apex of the implant has a flat shape. Has two-spiral channel at the apical end of the implant that provide self-tapping properties to the implant.

The implants are provided in several different dimensions, 3.5, 3.75, 4.2, 5.0, and 6.0mm of diameter, and lengths of 8, 10, 11.5, 13 and 16mm. Hex Connection 6.0 diameter implants do not come in 13 or 16mm length.

Cover screw, Healing Caps (3.8 and 4.6mm of diameters) and 3 types of abutments: Straight abutments, Angled abutment and Multi-unit abutments, are included in the system.

The FDA 510(k) summary for the Bonafix 2 Plus implant system does not contain the level of detail regarding device performance metrics that you are requesting for a typical AI or software as a medical device (SaMD) study.

This document describes a premarket notification for a Class II medical device, which is an endosseous dental implant. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove specific performance against quantitative acceptance criteria in a clinical study as would be done for an AI/SaMD product.

Here’s a breakdown of why I cannot fulfill your request as phrased, and what information is available:

The document does not describe a study that proves the device meets specific performance acceptance criteria in the way an AI/SaMD device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and material analysis.

Missing Information (for an AI/SaMD context):

1. Table of Acceptance Criteria and Reported Device Performance: This document does not present acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy, or AUC) typically used for AI/SaMD, nor does it report such performance for the Bonafix 2 Plus. The "performance" here is related to mechanical and biological properties demonstrating equivalence to existing devices.
2. Sample size used for the test set and data provenance: No test set is described in the context of an AI/SaMD study.
3. Number of experts used to establish ground truth & qualifications: Not applicable, as there's no diagnostic AI component requiring ground truth establishment by experts.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. There is no AI component for human-in-the-loop performance evaluation.
6. Standalone (i.e., algorithm only without human-in-the-loop) performance: Not applicable. This is a physical medical device.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide, reframed:

The "acceptance criteria" for this device are largely implied through meeting established industry standards for mechanical properties, biocompatibility, and sterilization, and demonstrating that any differences from predicate devices do not raise new safety or effectiveness concerns.

1. "Acceptance Criteria" (Implied by Standards) and "Reported Device Performance":

Since the "acceptance criteria" are not quantitative performance metrics in the AI/SaMD sense, I will list the standards to which the device was tested and the conclusion of those tests regarding "performance" relative to the predicate.

2. Sample Size for Test Set and Data Provenance:

• Test Set Description: The document describes non-clinical bench testing on devices, not a test set of patient data.
• Sample Size: Not explicitly stated for each test, but implied to be sufficient for the validation of each standard (e.g., number of implants for fatigue testing, number of samples for SEM/EDS, etc.).
• Data Provenance: The "data" comes from bench tests conducted by the manufacturer, not from retrospective or prospective patient data from specific countries.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable as this is not an AI/SaMD device requiring expert-established ground truth. The "ground truth" for the non-clinical tests would be the established scientific principles and standard requirements (e.g., proper material composition, the ability to withstand a certain load, sterilization effectiveness).

4. Adjudication Method:

• Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• No. This is a physical dental implant, not an AI system.

6. Standalone Performance (Algorithm Only):

• No. This refers to the performance of the physical device in bench tests against established standards.

7. Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" is defined by the validated and established scientific standards and testing protocols (e.g., ISO 14801 for dynamic fatigue, ISO 10993 for biocompatibility, ISO 11137 for radiation sterilization). It's not expert consensus, pathology, or outcomes data in the typical AI/SaMD context.

8. Sample Size for the Training Set:

• Not applicable. There is no AI model or training set discussed.

9. How Ground Truth for the Training Set Was Established:

• Not applicable.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (dental implant). It demonstrates substantial equivalence to existing devices through a series of non-clinical bench tests conforming to recognized standards, rather than through comparative clinical performance studies or specific performance metrics typical of AI/SaMD.

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