(276 days)
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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility according to ISO 10993-5:2009 | Cytotoxicity testing demonstrated the biocompatibility of the devices. |
| Bacterial Endotoxins Test according to USP | (Result implicit in "laboratory testing and determined device functionality") |
| Fatigue Testing according to ISO 14801:2007 | Fatigue testing of BONAFIX TWO implants and predicate devices were comparable. |
| Sterilization validation according to ISO 11137 series and ISO 17665 series | Sterility validation testing was performed and demonstrated the equivalence of the devices to their predicates. |
| Device functionality and conformance to design input requirements | BONAFIX has conducted laboratory testing and determined device functionality and conformance to design input requirements. |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.