Search Results

BoneTrust® Dental Implants are medical devices intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients' chewing function.

BoneTrust® implants can also be used for immediate loading when sufficient primary stability is achieved and with appropriate occlusal loading.

BoneTrust® Short Dental Implants with length 6.5 mm are intended for delayed loading only

BoneTrust® Abutments and Prosthetic parts are intended for use with Bone Trust Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdentulous or partially edentulous patients.

The BoneTrust® Implant System includes various sizes of threaded root-form dental implants and abutments intended to support prosthetic restorations in edentulous or partially edentulous patients.

The BoneTrust® Implants are bone level, root form implants constructed of commercially pure titanium (Grade 4) per ISO 5832-2, with a sand-blasted, acid-etched surface treatment. BoneTrust® Implants are screw- shaped dental implants with a Hexagon or conical torx internal connection.

BoneTrust® Dental Abutments are intended for cement-retained and screw-retained restorations. A cylindrical internal hexagon or conical torx allows connection to the BoneTrust® implant. BoneTrust® Dental Abutments are available in different designs

This document is a 510(k) summary for the BoneTrust® Implant System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a standalone study for novel performance metrics. Therefore, many of the requested sections about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable.

However, I can extract the information provided regarding non-clinical testing used to support substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a novel AI device. Instead, it relies on demonstrating "substantial equivalence" through non-clinical testing to legally marketed predicate devices. The "reported device performance" is essentially that the device performed comparably to predicate devices in the described tests.

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 does not provide specific sample sizes for the test sets in the non-clinical studies. It mentions "representative samples" for fatigue testing. Data provenance is not specified beyond being non-clinical testing performed to support substantial equivalence to legally marketed predicate devices.

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)

Not applicable. This is a 510(k) submission for a physical medical device (dental implants and abutments), not an AI/software device requiring ground truth establishment by human experts for diagnostic or similar tasks. The "ground truth" for the non-clinical tests would be the measurement results from the tests themselves (e.g., cytotoxicity levels, fatigue limits, physical characteristics).

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

Not applicable, as this is for a physical device and involves objective non-clinical tests rather than subjective human interpretation needing 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

Not applicable. This is not an AI-assisted diagnostic or interpretation device.

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

Not applicable. This is a physical device, not an algorithm.

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

For the non-clinical studies performed, the "ground truth" would be objective measurements obtained through standardized testing methods, such as:

• Biocompatibility: Laboratory results (e.g., cell viability in cytotoxicity tests).
• Fatigue testing: Load cycles to failure or endurance limit under specified conditions, as per ISO 14801.
• Sterilization: Sterility Assurance Level (SAL), microbial ingress testing, package integrity.
• Implant Surface Analysis: Microscopic imagery (SEM, BSE) and elemental composition data (EDX).
• Short Implants Performance: Quantitative measurements from comparative surface area analysis, histological examination for bone-to-implant contact (animal study), and force measurements for pull-out strength tests.

8. The sample size for the training set

Not applicable. There is no training set mentioned for this physical device.

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

Not applicable. There is no training set for this physical device.

Ask a specific question about this device