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The BoneTrust® Mini and Mini+ Implants are intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implant(s). Use of BoneTrust® Mini and Mini+ Implants is not to exceed one hundred and eighty (180) days.

BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments are intended for use with BoneTrust® Mini / Mini+ Dental Implants to provisional prosthetic reconstructions during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments is not to exceed one hundred and eighty (180) days.

BoneTrust® Mini Ball Attachments are intended to be used with BoneTrust® Mini / Mini+ Dental Implants to support and/or retain provisional removable dental prostheses during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Ball Attachments is not to exceed one hundred and eighty (180) days.

The BoneTrust® Mini Implant System is a two-piece dental implant system including various sizes of threaded root-form dental implants and abutments to provide temporary support of prosthetic restorations in edentulous or partially edentulous patients during the healing phase of permanent endosseous dental implant(s). The maximum duration of intraoral use of all members of the BoneTrust® Mini Implant System is 180 days.

The provided text describes a 510(k) premarket notification for the BoneTrust® Mini Implant System. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a new device meets specific performance acceptance criteria through the types of studies typically conducted for novel AI/ML-driven medical devices.

Therefore, the requested information about acceptance criteria tables, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment is not present in this document. This document primarily relies on a comparative analysis of:

• Indications for Use: The BoneTrust® Mini Implant System's intended use is compared to that of primary and reference predicate devices (EM Provisional, Sterngold 2.2mm Angled Micro ERA Dental Implant System, BoneTrust® Implant Systems, MIS LOCKIT Abutments System, Nobel Biocare AB, OSSTEM Implant Co. Ltd.). The conclusion is that the indications are "Similar to primary predicate device" or "Substantially Equivalent." The additional limitation of implant duration (max 180 days) is noted as not changing the intended use.

• Technological Characteristics: Detailed comparisons are made regarding:

  • Implant Material: Titanium Grade 4 ASTM F67, identical to reference device K182313.
  • Implant Type and Design: Screw-type, straight body/tapered body, self-tapping, with thread, two-piece design. Largely identical or similar to predicate/reference devices.
  • Implant-Abutment Connection: External Torx Implant/Abutment fixture. Differences from some predicates (one-piece design or different connection types) are stated not to raise concerns regarding safety and effectiveness.
  • Implant Dimensions: The proposed device's sizes (diameters and lengths) are stated to be "within range of primary predicate device."
  • Surface Treatment: Machined / Microstructured blasted etched surface passivated, stated as identical to K191751 and K182313.
  • Sterilization: Beta Radiation, identical to K182313.
  • Abutment Material, Surface, Size, Connection, Angulation, and Sterility: Comparisons are made to various predicate/reference abutments, with conclusions of "Identical" or minor differences not raising safety/effectiveness concerns.
  • Ball Attachment Material, Surface, Size, Connection, Angulation, and Sterility: Similar comparisons are made, concluding "Identical" or differences not impacting safety/effectiveness.

• Non-Clinical Testing Summary:

  • Clinical Studies: None were performed.
  • Biocompatibility: Relied on previous clearance of BoneTrust® Implant System (K182313) due to identical manufacturing process and materials. Periodic bacterial endotoxin testing (USP ) is performed, with historical data showing acceptable levels.
  • Fatigue Testing: Not deemed necessary as per FDA Guidance Document for Class II Special Controls, because the system does not contain angulated abutments.
  • Sterilization: Beta-radiation sterilized (SAL 10⁻⁶) according to ISO 11137-1:2006 and 11137-2:2013. Efficacy reliant on K182313 due to identical process. Unsterile prosthetic components are intended for end-user sterilization, with methods identical to K182313.
  • Shelf Life: 5 years, reliant on K182313 due to identical packaging system.
  • Implant Surface Analysis: Energy Dispersive X-ray Spectroscopy (EDX) and SEM analysis were conducted, and results support substantial equivalence to legally marketed predicate devices.

In summary, there is no study described in this document that proves the device meets specific acceptance criteria in the manner requested, because the submission focuses on demonstrating substantial equivalence to existing devices through comparative analysis and non-clinical testing rather than de novo clinical or performance studies with defined acceptance criteria for a novel AI/ML device.

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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.

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