Search Results

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.

Ask a specific question about this device

Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Medentika Abutment System is an abutment system including ten abutment designs compatible with eleven currently marketed implant systems. The abutment designs include abutments for single-tooth and multiple-tooth restoration for supporting cement-retained, screw-retained or overdenture prostheses. Platform diameters range from 3.3 mm to 7.0 mm. Corresponding implant diameters range from 3.25 mm to 7.0 mm. Angled abutment designs for connections with anti-rotational features are available in two orientations, Type 1 and Type 2. Type 1 is for abutments with the cone angle oriented toward the flat of the anti-rotational feature and Type 2 is for abutments with the cone angle oriented toward the corner or lobe of the anti-rotational feature. The maximum angle for any abutment within the eleven systems is 21 °

The provided text is a 510(k) summary for the Medentika Abutment System, a medical device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The context of this type of document is a regulatory submission, not a study evaluating AI performance or a diagnostic device. Therefore, the questions related to AI, ground truth establishment, expert consensus, sample sizes for AI training/testing, adjudication methods, and MRMC studies are not applicable to the information contained in this document. The document describes a "substantial equivalence" claim for a physical medical device (dental abutments), meaning it demonstrates the device is as safe and effective as a legally marketed device.

Here's the information that can be extracted or inferred based on the provided text, with responses to your questions where applicable and an explanation when not applicable:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with defined thresholds. Instead, it refers to regulatory compliance and equivalence to predicate devices. The "reported device performance" is demonstrated through various non-clinical tests designed to show the physical and mechanical properties are comparable to existing, legally marketed devices.

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

This information is not provided in the document. The document refers to "non-clinical testing data" for sterilization, biocompatibility, engineering, dimensional, and static/dynamic compression-bending tests. These types of tests typically involve a sample of units for each test, but the specific number of units is not detailed in this summary. The data provenance is also not specified, though the manufacturer (Medentika GmbH) is based in Germany. The tests are prospective in nature, as they involve testing the actual device components.

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 question is not applicable. This document describes a medical device approval based on physical properties and comparison to predicate devices, not an AI or diagnostic study requiring expert ground truth for a test set.

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

This question is not applicable. There is no "test set" in the context of expert review or diagnostic assessment for this type of device approval.

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

This question is not applicable. This is a physical medical device (dental abutment), not an AI-assisted diagnostic or imaging system.

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

This question is not applicable. This is a physical medical device, not an algorithm.

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

This question is not applicable in the context of expert-determined ground truth for a diagnostic task. For this device, the "ground truth" equivalent would be established by:

• Established ISO standards: For sterilization (ISO 17665-1, ISO 17665-2), biocompatibility (ISO 10993-5), and mechanical fatigue (ISO 14801). Compliance with these standards is considered the "truth" for safety and performance in their respective domains.
• Performance of predicate devices: The "truth" is that the predicate devices are legally marketed and considered safe and effective. The subject device demonstrates comparable performance to these established devices.

8. The sample size for the training set

This question is not applicable. This document describes the approval of a physical medical device, not an AI algorithm requiring a training set.

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

This question is not applicable. There is no "training set" in the context of AI for this device approval.

Ask a specific question about this device