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ICX-Implant System is indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. ICX- Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7.0 mm are indicated for delayed loading only.

ICX-Implant System CAD CAM abutments are intended for use with dental implants as a support for single unit or multiple unit prostheses in the maxilla of a partially or fully edentulous patient. All digitally designed abutments for use with ICX-Implant System CAD CAM abutments are intended to be manufactured at a medentis medical GmbH validated milling center.

The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system. ICX-Implant System, from medentis medical GmbH. The ICX-Implant System includes a range of endosseous dental implants and prosthetic components. All implants have a selftapping apical thread with a tapered body and root-form designs with an internal hex implant/abutment connection. The implant body surface is blasted and acid-etched.

Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations.

The provided text is a 510(k) summary for the "ICX-Implant System." This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to previously cleared devices rather than proving the device meets specific acceptance criteria through a standalone performance study.

Therefore, the document does not contain the detailed information required to fully answer all aspects of your request, especially regarding specific acceptance criteria for AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment for a test/training set in the context of an AI device.

The document does describe non-clinical performance data for the dental implant system itself (e.g., sterilization, biocompatibility, mechanical testing) to show its safety and effectiveness, but not for an AI component.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

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

• Missing: The document does not define "acceptance criteria" in the context of an AI/algorithm's performance (e.g., sensitivity, specificity, AUC). Instead, it discusses the substantial equivalence of the ICX-Implant System and its components to predicate devices based on technological characteristics, materials, and indications for use.
• The "Performance Data" section (Page 7) lists non-clinical tests performed, such as:
  • Validation of gamma irradiation sterilization to a sterility assurance level (SAL) of 10⁻⁶.
  • Bacterial endotoxin testing:

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BioHorizons Tapered Pro Conical dental implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

BioHorizons Tapered Short Conical dental implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. These dental implants must be restored using delayed loading, for single tooth replacement, or may be used with a terminal or intermediate abutment for fixed or removable bridgework or for overdentures. Tapered Short Conical implants should be used only when there is not enough space for a longer implant. If the ratio of crown length is unfavorable, the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.

BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed abutments for use with Conical CAD/CAM Ti Blanks and Ti Bases are to be sent to a BioHorizons validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system, Tapered Pro Conical Implant System, from BioHorizons Implant Systems Inc. The Tapered Pro Conical Implant System includes a range of ental implants and prosthetic components, BioHorizons Tapered Pro Conical implants feature a tapered screw-shaped design with a reverse buttress thread. Cutting flutes are incorporated into the thread to be self-tapping when placed into the prepared surgical site. The outer surface of the implant has been roughened with resorbable blast texturing (RBT) using a hydroxyapatite blast media. Internally, the implant features a deep conical prosthetic connection between implants and abutments with six anti-rotation cams at the base of the connection, intended to interface with the three cams of the prosthetic components. It is available with or without Laser-Lok treatment applied to the collar of the implant.

Tapered Pro Conical Implants are available in a range of implant diameters and lengths with two prosthetic platform (implant/abutment connection) sizes, as shown below. Internal surfaces of the Tapered Pro Conical Regular platform implants are anodized yellow to distinguish them from Narrow platform implants.

Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations. The Conical Ti-Base abutments are a two-piece abutment composed of a pre-manufactured Ti Base component and a CAD/CAM patient-matched mesostructure (superstructure) composed of sagemax® NexxZr zirconia (K130991).

The provided text is a 510(k) premarket notification summary for a dental implant system. It does not describe a study to prove the device meets acceptance criteria related to an AI/ML-driven medical device, nor does it contain information on the performance data, sample sizes, expert ground truth establishment, or multi-reader multi-case studies typically associated with such devices.

The document focuses on demonstrating substantial equivalence to predicate dental implants and their components. The "PERFORMANCE DATA" section (page 7 of the PDF, starting on page 8 of the transcription) lists non-clinical data such as validation of sterilization, bacterial endotoxin testing, shelf-life testing, biocompatibility, MRI compatibility, and mechanical testing, which are standard for dental implants.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about acceptance criteria and a study proving the device meets those criteria, specifically for an AI/ML medical device.

To be explicit, the document states:

• "No clinical data were included in this submission." (Page 7)
• The performance data discussed are entirely non-clinical and relate to the physical and material properties of the dental implants, not an AI or software component assessing images or providing diagnostic assistance.

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The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially or fully edentulous jaws for the purpose of restoring function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.

The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:

• · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
• · BioHorizons Multi Unit Abutment, 4.8mm, max 30°
  • · CONELOG® Implant System
• · Biomet 3 i Multi Unit Abutments, 4.8mm, max 30°
  • · TSXTM Implants
  • · Tapered Screw-Vent Implant
• · DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
  • · 3i OSSEOTITE®
  • · Astra Tech OsseoSpeed™
  • · Neodent Grand Morse
  • NobelReplace® Trilobe
  • · NobelReplace® Conical
  • · Nobel Brånemark System®
  • · Straumann BLX Implants
• · DESS Dental Multi Unit Abutments. Angled. 3.4-6.5 mm, max 30°
  • · NobelActive® NobelParallel Conical
  • Straumann® Bone Level
  • · Zimmer Screw Vent® and Tapered Screw-Vent®
• · Dentium SuperLine® Abutments, 4.5-5.5 mm, max30°
• · Genesis ACTIVE™ Multi-Unit Abutments, 4.8mm, max 30°
• · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
• KDG Abutments, 4.8mm, max 30°
• · Keystone Multi Unit Abutment, 4.8mm, 0°
• · Medentika Multi Unit Abutments, 4.8mm, max 30°
  • · EV Series Dentsply® Implants Astratech Osseospeed®
  • · F Series Nobel Biocare NobelActive® NobelReplace® Conical
  • · H Series Biomet 3i Certain®
  • L Series Straumann Bone Level
  • · N Series Straumann Soft tissue Level
  • · R Series Zimmer Dental Tapered Screwvent®
• Medentika Multi Unit Abutments, 4.8mm, 0°
  • E Series Nobel Biocare Replace™ Select
  • · I Series Biomet 3i Osseotite®
  • K Series Nobel Biocare™ Branemark
  • · S Series Astra Tech OsseoSpeedTM
  • · T Series Dentsply Friadent® Frialit/Xive®
• · MegaGen Multi Unit Abutments, 4.8mm, max 30°
• · Xpeed® AnyRidge® Internal Implant System
• AnyOne® Internal Implant System
• AnyRidge® Octa 1 Implant System
• AnyOne® External Implant System
• AnyRidge® Octa 1 Implant System
• AnyOne® Internal Implant System
• Rescue Internal Implant System
• MIS Multi-unit Abutments, 4.8mm
  • · C1 Conical Connection Implant System, max 30°
  • · V3 Conical Connection Implant System, max 30°
  • · Internal Hex Implant System, max 30°
  • · Conical Connection, max 30°
• · Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
• · Nobel Biocare™ Brånemark Multi Unit Abutment, 4.8 mm, max 17°
• · Nobel Biocare™ Multi Unit Abutment Plus, 4.8 mm, max 30°
• · Nobel Biocare™ Multi Unit Abutment, 4.8 mm, max 30°
• Nobel Biocare™ Multi Unit Abutments for Straumann and Astra Tech System, 4.8 mm, max 30°
• Nobel Biocare™ Multi Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
• · Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
• · OSSTEM Multi Unit Abutment, 4.8mm, max 30°
  • SS SA Fixture Implants
  • SA Implant System
  • · ET US SSS Prosthetic System
• · Paltop Multi Unit Abutment, 5.0 mm, max 17°
• · Southern Compact Conical Abutments, 4.8 mm
  • MAX Implant System, 0°
  • · Provata Implant System, max 30°
  • · Deep Conical (DC) Implants, 0°
  • · Piccolo Implants, 0°
  • · External Hex Implants, max 30°
• Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30°
• · Straumann® Screw Retained Abutment, 4.6 mm, max 30°
• · Zimmer Angled Tapered Abutments, 4.5 mm, max 30°

The Osteon Precision Milled Suprastructures (also referred to as superstructures) are metallic dental restorative devices that are intended to be attached by screw retention to dental implant abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function. These suprastructures attach to dental implant abutments using the prosthetic screws from the original equipment manufacturers (OEM) and are used to support the final multi-unit restoration.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's dental impression. The suprastructure is manufactured with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical.

Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence are categorized as Type A and Type B.

• Type A: Intended to act as a supporting structure to facilitate the attachment of a removable dental prosthesis and include Primary Bar and Nexus Removable Bar.
• . Type B: Intended to act as a supporting structure to facilitate the attachment of a fixed dental prosthesis and include Melbourne Bar and Nexus Fixed Bar (including Nexus Hybrid, Nexus Bridge, Micro Nexus, and Nexus Wraparound).

The provided FDA 510(k) summary (K233083) describes the acceptance criteria and study for the Osteon Precision Milled Suprastructure.

1. Table of Acceptance Criteria and Reported Device Performance

This submission is a 510(k) for an expansion of an existing device (K221019) to add compatibility with new OEM abutment systems and introduce three new Type B Nexus Fixed Bars. The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and material composition.

The tables below synthesize the design specifications (acceptance criteria) and the device's performance (reported as meeting these specifications) by demonstrating substantial equivalence to predicate devices.

Table 1: Comparison of General Characteristics and Materials (summarized for clarity)

Table 2: Design Specifications (Acceptance Criteria vs. Reported Performance)

*Note for Suprastructure Height: The Minimum Suprastructure Height for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3*-22 mm, where * indicates variability for this new bar.
**Note for Suprastructure Width: The Minimum Suprastructure Width for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3.4**-12 mm, where ** indicates variability for this new bar.

2. Sample size used for the test set and the data provenance

The submission is a 510(k) for an expansion of an existing device (K221019). The "study" proving the device meets acceptance criteria primarily relies on non-clinical data and demonstration of substantial equivalence to predicate devices.

• Test set/Sample size: The document does not describe a "test set" in the traditional sense of a clinical or imaging study with a defined sample size for statistical analysis. Instead, it relies on:
  • Reverse engineering analysis of OEM abutments and OEM abutment screws: This was done to confirm compatibility. The sample size for this analysis is not explicitly stated but would involve the specific OEM abutments listed for compatibility with the subject device.
  • Fatigue testing: The document states, "Fatigue testing was not performed since the Subject devices are abutment-borne and are not intended to compensate for angulation in excess of the maximum angulation of OEM angled abutments..." This indicates that engineering analysis and design specifications, rather than physical fatigue testing, were used to demonstrate performance in this regard.
• Data provenance: Not directly applicable as there isn't a "test set" from patients. The data relies on engineering analysis, existing predicate device data, and compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert readers to establish ground truth. Substantial equivalence claims are based on engineering, material, and design comparisons to legally marketed devices.

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

Not applicable. There is no "test set" or diagnostic performance study that would require an adjudication method.

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 device is a physical dental suprastructure, not an AI-powered diagnostic tool.

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

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

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

The "ground truth" equivalent for this submission is the established safety and effectiveness of the primary predicate device (K221019) and various reference devices, supported by:

• Compliance with recognized standards: Biocompatibility (ISO 10993-5, ISO 10993-12), sterilization validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, ANSI/AAMI/ISO 14937).
• Material specifications: Conformance to ASTM F136 for titanium alloy.
• Engineering analysis and design specifications: Comparison of design features to predicate devices and confirmation of compatibility through reverse engineering.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As above, there is no training set for this device.

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