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Medentika TiBase CAD/CAM 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.

The Medentika TiBases are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The TiBases are provided in several models and dimensions, according to the compatible implant systems declared in the Indications for Use statement.

The design of the CAD/CAM restorations is to be carried out through the Straumann CARES Visual Plug-In for Dental Wings CAD System. The patient-specific restorations must be milled by a Straumann milling center.

This document is a 510(k) submission for the Medentika CAD/CAM TiBases, which are dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a de novo approval requiring extensive clinical studies with acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes for AI/ML devices. Therefore, much of the requested information regarding AI/ML specific studies (MRMC, standalone performance, ground truth establishment for training/test sets, expert qualifications, adjudication methods) is not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this device (dental implant abutments), the "acceptance criteria" are related to mechanical performance and biocompatibility, demonstrating that the new devices are as safe and effective as the predicate devices. The performance data presented are primarily comparative to predicate devices rather than against specific numerical thresholds in a table.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of an AI/ML device evaluating data. For mechanical testing, specific sample sizes are not provided in this summary, but would typically be defined by the relevant ISO standards (e.g., ISO 14801). The "data provenance" would be from laboratory testing performed on the physical devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable for this type of device submission. Dental implant abutments do not use expert-established ground truth in the same way an AI diagnostic algorithm would.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, this is not an AI/ML device, so an MRMC study is not relevant.

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

Not applicable, as this is a physical medical device (dental implant abutment), not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility and sterilization, the "ground truth" is established by adherence to international standards (ISO 10993-1, ISO 17665-1/2) and successful completion of the tests defined within those standards. For mechanical testing, the "ground truth" is the established performance of the predicate device under specified fatigue test conditions as per ISO 14801.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

Not applicable.

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Indications for Use for GM implants and conventional abutments:

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Indications for Use for GM Titanium Base abutments:

Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.

All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Indications for Use for GM Pro Peek Abutments:

The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

The GM Line of the Neodent Implant System (GM Line) consists in an expansion of the Neodent Implant System previously cleared under K101945, K150182 and K153624, presenting a new design of Morse taper implant-to-abutment interface trade named GM line.

The GM line comprises a range of endosseous dental implants as well as conventional and CAD/CAM abutments described as follows:

The GM Line dental implants are threaded, self-tapping, root form with a Morse taper implantto-abutment interface with an internal hexagonal index exclusive to the GM line. They are made of titanium grade 4 conforming to ASTM F67. They are available in two types of surface treatment:

NeoPoros: rough surface created using an abrasive particle jet concept with controlled grain oxides, followed by acid etching creating uniform cavities in the implant surface.

Acqua: hydrophilic surface created from Neoporos rough surface that undergoes additional processing that renders hydrophilic surface.

GM Titamax implants: cylindrical shape with double threads of pyramidal profile, rounded apex.

GM Helix implants: conical shape, double threads with trapezoidal profile, a rounded apex.

GM Drive implants: conical shape with double and progressive threads, cutting chambers in the counterclockwise direction, blade-shaped apical thread, rounded apex.

The GM Line dental abutments are made of titanium alloy conforming to ASTM F136 and have a machined surface. The abutments are intended to be placed directly onto implants and are recommended according to the available interocclusal space, gingival height, and threedimensional position of the implant. They can be used in immediate or conventional rehabilitation procedures on the maxilla or mandible.

GM Cover Screws: devices for temporary use during the implant healing phase.

GM Healings: devices for temporary use for maintenance of the soft tissue during the osseointegration phase.

GM Micro Abutments / GM Mini Conical Abutment / GM Exact Mini Conical Abutment: intermediary prosthetic components to be installed onto GM implants to support the final prosthesis.

GM Exact Abutments: intermediary prosthetic components to be installed onto GM implants to support the final prosthesis.

GM Exact Click Universal Abutments (straight and angled): intermediary prosthetic components to be installed onto GM implants to support the final prosthesis.

GM Exact Titanium Base abutments: intermediary prosthetic components to be installed onto GM implants to support the final prosthesis; the Titanium Base two-piece abutments used as a base when fabricating a CAD/CAM customized restoration.

GM Pro PEEK Abutment: temporary intermediary prosthetic components to be installed onto the Implants to support the provisional prosthesis up to 6 months.

Protection Cylinders: prosthetic components with a tapered shape intended to be placed on abutments to protect them during the fabrication of the prosthesis and/or healing of the peri-implant tissues.

Coping Screws: prosthetic devices intended for coping fixation on the corresponding GM (screw-retained) abutment.

This document is a 510(k) Premarket Notification from the FDA regarding the "Neodent Implant System - GM Line." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than an independent study proving the device meets specific acceptance criteria in a clinical or performance study context.

Therefore, the information requested in your prompt (Acceptance Criteria, Study Design for proving performance, Sample Sizes, Expert consensus, MRMC studies, etc.) is not present in this document. This document details the comparison of the new device with existing ones based on:

1. Indications for Use: The new device's indications align with or are subsumed by those of the predicates.
2. Technological Characteristics: Materials, design features, sterilization methods, and compatibility are compared.
3. Performance Data (Mechanical Testing and Biocompatibility): This section confirms that the materials meet established standards (ASTM, ISO) and that the device components (implants, abutments) have undergone mechanical fatigue testing according to ISO 14801 and FDA guidance. Biocompatibility has been assessed for the materials used. However, it does not provide specific acceptance criteria or detailed results of these tests, simply stating that the performance is "equivalent" to predicate devices.

Summary of missing information based on your prompt:

• Table of acceptance criteria and reported device performance: Not provided in a quantifiable manner for clinical performance. Only mentions "equivalent" mechanical performance based on ISO standards.
• Sample sizes for test set and data provenance: No clinical test set involving human subjects is described. Mechanical tests likely involved specific numbers of devices, but these are not disclosed.
• Number of experts and qualifications for ground truth: Not applicable as no clinical ground truth assessment is detailed.
• Adjudication method for test set: Not applicable.
• MRMC comparative effectiveness study: Not conducted or reported. This submission relies on substantial equivalence to existing devices, not a comparative clinical trial with human readers/outcomes.
• Standalone performance (algorithm only): Not applicable as this is a physical medical device (dental implant system), not an AI algorithm.
• Type of ground truth used: For regulatory purposes, the "ground truth" for this submission is established through comparison to legally marketed predicate devices and adherence to relevant industry standards (ISO, ASTM) and FDA guidance for mechanical and biocompatibility testing. No clinical "ground truth" derived from patient outcomes or expert consensus on images is mentioned regarding the device's function.
• Sample size for training set: Not applicable as this is not an AI/ML device.
• How ground truth for training set was established: Not applicable.

In conclusion, this document demonstrates regulatory compliance and substantial equivalence through a comparison of device characteristics and a statement of meeting mechanical and biocompatibility standards, rather than presenting a detailed study proving the device meets specific, quantifiable clinical acceptance criteria.

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