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Custom Abutment AS Ti:
The Custom Abutment with Angled Screw Channel is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments with Angled Screw Channel are indicated for screw-retained single restorations or cemented retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Angled Screw Channel are intended to be sent to Straumann for manufacturing at a validated milling center.

ASC Screw:
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.

This premarket notification includes new digital abutments to the Neodent Implant System (GM, NGM and HS prosthetic interfaces). The abutments proposed on this submission are identical to devices already cleared in previous submissions of Neodent Implant System, according to predicate devices described above, being the only difference between them the introduction of a new angled channel solution. This submission intends to expand the portfolio of Neodent Implant System. The Custom Abutments AS Ti are composed of a unique body with two different regions: the upper region, which is the customizable portion, and the end region presents the prosthetic interface that fits with the implant, which does not allow customization. They must be sent to a Straumann Validated Milling

This document describes the Neodent Implant System - Custom Abutments and its FDA 510(k) clearance (K250614). The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results with specific acceptance criteria and performance metrics for a novel AI/software device.

Based on the provided text, the device is a physical medical device (dental implant abutment) and not an AI/software device. Therefore, the questions related to AI/software performance studies, such as sample size for test sets, expert adjudication, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.

The "Performance Testing" section primarily describes bench testing (dynamic fatigue and torsion tests), biocompatibility testing, and sterilization validation, which are standard for physical medical devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format typically seen for performance metrics of a diagnostic device. Instead, it describes general compliance with standards and the determination of "not a new worst case" for dynamic fatigue.

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

• Sample Size for Bench Testing (Dynamic Fatigue and Torsion): Not
  explicitly stated. The document mentions "a worst case analysis determined that the subject devices are not a new worst case compared to those devices tested for the primary predicate." This implies that testing was performed on a sufficient number of samples to make this determination, likely following the requirements of ISO 14801.
• Data Provenance: Not explicitly stated, but these are typically laboratory-based bench tests performed by the manufacturer or a contracted testing facility.

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

• Not Applicable. This is a physical device, and the testing involves objective measurements (e.g., force, torque, material properties) rather than expert interpretation of data for ground truth establishment.

4. Adjudication Method for the Test Set

• Not Applicable. As above, the tests are objective physical measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• Not Applicable. This is a physical device, not an AI-assisted diagnostic or decision support system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is a physical device. While it involves digital design using CAD/CAM software, the 'device' itself is the physical abutment, and its performance is evaluated through physical and material tests, not software algorithm performance.

7. The Type of Ground Truth Used

• Physical/Material Standards and Engineering Specifications. For dynamic fatigue and torsion tests, the "ground truth" or acceptance criteria are derived from established engineering principles, material properties (ASTM F136 for titanium alloy), and international standards (ISO 14801). For biocompatibility, it's compliance with ISO 10993 series.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device; there is no "training set" in the context of machine learning or AI models.

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

• Not Applicable. As above, no training set for an AI/ML model for this physical device.

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The Custom Abutment Ti with Screw is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments Ti with Screw are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Screw are intended to be sent to Straumann for manufacturing at a validated milling center.

The Custom Abutment with Angled Screw Channel is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments with Angled Screw Channel are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Angled Screw Channel are intended to be sent to Straumann for manufacturing at a validated milling center.

The Custom Abutments subject to this submission are similar to the devices already cleared in previous Neodent and Nuvo Implant System submissions, per the predicate and reference devices described above. This submission intends to expand the portfolio of digital abutments for the Grand Morse (GM), Narrow Grand Morse (NGM) and Helix Short (HS) lines, to provide more treatment options for customers. These abutments are composed of a unique body with two regions: the upper region is the customized portion, while the end region presents the prosthetic interface that fits with the implant, which does not allow customization.

They are intended for single use and provided non-sterilization recommended before installation in the mouth.

All proposed abutments are delivered to the final user already customized in a validated milling center, with a straight channel solution. For the GM line, the abutments could also be milled with a new angled channel solution for the screw access. All subject devices must be used with their corresponding prosthetic interface.

The provided text describes the Neodent Implant System - Custom Abutments, a medical device. This product is not an AI/ML device, and therefore does not have acceptance criteria or a study that proves the device meets those criteria in the way requested in the prompt.

The document discusses the substantial equivalence of the Neodent Implant System - Custom Abutments to legally marketed predicate devices, which is the basis for its 510(k) clearance by the FDA. The performance testing section describes bench tests (dynamic fatigue and torsion tests), sterilization validation, MR compatibility testing, and biocompatibility testing. These tests evaluate the physical, chemical, and biological properties of the device, comparing them to established standards and predicate devices to demonstrate equivalence, not to meet a set of acceptance criteria for an AI/ML algorithm's performance.

Because the device is not an AI/ML device, the specific information requested about acceptance criteria for AI performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established is not applicable and is not present in the provided text.

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