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Dental Implant Abutments Bone Level are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses.

Abutments can be used in single tooth replacements and multiple tooth restorations. The Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm.

The Dental Implant System OKTAGON® Bone Level is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

The Dental Implant System OKTAGON® Bone Level is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially of fully edentulous patients.

The devices covered in this submission are angled abutments and an addition to the currently available Dental Implants and Abutments OKTAGON® Bone Level.

The abutments are made of Titanium Grade 4, the alligator abutments and screws are made of Titanium Alloy (TiAl6V4); the connection to the implants is achieved by an internal octagon/nut construction and a metric thread.

This document is a 510(k) Summary for the Endosseous Dental Implant Abutments OKTAGON® Bone Level. It focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria for a novel device. Therefore, much of the requested information about acceptance criteria, study sizes, expert involvement, and ground truth types for AI/ML device studies is not applicable or not present in this document.

However, based on the provided text, here's what can be extracted and inferred:

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

Since this is a submission for substantial equivalence based on predicate devices, explicit "acceptance criteria" for novel device performance are not listed in a quantifiable table as they would be for a new technology with specific performance claims. Instead, the "acceptance criteria" are implied by adherence to recognized standards and similarity to predicate devices.

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

• Sample Size for Test Set: Specific sample sizes for the mechanical and biocompatibility tests are not disclosed in this summary. The document states that "performance tests (breakage and fatigue tests) have been conducted," but does not provide the number of units tested.
• Data Provenance: Not specified. The manufacturer is Hager & Meisinger GmbH, located in Neuss, Germany. Testing was likely conducted in Germany or by certified labs.
• Retrospective or Prospective: Not specified, but typically, these types of laboratory tests for medical devices are conducted prospectively under controlled conditions.

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 information is not applicable to this type of device submission. The device is a physical dental implant abutment, and its performance is evaluated through standardized material and mechanical testing, not through expert review of data like an AI/ML diagnostic device.

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

• This information is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in evaluating clinical data or outputs of AI/ML systems where subjective interpretation might be involved. The testing here involves objective measurements against engineering standards.

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 information is not applicable to this type of device submission. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation enhanced by AI. This device is a physical implant component.

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

• This information is not applicable to this type of device submission. This device does not involve an algorithm.

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

• The "ground truth" for this device's performance is based on established engineering and medical device standards. For example:
  • Mechanical Integrity: ISO 14801 (Fatigue Testing) and the FDA's Class II Special Controls Guidance document for dental implants.
  • Biocompatibility: ISO 10993-1, ISO 7405, ISO 10993-5.
  • Sterilization: ISO 17665-1, ISO 17665-2, ANSI/AAMI ST 79.
  • Materials: ASTM F136, ASTM F67, ISO 5832-2, ISO 5832-3.
  • The "ground truth" is adherence to these normative standards and comparison to the characteristics of legally marketed predicate devices.

8. The sample size for the training set

• This information is not applicable as this device does not involve a training set for an AI/ML algorithm.

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

• This information is not applicable as this device does not involve a training set for an AI/ML algorithm.

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