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IPS e.max® Press Abutment Solutions for Nobel Biocare is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained restorations.

IPS e.max Press Abutment Solutions for Nobel Biocare is recommended for the fabrication of:

• Hybrid abutments for single-tooth restorations -
• -Hybrid abutment crowns for restorations

IPS e.max Press will be used to press full ceramic pressed hybrid abutment crowns, or a customized hybrid abutment part which are luted on to recommended titanium connector abutments.

The provided document describes the IPS e.max® Press Abutment Solutions for Nobel Biocare (K124008), a dental device. The study demonstrating its acceptance is primarily a mechanical fatigue test under dynamic loading.

Here's the information as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The specific quantitative acceptance criteria of ISO 14801:2007 (e.g., number of cycles at a certain load without failure) are not explicitly stated in the provided text, only that the device "meets" them and is "substantially equivalent" to the predicate. The performance is reported as meeting the ISO standard and achieving substantial equivalence.

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

• Test Set Sample Size: Not explicitly stated. The text mentions "Fatigue tests... were completed using Nobel Biocare Replace Select Tapered TiU NP implant, Ø=3,5 mm, I=11.5mm and Snappy abutment 4.0 NobelReplace NP 0.75." This indicates at least one setup was tested, but the total number of samples or repetitions is not specified.
• Data Provenance: Not specified. It's likely an in-house laboratory study.

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

• Not applicable. This study is a mechanical performance test, not a clinical study requiring human experts for ground truth. The "ground truth" is established by adherence to the ISO 14801:2007 standard.

4. Adjudication Method for the Test Set:

• Not applicable. This was a mechanical test, not a subjective assessment requiring adjudication.

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

• No. The document explicitly states: "Clinical Studies: Clinical testing is not required and has not been performed." Therefore, an MRMC study was not conducted.

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

• Not applicable. This is a physical dental device, not a software algorithm. The "standalone performance" is its mechanical performance in a laboratory setting, which was indeed evaluated.

7. The Type of Ground Truth Used:

• Standardized Mechanical Performance Metrics: The ground truth for this device is based on the performance requirements outlined in the ISO 14801:2007 standard for "Dynamic fatigue performance applicable to endosseous implant systems."

8. The Sample Size for the Training Set:

• Not applicable. As this is a mechanical device, there is no "training set" in the context of an algorithm or AI.

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

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

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