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EK DIGITAL ABUTMENTS are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

EK DIGITAL ABUTMENTS are digitally designed patient specific abutments manufactured from titanium Alloy (Ti-6AI-4V ELI) and titanium alloy + zirconia. The EK Hybrid abutments are a two-piece abutment consisting of a pre-manufactured titanium base (ASTM F136) and a CAD/CAM patient-matched mesostructure component (ISO 6872) and PANAVIA F 2.0 (K032455) cement is used to attach the two structures. They are intended only for use with HIOSSEN EK dental implants to provide support for customized prosthetic restorations. EK DIGITAL ABUTMENTS are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. Each EK DIGITAL ABUTMENT is individually prescribed by the clinician.

The provided text is a 510(k) Summary for the EK Digital Abutments and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria, especially in the context of an AI/ML powered device. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing processes, and mechanical testing.

However, I can extract the information that is present concerning performance and testing:

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

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics. It indicates that the device's mechanical properties were evaluated against the ISO 14801 standard.

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

The document mentions "The worst case implant and titanium abutments" were chosen for the mechanical fatigue tests. It does not specify the exact number of samples or details on data provenance (country of origin, retrospective/prospective).

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 section is not applicable as the study described is a mechanical fatigue test of a physical device, not an AI/ML powered device relying on expert-established ground truth.

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

This section is not applicable.

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 section is not applicable. The device is a physical dental abutment, not an AI/ML diagnostic tool.

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

This section is not applicable.

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

For the mechanical fatigue testing, the "ground truth" is defined by the physical failure of the samples under controlled load and cycling conditions, as specified by the ISO 14801 standard. This is a physical, objective measurement rather than an expert interpretation or pathology.

8. The sample size for the training set

This section is not applicable as there is no mention of a training set, indicating this is not an AI/ML device.

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

This section is not applicable as there is no mention of a training set.

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