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Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they are to be placed out of occlusion. Final abutments may be placed into occlusion for implants with sufficient primary stability or for implants that are fully osseointegrated.

Temporary Abutments have a maximum duration of usage of 180 days.

The subject devices described in the submission are prosthetic components that are intended for use in prosthetic rehabilitations, directly or indirectly connected to the endosseous dental implant. These devices are intended for use as an aid in prosthetic rehabilitations. The subject devices described in this submission are to be added Straumann's existing prosthetic portfolio.

The provided text is a 510(k) summary for Straumann® Screw-Retained Abutments. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics and performance data, mainly bench testing and biocompatibility assessments. It explicitly states that no device-specific clinical data has been submitted.

Therefore, the information required to describe acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human reader study or performance metrics typical for AI devices (like sensitivity, specificity, AUC), is not present in this document.

This document describes a traditional medical device (dental implants and abutments) cleared via the 510(k) pathway, which fundamentally relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through novel clinical studies or AI algorithm validation.

To address the user's request, I must state that the information is not available in the provided document, as it pertains to a different type of device and regulatory submission pathway.

Specifically, the document states:

• "No device specific clinical data has been submitted to demonstrate substantial equivalence." (Page 12, Section 5.7.4)

Here's an explanation with respect to the user's request:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence through comparison with predicates, not on meeting predefined performance metrics from a study in the way an AI/software device would. The "performance data" refers to bench testing (dynamic fatigue, static strength, torque) and biocompatibility, which are compared to predicate devices rather than against specific numerical acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no clinical study (with test sets of patient data) was conducted or submitted. The 'samples' referred to in bench testing are physical abutment components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data involving human perception (like AI for image analysis) is not relevant here as no such clinical study was performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable. This is not an AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. This is not an AI-powered device with a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) summary for Straumann® Screw-Retained Abutments does not contain the type of AI/clinical performance study information requested. The device is a traditional medical device (dental implant components) and its clearance is based on substantial equivalence to predicate devices, verified through bench testing and biocompatibility assessments, not through human reader studies or AI algorithm performance evaluations on clinical datasets.

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The Straumann® screw-retained abutments are indicated to be placed implants to provide support for prosthetic reconstructions such as crowns, bridges and bars.

The final processed devices have the purpose of restoring chewing function.

Straumann® screw-retained abutments are indicated for screw-retained restorations.

The subject device is a modification of the NC Straight Ø4.6 mm GH 1.0 mm Screw Retained Abutment originally cleared to market per K133421. Dimensional changes have resulted in improved dynamic fatigue performance such that this device can now be used in the pre-molar region of the mouth in addition to the incisors.

The provided text is a 510(k) summary for a medical device (Straumann Screw-Retained Abutment) and outlines its equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/human-in-the-loop performance evaluation. The "Performance Testing" section describes bench testing for fatigue load limits, which is a mechanical engineering test, not a clinical or AI performance study.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device evaluation.

However, I can provide the information that is available about the "Performance Testing" from the document:

1. A table of acceptance criteria and the reported device performance
The document states that "Dynamic fatigue tests were conducted in accordance with the FDA guidance document dated May 12, 2004: 'Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseious Dental Implants and Endosseous Dental Abutments' and ISO 14801."
While specific acceptance criteria values (e.g., minimum load cycles or maximum load) and reported performance values are not explicitly provided in this summary, the standard ISO 14801 and the FDA guidance document would define these. The general performance claim is "improved dynamic fatigue performance" and "greater wall thickness in the flexure zone of the abutment."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This was bench testing, not a clinical study with patients or data.

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)
Not applicable. This was bench testing, not an expert-driven ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
No, an MRMC study was not done.

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 an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for mechanical testing is typically the physical measurement of material properties and performance under stress, as defined by engineering standards.

8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

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