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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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Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System 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.

Straumann® Screw Retained Abutments include one-piece straight and angled (17° and 30°) abutments, basal screws and abutment carrier pin. The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices.

This document is a 510(k) premarket notification for the Straumann® Screw Retained Abutments. It aims to demonstrate substantial equivalence to previously cleared predicate devices. Since this is not a diagnostic device and doesn't involve an AI algorithm, the information requested in your prompt (acceptance criteria, study details, expert input, MRMC study, standalone performance, training set) typically applies to AI/ML-based medical devices or diagnostic tools.

This submission focuses on engineering, material, and sterilization equivalence for a dental implant component. Therefore, the detailed AI/ML-specific questions in your prompt are not applicable to this document.

However, I can extract information related to the device's technical characteristics and the claim of substantial equivalence.

Here's a breakdown of what is applicable from your prompt, based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" in the format typically used for performance metrics of diagnostic algorithms. Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that the device's characteristics must be similar enough to the predicate to ensure equivalent safety and effectiveness.

The table provided (pages 5-6) serves as the primary evidence for this. It compares the Subject Device (Straumann® Screw Retained Abutments) to several Predicate Devices across various technical characteristics. The "performance" in this context is demonstrating that these characteristics are either identical or sufficiently similar to the legally marketed predicates.

The study proving the device meets its "acceptance criteria" (i.e., substantial equivalence) is the comparison to predicate devices and the verification/validation activities for the changes (primarily sterilization and packaging). The document explicitly states: "The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices." And "Packaging materials and configuration is equivalent to reference predicate device, Straumann® Healing Abutments, Healing Caps, Closure Screws, K130808."

The substantial equivalence is primarily based on:

• Identical Indications for Use.
• Identical fundamental operating principles.
• Identical materials (Ti-6Al-7Nb titanium alloy).
• Comparable design features (Implant-to-Abutment Connection, Interface Type, Platform Diameter(s), Abutment Angulation(s), Gingival Height(s), Orientation of Angulation to Engagement Features).
• Validation of the sterilization process according to recognized standards (ISO 11137-1 and ISO 11137-2) and equivalence of packaging to a previously cleared sterile device (K130808).

The following points are not applicable to this 510(k) submission for a non-AI/ML dental abutment:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or 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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

These points would be relevant for devices that involve algorithms, image interpretation, or diagnostics where a "ground truth" needs to be established and performance metrics (e.g., sensitivity, specificity, AUC) are calculated based on a test set. This submission is for a physical medical device (dental abutment) where the primary evaluation is based on engineering design, material properties, and manufacturing processes, demonstrated through comparison to legally marketed predicate devices and validation of changes like sterilization.

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The Straumann® Screw Retained Abutments are indicated to be placed into the NC and RC Bone Level implants of the Straumann® Dental Implant System 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 proposed Bone Level Screw Retained Abutments are a line extension of the Screw Retained Abutments previously cleared to market per K133421 and K141871. The proposed Screw Retained Abutment devices include one-piece straight and angled (17° and 30°) abutments, having a gingival height of 5.5 mm.

Here's an analysis of the provided text regarding acceptance criteria and studies, with the understanding that this document is a 510(k) summary for a medical device and not a report for an AI/ML device. Therefore, many of the requested fields related to AI/ML studies will not be applicable.

The document discusses the Straumann® Screw Retained Abutments, which are dental implant components.

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

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for performance. Instead, it demonstrates substantial equivalence to predicate devices through material and technological characteristics, and performance data from bench studies.

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 refers to "bench studies" and "dynamic fatigue test data" but does not explicitly state the sample size (number of abutments tested) for these tests. There's no information about the country of origin of the data or whether it was retrospective or prospective, as these are typically not relevant for benchtop mechanical testing of physical devices.

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 is not applicable as the device is a physical dental implant abutment, not an AI/ML imaging analysis tool. "Ground truth" in this context would come from engineering specifications, material standards, and physical measurements/tests, not expert consensus on interpretations.

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

Not applicable for a physical device undergoing bench testing.

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/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for showing substantial equivalence relies on:

• Engineering specifications and material standards: Conformance to ISO standards for material composition (ISO 5832-11) and mechanical testing (ISO 14801).
• Physical measurements: Dimensions (platform diameter, gingival height), angles, and connection types for comparison with predicate devices.
• Bench test results: Data from dynamic fatigue tests to demonstrate mechanical performance under simulated conditions.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no training set for this type of device.

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