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Both the P.004 RC/NC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.

The provided text is a 510(k) summary for a dental device, the "P.004 RC/NC Gold and Titanium Abutment for Bars." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through clinical or performance studies with detailed metrics.

Therefore, the information required in your request cannot be fully extracted from this document, as it describes a regulatory submission process based on equivalence rather than detailed performance study results.

Here's a breakdown of why and what little can be inferred:

• Acceptance Criteria and Reported Device Performance: This document does not present acceptance criteria or detailed performance data (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) in the way a clinical or technical validation study would. The document states, "The proposed abutments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed abutment has the same material composition, basic design and fundamental operating principles to the currently marketed devices." This is the core "proof" presented for regulatory acceptance under the 510(k) pathway.

• Study That Proves the Device Meets Acceptance Criteria: There is no specific study described that "proves" the device meets acceptance criteria in the manner of defining and then testing against specific performance thresholds. The 510(k) process relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is typically achieved by comparing technological characteristics, materials, and intended use, often supported by non-clinical bench testing for mechanical properties (though not detailed here), rather than multi-reader studies or ground truth comparisons.

Given these limitations of the provided text, here's what can be answered, and what cannot:

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

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 document does not describe a clinical or performance study with a "test set" in the context of AI/diagnostic device validation. It's a regulatory submission based on substantial equivalence to existing 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)

• Not Applicable. There is no "ground truth" establishment or expert review detailed in this document.

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

• Not Applicable. No test set or adjudication method is described.

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. This document does not describe an MRMC study. The device is a physical dental abutment, not an AI-assisted diagnostic tool for human readers.

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

• Not Applicable. This is a physical medical device (dental abutment), not an algorithm.

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

• Not Applicable. The concept of "ground truth" for comparative performance evaluation is not relevant to this 510(k) submission, which relies on demonstrating equivalence in design, materials, and intended use to predicate devices.

8. The sample size for the training set

• Not Applicable. No training set is described.

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

• Not Applicable. No training set or ground truth establishment is described.

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The bonding base is indicated for use with a standard ITI implant placed in the posterior oral cavity, to serve as a base for orthodontic attachment during orthodontic treatment.

The orthodontic bonding base is screwed onto the ITI Octa system. The bonding base has an interior icositetrahedron (24 facets) which allows a positioning in the desired angulation (15° steps). The bonding surfaces are eccentric to the implant axis such that four different distances are available between implant axis and bonding surface. An orthodontic bracket is cemented to the orthodontic bonding base and it acts as an anchor for the application of orthodontic forces during treatment. After orthodontic use, the bonding base is removed and a standard prosthetic restoration placed on the implant.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bonding Base Orthodontic Bonding Base:

Based on the provided 510(k) summary, formal acceptance criteria and a structured study demonstrating performance against those criteria are not explicitly detailed in a way that would be typical for a modern medical device submission. This document pre-dates many of the more rigorous requirements for clinical evidence and performance studies that are common today.

The "study" presented here is a demonstration of substantial equivalence to predicate devices, which is the primary pathway for 510(k) clearance. The acceptance criteria are implicitly met by showing that the device is similar in intended use, materials, and design to devices already on the market, and therefore, it is considered as safe and effective as those legally marketed devices.

Here's a breakdown of the requested information based on the provided text, with points that cannot be determined clearly marked:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the characteristics of the predicate devices. The "reported device performance" is a comparison to these predicates rather than an independent measure against objective benchmarks.

Study Details for Substantial Equivalence

The "study" here is the comparison table for substantial equivalence, not a typical performance study with patients or controlled laboratory tests against predefined success/failure criteria.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable in the context of a comparative substantial equivalence study based on design and materials. No test set of patient data or device performance data is described for this comparison.
• Data Provenance: Not applicable. The comparison is against the specifications and known characteristics of legally marketed predicate devices, not empirical data from a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth, in the sense of expert consensus on patient outcomes or interpretations, was not established for this type of submission. The "ground truth" for the comparison is the publicly available information and regulatory clearance status of the predicate devices.

4. Adjudication method for the test set:

• Not applicable. There was no test set requiring multi-expert adjudication.

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 device is not an AI/imaging device, and no MRMC study was performed or required for this type of submission.

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

• Not applicable. Not an algorithm or AI device.

7. The type of ground truth used:

• The "ground truth" used for this submission is the regulatory status and descriptive characteristics of legally marketed predicate devices. The argument is that because the new device is sufficiently similar to these cleared devices, it can be considered safe and effective.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device, so there is no training set in that context. The device design and materials were likely developed through engineering design processes, possibly including bench testing, but these are not described as a "training set."

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

• Not applicable. See point 8.

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