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The US/GS Ultra Wide System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The US/GS Ultra Wide System is for single and two stage surgical procedures. It is not for immediate load. The US/GS Ultra Wide System is intended to be used in the molar region.

The US/GS Ultra Wide System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

The provided text is a 510(k) summary for a dental implant system (Osstem US/GS Ultra Wide System). It outlines the device description, predicate devices, and indications for use. However, it does not contain specific details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot populate the table or provide detailed answers to most of the questions based solely on the provided text. The document states that "The US/GS Ultra Wide System has been subjected to safety, performance, and product validations prior to release" and "Safety tests including biocompatibility have been performed," but it does not describe these validations or tests, nor their results.

Here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
   • Not specified in the document.
2. 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 specified in the document.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set
   • Not specified in the document.
4. 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 document describes a dental implant, not an AI-assisted diagnostic device. Therefore, no MRMC study involving human readers and AI assistance would be relevant or expected.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   • Not applicable. This pertains to an algorithm's performance, which is not relevant to a physical dental implant device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   • Not specified in the document. The document does not describe what kind of ground truth would have been established for the "safety, performance, and product validations."
7. The sample size for the training set
   • Not applicable / Not specified. This refers to machine learning, which is not relevant to this device submission.
8. How the ground truth for the training set was established
   • Not applicable / Not specified. This refers to machine learning, which is not relevant to this device submission.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices for a dental implant. It does not contain the detailed study design, performance data, or ground truth establishment information typically found in clinical study reports for diagnostic or AI-enabled devices.

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