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The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation.

The IU Implant System Abutment is a dental implant superstructure made of titanium alloy. It is an abutment used to support or maintain the restoration after the implantation of the fixture in the oral cavity. The abutments are provided non-sterile and should be sterilized before use.

This document is a 510(k) summary for the IU Implant System Abutment, a dental implant superstructure. It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it does not contain the specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics such as sensitivity, specificity, accuracy, or effect size for AI assistance. The document focuses on showing the device's substantial equivalence to existing predicate devices based on design, materials, and non-clinical testing.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a breakdown of what can and cannot be provided based on the input:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria are implicitly related to demonstrating substantial equivalence to predicate devices through comparisons of material, design, intended use, and non-clinical testing results (fatigue, biocompatibility, sterilization, MRI safety).
• Reported Device Performance: Performance is reported in terms of meeting specific standards and showing substantial equivalence in non-clinical tests, rather than clinical performance metrics.

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 for performance metrics. The "tests" mentioned are non-clinical (sterilization, biocompatibility, fatigue, MRI review). These typically involve a specific number of samples for mechanical or material testing, but not a "test set" from patients or images.
• Data Provenance: The submission is from Warantec Co., Ltd. in the Republic of Korea. The testing itself (e.g., ISO standards) does not specify "data provenance" in the way clinical studies would.

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 information is relevant for clinical studies or studies using expert readers for image interpretation, which were not conducted for this submission ("No clinical data were included in this submission.").

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

• Not applicable. This relates to clinical or expert-read studies, which were not performed.

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 comparative effectiveness study was not done. This is a dental implant abutment, not an AI-powered diagnostic device. The submission explicitly states, "No clinical data were included in this submission."

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

• Not applicable. This is not an AI algorithm; it's a physical medical device.

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

• For the non-clinical tests:
  • Sterilization: Ground truth is defined by the objective measurement of sterility (SAL) and adherence to ISO standards.
  • Biocompatibility: Ground truth is established by chemical composition and biological response testing, adhering to material standards (ASTM F136) and prior submissions.
  • Fatigue: Ground truth is based on physical endurance under simulated physiological loads according to ISO standards.
  • MRI Safety: Ground truth is based on existing scientific literature and physics principles related to magnetic forces and materials.

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable. No training set was used.

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