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IDI Implant Systems (IDI Fixtures and IDI Abutments with screws) are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artifical tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and non-splinted applications. The device is intended for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

IDI Implant Systems are threaded root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. Also included are straight abutments which provide cemented and screw retained restorative options.

This document is a 510(k) summary for the IDI Implant Systems, an endosseous dental implant. It focuses on regulatory approval rather than a detailed study proving device performance against specific acceptance criteria. Therefore, most of the requested information regarding an AI medical device study is not present in this document.

However, I can extract the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain a table of acceptance criteria or reported device performance for an AI medical device. Instead, it describes a dental implant system. The "acceptance criteria" in this context would likely refer to engineering specifications and biocompatibility, which are not detailed in this regulatory summary.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This document describes a dental implant, not an AI medical device evaluated with a test set of data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. This document describes a dental implant, not an AI medical device that requires expert-established ground truth from a test set.

4. Adjudication Method for the Test Set:

Not applicable. This document describes a dental implant, not an AI medical device that would involve adjudication for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This document describes a dental implant, not an AI medical device that would typically undergo an MRMC study.

6. Standalone Performance Study:

Not applicable. This document describes a dental implant, not an AI medical device that is evaluated for standalone algorithm performance.

7. Type of Ground Truth Used:

Not applicable. This document describes a dental implant. The "ground truth" for a dental implant would be its physical properties, biocompatibility, and clinical performance as demonstrated through other means (e.g., mechanical testing, animal studies, clinical use data, but not typically in the sense of 'ground truth' for an AI system).

8. Sample Size for the Training Set:

Not applicable. This document describes a dental implant, not an AI medical device requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This document describes a dental implant, not an AI medical device that requires ground truth for a training set.

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