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IMZ implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulousareas to be restored with fixed arches, and es and es a loss to totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.

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The provided text is a 510(k) clearance letter from the FDA for a dental implant device called "IMZ Twin Plus Screw." This document primarily deals with regulatory clearance and indications for use, not a study demonstrating the device meets specific acceptance criteria with performance metrics.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Information about sample size, data provenance, or test sets.
3. Details about experts used for ground truth or adjudication methods.
4. Information about Multi-Reader Multi-Case (MRMC) studies or comparative effectiveness.
5. Data on standalone algorithm performance.
6. The type of ground truth used (e.g., pathology, outcomes).
7. Sample size or ground truth establishment for a training set.

The document is a legal notification that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market subject to general controls. It does not describe the specific performance testing or the results of such testing against acceptance criteria that would typically be detailed in a clinical or performance study report.

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IMZ implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulousareas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.

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I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria for a device, the study that proves the device meets the acceptance criteria, or any of the specific details requested in your prompt (e.g., sample size, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth type, training set details).

The document is a 510(k) clearance letter from the FDA for a device called "IMZ Twin Plus - Cylinder," which are dental implants. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. However, it does not contain the detailed performance study information you are seeking.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device