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The titanium endosseous implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices.

A cylinder shaped commercially pure titanium dental implant with external threads.

The provided text describes a 510(k) summary for a dental implant, "O" Butment ET Implant, seeking substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/software or a diagnostic device.

Therefore, I cannot fulfill the request as the provided input does not contain any of the required information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study.
• Standalone algorithm performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document discusses:

• Device Type: Dental Implant
• Purpose of 510(k): Substantial Equivalence
• Comparison Basis: Design, function, labeling, material composition, and intended use compared to predicate devices.
• Non-clinical tests: Lateral and vertical stress analysis, concluding physical integrity has not been compromised by modifications.

This is a traditional medical device approval document, not one related to software or AI performance assessment.

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