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The AS 123 Prosthetic Instrumentation System is a hand-operated instrument which facilitates the installation and removal of cover screws, temporary healing abutments, abutment screws and posts in dental implant procedures. All components are manufactured from surgical grade stainless steel.

This appears to be a 510(k) summary for a dental prosthetic instrument (AS 123 Prosthetic Instrument System) from 1996, not a medical device involving AI or complex performance metrics requiring such studies.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets is not applicable to this submission.

Here's why:

• Device Type: The AS 123 is a hand-operated tool for installing and removing dental implant components. It's a mechanical device, not an image analysis system, AI-driven diagnostic tool, or a device that produces quantitative outputs that would typically require the kind of performance studies you're asking about.
• Submission Date: The submission date is 1996. The types of rigorous statistical studies, AI performance metrics, and complex ground truth establishment methodologies you describe were not commonplace or even relevant for this type of device at that time (or even now, for such a simple mechanical instrument).
• Substantial Equivalence: The submission focuses on demonstrating substantial equivalence to existing predicate devices (Steri-Oss® "Prosthetic Instrumentation" and Implant Innovations, Inc. "Drivers and Placement Instruments"). This typically involves comparing features, materials, and intended use, rather than conducting new performance trials against a defined set of acceptance criteria in the manner you've outlined for AI-driven devices.

In summary, for K963951, the information requested is entirely out of scope for this type of device and regulatory submission.

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