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The IBS Implant System II is intended to replace missing teeth to restore chewing function. The IBS Implant System II can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The IBS Implant System II is consists of dental fixtures, screws and multiunit abutment cylinders.

The provided document is a 510(k) summary for the IBS Implant System II, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and non-clinical testing. It does not describe an acceptance criteria study with the requested details (number of experts, sample size for test/training set, ground truth methods, MRMC study, or standalone performance).

Instead, the document details a comparison of the new device to existing devices (predicates) regarding various technical specifications and non-clinical test results.

Since the document does not contain the information for acceptance criteria and a study proving device meets it as requested, I cannot complete the table or answer the specific questions.

No information for the requested table and study details is available in the provided text. The document focuses on demonstrating substantial equivalence through comparison with predicate devices and non-clinical tests (biocompatibility, endotoxin, sterilization validation, shelf-life validation, fatigue). These are not presented as a study with specific acceptance criteria that the device performed against in the way an AI/software performance study would be evaluated.

Therefore, the requested table of acceptance criteria and reported device performance cannot be generated. Similarly, specific details about sample size (training/test), data provenance, expert involvement, adjudication, MRMC, or standalone performance are not provided as these types of studies are typically associated with performance claims for diagnostic or prognostic devices, not for substantial equivalence of an endosseous dental implant based on physical and material properties.

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