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Aria Bio's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Aria Bio Dental Implant System consists of two stage endosseous form dental implants, hexagonal and conical implants and hexagonal and conical abutments; cover screws and healing caps; abutment systems and superstructures and surgical instruments.

The provided document describes a 510(k) premarket notification for Aria Bio's Dental Implant System, asserting its substantial equivalence to predicate devices. The document does not describe acceptance criteria for particular performance metrics nor does it present detailed study results proving a device meets specific acceptance criteria in the format requested.

Instead, the document focuses on demonstrating substantial equivalence through:

• Comparison of indications for use and technological characteristics with predicate devices.
• Reporting that a series of performance tests (fatigue, surface analysis, biocompatibility, sterilization, shelf life) were performed and that "All results are supporting Aria Bio's labeling claims in order to establish substantial equivalency." However, it does not provide the specific acceptance criteria for these tests, nor the detailed results.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details regarding sample sizes for training/test sets, ground truth establishment, or specific study types like MRMC, as this information is not present in the provided text.

The document states:

• "A series of performance tests and evaluations were performed to demonstrate that Aria Bio's Dental Implant System does not raise any new issues that may affect its substantial equivalency with its predicate devices. These evaluations include fatigue (ISO 14801), surface analysis by SEM/EDS and XPS, biocompatibility in accordance with ISO 10993-1, sterilization validation (ISO 11137-2, AAMI TIR 33, ISO 17665-1) and shelf life validation (ISO 11607-1) in order to assure maintaining of SAL 10° along the shelf life."
• "All results are supporting Aria Bio's labeling claims in order to establish substantial equivalency."

This indicates that these tests were conducted, and their outcomes were deemed acceptable based on established industry standards (e.g., ISO 14801 for fatigue testing, ISO 10993-1 for biocompatibility). However, the specific quantitative acceptance criteria or the actual performance results (e.g., specific fatigue limits, exact sterilization validation parameters, detailed surface analysis findings) are not provided in the document beyond stating that they were performed and supported substantial equivalence.

Without these specific details, I cannot construct the requested table or answer most of the specific questions about the study design and results.

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