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The DIO SM Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four interforminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

The DIO SM Implant System is comprised of dental implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.

The provided document is a 510(k) summary for the DIO SM Implant System, which is a dental implant device. It details a modification to a previously cleared device. However, the document does not contain information about acceptance criteria, device performance, specific studies with sample sizes, expert ground truth establishment, or any AI-related data as requested.

The submission is focused on demonstrating substantial equivalence to a predicate device (SM Implant System, K061797) based on material, design, intended use, and other technological characteristics. The performance section explicitly states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This suggests bench testing, but no specific results or acceptance criteria are provided in the public summary.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, expert involvement, or AI performance, as this information is not present in the provided text.

The document mainly focuses on:

• Device Identification: Submitter, device name, classification.
• Predicate Device: Identification and comparison tables demonstrating substantial equivalence.
• Intended Use: Description of how the device is used.
• Regulatory Information: 510(k) number, FDA review and approval.

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