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The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The Luna Dental Implant System - Healing Abutment is to be connected to the implant and is to heal gingiva before setting abutment on the implant in the oral cavity. It is made of commercially pure titanium alloy Gr4. It offers narrow and regular platform types, and the narrow type has anodizing surface treatment in purple to be distinguished from the regular type.

The provided text is a 510(k) summary for the Luna Dental Implant System - Healing Abutment, a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and performance data from a clinical or non-clinical study designed to prove the device meets specific performance metrics.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to proving device performance against specific criteria.

The 510(k) summary explicitly states its basis for substantial equivalence:
"The Luna Dental Implant System - Healing Abutment is substantially equivalent to its predicate device (K123155) in terms of indications for use, raw material, and design. The differences are in body design and size range. The design change does not raise a question in substantial equivalence since the change is not significant. We have identified a reference device that encompass the size range of the subject device. Based on the information submitted here in we conclude that the subject device is substantially equivalent to the predicate devices."

The "Non-Clinical Testing" section merely states: "Risk analysis was conducted according to ISO14971 to evaluate the effect of the modification. The risk assessment did not show that the device changes affected biocompatibility, sterilization, and shelf life such that the testing in the prior (predicate) file is still applicable." This indicates that no new performance testing was conducted or deemed necessary to demonstrate the modified device meets specific acceptance criteria, as its equivalence to the predicate implies it meets the same criteria the predicate device did.

In summary, this 510(k) document is a declaration of substantial equivalence, not a report of a study designed to establish acceptance criteria for a novel device and prove its performance against those criteria.

Since the requested information (acceptance criteria, performance data, sample sizes, expert details, etc.) is not present in the provided text, I cannot complete the table or answer the specific questions about the study from this document.

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