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The American Dental Implant System is intended to be used in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients. As per Part 21, CFR 801 Subpart D, this item is for Prescription Use and as such is only sold on or by the order of a licensed dentist.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and study proving device performance for the "American Dental Implant Abutment System."

The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a legally marketed predicate device. It defines the device name, regulation number, regulatory class, and lists the "Indications for Use."

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, or the number/qualifications of experts used for ground truth.
• Adjudication methods.
• Information on multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set or how its ground truth was established.

This type of information is typically found in the 510(k) submission itself, supporting studies, or a more detailed technical report, rather than in the FDA clearance letter.

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The American Dental Implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.

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This FDA 510(k) clearance letter (K042462) for the American Dental Implant device does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The document is a clearance letter indicating that the FDA has found the device to be substantially equivalent to legally marketed predicate devices. It states that the device is an "Endosseous Implant" and is "intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function."

All the requested information about acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, and ground truth establishment is absent from this document.

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

Ask a specific question about this device