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ITT dental implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges or overdentures in edentulous or partially edentulous patients.

The All-in-One implants are screw and cylinder type dental implants made from CP titanium, Grade 4. They are available in various diameters and insertion lengths. The implants have the same rough surface as cleared ITI endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue.

The provided text describes a 510(k) summary for the ITI Dental Implant System, which is a medical device submission to the FDA. This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on:

• Applicant and device identification.
• Declaration of substantial equivalence to previously cleared devices (K894593, K894595, K971578, K954512, K960288, K954347, K960417).
• Description of the device (materials, design, surfaces).
• Intended use (supporting crowns, bridges, or overdentures in edentulous or partially edentulous patients).
• FDA's response letter acknowledging the 510(k) submission and permitting market entry based on substantial equivalence.

Therefore, I cannot fulfill your request to describe acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

For a 510(k) submission, the "proof" often comes from demonstrating that the device is substantially equivalent to a predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. While performance testing is usually conducted to support the substantial equivalence claim, the specifics of such tests (acceptance criteria, results, expert reviews, sample sizes) are not detailed here.

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