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The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The copings and milling cylinders are used as part of the prosthetic restoration.

The ITI Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially, or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission include an abutment, copings, and milling cylinders.

The provided document is a 510(k) summary for a medical device clearance, specifically an abutment for dental implants. It does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as it is not a diagnostic device or a device that requires performance metrics in the way implied by the request.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device. This means the manufacturer is asserting that the new device is as safe and effective as a device already on the market, rather than needing to prove its performance against specific acceptance criteria through a clinical study.

Therefore, I cannot provide the requested information from the given text.

To explain why the requested information isn't present:

• Acceptance Criteria & Reported Device Performance: This device is a mechanical component (an abutment for a dental implant). Its "performance" is implicitly tied to its structural integrity, biocompatibility, and functional fit, which are often addressed through material specifications, design comparisons, and potentially bench testing (mechanistic rather than clinical performance). The 510(k) summary states that the subject device has an "almost identical design" to the predicate, implying its performance should be similar.
• Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication Method, MRMC Comparative Effectiveness Study, Standalone Performance, Type of Ground Truth, Training Set Size & Ground Truth Establishment: These points are all relevant to clinical studies evaluating the diagnostic accuracy or clinical effectiveness of a device, especially for AI/ML-driven or diagnostic/screening tools. This dental abutment is a prosthetic component, not a diagnostic or AI device, so these types of studies are not typically required for its clearance. The "study" here is the comparison to the predicate device, not a performance study as described in the request.

The core of this 510(k) submission is the statement: "The subject devices are substantially equivalent to previously cleared ITI abutments. The intended use of the subject abutment is identical to the predicate abutment. The subject device has an almost identical design as the predicate device. The labeling and instructions for use for both devices are the same." This is the basis for its clearance, not a detailed performance study with acceptance criteria.

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