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The intended use of the ITI Protection Healing Caps is to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the prosthetic phase to achieve an esthetic result with the final restoration. The primary indication for the Protection Healing Cap is in the esthetic zone of the orgal cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations.

The ITI Protection Healing Cap is a device which is mounted onto an 171 implant after the abutment has been placed into the implant and serves to protect the outer configuration of the abutment and which the clinician can modify to maintain and condition the precise contours of the soft tissue during the prosthetic phase. The primary indication for the Protection Healing Cap is in the esthetic zone of the oral cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations. The protection healing caps remain in place for approximately 2 weeks while the tinal restoration is being constructed.

The ITI Protection Healing Cap is available in two sizes. The small cap has a diameter of 5.8 mm and a height of 4.0 mm. The large cap has a diameter of 6.2 mm and a height of 5.0 mm. The Profection Healing Caps are designed with a 65° bevel which extends 0.5 mm (small) to 0.7 mm (large) beyond the outer edge of the implant making it possible to modify the dimension of the caps.

The ITI Protection Healing Caps are composed of Polyetheretherketone (PEEK) which is extruded from its granulated form and lathed to form the caps.

The provided text describes a medical device, the ITI Protection Healing Cap, and compares it to predicate devices. However, it does not include information about acceptance criteria, a study proving the device meets those criteria, or any details related to AI, algorithms, or human reader performance.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria, study details, AI/algorithm performance) is not present in the provided text.

Specifically, the document is a 510(k) summary for a physical medical device (a dental healing cap), not an AI/software device. The sections you requested (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are typically relevant for studies evaluating the performance of diagnostic or prognostic algorithms, especially in imaging or data analysis.

The document focuses on:

• Device Description: What the device is made of and how it works.
• Intended Use: What the device is for.
• Comparison to Predicate Devices: Showing that the new device is substantially equivalent to existing, legally marketed devices based on features like material, design (dimensions), and intended use.

There is no mention of any study to prove specific performance metrics or acceptance criteria beyond the general concept of substantial equivalence to predicate devices for regulatory clearance.

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