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The Ti Prepable Abutments are designed for use as a terminal or intermediate abutment for cement retained prostheses. It allows for preparation for the crown to be attached. It can be used for a single or multiple-unit restoration. The abutment is intended to be prepared and placed with patient specific margins.

The Prepable Abutment is a titanium alloy post with an unprepared shape that allows for preparation by the end user. The spline tines on the inside of the abutment provide an anti-rotation feature and the abutment is secured with a separate retaining screw.

This document is a 510(k) Pre-Market Notification for a dental device, specifically a "Ti Prepable Abutment" by Zimmer Dental. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting detailed clinical study data with specific acceptance criteria and performance metrics in the way a PMA (Pre-Market Approval) or de novo submission would.

Therefore, the input document does not contain the information requested in the prompt regarding acceptance criteria and a study that proves the device meets them.

Here's why and what information is available:

• 510(k) Focus: The core of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, intended use, and performance data (often non-clinical, such as mechanical testing). It does not usually involve extensive clinical trials with specific performance metrics and acceptance criteria for clinical outcomes like diagnostic accuracy.
• Mechanical Testing Mentioned: The document explicitly states: "Mechanical fatigue testing has demonstrated that the change in retaining screw does not adversely affect the mechanical strength of the implant/abutment assembly." This is a key piece of performance data for a 510(k) in this context, demonstrating that a design change (the retaining screw) does not degrade mechanical performance. However, specific acceptance criteria for this mechanical testing (e.g., "must withstand X cycles at Y load") and the detailed study protocol/results are not provided in this summary.

Therefore, I cannot populate the requested table or answer the questions precisely as formulated because the provided text is a regulatory summary for a 510(k) submission and does not include the detailed clinical study information you're asking for.

If this were a different type of regulatory submission (e.g., for an AI/ML diagnostic device), the requested information would be expected.

Response to your prompt based on the lack of information in the provided document:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not provided in the document.
• Reported Device Performance: "Mechanical fatigue testing has demonstrated that the change in retaining screw does not adversely affect the mechanical strength of the implant/abutment assembly." Specific numerical values or criteria are not given.

2. Sample size used for the test set and the data provenance:

• Not applicable/Not provided. The document refers to "mechanical fatigue testing," which is likely bench testing, not a clinical test set with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. Ground truth establishment by experts is not relevant for the type of testing described (mechanical fatigue).

4. Adjudication method for the test set:

• Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI/ML device; it's a mechanical dental abutment. An MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. Not an algorithm/AI device.

7. The type of ground truth used:

• For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks for mechanical strength and fatigue resistance, which are not detailed here.

8. The sample size for the training set:

• Not applicable/Not provided. No training set is mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not applicable/Not provided.

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