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Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

The Straumann P.004 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 in this submission are abutments.

The basal portion of the abutment has 4 grooves diametrically opposed that engage in the 4 protrusions of the P.004 implant. The abutment is seated in the implant with a screw which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw-retained restorations.

This document is a 510(k) summary for a dental abutment, demonstrating substantial equivalence to a predicate device. It does not contain information about a study with acceptance criteria and device performance in the way typically expected for a medical imaging AI device or a similar diagnostic tool where specific performance metrics like sensitivity, specificity, or accuracy are reported against a ground truth.

Instead, the document focuses on demonstrating substantial equivalence for a physical medical device (dental abutment) based on its intended use, material, fundamental operating principles, and basic design being identical or substantially equivalent to previously cleared predicate devices.

Therefore, many of the requested categories for robust clinical study data are not applicable to this type of submission.

Here's a breakdown based on the provided text, indicating where information is present versus where it is not applicable for this specific type of device and submission:

Acceptance Criteria and Device Performance Study for P.004 NC Gold Abutment for Crowns

This 510(k) submission (K072497) for the P.004 NC Gold Abutment for Crowns aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than performing a de novo clinical study with specific performance acceptance criteria for a diagnostic or AI-driven device. The "acceptance criteria" here are implicitly related to demonstrating that the new device shares the same technological characteristics and intended use as the predicate devices, and therefore can be marketed.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence of a physical dental abutment and not a performance study for a diagnostic device, explicit acceptance criteria with numerical performance metrics (e.g., sensitivity, specificity, accuracy) are not reported in this document. The "performance" assessment is based on a comparison of technological characteristics and intended use to predicate devices, implying that if these are substantially equivalent, the device performs adequately for its intended use.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. This submission does not describe a clinical performance study with a "test set" of patients or cases in the context of diagnostic or AI performance. The equivalence is based on the design, materials, and intended use of the device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. No ground truth establishment for a test set is described as this is not a diagnostic device performance study.

4. Adjudication Method for the Test Set

Not Applicable. No adjudication method for a test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This type of study is relevant for diagnostic performance, especially for AI algorithms, and is not applicable to the substantial equivalence determination for a physical dental abutment.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This refers to AI algorithm performance and is entirely irrelevant to this device submission.

7. Type of Ground Truth Used

Not Applicable. No ground truth in the context of diagnostic performance (e.g., pathology, outcomes data) is used. The "truth" for this submission is whether the device's characteristics align with those of cleared predicate devices.

8. Sample Size for the Training Set

Not Applicable. This refers to AI algorithm training data, which is not relevant to this submission.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. This refers to AI algorithm training data ground truth, which is not relevant to this submission.

Summary of the Document's Focus:

This 510(k) summary for the P.004 NC Gold Abutment for Crowns relies on the concept of substantial equivalence to predicate devices (P.004 RC Gold Abutment for Crowns, K070549, and Straumann P.004 Dental Implants, K062129). The core argument is that:

• The intended use is the same.
• The material is the same.
• The fundamental operating principles are the same.
• The basic design is substantially equivalent.

Because these critical characteristics match the predicate devices, the FDA determined that the new device can be legally marketed without requiring extensive new clinical performance data. The FDA's acceptance of the 510(k) is the "proof" that the device meets the implicit acceptance criteria for substantial equivalence.

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