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Healing Caps are intended for placement onto dental implants to protect the inner configuration and shoulder of the implant and to maintain, stabilize and form the soft tissue during the healing phase.

The Straumann 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, permanent and temporary abutments, healing caps and surgical and prosthetic parts and instruments. The device covered in this submission is a healing cap.

This submission does not contain a study that proves the device meets specific acceptance criteria using reported performance metrics. Instead, the 510(k) summary for the "RN Healing Cap, Concave" relies on substantial equivalence to a previously cleared predicate device (RN Esthetic Healing Caps, K960634).

Here's a breakdown of why and what information is available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The submission explicitly states: "The proposed healing cap is substantially equivalent to the currently cleared device. The intended use, material, basic design and fundamental operating principles are identical to the predicate device." This means the performance is assumed to be equivalent to the predicate, and no new performance data or acceptance criteria are presented for this specific device in this document.

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

Not applicable. No new test set data is presented.

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

Not applicable. No new test set data is presented.

4. Adjudication method for the test set:

Not applicable. No new test set data is presented.

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:

Not applicable. This is a medical device (healing cap for dental implants), not an AI-powered diagnostic or comparative effectiveness study involving human readers.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used:

Not applicable. There is no new ground truth established for this submission. The basis for clearance is substantial equivalence to a predicate device. The "ground truth" here is the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary of Acceptance and Evidence:

The "acceptance criteria" in this context are primarily regulatory: demonstrating substantial equivalence to a legally marketed predicate device. The "study" proving this is a comparison of technological characteristics and intended use, rather than a clinical trial or performance study of the new device itself.

The key points from the provided text are:

• Acceptance Criteria (Implicit): The device must be "substantially equivalent" to a predicate device (RN Esthetic Healing Caps, K960634) in terms of intended use, material, basic design, and fundamental operating principles.
• Proof of Meeting Acceptance Criteria: The submission states that "The proposed healing cap is substantially equivalent to the currently cleared device. The intended use, material, basic design and fundamental operating principles are identical to the predicate device." This statement, along with detailed device descriptions (which are not fully provided in the given text but would be part of a complete 510(k) submission), serves as the "proof" for regulatory clearance based on substantial equivalence. No new performance data is presented or required for a 510(k) based solely on substantial equivalence.

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