Search Results

PrimaConnex Ceramic Abutments are intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

PrimaConnex Ceramic Abutments are intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

This device is a ceramic abutment for dental implants and its approval is based on substantial equivalence to predicate devices, not on a study with specific acceptance criteria and performance metrics like those for AI/ML devices. Therefore, much of the requested information (sample size, expert ground truth, MRMC study, stand-alone performance, training set details) is not applicable to this type of medical device submission.

Here's a breakdown of the relevant information from the provided text, indicating why certain sections of your request cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided because a traditional "acceptance criteria" and "reported device performance" (in terms of sensitivity, specificity, accuracy, etc.) are not applicable for a device seeking substantial equivalence based on material and design similarities, rather than performance against a diagnostic or predictive task.

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

Not applicable. There was no "test set" in the context of evaluating an AI/ML device. The device is a physical component.

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

Not applicable. Ground truth, in the sense of expert consensus on diagnostic labels, is not relevant for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 device is not an AI/ML tool intended to assist human readers.

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

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this type of device, the "ground truth" is largely based on material properties, mechanical testing (which would be referenced in a more detailed submission, but not in this summary), and clinical experience with similar devices. The 510(k) summary focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" for physical medical devices like this.

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

Not applicable.

Summary of the Approval Basis for K062876:

The approval of the PrimaConnex® Ceramic Abutments is based on demonstrating substantial equivalence to predicate devices. This means the manufacturer showed that their new device is as safe and effective as a legally marketed device that is not subject to PMA (Pre-market Approval).

The arguments for substantial equivalence presented in the K062876 summary are:

• Identical Intended Use: The device shares the same intended use as some predicate devices.
• Identical Design: The device shares the identical design with one predicate (PrimaConnex Esthetic Contour Abutments).
• Identical Biocompatible Material: The device incorporates the identical biocompatible material as some predicate devices.
• Same Shelf Life: The device has the same shelf life as one predicate.
• Same Packaging and Sterilization: The device is packaged and sterilized using the same materials and processes as some predicate devices.
• Same Fundamental Scientific Technology: The device incorporates the same fundamental scientific technology as one predicate.

In essence, Lifecore Biomedical, Inc. successfully argued that the PrimaConnex® Ceramic Abutments are sufficiently similar to already approved devices in terms of function, materials, and manufacturing processes, and therefore do not raise new questions of safety or effectiveness.

Ask a specific question about this device