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.

Device Description

AI/ML Overview

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.

Acceptance Criteria	Reported Device Performance
Not Applicable	Not Applicable

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.

Summary

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K062876

Lifecore Biomedical, Inc. Special 510(k) Premarket Notification PrimaConnex® Ceramic Abutments

NOV - 1 2006

510(K) SUMMARY [As required by 21 CFR 807.92(c)]

1. Submitter's Name and Contact Person

Lifecore Biomedical, Inc.	Brian Smekal
3515 Lyman Blvd	Regulatory Affairs Specialist
Chaska, MN 55318	Ph: 952-368-6306; Fax: 952-368-4278

2. General Information

Trade Name	PrimaConnex® Ceramic Abutments
Common Name	Ceramic Abutments
Classification Name	Endosseous Implant Abutment
Identification of Predicate Devices	Esthetic Contour Straight Abutments forthe PrimaConnex Internal ConnectionImplant System, Lifecore Biomedical(K051614)PrimaConnex Ceramic Copings, LifecoreBiomedical (K060530)Astra Tech Implants - Dental SystemCeramic Abutment, Astra Tech, Inc.(K023631)

3. Device Description

4. Intended Use

PrimaConnex Ceramic Abutments are intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous

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Lifecore Biomedical, Inc. Special 510(k) Premarket Notification PrimaConnex® Ceramic Abutments

mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

5. Substantial Equivalence Comparison

Summary of how the PrimaConnex Ceramic Abutment is substantially equivalent to the PrimaConnex Esthetic Contour Abutment (K051614):

. Have the same intended use,
Incorporate the identical design, .
. Have the same shelf life, and
Are packaged and sterilized using the same materials and processes. .

Summary of how the PrimaConnex Ceramic Abutment is substantially equivalent to the PrimaConnex Ceramic Copings (K060530):

Incorporate the identical biocompatible material, .
Are packaged using the same materials and processes. .

Summary of how the PrimaConnex Ceramic Abutment is substantially equivalent to the Astra Tech Implants - Dental System Ceramic Abutment (K023631):

Have the same intended use, .
Incorporate the identical biocompatible material, .
Incorporate the same fundamental scientific technology. .

In summary, the PrimaConnex Ceramic Abutment described in this submission is, in our opinion, substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brain Smekal Regulatory Affairs Specialist Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318

NOV - 1 2006

Re: K062876

Trade/Device Name: PrimaConnex® Ceramic Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 20, 2006 Received: October 24, 2006

Dear Mr. Smekal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Smekal

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Liu, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K062876

Device Name: PrimaConnex® Ceramic Abutments

Indications for Use:

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suser Punes

READON, Gener John, Donner De

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Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)