The Lifecore PrimaConnex® CAD/CAM Abutment System is intended for use as an accessory to a Lifecore PrimaConnex endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae in the construction of single-unit cement retained restorations on Lifecore PrimaConnex CAD/CAM Abutments.

Device Description

The PrimaConnex CAD/CAM Abutments and abutment-specific ceramic copings are placed onto the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

The abutments and copings are milled using computer-assisted technology that enables the creation of final abutments that are manufactured with specific geometry to meet individual anatomic variations in patient tooth and jaw structure.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Lifecore PrimaConnex® CAD/CAM Abutment System." This is a dental device, specifically an abutment and coping system for endosseous dental implants.

The information provided is primarily focused on establishing substantial equivalence to predicate devices, which is a regulatory pathway for medical devices in the US. It does not describe a study involving "acceptance criteria" in the sense of a diagnostic or AI-driven device's performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "study" referred to is a physical performance test for a mechanical device.

Here's an analysis based on the provided text, addressing your questions to the extent possible for this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (dental abutment system), the "acceptance criteria" are related to mechanical strength and fatigue resistance, rather than diagnostic accuracy. The study mentioned is "Static and Dynamic Fatigue Testing of Endosseous Dental Implant Systems."

Acceptance Criteria Category	Reported Device Performance
Mechanical Strength/Fatigue	Demonstrated to withstand static and dynamic fatigue testing as described in Attachment B. Specific quantitative results (e.g., force applied, number of cycles) are not provided in this summary documento.
Material Composition	Substantially equivalent to predicate devices (implied: meets established biocompatibility and material strength standards).
Intended Use	Same as predicate devices.
Fundamental Scientific Technology	Same as predicate devices.
Principles of Operation	Same as predicate devices.
Basic Design	Same as predicate devices.

Note: The submission states that the device is "substantially equivalent" to predicate devices, meaning it meets the same functional and safety requirements, which includes performance under mechanical stress. The detailed results of the static and dynamic fatigue testing would be in "Attachment B," which is not provided.

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

Sample Size: The document does not specify the sample size for the static and dynamic fatigue testing. For physical testing of medical devices, sample sizes are typically much smaller than for clinical studies (e.g., a few units per test condition).
Data Provenance: The testing was conducted by or for the manufacturer, Lifecore Biomedical, Inc. The country of origin of the data is implicitly the United States (Chaska, MN). The study is prospective in the sense that the tests were designed and executed to evaluate the new device.

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

This question is not applicable to this type of device submission. The "ground truth" for a mechanical device is established by engineering standards and test methods (e.g., ISO, ASTM standards for dental implant systems) for static and dynamic fatigue, not by expert medical opinion on a diagnosis. The testing itself measures physical properties against these established engineering benchmarks.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements among human readers or experts in diagnostic studies. For mechanical testing, the "adjudication" is based on whether the device passes the predefined physical test criteria.

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

This question is not applicable. This is a physical medical device (dental abutment), not an AI or diagnostic software device. Therefore, no MRMC study or AI-assistance comparison was conducted.

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

This question is not applicable. This is not an algorithm or AI-driven device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering standards and established physical test methods for dental implant systems, specifically related to static and dynamic fatigue strength. These standards define the acceptable performance limits for such devices.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of a physical medical device like a dental abutment. Training sets are relevant for machine learning algorithms.

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

This question is not applicable. As there is no training set for this type of device.

Summary for K072241 (Lifecore PrimaConnex® CAD/CAM Abutment System):

This 510(k) submission successfully demonstrated substantial equivalence to predicate devices for a dental abutment system. The "study" referenced is focused on mechanical performance testing (static and dynamic fatigue) rather than clinical diagnostic accuracy or AI performance. The acceptance criteria and performance are based on engineering standards and physical test results, confirming the device's mechanical integrity and safety for its intended use, rather than a statistical evaluation of diagnostic accuracy.

Summary

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K072241

510(k) SUMMARY AND CERTIFICATION [As required by 21 CFR 807.92(c)]

1. Submitter's Name and Contact Person		NOV 9 2007
Lifecore Biomedical, Inc.3515 Lyman BlvdChaska, MN 55318	Judith Medlock-HayesRegulatory Affairs SpecialistPh: 952.368.6364; Fax: 952.368.4278

2. General Information

Trade Name	Lifecore PrimaConnex® CAD/CAMAbutment System
Common Name	Endosseous dental implant abutmentCeramic Coping
Classification Name	Abutment: Endosseous dental implantabutment21 CFR §872.3630,Coping: Porcelain Tooth21 CFR §872.3290
Product Code	NHA, ELL
Identification of Predicate Devices	DDS-ZR Zirconia (DDS Services) (K041645) PrimaConnex Implant System(Lifecore Biomedical, Inc.) (K051614) Atlantis Components' Abutment forZimmer Internal Connection (AtlantisComponents, Inc.) (K053373) PrimaConnex Ceramic Copings(Lifecore Biomedical, Inc.) (K060530) Atlantis Components' Abutment forAstra Implant (Atlantis Components,Inc.) (K070833)

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3. Device Description

4. Intended Use

The Lifecore PrimaConnex CAD/CAM Abutment System is intended for use as an accessory to a Lifecore PrimaConnex endosseous implant to support a prosthetic device in a partially or completely edentulous patient. They are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae in the construction of single-unit cement retained restorations on Lifecore PrimaConnex CAD/CAM Abutments.

5. Substantial Equivalence Comparison

The PrimaConnex CAD/CAM Abutment System and predicate devices are substantially equivalent in intended use, material composition, fundamental scientific technology, principles of operation, and basic design. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the PrimaConnex CAD/CAM Abutment System.

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Summary of Attachments

Attachment A:	Device and Accessory Drawings
Attachment B:	Static and Dynamic Fatigue Testing of Endosseous DentalImplant Systems – PrimaConnex® CAD/CAM AbutmentSystem
Attachment C:	Predicate Device Information
Attachment D:	Declaration of Conformity

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of a human figure with three arms or lines extending from the head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

Ms. Judith Medlock-Hayes Regulatory Affairs Specialist Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318

Rc: K072241

Trade/Device Name: PrimaConnex® CAD/CAM Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA, ELL Dated: August 10, 2007 Received: August 13, 2007

Dear Ms. Medlock-Hayes:

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 - Ms. Clement

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 vour 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Nail R. Qghn
Chiu Lin, Ph.D.,

hiu 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

510(k) Number (if known):

Device Name: PrimaConnex® CAD/CAM Abutment System

Indications for Use:

Prescription Use X_________ AND/OR

Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runns

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072241

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.)