Both the P.004 RC/NC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) summary for a dental device, the "P.004 RC/NC Gold and Titanium Abutment for Bars." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through clinical or performance studies with detailed metrics.

Therefore, the information required in your request cannot be fully extracted from this document, as it describes a regulatory submission process based on equivalence rather than detailed performance study results.

Here's a breakdown of why and what little can be inferred:

Acceptance Criteria and Reported Device Performance: This document does not present acceptance criteria or detailed performance data (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) in the way a clinical or technical validation study would. The document states, "The proposed abutments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed abutment has the same material composition, basic design and fundamental operating principles to the currently marketed devices." This is the core "proof" presented for regulatory acceptance under the 510(k) pathway.
Study That Proves the Device Meets Acceptance Criteria: There is no specific study described that "proves" the device meets acceptance criteria in the manner of defining and then testing against specific performance thresholds. The 510(k) process relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is typically achieved by comparing technological characteristics, materials, and intended use, often supported by non-clinical bench testing for mechanical properties (though not detailed here), rather than multi-reader studies or ground truth comparisons.

Given these limitations of the provided text, here's what can be answered, and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified as quantitative criteria in this document. The overarching "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.	The device (P.004 RC/NC Gold and Titanium Abutment for Bars) is described as having "the same material composition, basic design and fundamental operating principles" as the predicate devices (Straumann P.004 Dental Implants, synOcta® Gold Coping, synOcta® Titanium Coping, Abutment for Bars). Its intended use is also identical.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable. This document does not describe a clinical or performance study with a "test set" in the context of AI/diagnostic device validation. It's a regulatory submission based on substantial equivalence to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. There is no "ground truth" establishment or expert review detailed in this document.

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

Not Applicable. No test set or adjudication method is described.

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

No. This document does not describe an MRMC study. The device is a physical dental abutment, not an AI-assisted diagnostic tool for 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 (dental abutment), not an algorithm.

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

Not Applicable. The concept of "ground truth" for comparative performance evaluation is not relevant to this 510(k) submission, which relies on demonstrating equivalence in design, materials, and intended use to predicate devices.

8. The sample size for the training set

Not Applicable. No training set is described.

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

Not Applicable. No training set or ground truth establishment is described.

Summary

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222 % 2007

Section I 510(k) Summary

Applicant's Name and Address 1.

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2507 Fax Number: 978-747-0023 Contact Person: Paige Sweeney Manager, Regulatory Affairs Date of Submission: July 11, 2007

2. Name of the Device

Trade Name:	P.004 RC/NC Gold Abutment for BarsP.004 RC/NC Titanium Abutment for Bars
Common Name:	Abutment, Dental, Endosseous implants
Classification Name:	Abutment, Dental, Endosseous implants
Regulation Number:	§872.3630

es Legally Marketed Device to which Equivalence is Claimed (Predicate Device)

Straumann P.004 Dental Implants, K062129 RN synOcta® Gold Coping, K990342 RN synOcta® Titanium Coping, K990342 RN Abutment for Bars, K894844

4. Description of the Device

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5. Intended Use of the Device

Technological Characteristics 6.

The proposed abutments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed abutment has the same material composition, basic design and fundamental operating principles to the currently marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized image of an eagle or bird-like figure with its wings spread, suggesting protection and care.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2007

Ms. Paige Sweeney Manager, Regulatory Affairs Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

Re: K071919

Trade/Device Name: P.004 RC/NC Gold and Titanium Abutment for Bars Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 11, 2007 Received: July 12, 2007

Dear Ms. Sweeney:

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. Sweeney

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

Sincerely yours.

Smute y. Mchael Oms.

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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K071919

Indications for Use Statement

P.004 RC/NC Gold and Titanium Abutment for Bars Device Name:

Indications for Use:

× Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Page 1 of 1
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature

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

510(k) Number:	K071919
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510(k) Submission: P.004 RC/NC Gold and Titanium Abutments for Bars July 11, 2007 Proprietary and Confidential

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.)