Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Titanium Abutment is indicated for cemented restorations. The abutment can be used in single tooth replacements and multiple tooth restorations.

Device Description

The Straumann Dental Implant System is an integrated system of endosseous dental implants designed to support prosthetic restorations {crowns, bridges, overdentures}. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The subject device, the Straumann C.A.R.E.S. Titanium Abutment, is designed to be custom modified for a particular patient, then inserted into the implant with a basal screw. The titanium abutment provides support for a prosthetic reconstruction, such as a crown. The Straumann C.A.R.E.S. Titanium abutment is intended for cemented restorations and can be customized to meet high anatomical and esthetic demands. The esthetic properties of the Straumann C.A.R.E.S. Titanium Abutment are designed to create a natural appearance of the soft tissue margin as well as excellent results for crown restoration.

AI/ML Overview

This document is a 510(k) summary for the Straumann C.A.R.E.S. Titanium Abutment. It details the device's identity, intended use, and claims of substantial equivalence to a predicate device. However, it does not contain information about formal acceptance criteria, studies, or performance data in the way typically expected for a detailed device validation and verification report.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting specific, quantitative acceptance criteria for performance.
Reported Device Performance: Not reported in terms of specific metrics or quantitative data from a study. The document states that "Technological characteristics of the device, including material composition, principles of operation, and basic design are identical to the predicate device." This is a qualitative statement of equivalence, not a report of performance against defined criteria.

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

Sample Size for Test Set: Not applicable. The document does not describe a clinical or performance "test set" in the context of an algorithm or AI. It describes a medical device, an abutment, whose design and materials are compared to a predicate.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No data in this sense is presented.

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

Not applicable. This document is not about an AI/algorithm-based device requiring expert ground truth for a test set.

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

Not applicable. No test set requiring adjudication 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

Not applicable. This device is a physical dental abutment, not an AI or algorithm. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not applicable. This is not an algorithm.

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

Not applicable. No ground truth in the context of an AI/algorithm is relevant here. The "ground truth" for this device's safety and effectiveness relies on its similarity to a previously cleared device and the established performance of its materials and design, which are generally well-understood in the dental industry.

8. The sample size for the training set

Not applicable. No training set for an AI/algorithm is mentioned.

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

Not applicable. No training set ground truth to establish.

Summary of what the document does provide regarding "proof of meeting acceptance criteria":

Basis for Substantial Equivalence: The primary "proof" in this 510(k) is the claim that the Straumann C.A.R.E.S. Titanium Abutment is substantially equivalent to the Straumann synOcta Meso Abutment (K033243).
Method of demonstrating equivalence: This equivalence is asserted because the "Technological characteristics of the device, including material composition, principles of operation, and basic design are identical to the predicate device."
Acceptance by FDA: The FDA's letter (pages 2-4) formally acknowledges the substantial equivalence (K052272), allowing the device to be marketed. This regulatory approval is the "acceptance" in the context of a 510(k) submission, indicating that the FDA finds the device as safe and effective as the predicate.

In essence, for this specific type of medical device (a physical implant component), the "acceptance criteria" are demonstrating substantial equivalence to a predicate device, and the "study that proves the device meets the acceptance criteria" is the 510(k) submission itself, along with the FDA's clearance letter. This is a very different paradigm than validating an AI/algorithm's performance against specific metrics using a test set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the text "JAN 3 2006" on the top line and "K052272" on the second line. The second line is underlined. The text appears to be handwritten.

510 (k) Summary

1 . Applicant's Name and Address

Straumann Manufacturing (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, Massachusetts 01810 Telephone Number: 800-448-8168 Fax Number: 978-747-003 1 Contact Person: Elaine Alan Regulatory and Clinical Affairs

2. Name of the Device

Trade Name:	Straumann Computer Aided Restoration Service(C.A.R.E.S.) Titanium Abutment
Common Name:	Abutment for endosseous implant
Classification Name:	Accessory to dental implant,21 CFR 872.3640

3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)

Straumann's synOcta Meso Abutment (K033243)

Description of the Device এ.

The Straumann C.A.R.E.S. Titanium abutment is intended for cemented restorations and can be customized to meet high anatomical and esthetic demands. The esthetic properties of the Straumann C.A.R.E.S. Titanium Abutment are designed to create a natural appearance of the soft tissue margin as well as excellent results for crown restoration.

{1}------------------------------------------------

K052272

5. Intended Use of the Device

The Straumann C.A.R.E.S. Titanium Abutment is a device that provides support for cement-retained prosthetic reconstruction, such as a crown. The Straumann C.A.R.E.S. Titanium Abutment is of particular interest in the anterior, canine, and premolar regions where there are high esthetic demands, will be uniquely customized for an individual then placed into the dental implant.

ర. Basis for Substantial Eguivalence

The Straumann C.A.R.E.S. Titanium Abutment is substantially equivalent to previously cleared meso titanium abutments intended to be used with endosseous dental implants. The design of the subject abutment is very similar to the previously cleared Straumann synOcta Meso Abutment (K033243). Technological characteristics of the device, including material composition, principles of operation, and basic design are identical to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings or feathers.

Public Health Service

JAN 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elaine Alan Regulatory Affairs Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

Re: K052272

Trade/Device Name: Straumann C.A.R.E.S. Titanium Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: December 20, 2005 Received: December 21, 2005

Dear Ms. Alan:

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 affectung 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.

{3}------------------------------------------------

Page 2 - Ms. Alan

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,

Clive

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

{4}------------------------------------------------

K052272

Indications for Use

510(k) Number (if known): K

Straumann C.A.R.E.S. Titanium Abutment Device Name:

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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)

Page 1 of 1

Siner Quero

K052277

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.)