The Elliptic Matrix attaches to the retentive anchor by functioning like a spring when the four lamellae are activated. The titanium housing gives the matrix more support and retention for the denture.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Elliptic Matrix," an endosseous dental implant component. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new performance criteria through extensive studies. As such, the information typically requested for AI/software-based devices (e.g., acceptance criteria, detailed study results, multi-reader multi-case studies, ground truth establishment for training) is not present in this type of submission.

Therefore, many of the requested fields cannot be filled as they pertain to performance testing that is not part of a substantial equivalence claim for a physical, mechanical medical device like this one.

Here's a breakdown of the available information:

Device Name: Elliptic Matrix
Intended Use: The Elliptic Matrix is attached onto the retentive anchor abutment to provide support and retention for a denture.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in this document for the Elliptic Matrix.	The device is deemed substantially equivalent to the predicate Gold Matrix (K894844). The basis for this equivalence is that the intended use is identical, the design is "almost identical," and the labeling/instructions for use are similar. This implies that the Elliptic Matrix is expected to perform to the same standards as the predicate device.

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

Sample size for test set: Not applicable. This submission is for a physical medical device and relies on substantial equivalence to a predicate, not performance data from a specific test set.
Data provenance: Not applicable.

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. This is not an AI/software device and does not involve expert-established ground truth for a test set.

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 is a physical dental implant component, not an AI-assisted diagnostic tool.

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. The "ground truth" in this context is the performance and safety established for the predicate device to which it claims equivalence.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a training set.

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

Not applicable.

Summary

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MAR 1 8 2004

ATTACHMENT 6 - 510(k) Summary

Applicant's Name and Address 1.

Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 Telephone Number: 781-890-0001 781-890-0791 Fax Number: Contact Person: John King Regulatory Affairs

2. Name of the Device

Trade Name:	Elliptic Matrix
Common Name:	Endosseous dental implant
Classification Name:	Endosseous dental implant
	21 CFR 872.3640

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

Gold Matrix (K894844)

4. Description of the Device

5. Intended Use of the Device

The Elliptic Matrix is attached onto the retentive anchor abulment to provide support and retention for denture.

റ. Basis for Substantial Equivalence

The subject device is substantially equivalent to previously cleared Gold Matrix. The intended use of the subject Elliptic Matrix is identical to the predicate Gold Matrix.

The subject device has an almost identical design as the predicate device. The labeling and instructions for use for both devices are similar.

510(k) Elliptic Matrix March 1, 2004 Page 16 of 20

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest wings and a body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2004

Institut Straumann AG C/O Mr. John King Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451

Re: K040539

Trade/Device Name: Elliptic Matrix Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: III Product Code: NHA Dated: March 1, 2004 Received: March 2, 2004

Dear Mr. King:

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. King

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 moan that I DT may must statutes and regulations administered by other Federal agencies. or the For of any I ouchar the Act's requirements, including, but not limited to: registration r od inust comply with a wart 807); labeling (21 CFR Part 801); good manufacturing practice and libang (2) es a set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as lectronic 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) This letter will and in yourse Finding of substantial equivalence of your device to a premaired predicate in - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rryou desire specific at 100 201 pliance at (301) 594-4613. 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 may obtain 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/cdrl/dsma/dsmamain.html

Sincerely yours,

Susan Runner

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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K040539

Page 1 of_1

510(k) Number (if known):

Elliptic Matrix Device Name:

Indications For Use:

The Elliptic Matrix is attached onto the Straumann Retentive Anchor abutment to provide support and retention for an overdenture.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Kein Whaley son V.S.R

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

510(k) Number: K040539

510(k) Elliptic Matrix March 1, 2004 Page 19 of 20

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.)