The XiVE® Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE® dental implants (≥ 9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

Device Description

The XiVE® Dental Implant System consists of subgingival threaded dental imolants in 3.4 - 5.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIADENT Surface M2.1. The XiVE® Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for single tooth replacement, fixation of bridges and complete dentures. In the edentulous mandible, the XiVE® dental implants are indicated for immediate loading procedures using the standard protocol.

AI/ML Overview

The provided document is a 510(k) summary for the FRIADENT GmbH XIVE® Dental Implant System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria via a clinical study with an AI component. Therefore, much of the requested information regarding AI device evaluation is not applicable to this document.

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

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

The document does not specify quantitative acceptance criteria or report specific performance metrics against such criteria in the way a clinical study for an AI device would. The core of this 510(k) is to demonstrate "substantial equivalence." The "performance evaluations" mentioned are general and refer to the device performing "as intended," not against specific numerical thresholds.

Acceptance Criteria (Not Explicitly Stated for this 510(k))	Reported Device Performance (as stated in the 510(k))
(Implicit) Substantial Equivalence to Predicate Devices	The device is substantially equivalent to the predicate devices in terms of design, materials, mechanical strength, prosthetic and laboratory options, and intended use.
(Implicit) Performs as Intended	"Performance evaluations of the XiVE® dental implant system show that the device performs as intended."
(Implicit) Biocompatibility / Safety (as per predicate)	Constructed of CP-2 titanium, which is consistent with existing cleared devices.

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 510(k) submission does not describe a clinical study with a "test set" in the context of an AI device. The comparison is primarily based on technological characteristics and intended use relative to predicate devices. The "performance evaluations" mentioned are not detailed as a specific study with a quantifiable sample size.

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 submission does not involve AI model development or ground truth establishment by experts in the context of a "test set."

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

Not applicable. There is no mention of a test set or adjudication for an AI device.

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 not an AI device, and no MRMC study is described.

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

Not applicable. This is not an AI device.

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

Not applicable. There is no AI model requiring ground truth. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no training set.

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

Not applicable. There is no AI device or training set.

Summary based on the provided document:

The K032158 submission for the XiVE® Dental Implant System focuses on demonstrating substantial equivalence to previously cleared predicate devices (K013867 and K021318). The primary argument for equivalence is that the device has the same design, materials (CP-2 titanium), mechanical strength, prosthetic options, instructions for use, and intended use as the predicate devices. The only stated difference is a change in the surface morphology to the "FRIADENT Surface M2.1." The submission asserts that "Performance evaluations of the XiVE® dental implant system show that the device performs as intended." This implies that internal testing or existing knowledge about the materials and design support its function, but no detailed study or specific quantitative acceptance criteria are provided in this summary. The FDA's clearance letter confirms their agreement that the device is substantially equivalent to the predicate.

Summary

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K032158

AUG 1 4 2003

SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 17:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

SUBMITTER INFORMATION 17.1

a.	Company Name:	FRIADENT GmbH.
b.	Company Address:	Steinzeugstrasse 50Mannheim D-68229Germany
c.	Company Phone:Company Facsimile:	(011) 49 621 43 02 1121(011) 49 621 43 02 2121
d.	Contact Person:	Heike DietzlerRegulatory Affairs Manager
e.	Date Summary Prepared:	July 14, 2003

DEVICE IDENTIFICATION 17.2.

a. Trade/Proprietary Name:	XIVE® Dental Implant System
b. Classification Name:	Endosseous Dental Implants21 CFR 872.3640

17.3 IDENTIFICATION OF PREDICATE DEVICES

Company	Device	510(k) No.	Date Cleared
FRIADENT GmbH	XiVE® Dental ImplantSystem	K013867	03/15/2002
FRIADENT GmbH	XiVE® Dental ImplantSystem	K021318	08/02/2002

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DEVICE DESCRIPTION 17.4

17.5 SUBSTANTIAL EQUIVALENCE

The XiVE® dental implants with the FRIADENT Surface M2.1 are substantially equivalent to the current XiVE® Dental Implant Systems in terms of design. materials, mechanical strength, prosthetic and laboratory options and intended use.

17.6 INTENDED USE

The XiVE® Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentuolous mandible, a minimum of four XIVE® dental implants (39.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

TECHNOLOGICAL CHARACTERISTICS 17.7

The XiVE® dental implant is available in 3.4, 3.8, 4.5, and 5.5mm screw-type implants with the FRIADENT Surface M2.1. The lengths of the implants range from 8 -- 18mm. The XiVE® dental implants are constructed of CP-2 titanium. A variety of prosthetic options are available for the XiVE® system including, MH-6, MH-2, AuroBase, CeraBase, ProTect, PassivFit, TempBase, Gold

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Copings, Telescopic, Ball and Socket Attachments, Bar/Clip, and Select Abutments.

The XiVE® dental implants with the FRIADENT Surface M2.1 is equivalent to the current XiVE® Dental Implant System in terms of design, materials, mechanical strength, prosthetic options, instructions for use and intended use. The only difference is the change in the surface morphology of the dental implant to the FRIADENT Surface M2.1.

CLASS III CERTIFICATION AND SUMMARY 17.8

This notification contains a Class III certification and summary of adverse safety and effectiveness information pursuant to 513(f) of the Federal Food, Drug, and Cosmetic Act.

CONCLUSIONS 17.9

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer-s Checklist is provided in this submission. Performance evaluations of the XiVE® dental implant system show that the device performs as intended. Comparison of the XIVE® dental implant system to the predicate devices show that the device is substantially equivalent. The complete surface characterization of the new FRIADENT Surface M2.1 has been detailed in a Device Master File.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2003

FRIADENT GmbH C/O Carol Patterson Paterson Consulting Group, Incorporated 21911Erie Lane Lake Forest, California 92630

Re: K032158

Trade/Device Name: The XiVE® Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: July 14, 2003 Received: July 15, 2003

Dear Mr. Patterson:

We have reviewed your Section 510(k) market 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. Paterson

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 (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 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/dsma/dsmamain.html

Sincerely vours,

Susan Runner

Susan Runner, DDS, MA Interim 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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K032158

INDICATION FOR USE

510(k) Number:

Device Name:

XiVE® Dental Implant System

Indications for Use:

The XiVE® Dental Implant System is indicated for the following:

Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations.

In the edentulous mandible, a minimum of four XiVE® dental implants (≥ 9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

Kein Moley for MSR

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

510(k) Number: K032158

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
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(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

CONFIDENTIAL
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Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.