The XiVE 3.0 Dental Implant System consists of subgingival threaded dental implants with a 3.25mm diameter and lengths of 11 -- 15mm . The implants are coated with the FRIOS Deep Profile Surface. The XiVE Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for two stage procedures for single tooth replacement in the anterior regions of the mouth.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the FRIADENT GmbH XiVE® 3.0 Dental Implant System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as would be found for a novel AI/software medical device.

Therefore, many of the specific details requested regarding acceptance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods are not explicitly present in the provided text, as this type of information is typically not included in a 510(k) summary for a dental implant demonstrating substantial equivalence.

Here's an analysis based on the available information:

Description of Acceptance Criteria and Proving Device Meets Criteria

The document states: "Performance evaluations of the XiVE 3.0 dental implant system show that the device performs as intended for the anterior region of the mouth. Comparison of the XiVE 3.0 dental implant system to the predicate device show that the device is substantially equivalent."

This suggests that the "acceptance criteria" primarily revolved around demonstrating substantial equivalence to the predicate device in terms of design, materials, coatings, mechanical strength, prosthetic options, and intended use, as well as satisfactory performance for its intended use. The specific quantitative criteria for "performance as intended" are not elaborated.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (FRIALIT-2® 3.4mm Dental Implant System) in:	The XiVE® 3.0 dental implant is substantially equivalent to the FRIALIT-2® 3.4mm Dental Implant Systems in terms of design, materials, coatings, mechanical strength, prosthetic options and single tooth intended use.
- Design	(Implied to meet, as per substantial equivalence statement)
- Materials	Constructed of CP-2 titanium, identical to predicate in materials.
- Coatings	Coated with FRIOS Deep Profile Surface, identical to predicate in coatings.
- Mechanical Strength	Tested for compressive and static strength. (Specific results not provided but implied to meet)
- Prosthetic Options	Variety of prosthetic options (EstheticBase, AuroBase, Select, Telescopic Abutments), identical to predicate.
- Intended Use (single tooth replacement in anterior regions)	Performs as intended for the anterior region of the mouth. Indicated for single tooth restorations in the region of 7 to 10 and 23 to 26.
Finite Element Analysis (FEA) results	Finite element analysis performed. (Specific results not provided, but implied to meet)

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

Sample size: Not specified. The document mentions "performance evaluations" and mechanical testing (compressive, static strength, finite element analysis) but does not provide numbers of devices tested or specific clinical data from a "test set."
Data provenance: Not explicitly stated. The tests conducted (compressive, static strength, finite element analysis) are typically laboratory-based engineering tests rather than clinical trials with patient data.

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

Not applicable as this is not a study requiring expert-established ground truth in the context of diagnostic interpretation (e.g., radiology). The "ground truth" for a dental implant would be its physical properties and mechanical performance.

4. Adjudication method for the test set

Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.

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 dental implant, not an AI/software device that assists human readers.

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

Not applicable. This is a dental implant, not an algorithm.

7. The type of ground truth used

The ground truth for a dental implant's performance would be derived from engineering specifications, material science standards, and mechanical testing results (e.g., strength, fatigue life, material composition). The document mentions "compressive and static strength and finite element analysis," which are methods to establish this type of ground truth.

8. The sample size for the training set

Not applicable. This is a dental implant, not a machine learning model, so there is no "training set."

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

Not applicable.

Summary

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FRIADENT GmbH XiVE® 3.0 Dental Implant System AUG 1 2 2003 Original Premarket 510(k) Notification

SECTION 16:

SUMMARY OF SAFETY AND EFFECTIVENESS

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 16.1

a.	Company Name:	FRIADENT GmbH.
b.	Company Address:	Steinzeugstrasse 50Mannheim D-68229Germany
c.	Company Phone:Company Facsimile:	(011) 49 06 21 4 86 1549(011) 49 06 21 4 86 1866
d.	Contact Person:	Heike DietzlerRegulatory Affairs Manager
e.	Date Summary Prepared:	February 27, 2003

DEVICE IDENTIFICATION 16.2.

a. Trade/Proprietary Name:	XiVE® 3.0 Dental Implant System
b. Classification Name:	Endosseous Dental Implants21 CFR 872.3640

IDENTIFICATION OF PREDICATE DEVICES 16.3

Company	Device	510(k) No.	Date Cleared
FRIADENT GmbH	FRIALIT-2 3.4mm DentalImplant with Deep ProfileSurface	K994376	03/24/2000

16.4 DEVICE DESCRIPTION

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is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for two stage procedures for single tooth replacement in the anterior regions of the mouth.

ા રેજરી રહ્યું હતું. સંદર્ભ SUBSTANTIAL EQUIVALENCE

The XiVE® 3.0 dental implant is substantially equivalent to the current FRIALIT-2® 3.4mm Dental Implant Systems in terms of design, materials, coatings, mechanical strength, prosthetic options and single tooth intended use.

16.6 INTENDED USE

The XIVE 3.0 Dental Implant System is indicated for single tooth restorations in the region of 7 to 10 and 23 to 26.

16.7 TECHNOLOGICAL CHARACTERISTICS

The XiVE® 3.0 dental implant is identical to the current FRIALIT-2® 3.4mm dental implants in terms of coatings, materials and prosthetic options. The XiVE® 3.0 dental implant is 3.25mm diameter screw-type implant with FRIOS® Deep Profile Surface. The lengths of the implants range from 11 - 15mm. The XiVE 3.0 dental implants are constructed of CP-2 titanium. A variety of prosthetic options are available for the XiVE 3.0 system including EstheticBase, AuroBase, Select and Telescopic Abutments. The XiVE 3.0 dental implant system was tested for compressive and static strength and finite element analysis.

16.8 CLASS III CERTIFICATION AND SUMMARY

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.

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16.9 CONCLUSIONS

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 3.0 dental implant system show that the device performs as intended for the anterior region of the mouth. Comparison of the XiVE 3.0 dental implant system to the predicate device show that the device is substantially equivalent.

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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 & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

AUG 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Friadent GmbH C/O Ms. Carol Patterson Patterson Consulting Group. Incorporated 21911 Erie Lane Lake Forest, California 92630

Re: K030639

Trade/Device Name: XiVE® 3.0 Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: July 23, 2003 Received: July 25, 2003

Dear Ms. Patterson:

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. Patterson

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 yours,

Suser Rums

Susan Runner, DDS, MA, Interim Director Division of Anesthesiology, General Hospital Infection Control and Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

K030639

510(k) Number:

Device Name: XiVE® 3.0 Dental Implant System

Indications for Use:

The XiVE 3.0 Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Kein Marley for MSN
(Division Sign-Off)

General Hospital.

510/

CONFIDENTIAL

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.