(114 days)
Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations.
The XiVE Dental Implant System consists of subgingival threaded dental implants in 3.4 - 5.5mm diameters with 8 - 18mm lengths. 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 twth replacement and the fixation of bridges and complete dentures.
The provided text is a 510(k) summary for the FRIADENT GmbH XiVE Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets them in the context of performance metrics that would typically be associated with AI/ML-based medical devices (e.g., sensitivity, specificity, AUC).
Instead, the document emphasizes:
- Substantial Equivalence: The core of the submission is to demonstrate that the XiVE Dental Implant System is substantially equivalent to legally marketed predicate devices (Nobel BioCare Branemark System Standard 3.75mm Fixture and FRIADENT GmbH FRIALIT-2 Dental Implant With Deep Profile Surface) in terms of design, materials, coatings, prosthetic options, mechanical strength, functionality, and intended use.
- Safety and Effectiveness: The document states, "Performance evaluations of the XiVE dental implant system show that the device performs as intended." and mentions "The XiVE dental implant system was tested for compressive and static strength and finite element analysis." However, it does not provide specific acceptance criteria values or detailed study results for these tests.
Given the nature of the provided document (a 510(k) summary for a dental implant, not an AI/ML device), many of the requested points are not applicable or cannot be extracted. I will address the points based on the information available and note when information is not present in the document.
Acceptance Criteria and Study for FRIADENT GmbH XiVE Dental Implant System
The provided document primarily focuses on demonstrating substantial equivalence of the XiVE Dental Implant System to predicate devices rather than presenting specific performance metrics against pre-defined acceptance criteria, especially in the way an AI/ML device would. The "performance evaluations" mentioned are broadly stated and do not include quantitative acceptance criteria or detailed study results.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or corresponding reported device performance values similar to what would be found for an AI/ML diagnostic device (e.g., sensitivity > X%, specificity > Y%). The evaluation primarily rests on demonstrating equivalence to predicate devices.
The closest to "acceptance criteria" and "performance" mentioned are:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: To predicate devices in design, materials, coatings, prosthetic options, and intended use. | "The XiVE® dental implant is substantially equivalent to the current FRIALIT-2® Dental Implant Systems in terms of design, materials, coatings, prosthetic options and intended use." "The XiVE® dental implant is substantially equivalent to the Nobel BioCare Branemark 3.75mm dental implant in terms materials, functionality, mechanical strength and intended use." |
| Mechanical Strength: Demonstrated through testing (compressive, static, finite element analysis). | "The XiVE dental implant system was tested for compressive and static strength and finite element analysis." "Performance evaluations of the XiVE dental implant system show that the device performs as intended." |
| Intended Use: Supports single tooth, bridge and overdenture restorations once osseointegrated. | "Once the XiVE Dental Implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations." (Stated as intended use and implicitly accepted through equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The filing describes generic "performance evaluations" and "testing for compressive and static strength and finite element analysis" but does not detail the size of any test sets (e.g., number of implants tested) or the provenance of the data. Given it's a physical implant, "data provenance" in the sense of patient data is not directly applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. This concept typically applies to diagnostic devices where expert review (e.g., radiologists, pathologists) establishes a "ground truth" for evaluating algorithm performance. For a physical dental implant, performance is assessed through engineering tests (mechanical, material, biocompatibility) and clinical outcomes, not expert-adjudicated ground truth on a test image/data set.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, an adjudication method like 2+1 or 3+1 is relevant for establishing ground truth in diagnostic studies, not for the physical and mechanical testing of a dental implant.
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
This information is not applicable and not provided. MRMC studies and the concept of "human readers improving with AI assistance" are relevant for AI/ML-based diagnostic or assistive devices, not for a physical dental implant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a physical dental implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the XiVE Dental Implant System is established through:
- Engineering specifications and standards: For material properties, mechanical strength (compressive, static), and finite element analysis.
- Biocompatibility testing: To ensure safety in the body (implied, common for implants).
- Clinical outcomes: While not detailed, ultimately, successful osseointegration and long-term support of restorations in patients would be the ultimate "ground truth" for its intended function.
The document implicitly relies on these types of "ground truth" by stating the device "performs as intended" and is "substantially equivalent" to devices proven safe and effective.
8. The Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" in the context of a physical dental implant device. This concept applies to AI/ML algorithms.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided. As there is no training set, there is no ground truth establishment for it.
In summary, the provided document is a 510(k) premarket notification summary for a physical dental implant. It demonstrates substantial equivalence to predicate devices based on design, materials, mechanical properties (tested, but not detailed), and intended use. The questions posed are largely tailored for AI/ML-based medical devices, which the XiVE Dental Implant System is not. Therefore, specific details regarding acceptance criteria as quantitative performance metrics, sample sizes for test/training sets, expert adjudication, or AI performance metrics are absent and not relevant to this type of device submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of an eagle with three lines representing its wings and head. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 2005
FRIADENT GmbH C/O Ms. Carol Patterson Patterson Consulting Group, Incorporated 21911 Erie Lane Lake Forest, California 92630
Re: K013867
Trade/Device Name: Xive Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: III Product Code: DZE Dated: February 21,2002 Received: February 22,2002
Dear Ms. Patterson:
This letter corrects our substantially equivalent letter of March 15, 2002 regarding the company name.
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 (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 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 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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:Nwww.fda.gov/cdrh/dsmaldsmamain.html
Sincerely yours.
Suite Michael 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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867
FRIADENT GmbH XiVE Dental Implant System 510(k) Amendment, #K013867, February 5, 2002
INDICATION FOR USE
510(k) Number: K013867 XiVE® Dental Implant System Device Name: The XiVE Dental Implant System is indicated as follows: Indications for Use: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109) Over-The-Counter Use
hrlillra
("Tivision Sign-Off) Control of Dental, Infection Control, ୍ତ General Hospital Devices K1)3862 ್ 100k) Number _
CONFIDENTIAL
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SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16:
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) 49 621 4302 1121(011) 49 621 4302 2121 |
| d. | Contact Person: | Heike DietzlerRegulatory Affairs Manager |
| e. | Date Summary Prepared: | February 21,2002 |
16.2. DEVICE IDENTIFICATION
| a. Trade/Proprietary Name: | XiVE® Dental Implant System |
|---|---|
| b. Classification Name: | Endosseous Dental Implants21 CFR 872.3640 |
16.3 IDENTIFICATION OF PREDICATE DEVICES
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Nobel BioCare | Branemark System Standard3.75mm Fixture | K925765 | 10105193 |
| FRIADENT GmbH | FRIALIT-2 Dental ImplantWith Deep Profile Surface | K945847 | 03/15/95 |
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16.4 DEVICE DESCRIPTION
The XiVE Dental Implant System consists of subgingival threaded dental implants in 3.4 - 5.5mm diameters with 8 - 18mm lengths. 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 twth replacement and the fixation of bridges and complete dentures.
16.5 SUBSTANTIAL EQUIVALENCE
The XiVE® dental implant is substantially equivalent to the current FRIALIT-2® Dental Implant Systems in terms of design, materials, coatings, prosthetic options and intended use. The XIVE® dental implant is substantially equivalent to the Nobel BioCare Branemark 3.75mm dental implant in terms materials, functionality, mechanical strength and intended use.
INTENDED USE 16.6
Once the XiVE Dental Implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations.
16.7 TECHNOLOGICAL CHARACTERISTICS
The XiVE® dental implant is identical to the current FRIALIT-2® dental implants in terms of coatings, materials and prosthetic options. The XiVE® dental implant is available in 3.4, 3.8, 4.5 and 5.5 mm screw-type implants with FRIOS® Deep Profile Surface. 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, EstheticBase, Cerabase, AuroBase and Protect Abutments, PassivFit, Ball and Socket Attachments. Bar Copings, Round Bar. Bar Clip, and Telescopic
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Abutments. The XiVE dental implant system was tested for compressive and static strength and finite element analysis.
The XiVE Dental Implant system is equivalent to the Nobel BioCare Branemark Standard Dental Implant System in terms of design, mechanical strength and intended use.
CLASS III CERTIFICATION AND SUMMARY 16.8
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.
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 dental implant system show that the device performs as intended. Comparison the XiVE dental implant system to the predicate devices, show that the device is substantially equivalent.
§ 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.