(27 days)
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.
The XiVE® 3.0 Dental Implant System consists of subgingival threaded dental implants with 11 - 15mm lengths. The implants are coated with the FRIADENT Surface M2.1. The XiVE® 3.0 Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single tooth and splinted tooth restorations in the anterior regions of the mouth.
The provided text does not contain detailed information about specific acceptance criteria or a study proving that the dental implant device meets those criteria in the form usually associated with AI/ML-driven device evaluations (e.g., sensitivity, specificity, AUC, human reader improvement).
Instead, this document is a 510(k) summary for a dental implant system, which is a physical device, and the evaluation focuses on its substantial equivalence to a predicate device. The "performance evaluations" mentioned are likely related to mechanical strength, biocompatibility, and similar engineering and biological assessments, rather than diagnostic AI performance metrics.
Here's an analysis based on the provided text, highlighting what is and is not present concerning your request:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the format requested for an AI/ML device. The document states:
- "Performance evaluations of the XiVE® 3.0 dental implant system show that the device performs as intended."
- "Comparisons of the XiVE® 3.0 dental implants to the predicate devices show that the device is substantially equivalent."
These are general statements about the device meeting expectations, but specific quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) and their corresponding performance values are not detailed in this summary. The 510(k) process for this type of device typically relies on demonstrating equivalence in design, materials, and mechanical properties to a previously cleared predicate device.
2. Sample size used for the test set and the data provenance:
This information is not available in the provided text. For a physical device like a dental implant, "test set" might refer to the number of implants subjected to mechanical testing or animal/human studies for biocompatibility and integration. However, the details of such tests (sample size, nature of the data, origin) are not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable and not mentioned. For a dental implant, "ground truth" would relate to its physical properties, biocompatibility, and osseointegration, which are established through engineering tests, material science, and clinical observations, not expert consensus on image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable and not mentioned. Adjudication methods like 2+1 or 3+1 are typically used in AI/ML performance studies where multiple human readers independently evaluate cases to establish a robust ground truth for diagnostic tasks.
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 is not applicable and not mentioned. MRMC studies and the concept of "human readers improving with AI assistance" are relevant to AI-powered diagnostic devices, not purely mechanical dental implants.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable and not mentioned, for the same reasons as above. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
As discussed, the concept of "ground truth" in the context of an AI device's diagnostic performance is not directly applicable here. For a dental implant, performance is assessed against established engineering standards, material specifications, and clinical outcomes related to successful osseointegration and long-term stability. The text indicates "complete surface characterization of the new FRIADENT Surface M2.1 has been detailed in a Device Master File," which would be part of the technical documentation establishing its characteristics.
8. The sample size for the training set:
This is not applicable and not mentioned. There is no AI/ML algorithm being "trained" in this context.
9. How the ground truth for the training set was established:
This is not applicable and not mentioned.
In summary, the provided document describes a 510(k) submission for a dental implant system, a physical device, and its clearance is based on demonstrating substantial equivalence to an existing predicate device. The information requested regarding AI/ML device performance metrics (acceptance criteria for diagnostic performance, test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) is not present in this document because it is not an AI/ML device submission.
{0}------------------------------------------------
OCT = 2 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: | September 15, 2003 |
DEVICE IDENTIFICATION 17.2.
| a. Trade/Proprietary Name: | XiVE® 3.0 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® 3.0 Dental ImplantSystem | K030639 | 08/12/2003 |
17.4 DEVICE DESCRIPTION
The XiVE® 3.0 Dental Implant System consists of subgingival threaded dental implants with 11 - 15mm lengths. The implants are coated with the FRIADENT
{1}------------------------------------------------
Surface M2.1. The XiVE® 3.0 Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single tooth and splinted tooth restorations in the anterior regions of the mouth.
17.5 SUBSTANTIAL EQUIVALENCE
The XiVE® 3.0 dental implants with the FRIADENT Surface M2.1 are substantially equivalent to the current XiVE® 3.0 Dental Implant Systems in terms of design, materials, mechanical strength, prosthetic and laboratory options and intended use.
17.6INTENDED 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.
TECHNOLOGICAL CHARACTERISTICS 17.7
The XiVE® 3.0 dental implant is available in screw-type subgingival implants with the FRIADENT Surface M2.1. The lengths of the implants range from 11 l 5mm. 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, AuroBase, EstheticBase, Telescopic, and Select Abutments.
The XiVE® 3.0 dental implants with the FRIADENT Surface M2.1 is equivalent to the current XiVE® 3.0 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.
{2}------------------------------------------------
17.8 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.
17.9 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. Comparisons of the XiVE® 3.0 dental implants 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.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2003
Patterson Consulting Group, Incorporated C/O Ms. Carol Patterson Friadent GmbH 21911 Erie Lane Lake Forest, California, 92630
Re: K032750
Trade/Device Name: XiVE® 3.0 Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implants Regulatory Class: III Product Code: DZE Dated: September 3, 2003 Received: September 5, 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 vour 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.
{4}------------------------------------------------
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 (OS) 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 Rionrer
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
{5}------------------------------------------------
INDICATION FOR USE
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.
Keii H.ley for MSR
(Division Sign-Off) eneral Hospital, Division of Anesthesiology, G Infection Control, Dental 510(k) Number
(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)
OR
Over-The-Counter Use
§ 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.