(69 days)
The XiVE® TG Abutment is intended for use to fabricate screw-retained or cementable crowns and bridges.
The XiVE® TG Abutment is part of the XiVE® TG Transgingival Dental Implant System. The XIVE® TG Abutment is intended for the fabrication of screwretained or cementable crowns and bridges. The XiVE® TG Abutment is constructed of CP-2 titanium and is available in a 3.4 - 4.5mm diameter to correspond to the XiVE® transgingival implant bodies. The XiVE® TG Abutment is available with a straight or angled configuration.
The provided text describes a 510(k) premarket notification for a dental device, the XiVE® TG Abutment. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance data.
Therefore, the requested information elements related to specific acceptance criteria, detailed study design, sample sizes for test/training sets, expert involvement, and ground truth establishment are not explicitly available in the provided text.
Based on the information given, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific, quantifiable acceptance criteria. Instead, it states that "Performance evaluations of the XiVE® TG abutment show that the device performs as intended." The primary "acceptance criteria" for a 510(k) submission are based on demonstrating substantial equivalence to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness.
| Acceptance Criteria (Inferred from 510(k)) | Reported Device Performance (Inferred from 510(k)) |
|---|---|
| Substantial equivalence in design | "similar in design" to predicate device |
| Substantial equivalence in functionality | "equivalent to the predicate device in functionality" |
| Substantial equivalence in materials | "equivalent to the predicate device in materials" |
| Substantial equivalence in mechanical strength | "equivalent to the predicate device in mechanical strength" |
| Performs as intended | "device performs as intended" |
2. Sample sized 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 mentioned. The document refers to "Performance evaluations," but no details about the studies or sample sizes are provided.
- Data provenance: Not mentioned. It's likely the evaluations were conducted by FRIADENT GmbH in Germany, given the company's location, but this is not explicitly stated for the "performance evaluations."
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 and not mentioned. This type of detail is typically for diagnostic AI/CAD devices where expert interpretation forms the ground truth. For a dental abutment, performance is based on mechanical properties and clinical use, often tested physically or in animal/cadaver models, or by comparison to existing devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable and not mentioned.
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 a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device would likely be established through:
- Mechanical testing: Demonstrating structural integrity, fatigue resistance, and fit according to established standards.
- Material compatibility: Verification of biocompatibility.
- Clinical performance: Although not detailed in this summary, clinical experience with predicate devices and possibly limited in-house testing would inform the "performs as intended" conclusion. However, no specific "ground truth" data of these types are presented.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires training data in the traditional sense.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a handwritten string of characters, which appears to be a combination of letters and numbers. The string reads 'K032302'. The characters are written in a cursive style, with some connections between the letters and numbers. The writing is dark and clear against a light background.
OCT = 2 2003 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 06 21 4302 1121(011) 49 06 21 4302 2121 |
| d. Contact Person: | Heike DietzlerRegulatory Affairs Manager |
| e. Date Summary Prepared: | July 23, 2003 |
16.2. DEVICE IDENTIFICATION
| a. | Trade/Proprietary Name: | XiVE® TG AbutmentAccessory to the XiVE® TGDental Implant Systems |
|---|---|---|
| b. | Classification Name: | Endosseous Dental Implants21 CFR 872.3640 |
16.3 IDENTIFICATION OF PREDICATE DEVICES
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| FRIADENT GmbH | XiVE® TransgingivalDental Implant System | K024004 | 03/03/2003 |
| Staumann USA | synOcta Abutment | K022859 | 09/19/2003 |
{1}------------------------------------------------
16.4 DEVICE DESCRIPTION
The XiVE® TG Abutment is part of the XiVE® TG Transgingival Dental Implant System. The XIVE® TG Abutment is intended for the fabrication of screwretained or cementable crowns and bridges. The XiVE® TG Abutment is constructed of CP-2 titanium and is available in a 3.4 - 4.5mm diameter to correspond to the XiVE® transgingival implant bodies. The XiVE® TG Abutment is available with a straight or angled configuration.
ાર્ભર SUBSTANTIAL EQUIVALENCE
The XiVE® TG Abutment is substantially equivalent to the XiVE® TG Bar Coping Abutment. The XiVE® TG Abutment is equivalent to the predicate device in design, functionality, materials, mechanical strength. The XiVE® TG Abutment is substantially equivalent to the synOcta Abutment. The XiVE® TG Abutment is equivalent to the predicate device in functionality, materials and intended use.
16.6 INTENDED USE
The XIVE® TG Abutment is intended for use in the fabrication of screw-retained and cementable crowns and bridges.
16.7 TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the XiVE® TG Abutment with the predicate devices is provided within this submission. Both the XiVE® TG Abutment and the predicate device are similar in design, mechanical strength, materials and functionality. The XiVE® TG Abutment is available in diameters corresponding to those of the implant bodies and in a straight or angled configuration.
{2}------------------------------------------------
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® TG abutment show that the device performs as intended. Comparison the XiVE® TG abutment to the predicate devices show that the device is substantially equivalent.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with stylized wings and body.
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: K032302
Trade/Device Name: XiVE® TG Abutment Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implants 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.
{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 vour device to proceed to the market.
If vou 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,
Susan Runne
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® TG Abutment
Indications for Use:
The XiVE® TG Abutment is intended for use to fabricate screw-retained or cementable crowns and bridges.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Huby for MSA
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K03230
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.