(132 days)
The FRIALIT-2® MH-2 Abutment is intended for use in multiple unit bridges and bar overdentures.
The FRIALIT-2® MH-2 Abutment is part of the FRIALIT-2® Dental Implant System. The MH-2 Abutment is designed to support multiple unit bridges and bar overdentures. The MH-2 Abutment is constructed of CP-2 titanium and is available in the same diameters as the FRIALIT-2® implant bodies. Each MH-2 Abutment diameter is available with a 1, 2, 3, or 5mm gingival cuff height. The 3.8 and 4.5mm abutments are also available with a 9mm gingival cuff height.
The provided text describes the FRIALIT-2® MH-2 Abutment, a component of a dental implant system. The document is a 510(k) premarket notification for this device.
However, the documentation does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/software as a medical device (SaMD) submission. This 510(k) is for a physical medical device (a dental abutment), and its clearance is based on demonstrating substantial equivalence to predicate devices, not on performance metrics against predefined acceptance criteria for a software algorithm.
Therefore, I cannot populate the table or answer the specific questions related to AI/SaMD studies (e.g., sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance) as this information is not present in the provided document.
The core of this submission is a comparison to predicate devices to demonstrate similar material, design, function, and intended use, thereby establishing substantial equivalence.
Here's how I can address the request based on the provided text, while highlighting the absence of AI/SaMD-specific study details:
This 510(k) submission for the FRIALIT-2® MH-2 Abutment is for a physical dental device and does not involve AI/SaMD. Therefore, the typical acceptance criteria and study designs associated with AI/SaMD (e.g., performance metrics, ground truth, training/test sets, MRMC studies) are not applicable or detailed in this document.
The primary "acceptance criterion" for this type of submission is Substantial Equivalence to legally marketed predicate devices.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (for Substantial Equivalence Evaluation) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Material: Constructed of biocompatible material (CP-2 titanium) | Material is CP-2 titanium, similar to predicate devices. |
| Design: Similar design characteristics for dental abutments. | Design is similar to predicate devices (original MH-2 Abutment and Nobel BioCare Abutment). |
| Functionality: Designed to support multiple unit bridges and bar overdentures. | Functionality is similar to predicate devices, intended for multiple unit bridges and bar overdentures. |
| Intended Use: For use in multiple unit bridges and bar overdentures. | Intended use matches predicate devices: for multiple unit bridges and bar overdentures. |
| Technological Characteristics: Correspond to implant bodies, available in various gingival cuff heights. | Technological characteristics (diameters corresponding to implant bodies, various gingival cuff heights) are similar to or consistent with predicate devices. |
Study that proves the device meets the acceptance criteria:
The "study" or justification for meeting acceptance criteria for this conventional medical device is the "Substantial Equivalence" comparison to predicate devices, as detailed in sections 16.5 and 16.7 of the submission. The argument is that because the new device is fundamentally similar in material, design, function, and intended use to already cleared devices, it is equally safe and effective.
Regarding the specific questions related to AI/SaMD, the information is not applicable or available in this document:
- Sample size used for the test set and the data provenance: Not applicable as this is not an AI/SaMD study.
- 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 an AI/SaMD study requiring expert consensus for ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable as this is not an AI/SaMD study with a training set.
- How the ground truth for the training set was established: Not applicable.
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FRIADENT GmbH FRIALIT-2® MH-2 Abutment
Original Premarket 510(k) Notification
APR 2 0 2000
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
16.2.
| 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: | Birgit UngerQuality Management and Regulatory Affairs |
| e. | Date Summary Prepared: | December 8, 1999 |
| DEVICE IDENTIFICATION |
| a. | Trade/Proprietary Name: | FRIALIT-2® MH-2 AbutmentAccessories to the FRIALIT-2 DentalImplant Systems |
|---|---|---|
| b. | Classification Name: | Endosseous Dental Implants21 CFR 872.3640 |
16.3 IDENTIFICATION OF PREDICATE DEVICES
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| FRIADENT | FRIALIT-2® Stepped CylinderWith FRIOS® Coating System | K945849 | 03/15/96 |
| Nobel BioCare | Branemark Self-Tapping MK IIDental Implant System | K962130 | 07/22/96 |
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16.4 DEVICE DESCRIPTION
The FRIALIT-2® MH-2 Abutment is part of the FRIALIT-2® Dental Implant System. The MH-2 Abutment is designed to support multiple unit bridges and bar overdentures. The MH-2 Abutment is constructed of CP-2 titanium and is available in the same diameters as the FRIALIT-2® implant bodies. Each MH-2 Abutment diameter is available with a 1, 2, 3, or 5mm gingival cuff height. The 3.8 and 4.5mm abutments are also available with a 9mm gingival cuff height.
16.5 SUBSTANTIAL EQUIVALENCE
The FRIALIT-2® MH-2 Abutment is substantially equivalent to the current MH-2 Abutment of FRIADENT's FRIALIT-2® Dental Implant Systems and to the Nobel BioCare Abutment of the Self-Tapping Mk II Dental Implant System.
The fundamental technical characteristics of the FRIALIT-2® MH-2 Abutment are similar to those of the predicate. The proposed FRIALIT-2® MH-2 Abutment is equivalent to the current MH-2 Abutment is material, function and intended use. The FRIALIT-2® MH-2 Abutment is equivalent to the Nobel BioCare Abutment in design, functionality and intended use.
16.6 INTENDED USE
The FRIALIT-2® MH-2 Abutment is intended for use in multiple unit bridges and bar overdentures.
16.7 TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the FRIALIT-2® MH-2 Abutment with the predicate devices is provided within this submission. Both the FRIALIT-2® MH-2 Abutment and the predicate devices are similar in design, materials and functionality. The FRIALIT-2® MH-2 Abutment is available in
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diameters corresponding to those of the implant bodies. Each MH-2 Abutment diameter is available with a 1, 2, 3, or 5mm gingival cuff height. The 3.8 and 4.5mm diameter MH-2 Abutment is also available with a 9mm gingival cuff height.
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.
16.9 510(K) CHECKLIST
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.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2000
FRIADENT GmbH C/O Ms. Carol Patterson Consultant Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, California 92630
Re : K994174
FRIALIT-2® MH-2 Abutment Trade Name: Requlatory Class: III Product Code: DZE March 9, 2000 Dated: Received: March 15, 2000
Dear Ms. Patterson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 -Ms. Patterson
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdfa.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
To Be Assigned By FDA 510(k) Number:
Device Name: FRIALIT-2® MH-2 Abutment
The FRIALIT-2® MH-2 Abutment is intended for use in Indications for Use: multiple unit bridges and bar overdentures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S.L. Shire Dimo Lor MSR
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital 510(k) Number _
Prescription Use ✓
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
§ 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.