(52 days)
3i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.
The provided 510(k) summary for the OSSEOTITE® Dental Implants does not describe an AI/ML powered device, therefore, many of the requested details about acceptance criteria, study methods, and ground truth are not applicable. This document is a summary for a traditional medical device (dental implants) and focuses on substantial equivalence to predicate devices rather than performance metrics typically associated with AI.
However, I can extract the relevant information presented in the document pertaining to the closest equivalent of "acceptance criteria" and the study that supports it.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|
| No significant difference in long-term cumulative survival of OSSEOTITE® implants in smokers and non-smokers (compared to previous labeling which might have included smoking as a warning/precaution). | A meta-analysis of clinical data indicated no significant difference in the long-term cumulative survival of OSSEOTITE® in smokers and non-smokers. | Meta-analysis of clinical data |
| Long-term survival of OSSEOTITE® implants in smokers to be greater than that of 3i machined implants in smokers. | A second analysis demonstrated that the long-term survival of OSSEOTITE® implants in smokers is greater than that of 3i machined implants in smokers. | Meta-analysis/Clinical data analysis |
| Substantial equivalence of OSSEOTITE® implants with revised Instructions for Use labeling to predicate OSSEOTITE® implants. | The presented data supports the conclusion that the OSSEOTITE® implants with revised Instructions for Use labeling are substantially equivalent to the predicate OSSEOTITE® implants. | Comparison to predicate devices |
Detailed Study Information (where applicable and extractable)
-
Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The document refers to a "meta-analysis of clinical data" and "a second analysis" but does not provide the number of patients or implants included in these analyses.
- Data provenance: Not explicitly stated. It is inferred that the data is clinical, but the country of origin, whether retrospective or prospective, is not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The "ground truth" here is implied to be clinical outcomes (implant survival), which would be derived from patient data, not expert consensus on an image or diagnostic output.
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Adjudication method for the test set:
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or diagnostic assessments. This study relies on clinical outcomes data.
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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 an AI/ML device, and no MRMC study was performed or is relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/ML device.
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The type of ground truth used:
- Clinical outcomes data (specifically, long-term cumulative survival of dental implants).
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The sample size for the training set:
- Not applicable/Not provided. Dental implants do not typically have "training sets" in the context of AI/ML. The "meta-analysis of clinical data" would represent the overall dataset analyzed for the study.
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How the ground truth for the training set was established:
- Not applicable. The "ground truth" (clinical survival) would have been established through follow-up observations of patients who received the implants in clinical studies. The details of how this was measured (e.g., specific criteria for survival, follow-up period) are not provided in this summary.
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DEC 1 8 2001
510(k) Summary for the OSSEOTITE® Dental Implants
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|---|---|
| Submitter | Implant Innovations, Inc. (3i) |
| Contact Person | Jacquelyn A. Hughes, RACDirector, Regulatory Affairs & Quality AssuranceImplant Innovations, Inc.4555 Riverside DrivePalm Beach Gardens, Florida 33410Phone: 561-776-6819Fax: 561-776-6852E-mail: jhuges@3implant.com |
| Date Prepared | October 26, 2001 |
| Name | OSSEOTITE® Dental Implants |
| Classification Names | Implants, Endosseous |
| Device Classification | Classification: Class IIIClassification Panels: DentalRegulation Number: 872.3640 |
| Predicate Devices | OSSEOTITE® Dental Implants, K983347 (cleared 1/99)OSSEOTITE® Dental Implant System, K980549 (cleared 4/98)3i Standard Threaded/Self-Tapping Threaded Implant, K935544 (cleared 3/95) |
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| PerformanceStandards | Performance standards have not been established by the FDA under section514 of the Federal, Food, Drug and Cosmetic Act |
|---|---|
| DeviceDescription | The proposed OSSEOTITE® implants are identical to the predicate implantscurrently on the market, K983347, K980549, K935544. |
| IndicationsforUse | 3i dental implants are indicated for surgical placement in the upper or lowerjaw to provide a means for prosthetic attachment to restore a patient'schewing function. |
| TechnologicalCharacteristic | The proposed OSSEOTITE® implants are identical to the predicate implantscurrently on the market, K983347, K980549, K935544. |
| Summary ofTestingSupportingthe Change | 3i has conducted a meta-analysis of clinical data on the OSSEOTITE®implants. The results indicate that there is no significant difference in thelong-term cumulative survival of the OSSEOTITE® in smokers and non-smokers. A second analysis further demonstrates that the long-term survivalof OSSEOTITE® implants in smokers is greater than that of 3i machinedimplants in smokers. Thus, these data also further support not includingsmoking and tobacco use as a Warning or Precaution for the OSSEOTITE®implants. |
| Conclusion | The OSSEOTITE® implants with revised Instructions for Use labeling aresubstantially equivalent to the predicate OSSEOTITE® implants. |
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 82001
Ms. Jacquelyn A. Hughes Director, Regulatory Affairs & Quality Assurance Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K013570
Trade/Device Name: Osseotite® Dental Implants Regulation Number: 872.3640 Regulation Name: Implants, Endosseous Regulatory Class: III Product Code: DZE Dated: November 27, 2001 Received: November 28, 2001
Dear Ms. Hughes:
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.
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.
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Page 2 - Ms. Hughes
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: OSSEOTITE® Dental Implants
Indications For Use:
3i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Susan Runos
(Division Sign-Off) Division Sign Only Infection Control, the Caneral Hospital Devices -013510 r ============================================================================================================================================================================
§ 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.