(112 days)
3i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment.
The 3 i IOLTM Dental Implants are offered in both externally hexed and internally connected designs. The devices are tapered implants designed to mimic the shape and form of a natural tooth.
The provided document, K031632 for the 3i IOL™ Dental Implants, is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical performance studies with specific acceptance criteria as you might find for a PMA (Pre-Market Approval).
Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance studies is not explicitly present or applicable in this type of regulatory document.
Here's what can be extracted and inferred based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" described is in terms of the device's characteristics being "similar" to these predicate devices.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Form, Fit, and Function: Device should perform similarly to predicate devices in its intended use. | "The 3i IOL™ Dental Implants contain features and functions which are similar to the currently available OSSEOTITE NT™ Implants and 3i Innovative Implants and Cover Screws." |
| Material Composition: (Not explicitly stated, but implied as part of characteristic similarity) | (Not explicitly stated, but assumed to be similar to predicate devices for substantial equivalence) |
| Indications for Use: Must be the same or similar to predicate devices. | "3i IOL Dental Implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment." (Matches predicate's likely indications) |
2. Sample size 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 applicable/not provided. This 510(k) does not present a clinical test set with performance data.
- Data Provenance: Not applicable/not provided.
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/not provided. Ground truth establishment with experts is typically associated with performance studies, which are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not provided.
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/not provided. This is a dental implant, not an imaging AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/not provided in the context of a performance study. The "ground truth" for this 510(k) is the successful long-term performance and safety of the predicate devices to which the 3i IOL™ Dental Implants are compared.
8. The sample size for the training set
- Not applicable/not provided. This document does not describe an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/not provided.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" or evidence provided in this K031632 510(k) filing for the 3i IOL™ Dental Implants is the demonstration of substantial equivalence to several legally marketed predicate devices. The core argument is:
- The 3i IOL™ Dental Implants are designed for surgical placement in the upper or lower jaw for prosthetic attachment.
- They are available in externally hexed and internally connected designs and are tapered to mimic natural teeth.
- Crucially, the document states: "The 3i IOL Dental Implants contain features and functions which are similar to the currently available OSSEOTITE NT Implants and 3i Innovative Implants and Cover Screws."
The FDA's decision to clear the device implies they agreed with the submitter's assertion that the new device shares sufficient technological characteristics and indications for use with the predicate devices to be considered "substantially equivalent" in terms of safety and effectiveness, without requiring new clinical performance data. The listed predicate devices (K014235, K972444, K935544, K980549, K983347, K022009) serve as the existing proof of concept and safety/effectiveness for similar designs and functionalities.
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Implant Innovations, Inc. 510(k) Premarket Notification – 3i IOL™ Dental Implants
Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter | Implant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410 |
|---|---|
| Contact | Jacquelyn A. Hughes, RACDirector, Regulatory Affairs and Quality AssuranceImplant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410Tel. 561-776-6819Fax. 561-776-6852Email jhughes@3implant.com |
| Date Prepared | May 23, 2003 |
| Device Name | 3i IOLTM Implants |
| Classification Name | Endosseous Dental Implant |
| DeviceClassification | Class IIIDental Devices Panel21 CFR § 872.3640 |
| PredicateDevices | K014235 - OSSEOTITE® NTTM Dental ImplantsK972444 - 3i Innovative Implants and Cover ScrewsK935544 - Threaded Self-Tapping Threaded ImplantsK980549 – OSSEOTITE Dental ImplantsK983347 – OSSEOTITE Dental ImplantsK022009 – 3i Dental Implants |
| Performance | Performance standards have not been established by theFDA under Section 514 of the Federal Food, Drug and |
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| Device Description | The 3 i IOLTM Dental Implants are offered in bothexternally hexed and internally connected designs. Thedevices are tapered implants designed to mimic the shapeand form of a natural tooth. |
|---|---|
| Indications forUse | 3 i IOL Dental Implants are indicated for surgicalplacement in the upper or lower jaw to provide a means forprosthetic attachment. |
| TechnologicalCharacteristics | The 3 i IOL Dental Implants containfeatures and functions which are similar to the currentlyavailable OSSEOTITE NTTM Implants and 3 i InnovativeImplants and Cover Screws. |
| Conclusion | The 3 i IOL Dental Implants are substantially equivalent tothe legally marketed OSSEOTITE NT Implants and 3 iInnovative Implants and Cover Screws. |
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Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread. The image is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2003
Ms. Jacquelyn A. Hughes Director Regulatory Affairs Implant Innovations, Incorporation 4555 Riverside Drive Palm Brach Gardens, Florida 33410
Re: K031632
Trade/Device Name: Osseotite IOL™ Implants Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implants Regulatory Class: III Product Code: DZE Dated: May 23, 2003 Received: June 26, 2003
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.
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Page 2 - Ms. Hughes
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,
Susan Penroe
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
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Page _ 1 _of _ 1
510(k) Number (if known): _ _ 031632
Device Name: 3i 1OL 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Muluy for M.Se
(Division Sicn-Off) ision of Anasthesiclogy, General Hospital, Infection Control, Dental D
510(k) Number:
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.