(21 days)
Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.
The OSSEOTITE NT Certain Implants are internally connected, tapered implants designed to mimic the shape and form of a natural tooth
The provided text is a 510(k) premarket notification for a medical device called OSSEOTITE NTTM Certain™ Implants. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.
Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes for training/test sets, expert qualifications, and specific performance metrics cannot be directly extracted from the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act."
This indicates that there are no pre-defined quantitative acceptance criteria against which the device's performance is measured in this submission. The submission relies on demonstrating substantial equivalence to existing legally marketed devices.
Therefore, a table of acceptance criteria and reported device performance, as typically understood in a study proving performance, cannot be generated from this document. The "performance" demonstrated is that the device has "features and functions which are similar to the currently available OSSEOTITE NT Certain Implants and the OSSEOTITE NT Implants."
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The submission is not based on a new performance study with a test set of patient data to validate against specific metrics. It is an equivalence claim to existing devices.
- Data Provenance: Not applicable. No new patient data study is described for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no described test set requiring ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no described test set requiring adjudication.
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:
- No. This submission is for a dental implant (hardware), not an AI-powered diagnostic device. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This submission is for a dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The submission is based on demonstrating substantial equivalence to predicate devices, not on proving device performance against a specific ground truth.
8. The sample size for the training set:
- Not applicable. No new performance study or algorithm training is described.
9. How the ground truth for the training set was established:
- Not applicable. No new performance study or algorithm training is described.
Summary of what the document does provide regarding safety and effectiveness:
The core of this 510(k) submission is to establish substantial equivalence to predicate devices. The arguments for safety and effectiveness are based on the premise that because the new device's technological characteristics, materials, and intended use are "similar" to or the same as legally marketed predicate devices (OSSEOTITE NT Certain Implants K031475, OSSEOTITE NT Dental Implants K014235, 3i Implants K030614), it can be considered equally safe and effective.
The conclusion states: "The proposed OSSEOTITE NT Certain Implants are substantially equivalent to the legally marketed OSSEOTITE NT Certain Implants and the OSSEOTITE NT Implants." This is the "study" and "proof" presented in this type of submission when explicit performance standards are not established for the device type.
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JUN 1 6 2004
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 Riverside | |
| Palm Beach Gardens, FL 33410 | |
| Contact | Jeannette G. Dailey |
| Regulatory Affairs Manager | |
| Implant Innovations, Inc. | |
| 4555 Riverside | |
| Palm Beach Gardens, FL 33410 | |
| Tel. 561-776-6913 | |
| Fax. 561-514-6316 | |
| Email jdailey@3implant.com | |
| Date Prepared | May 24, 2004 |
| Device Name | OSSEOTITE NTTM Certain™ Implants |
| Classification Name | Endosseous Dental Implant |
| DeviceClassification | Class IIIDental Devices Panel21 CFR § 872.3640 |
| PredicateDevices | OSSEOTITE NT Certain ImplantsK031475OSSEOTITE NT Dental ImplantsK0142353i ImplantsK030614 |
| Performance | Performance standards have not been established by theFDA under Section 514 of the Federal Food, Drug andCosmetic Act. |
| Device Description | The OSSEOTITE NT Certain Implants are internallyconnected, tapered implants designed to mimic the shapeand form of a natural tooth |
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| Indications forUse | The OSSEOTITE NT Certain Implants are intended forsurgical placement in the upper or lower jaw to provide ameans for prosthetic attachment to restore a patient'schewing function. |
|---|---|
| TechnologicalCharacteristics | The proposed OSSEOTITE NT Certain Implants containfeatures and functions which are similar to the currentlyavailable OSSEOTITE NT Certain Implants and theOSSEOTITE NT Implants. |
| Conclusion | The proposed OSSEOTITE NT Certain Implants aresubstantially equivalent to the legally marketedOSSEOTITE NT Certain Implants and the OSSEOTITENT Implants. |
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 2004
Ms. Jeannette G. Dailey, RAC Regulatory Affairs Manager Implant Innovations, Incorporation 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K041402
Trade/Device Name: OSSEOTITE NTTM Certain™ Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: May 24, 2004 Received: May 26, 2004
Dear Ms. Dailey:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your securermined the device is substantially equivalent (for the relerenced above and have aboutinglosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale commerce prior to thay 20, been reclassified in accordance with the provisions of Antichuments, or to do root in the Act (Act) that do not require approval of a premarket the rederal 1 000, Drag, and Orbu may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include confors provisions of the ristration, 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 If your device is classified (occ as a difional controls. Existing major regulations affecting (1 Mr), it may of subject to tual of Federal Regulations, Title 21, Parts 800 to 898. In your device can oo round in firther announcements concerning your device in the Federal Register.
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Page 2 - Ms. Dailey
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DX 3 issualled on that your device complies with other requirements mean that FDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal statuse and sigments, including, but not limited to: registration You must comply with an the Piece Frq (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), labelity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality of 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) I his letter will anow you to begin mainering your substantial equivalence of your device to a premarket notification. The PDF maing or clossification 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), If you desire specific advice to: Jour de at (301) 594-4613. Also, please note the regulation prease contact the Office or Somps to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may Goant other general micromational and Consumer Assistance at its toll-free Dryiston of 2162-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Clive Liu, Ph.D.
Chiu Lin, Ph.D. 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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Indications for Use
Korido 2 510(k) Number (if known):
Device Name: OSSEOTITE NT™ Certain™ Implants
Indications for Use:
Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.
Prescription Use __ ﮨﮯ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
sion Sign-Off) ion of Anesthesiology, General Hospital. Infection Control, Dental Devices
204147 510(k) Number:_
§ 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.