CERTAIN PREVAIL DENTAL IMPLANT by IMPLANT INNOVATIONS, INC.

3 i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

Device Description

The Certain PREVAIL Implants are parallel walled, straight collared internally connected implants with a lateralized seating surface. They will be available in lengths of 8.5, 10.0, 11.5, 13.0 and 15mm. The diameters will be 4.0 and 5.0mm. The collar diameters will be 4.1mm for the 4.0mm diameter implants and 5.0mm for the 5.0mm implants. The seating surface will lateralize back to 3.4mm for the 4.0mm diameter implants, and 4.1mm for the 5.0mm implants. The material these devices are made out of is Titanium Alloy [Ti6A14V] per ASTM F-136.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (Certain™ PREVAIL™ Implants). It largely focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as one would find in a clinical trial or a standalone AI/software device submission.

Therefore, much of the requested information regarding acceptance criteria, study design elements (sample size, ground truth, experts, adjudication, MRMC, standalone performance, training set details) is not present in the provided document.

However, I can extract the information that is available and highlight what is missing based on the nature of this type of submission.

Here's the breakdown of what can be inferred or explicitly stated:

Acceptance Criteria and Device Performance

This submission is a 510(k) for an implantable dental device, not a software or AI device. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a legally marketed predicate device (OSSEOTITE® IOL Dental Implants), rather than meeting specific numerical performance metrics like sensitivity, specificity, or accuracy for a diagnostic algorithm.

The device performance is described in terms of its technological characteristics being similar to the predicate.

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance (as stated in the submission)
Technological Characteristics: The device's design, materials, and intended function should be similar to the predicate device to ensure safety and effectiveness.	"The Certain™ PREVAIL™ Implants contain features Technological and functions which are similar to the currently available OSSEOTITE® IOL Implants." "The material these devices are made out of is Titanium Alloy [Ti6A14V] per ASTM F-136."
Indications for Use: The device should have the same indications for use as the predicate, or minor differences that do not raise new questions of safety or effectiveness.	The Indications for Use are provided and deemed substantially equivalent to the predicate, including specific details regarding immediate loading.
Mechanical/Physical Properties: While not explicitly detailed as acceptance criteria here, dental implants typically require demonstrating properties like strength, fatigue resistance, and biocompatibility, often through testing to established standards or comparison to predicate device data. (No specific data tables provided in this excerpt)	The device is described as "parallel walled, straight collared internally connected implants with a lateralized seating surface." It specifies available lengths, diameters, and collar diameters.
Conclusion of Substantial Equivalence: The FDA's ultimate agreement that the device is substantially equivalent to a legally marketed predicate.	"The Certain PREVAIL Implants are substantially Conclusion equivalent to the legally marketed OSSEOTITE® IOL Implants." (Submitter's conclusion) "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..." (FDA's conclusion)

Study Details (as applicable for this type of submission)

Given this is a 510(k) for a physical implant, the concept of a "study" with test sets, ground truth, and experts as if it were an AI/software device is not directly applicable. Substantial equivalence for such devices often relies on comparisons of design, materials, manufacturing processes, and potentially non-clinical testing (e.g., mechanical, biocompatibility) rather than clinical studies in the sense of comparing performance characteristics against a ground truth dataset.

Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance on a test set of data. The "test" is demonstrating equivalence through a comparison of device characteristics, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for a test set of data is established in this summary. The FDA reviewers (experts in regulatory review) assess the submission for substantial equivalence.
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. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in a 510(k) for a physical device is generally the established safety and effectiveness of the predicate device. The new device is compared against this standard.
The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

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Submitter	Implant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410	FEB 23 2007
Contact	Jim BanicRegulatory Affairs SpecialistImplant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410Tel. 561-776-6932Fax. 561-514 6316Email: jbanic@3implant.com
Date Prepared	07 June 2006
Device Name	Certain™ PREVAIL™ Implants
Classification Name	Endosseous Dental Implant
DeviceClassification	Class IIDental Devices Panel21 CFR § 872.3640
PredicateDevices	OSSEOTITE IOL Dental ImplantsK031632, K051189
Performance	Performance standards have not been established by theFDA under Section 514 of the Federal Food, Drug andCosmetic Act.
Device Description	The Certain PREVAIL Implants are parallel walled,straight collared internally connected implants with alateralized seating surface. They will be available inlengths of 8.5, 10.0, 11.5, 13.0 and 15mm. The diameterswill be 4.0 and 5.0mm. The collar diameters will be 4.1mmfor the 4.0mm diameter implants and 5.0mm for the 5.0mmimplants. The seating surface will lateralize back to 3.4mmfor the 4.0mm diameter implants, and 4.1mm for the5.0mm implants. The material these devices are made outof is Titanium Alloy [Ti6A14V] per ASTM F-136.

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3i dental implants are intended for surgical placement in Indications for Use the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

008

The Certain™ PREVAIL™ Implants contain features Technological and functions which are similar to the currently available Characteristics OSSEOTITE® IOL Implants.

The Certain PREVAIL Implants are substantially Conclusion equivalent to the legally marketed OSSEOTITE® IOL Implants.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jim Banic Regulatory Affairs Specialist 3i Implant Innovations. Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

FEB 2 3 2007

Re: K061629

Trade/Device Name: Certain™ PREVAIL™ Dental Implants Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 24, 2007 Received: January 25, 2007

Dear Mr. Banic:

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 -Mr. Banic

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Clares

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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1061629 510(k) Number (if known):

Device Name: Certain™ PREVAIL™ Dental Implants

Indications for Use:

In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

Over the Counter Use:

Susan Dunne

is of of Anesthestology, Concelal Huspisal, · mon Control, Dental Devices

061629

Regulation Number and Section

§ 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.