3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

Device Description

The OSSEOTITE NT Certain Implants are internally connected, tapered implants designed to mimic the shape and form of a natural tooth.

AI/ML Overview

Let's break down the provided text to extract the requested information.

Analysis of the Provided Text:

The document is a 510(k) Premarket Notification for OSSEOTITE NT™ CERTAIN™ Implants. The core purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing the new device's technological characteristics, indications for use, and performance to those of the predicate. It does not generally involve an extensive independent clinical study with predefined acceptance criteria and a detailed statistical analysis of performance metrics like accuracy, sensitivity, or specificity in the same way a PMA (Premarket Approval) submission would.

Instead, the "study" demonstrating the device meets acceptance criteria in a 510(k) is often a comparative analysis against the predicate device to show that it is as safe and effective.

Here's how to interpret the information and answer your questions given the context of a 510(k):

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from 510(k) Process)	Reported Device Performance (from Summary of Safety and Effectiveness)
Substantial Equivalence: The device must be as safe and effective as predicate devices. This implies:	The OSSEOTITE NT Certain Implants contain features and functions which are similar to the currently available OSSEOTITE NT™ Implants and 3i Innovative Implants and Cover Screws.
Similar Indications for Use: Indications for the new device should fall within those of predicate devices.	The OSSEOTITE NT Certain 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. (This matches the general use of dental implants).
Similar Technological Characteristics: The design, materials, and operating principles should be comparable to predicate devices.	"The OSSEOTITE NT Certain Implants are internally connected, tapered implants designed to mimic the shape and form of a natural tooth." This design is presented as similar to predicate devices.
No New Safety or Effectiveness Questions: The device should not raise new concerns compared to predicate devices.	The conclusion states: "The OSSEOTITE NT Certain Implants are substantially equivalent to the legally marketed OSSEOTITE NT Implants and 3i Innovative Implants and Cover Screws." This directly addresses the absence of new safety/effectiveness concerns relative to predicates.

Explanation: In a 510(k), "acceptance criteria" are implicitly met by demonstrating substantial equivalence. The "reported device performance" is the manufacturer's assertion and justification that these criteria are met through comparison to predicate devices, rather than through independent clinical performance metrics.

Regarding the "Study that proves the device meets the acceptance criteria":

For a 510(k), the "study" is primarily the comparison to predicate devices. The document explicitly states: "The OSSEOTITE NT Certain Implants are substantially equivalent to the legally marketed OSSEOTITE NT Implants and 3i Innovative Implants and Cover Screws." This substantial equivalence is the proof for a 510(k). The basis for this determination is the comparative analysis of indications for use and technological characteristics against the identified predicate devices (K014235, K972444, K935544, K980549, K983347, K022009).

Now, let's address the specific numbered points based on the provided text, and acknowledge when the information is not present in this type of submission.

2. Sample sized 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. A 510(k) for a dental implant primarily relies on engineering specifications, material science, and comparison to predicate devices, not typically a "test set" in the context of clinical performance data collection. No patient data or clinical study data is presented.
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)

Number of Experts: Not applicable/Not provided. This type of information is generally associated with clinical trials or diagnostic device performance studies, which are not detailed here. The "ground truth" for a 510(k) for a new version of an implant is typically established by engineering standards, biocompatibility testing (which is assumed to have been done, but not detailed here), and the prior approval status of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable/Not provided. This refers to methods for resolving discrepancies in expert opinion for diagnostic assessments, which is not relevant to this 510(k) submission as no such "test set" requiring expert adjudication is described for clinical performance.

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

MRMC Study: No. This is a dental implant, not an imaging device or AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant or described.
Effect Size of AI: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance Study: No. This device is a passive dental implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: For a dental implant 510(k), the "ground truth" for demonstrating substantial equivalence is generally established by:
- Engineering specifications and material properties: Ensuring the device meets accepted standards for strength, biocompatibility, and durability.
- Successful historical use of predicate devices: The fact that the predicate devices are legally marketed and have a history of safe and effective use provides the "ground truth" for the new device's design principles and intended use.
- (Implied) Biocompatibility testing: Not explicitly detailed here, but standard for implants.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/Not provided. No "training set" in the context of machine learning or complex diagnostic algorithms is relevant to this submission.

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable/Not provided. As there is no training set described, this question is not relevant.

Summary of 510(k) Context:

It's crucial to understand that a 510(k) premarket notification, especially for a device like a dental implant that is similar to existing ones, focuses on demonstrating substantial equivalence to predicate devices. It typically does not involve new, extensive clinical trials with statistical endpoints, large test sets, expert adjudication, or AI performance metrics. The "proof" in this context is the detailed comparison of the new device's design, materials, manufacturing, and intended use against those of already-approved predicate devices to show that it is just as safe and effective. The provided document aligns perfectly with this 510(k) paradigm.

Summary

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JUL 288 2003

Implant Innovations, Inc. Thiplant Innovations, Inc.

510(k) Premarket Notification - OSSEOTITE NT™ CERTAIN™ 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 8, 2003
Device Name	OSSEOTITE NT™ CERTAIN™ Implants
Classification Name	Endosseous Dental Implant
Device Classification	Class IIIDental Devices Panel21 CFR § 872.3640
Predicate Devices	K014235 - OSSEOTITE NT™ 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 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 areindicated for surgical placement in the upper or lower jawto provide a means for prosthetic attachment to restore apatient's chewing function.
TechnologicalCharacteristics	The OSSEOTITE NT Certain Implants containfeatures and functions which are similar to the currentlyavailable OSSEOTITE NTTM Implants and 3i InnovativeImplants and Cover Screws.
Conclusion	The OSSEOTITE NT Certain Implants are substantiallyequivalent to the legally marketed OSSEOTITENTImplants and 3i Innovative Implants and Cover Screws.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2003

Ms. Jacquelyn A. Hughes Director, Regulatory Affairs Quality Assurance 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K031475

Trade/Device Name: Osseotite NTTM Certan™ Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: May 8, 2003 Received: May 9, 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 (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), 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,

Patricia Cuariteffer

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): _K03/475

Device Name: OSSEOTITE NT™ CERTAIN™ Implants

Indications for Use:

3i dental implants are intended 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)

MKE for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Dev

510(k) Number: _

<031475

Prescription Use:
(Per 21 CFR 801.109)

Over the Counter Use:_

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.