The Intra-Lock Hydroxyapatite Coated Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis, from single tooth replacement to full arch reconstruction.

Device Description

The Intra-Lock Hydroxyapatite Coated Implants consists of root form dental implants that are manufactured from CP Ti and have a Hydroxyapatite coating. These implant designs are either threaded or smooth cylindrical shapes and are substantially equivalent to devices previously marketed. They have the same indications and applications for surgical restoration of partially or fully edentulous patients as pre-amendment devices.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the Intra-Lock Hydroxyapatite Coated Implants. It details the device's characteristics, indications for use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

The submission is a "Special 510(k): Abbreviated 510(k)" which relies on conformity with FDA's guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA." This type of submission generally means that the device is substantially equivalent to existing devices and adheres to established performance standards or recognized consensus standards, rather than presenting a novel study with specific acceptance criteria and performance data for a new technology or algorithm.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document, as such a study is not described.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided. The document does not list specific acceptance criteria or performance metrics for the Intra-Lock Hydroxyapatite Coated Implants. It relies on substantial equivalence to predicate devices and conformity to a guidance document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. No test set or study data is mentioned.

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)

Cannot be provided. No ground truth establishment or expert involvement in a test set is discussed.

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

Cannot be provided. No adjudication method for a test set is mentioned.

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

Cannot be provided. This device is a dental implant, not an AI-assisted diagnostic tool.

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

Cannot be provided. This device is a dental implant, not an algorithm.

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

Cannot be provided. No ground truth for device performance is mentioned as there is no study described. The "ground truth" for regulatory approval here is the demonstrated substantial equivalence to legally marketed predicate devices and adherence to relevant guidance.

8. The sample size for the training set

Cannot be provided. There is no mention of a training set for an algorithm.

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

Cannot be provided. There is no mention of a training set for an algorithm.

Summary of available information:

Device Name: Intra-Lock Hydroxyapatite Coated Implants
Sponsor: Intra-Lock International
Predicate Devices: Ace HA Screw Implant System (K021244), HA-TI Implant (K003045), BMR Dental Implant System (K010343), Replace Ha Coated Implants (K962845), Sterngold HA Coated Screws (K981516), Restore HA Coated Implants (K960288).
Product Description: Root form dental implants manufactured from CP Ti with a Hydroxyapatite coating. They are threaded or smooth cylindrical shapes.
Indications for Use: To restore partially or fully edentulous patients, suitable for mandible or maxilla, and to support removable or fixed prosthesis (single tooth to full arch reconstruction).
Basis for Approval: Special 510(k): Abbreviated 510(k) demonstrating conformity with FDA's "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA" and substantial equivalence to predicate devices.

The document focuses on regulatory compliance through substantial equivalence to existing devices and adherence to guidance, rather than presenting a performance study with specific acceptance criteria that would typically be associated with a novel device or software.

Summary

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K031322

DEC 2 3 2003

510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Intra-Lock International is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Intra-Lock International chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

Trade Name:	Intra-Lock Hydroxyapatite Coated Implants
Sponsor:	Intra-Lock International1200 North Federal Highway, Suite 200Boca Raton, FL 33432Registration No.:3003631996
Device Generic Name:	HA Coated Dental Implants
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class III.

Predicate Devices:

Ace HA Screw Implant System	K021244
HA-TI Implant	K003045
BMR Dental Implant System	K010343
Replace Ha Coated Implants	K962845
Sterngold HA Coated Screws	K981516
Restore HA Coated Implants	K960288

Product Description:

Indications for Use:

The Intra-Lock Hydroxyapatite Coated Implants have been designed to restore partially or fully edentulous The implants have been designed to be used in either the mandible or maxilla and to support patients. removable or fixed prosthesis, from single tooth replacement to full arch reconstruction.

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Safety and Performance:

This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Previoret Notifications." In support of this 510(k), Intra-Lock International has provided information to demonstate conformity with FDA's guidance document entitled: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA.

Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the Intra-Lock Hydroxyapatite Coated Implants have been shown to be safe and effectiver for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2003

Mr. Jeffrey Sakoff Vice Present & Director of Operations Intra-Lock International 1200 N. Federal Highway, Suit #200 Boca Raton, Florida 33432

Re: K031322

Trade/Device Name: Intra-Lock Hydroxyapatite Coated Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: September 29, 2003 Received: September 30, 2003

Dear Mr. Sakoff:

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. Sakoff

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,

Kein Muley

Se 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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Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Intra-Lock Hydroxyapatite Coated Dental Implants Device Name:

Indications for Use:

(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

M. Ulich for MSR

(Division Sigr (Division Sign-Oll)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K031522

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.