The 3A Dental Implant System is intended for single or multiple surgical implantation (with or without tissue integration) in the maxillary and or mandibular arches for the purpose of providing prosthetic support for dental restorations in partially or totally edentulous individuals. May be used for single tooth restoration.

Device Description

The 3A Dental Implant System is a CP titanium implant that are self-tapping or standard screw-type design. The implant body has a surface finish for either smooth (bright) or The implants are available in various insertion lengths and textured (abrasive blasted). diameters

AI/ML Overview

The provided text describes a 510(k) premarket notification for the 3A Dental Implant System, which is a Class III medical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria for a novel AI/software device. Therefore, much of the requested information regarding AI device testing is not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" as typically defined for AI/software devices (e.g., in terms of sensitivity, specificity, AUC) is not present in this 510(k) submission. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to legally marketed predicate devices. The "reported device performance" is described in terms of material properties and design similarity, and functional testing to assure safety and efficacy.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (3A Dental Implant System)
Indications for Use	Same as Brånemark Nobel Biocare (K993595) and ITI Dental Implant System (K002374)	Mandible and Maxilla (Single or multiple surgical implantation for prosthetic support in partially or totally edentulous individuals; may be used for single tooth restoration)
Design	Same as Brånemark Nobel Biocare (K993595) and ITI Dental Implant System (K002374)	External Hex and Morse Taper
Material	Same as Brånemark Nobel Biocare (K993595) and ITI Dental Implant System (K002374)	Titanium and Titanium Alloy (CP titanium)
Implant Sterile	Same as Brånemark Nobel Biocare (K993595) and ITI Dental Implant System (K002374)	Yes
Implant Diameters	Equivalent to Brånemark Nobel Biocare (K993595) and ITI Dental Implant System (K002374)	3.75 – 5.5 mm
Implant Lengths	Equivalent to Brånemark Nobel Biocare (K993595) and ITI Dental Implant System (K002374)	7 – 18 mm
Attachments	Equivalent to Brånemark Nobel Biocare (K993595) and ITI Dental Implant System (K002374)	Various abutments and components
Functional Performance	Sufficient to assure safe and efficacious use (as demonstrated by predicate devices)	Testing of a "typical" or representative, standard system configuration utilizing an "angled abutment" was conducted on samples of titanium, demonstrating performance sufficient to assure both safe and efficacious use.

2. Sample Size Used for the Test Set and Data Provenance

The text refers to "samples of titanium" used for testing, but it does not specify the sample size. The testing appears to be primarily mechanical/materials testing rather than clinical data from a "test set" in the context of an AI study.
Data provenance is not described in terms of country of origin or retrospective/prospective data collection because it's not a clinical study involving patient data. The testing was laboratory-based.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not an AI/software device that requires expert adjudication for ground truth. The "ground truth" for a dental implant would be its physical and mechanical properties and its performance in a laboratory setting under simulated conditions, compared against established engineering standards or the performance of predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this type of device (a dental implant). The device is not an AI or imaging diagnostic tool that would involve human readers.

6. If a Standalone Study Was Done

A form of standalone testing was done in the sense that the device itself (or "samples of titanium" representing it) underwent testing. The text states: "Testing of a 'typical' or representative, standard system configuration utilizing an 'angled abutment' was conducted on samples of titanium." This appears to be laboratory bench testing rather than a clinical trial.

7. The Type of Ground Truth Used

The ground truth for this device is based on engineering specifications, material science, and functional performance testing (e.g., strength, durability, biocompatibility) of the titanium samples and the integrated system. The ultimate "ground truth" for substantial equivalence is the existing safety and efficacy profile of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device.

Summary

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K011879

12.0 SUMMARY OF SAFETY AND EFFECTIVENESS

Distributor:	Osseco Biosource, Ltd.64 Old Orchard, Suite 320Skokie, Illinois 60077
Regulatory Contact:	Michele H. VovolkaVantage Consulting International, Ltd
Telephone Number:	847-856-0355
Fax Number:	847-856-0357
Date Summary Prepared:	May 29, 2001
Product Trade Name:	3A Dental Implant System
Common Name:	Endosseous Implant
Classification:	Endosseous ImplantClass III per 21 CFR 872.3640
Predicate Devices:	Brånemark Nobel BiocareITI Dental Implant System

Description:

Intended Uses/Indications:

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Substantial Equivalence:

Characteristic	3A DentalImplant Systems	BrånemarkNobel BiocareK993595	ITI DentalImplant SystemK002374
Indications for Use	Mandible andMaxilla	Same	Same
Design:	External Hex andMorse Taper	Same	Same
Material	Titanium andTitanium Alloy	Same	Same
Implant Sterile	Yes	Same	Same
Implant Diameters	3.75 – 5.5 mm	Equivalent	Equivalent
Implant Lengths	7 – 18 mm	Equivalent	Equivalent
Attachments	Various abutmentsand components	Equivalent	Equivalent
Product Code	DZE	Same	Same

COMPARISON TABLE

Summary of Testing:

Testing of a "typical" or representative, standard system configuration utilizing an "angled abutment" was conducted on samples of titanium. The testing demonstrated performance sufficient to assure both safe and efficacious use of the implant system.

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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2002

Osseco Biosource, Limited C/O Ms. Michele H. Vovolka Vantage Consulting International, Litimed P.O. Box 848 Grayslake, Illinois 60030

Re: K011879

Trade/Device Name: 3A Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: May 27, 2002 Received: May 29, 2002

Dear Ms. Vovolka:

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.

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.

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Page 2 - Ms. Vovolka

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski 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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KO11879 510(k) Number (if known):

3A Dental Implant System 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 OR (Per 21 CFR 801.109)

Over -The-Counter Use

Susan Runner

Division Sign Off

(Division Sign-Off) Division of Dental, Infection Control, And General Hospital Devices

510(k) Number K011879

Osseco Biosource, Ltd. 510(k) Notification

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.