ENDOSSEOUS DENTAL IMPLANT SYSTEM by NORTHERN IMPLANTS, LLC

The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

Device Description

AI/ML Overview

This 510(k) submission (K053478) for the NSI Hexed and Non-Hexed Endosseous Implant System did not include a study or defined acceptance criteria related to device performance in an AI/software context. This submission is for an endosseous dental implant system, which is a physical medical device, not an AI or software-based device.

The "acceptance criteria" and "device performance" in this context refer to the physical and manufacturing properties of the dental implants, as well as their sterilization and packaging. There are no performance metrics like sensitivity, specificity, or accuracy that would be associated with AI/software devices.

Here's a breakdown of the information provided in the context of a physical device submission:

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

The submission details specific standards that the device and its manufacturing processes meet, rather than specific numerical performance metrics in the way one would describe AI.

Acceptance Criteria (Standards Met)	Reported Device Performance / Compliance
Material Standards:
ASTM F67-95 Grade III or Grade IV Titanium	Northern Implant's screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium.
Sterilization Standards & Method:	Sterilization of these implants is achieved using Co60 irradiation, with a minimum dose of 25.0 kGy (2.5 m rads), creating a Sterility Assurance Level of 10⁻⁴. Validation of sterilization is done as specified by the Association for the Advancement of Medical Instrumentation (AAMI).
ISO 11137	Compliance with "Sterilization of Health Care Products – Requirements for validation and routine control – Radiation sterilization."
ISO 11737-2	Compliance with "Sterilization of Medical Devices – Microbial Methods – Part 2: Tests of sterility performed in the validation of a sterilization process."
ISO 13409	Compliance with "Sterilization of Health Care Products – Radiation Sterilization – substantiation of 25kGy as a sterilization dose for small or infrequent production batches."
Packaging Validation Standards:	Packaging validation protocols followed the listed standards.
ASTM D 4169-04	Compliance with "Standard Practice for Performance Testing of Shipping Containers and Systems."
ASTM F 88-00	Compliance with "Standard Test Method for Seal strength of Flexible Barrier Materials."
ASTM F 1929-98	Compliance with "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration."
ISO 11607	Compliance with "Packaging for terminally sterilized medical devices."
Technological Characteristics & Design Comparability	The physical properties and designs of the additional implants and accessories were comparable to legally marketed predicate devices. "Any differences in the technological characteristics did not raise new issues of safety or effectiveness."

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

Not Applicable. This submission explicitly states: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission." Therefore, there is no "test set" in the context of clinical performance data or AI evaluation. The "data" refers to the results of testing against the physical/manufacturing standards mentioned in point 1. These tests are typically performed in a laboratory setting by the manufacturer.

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)

Not Applicable. As no clinical studies or AI evaluations were conducted, there was no need for experts to establish ground truth in this context. The "ground truth" for the physical device relates to its adherence to material, manufacturing, sterilization, and packaging standards, which are verified through established engineering and quality control procedures.

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

Not Applicable. No clinical studies or AI evaluations were performed.

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

Not Applicable. This is a physical dental implant, not an AI or imaging device that would involve human readers.

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

Not Applicable. This device is an implant, not an algorithm.

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

Not Applicable (in the AI/clinical sense). The "ground truth" for this device's acceptance is its compliance with established engineering, material, sterilization, and packaging standards (e.g., ASTM, ISO standards) and its substantial equivalence to predicate devices. This is verified through laboratory testing and documentation, not clinical outcomes or expert consensus on interpretations of data.

8. The sample size for the training set

Not Applicable. No AI or machine learning model was developed or trained for this device.

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

Not Applicable. As no AI training occurred, no ground truth for a training set was established.

Summary:

This 510(k) submission is for a physical medical device (dental implants). The "acceptance criteria" and "study" described in the document relate to the manufacturing process, materials, sterilization, and packaging of the implants, rather than clinical performance studies or AI/software validation. The claim for substantial equivalence is based on the device's similar technological characteristics and intended use to legally marketed predicate devices, and its compliance with relevant voluntary industry standards for materials, sterilization validation, and packaging. No clinical studies were conducted or deemed necessary for this particular submission.

Summary

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K053478

5 2006 APR

510(k) Premarket Notification Summary

Name/Address of Submitter: Northern Implants, LLC 10355 B Democracy Lane Fairfax, VA 22030

Establishment Registration Number: 3003845138

Contact Person: Greta M. Hols Phone: (703) 278-3953 Fax: (703) 278-3954

Date Summary Prepared: December 1, 2005

Device Classification Name: Endosseous Implant and Accessories

Device Classification Regulation Number: 21 CFR 872.3640 and 21 CFR 872.3630

Device Regulatory Status: Class II Special Controls

Trade Name: Endosseous Dental Implant

Purpose: The purpose of this 510(k) is to include additional implants and accessories in the NSI Hexed and Non-Hexed Endosseous Implant System that did not fall within the size range and design shapes identified in prior 510(k) submissions for our system.
Performance Standards: FDA has not established a performance standard applicable to endosseous implants and their accessories. The materials in the NSI Hexed Implant System meet applicable voluntary standards. Northern Implant's screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium.
Predicate Devices: K003620 NSI Hexed and Non-Hexed Implant System K020617 NSI Hexed and Non-Hexed Implant System K954347 Implant Innovations 3.25mm microminiplant
Device Description and Intended Use: The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

Sterilization Methods Used: Sterilization of these implants will be achieved using Co60 irradiation, with a minimum dose of 25.0 kGy (2.5 m rads), creating a Sterility Assurance Level of 104. Validation of sterilization will be done as specified by the Association for the Advancement of Medical Instrumentation (AAMI). Standards utilized include:

ISO 11137	Sterilization of Health Care Products – Requirements for validation and routine control –Radiation sterilization
ISO 11737-2	Sterilization of Medical Devices – Microbial Methods – Part 2: Tests of sterilityperformed in the validation of a sterilization process
ISO 13409	Sterilization of Health Care Products – Radiation Sterilization – substantiation of 25kGyas a sterilization dose for small or infrequent production batches.

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Packaging Validation:

Validation protocols followed the following standards:

ASTM D 4169-04	Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F 88-00	Standard Test Method for Seal strength of Flexible Barrier Materials
ASTM F 1929-98	Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging byDye Penetration
ISO 11607	Packaging for terminally sterilized medical devices

Technological Characteristics: The physical properties and designs of the additional implants and accessories in the NSI Hexed and Non-Hexed Implant System were company with legally marketed predicate devices. The technological characteristics were comparable.
Brief Discussion of Clinical Studies: Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission.
Conclusions Drawn: The NSI Hexed and Non-Hexed Implant System has the same intended use as, and technological characteristics similar to, the legally marketed predicate devices. Any differences in the technological characteristics did not raise new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol of a stylized eagle or bird-like figure with three curved lines representing its wings or feathers.

5 2006 APR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Greta M. Hols Northern Implants, Limited Liability Company 10355 B Democracy Lane Fairfax, Virginia 22030

Re: K053478

Trade/Device Name: Endosseous Dental Implant System Regulation Number: 872.3640 Regulation Name: Endossesous dental implant Regulatory Class: II Product Code: DZE Dated: March 23, 2006 Received: March 31, 2006

Dear Ms. Hols:

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 (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 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. Greta M. Hols

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 continue 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 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Curec

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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Indication for Use

510(k) Number: K053478

Device Name: Endosseous Dental Implant System

Indication for Use: The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

Concurrence of CDRH Office of Device Evaluation

Prescription Use OR Over-the-counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR801.109) v General F 3 of 56

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.