The Neoss ProActive Implant is for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neoss ProActive Implant is intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

Device Description

The Neoss ProActive is an modified version of the Neoss Bimodal Implant (K043195), Identical to K043195, the ProActive Implant is a threaded, internal abutment connection, root-form titanium dental implant. The ProActive assortment consists of a number of implants with a diameter of Ø3,5 to Ø5,5 mm and lengths between 7,0 - 19.0 mm having the same internal abutment dimension independent of implant diameter. The internal connection being equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. Supplied sterile.

AI/ML Overview

The provided 510(k) summary for the Neoss ProActive Implant does not contain the detailed information requested regarding acceptance criteria and a study proving device performance as typically understood for AI/ML-based medical devices.

This submission is for a dental implant, which is a physical device, not a software or AI/ML diagnostic tool. Therefore, the traditional metrics of sensitivity, specificity, accuracy, and detailed ground truth generation processes that would be relevant for devices making diagnostic claims are not applicable or present in this type of submission.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Neoss Bimodal Implant K043195) due to a modification in the surface finish process. The performance is assessed through comparisons of physical characteristics and biological responses in animal models, rather than a clinical study with a human test set and expert adjudication.

Here's a breakdown of what is and is not available based on the provided text:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Implied/General:
Compliance to device specifications	All functions verified to operate as designed.
Safety and Effectiveness equivalent to predicate device (K043195)	Demonstrated through similar intended use, operating principle, basic device design, physical properties, and materials.
Increased strength of osseointegration when compared to machined surfaces (animal testing)	Exhibit an increase in the strength of osseointegration
Increased bone to implant contact when compared to grit-blasted surfaces (animal testing)	Exhibit an increased bone to implant contact

Note: These are based on biological responses in animal testing and general performance verification, not metrics like sensitivity or specificity.

2. Sample size used for the test set and data provenance:

The document mentions "animal testing" but does not specify the sample size, type of animals, or country of origin for these tests. This is a pre-clinical, non-human study.
The study is retrospective in the sense that it's comparing a modified device to a previous one, but the specific animal tests themselves would be prospective experiments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the "ground truth" for a physical dental implant's performance would be established through mechanical testing, material characterization, and biological response in animal models, not expert clinical interpretation of images or other data.

4. Adjudication method for the test set:

Not applicable for this type of device.

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/ML diagnostic tool.

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

Not applicable. This is a physical dental implant.

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

The closest concept to "ground truth" here would be the biological outcomes observed in animal models (e.g., strength of osseointegration, bone-to-implant contact) and engineering/material properties verified during performance testing.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set. The "development" of the device involves engineering design and pre-clinical testing.

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

Not applicable.

In summary: The provided 510(k) pertains to a hardware modification (surface finish) of an existing dental implant. The safety and effectiveness data provided are based on pre-clinical animal testing and engineering verification, not clinical studies with human participants or the detailed performance metrics typically associated with AI/ML-based diagnostic devices.

Summary

{0}------------------------------------------------

K083561

Section 6: 510(k) Summary

Applicant:

FEB 1 1 2009 Neoss Ltd Windsor House Cornwall Road Harrogate, HG1 2PW, UK Johanne Hamill Phone: +44 (0) 1423 817733 , +46 (0)709 792 892 Fax: +44(0) 1423 817744 E-mail: Johanne.hamill@neoss.com

US Contact:

Cherita James M Squared Associates, Inc. 901 King Street, Suite 200 Alexandria, Virginia 22314 Phone: 703-562-9800 Ext. 257 Facsimile: 703-562-9797 Establishment Registration Number: 3005846524

Manufacturing:

Implants

Elos AB Bäckedalsvägen 6 SE-540 16Timmersdala, Sweden. Registration Number: 3003847101

Pinol AS Engsvej 33 DK-3330 Gorlose, Denmark. Registration Number: Not yet available

Packaging Facility

Wesley Coe Ltd Gas Lane Ely, Cambridgeshire CB7 4GH, UK Registration Number: 8044131

Sterilization Facility

Swann-Morton Ltd Owlerton Green Hillsborough, Sheffield, S6 2BJ, UK Registration Number: 9611194

Neoss Ltd.

{1}------------------------------------------------

Neoss ProActive Implant

Special 510(k) Premarket Application

Date submitted:	November 25, 2008
Proprietary Name:	Neoss ProActive Implant
Common Name:	Dental implant
Classification Status:	Class II
Product Codes:	DZE
Regulation:	872.3640 Implant, Endosseous, Root Form
Predicate Device:	Neoss Bimodal Implant K043195

Device Description:

Indication for Use: as per K043195, as cleared for Neoss Bimodal Implant

The Neoss ProActive Implant is for single-stage and two-stage surgical procedures and cement or screw retained restorations.

The Neoss ProActive Implant are intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

Summary of Technological Characteristics:

The modification to the Neoss Bimodal Implant since its previous clearance in K043195 is a change to the surface finish process only. The modifications are changes required to improve device performance. In animal testing, grit-blasted and acid-etched surfaces exhibit an increase in the strength of osseointegration when compared to machined surfaces. Additionally, in animal testing, grit-blasted and acid-etched surfaces exhibit an increased

{2}------------------------------------------------

Neoss ProActive Implant

bone to implant contact when compared to grit-blasted surfaces. These minor differences do not affect the safety or performance of the device and do not change the intended use of the ProActive Implant when compared to the Neoss Bimodal Implant.

Summary of Nonclinical Testing:

Based on the Risk Analysis, performance testing was conducted to confirm compliance to device specifications; all functions were verified to operate as designed.

Substantial Equivalence Discussion:

The change to the surface finish process of the Neoss ProActive Implant does not change the intended use nor do they affect the safety and effectiveness as compared to the Neoss Bimodal Implant previously cleared in K043195.

Conclusion:

The modified Neoss ProActive Implant has the following similarities to the Neoss Bimodal Implant previously cleared in K043195:

. has the same indicated use,
uses the same operating principle, .
. incorporates the same basic device design and physical properties,
. incorporates the same materials.

Therefore the modification to the Neoss ProActive Implant can be found substantially equivalent to the Neoss Bimodal Implant.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neoss Limited C/o Ms. Cherita James M Squared Associates, Incorporated 901 King Street. Suite 200 Alexandria, Virginia 22314

FEB 1 1 2009

Re: K083561

Trade/Device Name: Neoss ProActive Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 9, 2009 Received: January 12, 2009

Dear Ms. James:

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 Eederal Register.

{4}------------------------------------------------

Page 2 - Ms. James

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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Saylite Y. Michael Oms.

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Section 5: Indications for Use Statement

510(k) Number (if known): K0835 6)

Device Name: Neoss ProActive Implant

Indications For Use: The Neoss ProActive Implant is for single-stage and two-stage surgical procedures and cement or screw retained restorations.

The Neoss ProActive Implant is intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runser

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of _

510(k) Number:

Neoss Ltd,
November 25, 2008

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.