The N-Force Fixation System is intended for the fixation of bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver injectable bone void fillers to a surgical site.

Device Description

The N-Force Fixation System includes fully and partially cannulated screws in various diameters and lengths, in both fenestrated and non-fenestrated options. The system also includes washers and accompanying instruments.

The N-Force Fixation System implants are made of titanium alloy.

AI/ML Overview

This document is a 510(k) premarket notification for the InnoVision N-Force Fixation System. It establishes substantial equivalence to a predicate device, which means detailed studies proving device performance against specific acceptance criteria for a novel device are not typically included in these types of FDA submissions. Instead, the submission relies on demonstrating the new device is as safe and effective as a legally marketed predicate.

Therefore, the following information, if applicable, would be derived from the provided document, but it's important to understand that a 510(k) does not typically contain the level of detailed study information (e.g., sample sizes for test sets, expert qualifications, MRMC studies, ground truth details for training sets) that would be found in a De Novo submission or a PMA application for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated Equivalence to)	Reported Device Performance (Summary)
Predicate N-Force Fixation System (K102528, K132244)	Demonstrated substantial equivalence in:
- Indications	- Indications for use match predicate.
- Design	- Design similar, with fully/partially cannulated, fenestrated/non-fenestrated screws, washers, and instruments.
- Function	- Functions similarly for bone fixation and BVF delivery.
- Performance (Mechanical)	- Mechanical testing (static three-point bending, torsion, axial pull-out, insertion torque) demonstrated similar performance.
- Performance (BVF Injection)	- Bone void filler injection testing (injectability, void fill imaging, paste hardness, X-Ray diffraction, static extraction torque) demonstrated similar performance.
- Materials	- Implants made of titanium alloy, similar to predicate.
- Ability to deliver BVF to a surgical site	- Explicitly stated as equivalent.

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

The document states "Testing performed on the N-Force Screw indicates that it is substantially equivalent to the predicate devices." However, it does not specify the exact sample sizes used for each type of mechanical or BVF injection test.

Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned in this 510(k) summary, as the focus is on laboratory-based mechanical and functional testing rather than clinical data.

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

This information is not applicable and not provided. Substantial equivalence for this device relies on mechanical and material testing, not on human interpretation of medical images or data requiring expert consensus for a "ground truth" as typically seen in AI/diagnostic device studies.

4. Adjudication method for the test set

This information is not applicable and not provided, as the testing involves objective mechanical and material properties rather than subjective interpretation requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical implant (bone fixation system), not a diagnostic device that would typically involve human readers or AI assistance in interpretation.

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

This is not applicable as the device is a physical implant, not an algorithm or AI system.

7. The type of ground truth used

For mechanical and material testing, the "ground truth" would be established by the physical properties and performance characteristics of the predicate device, as well as established engineering standards and specifications for medical implants. For example, for "static three-point bending," the ground truth would be the established maximum bending moment or deflection tolerance for the predicate, and against which the new device's performance is compared.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device, not an AI or machine learning system that requires a "training set."

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

This is not applicable for the reasons stated in point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 24, 2015

InnoVision, Incorporated % Ms. Hollace Saas Rhodes Director, Orthopedic Regulatory Affairs 1331 H Street NW, 12th Floor Washington, District of Columbia 20005

Re: K151146

Trade/Device Name: N-Force Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 28, 2015 Received: April 29, 2015

Dear Ms. Rhodes:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K151146

Device Name N-Force Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Manufacturer:	InnoVision, Inc.1975 Nonconnah BoulevardMemphis, TN 38132
Device Trade Name:	N-Force Fixation System
Common Name:	Smooth or threaded metallic bone fixation fastener
Date Prepared:	April 28, 2015
Prepared By:	Musculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Device Trade Name:	N-Force Fixation System
Classification:	21 CFR 888.3040, Smooth or threaded metallic bone fixationfastener
Class:	II
Product Code:	HWC

Indications for Use:

The N-Force Fixation System is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver injectable bone void fillers to a surgical site.

Device Description:

The N-Force Fixation System implants are made of titanium alloy.

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Predicate Device:

The N-Force Fixation System is substantially equivalent to the predicate N-Force Fixation System (K102528, K132244) with respect to indications, design, function, performance, materials and its ability to deliver BVFs to a surgical site.

Substantial Equivalence:

Testing performed on the N-Force Screw indicates that it is substantially equivalent to the predicate devices. Mechanical testing of the screw included static three-point bending, torsion, axial pull-out, and insertion torque. Bone void filler injection testing included injectability, experimental void fill imaging, relative paste hardness, X-Ray diffraction, and static extraction torque.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.