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 the following bone void fillers to a surgical site:

. Beta-bsm (ETEX Corporation)
CarriGen (ETEX Corporation) .

Device Description

The N-Force Fixation System is a screw system for fracture fixation. It includes fully and partially cannulated screws in various lengths, and accompanying instruments.

The N-Force Fixation System screws are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The N-Force Fixation System is cannulated and fenestrated which allow it to be used as a delivery system for ETEX Beta-bsm and ETEX CarriGen bone void fillers.

AI/ML Overview

The N-Force Fixation System is a medical device and the provided text describes its 510(k) summary for FDA clearance. The concept of "acceptance criteria" and "device performance" in the context of diagnostic AI or image analysis tools, as suggested by the prompt's structure, does not directly apply to this device. This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of intended use, design, function, and materials.

Therefore, the requested information elements related to AI/algorithm performance, ground truth, expert consensus, and reader studies are not applicable to this submission.

Here's an adaptation of the requested table and a summary of the available information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from predicate devices and relevant standards)	Reported Device Performance (N-Force Fixation System)
Mechanical Performance	Not explicitly stated as numerical criteria in this summary. Implied to meet or exceed relevant standards and performance of predicate devices for:- Static three-point bending- Torsion- Axial pullout- Insertion torque- Extraction torque	"Testing performed on the N-Force Screw indicates that it is substantially equivalent to predicate devices."Specific tests performed:- Static three-point bending- Torsion- Axial pullout- Insertion torque- Extraction torque(No quantitative results or specific pass/fail rates are provided in this summary, but the conclusion of substantial equivalence implies satisfactory performance.)
Material Composition	Titanium Alloy (Ti-6Al-4V) conforming to ASTM F136 (based on predicate devices)	Made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136.
Bone Void Filler Delivery Capability	Ability to deliver bone void filler materials (Beta-bsm and CarriGen) comparable to ETEX-recommended instruments.	Additional testing was performed to demonstrate substantial equivalence to ETEX recommended instruments with respect to their ability to deliver bone void filler material.
Indications for Use (Substantial Equivalence)	Fixation of bone fractures and bone reconstructions. Delivery of specific bone void fillers. (Based on predicate devices and intended use)	Intended for the fixation of bone fractures and bone reconstructions. Can also be used to deliver Beta-bsm and CarriGen bone void fillers. Concluded to be "substantially equivalent ... with respect to its indications for use".
Design & Function (Substantial Equivalence)	Screw system for fracture fixation, fully and partially cannulated, fenestrated. (Based on predicate devices)	Described as a screw system for fracture fixation, including fully and partially cannulated screws. Cannulated and fenestrated to allow use as a delivery system. Concluded to be "substantially equivalent ... with respect to its ... design, function".

Study Details Based on Provided Information:

Sample size used for the test set and the data provenance:
- Test set sample size: Not specified. The study primarily relies on mechanical testing of the device itself, rather than a "test set" of patient data as understood in AI/imaging studies. It involved various screws and instruments.
- Data provenance: Not specified, but generally refers to laboratory mechanical testing data conducted by or for the manufacturer. It is prospective testing, designed to evaluate the physical properties of the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission is for a medical device (surgical screw system) and does not involve subjective assessment of images or data by experts to establish "ground truth" in the way an AI diagnostic device would. Ground truth here relates to the engineering specifications and performance against established standards and predicate devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No human adjudication of results in the traditional sense. Mechanical tests typically involve standardized procedures and measurements (e.g., force, torque, displacement) which are objective.
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 not a diagnostic AI device or an imaging device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering and material standards (e.g., ASTM F136 for titanium alloy) and the mechanical performance of legally marketed predicate devices. The N-Force Fixation System's performance in terms of static three-point bending, torsion, axial pullout, insertion torque, and extraction torque is compared against these benchmarks to establish substantial equivalence.
The sample size for the training set:
- Not applicable. No training set in the context of machine learning or AI is involved.
How the ground truth for the training set was established:
- Not applicable. No training set in the context of machine learning or AI is involved.

Summary

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510(k) Summary

JUL 28 2011

Contact:	Michelle McDonoughMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Date Prepared:	July 21, 2011
Device Trade Name:	N-Force Fixation System
Manufacturer:	Innovision, Inc.1975 Nonconnah Blvd.Memphis, TN 38132.
Common Name:	Smooth or threaded metallic bone fixation fastener
Classification:	21 CFR 888.3040
Class:	II
Product Code:	HWC

Indications For Use:

. Beta-bsm (ETEX Corporation)
CarriGen (ETEX Corporation) .

Device Description:

The N-Force Fixation System is a screw system for fracture fixation. It includes fully and partially cannulated screws in various lengths, and accompanying instruments.

Predicate Devices:

The N-Force Fixation System was shown to be substantially equivalent to previously cleared screw devices including Treu Bone Fixation Screws and Pins (K083912) and S&N 4.0mm Cannulated Screws (K993106); the Haig Nail System (K961213 and K991889) which, like the

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N-Force Screw, is a fracture fixation device that temporarily serves as a surgical instrument; and the delivery systems used with ETEX Beta-bsm and ETEX CarriGen bone void fillers (K101557).

Substantial Equivalence:

Testing performed on the N-Force Screw indicates that it is substantially equivalent to predicate devices. Mechanical testing of the screw included static three-point bending, torsion, axial pullout, insertion torque, and extraction torque. Additional testing was performed to demonstrate the substantial equivalence of the N-Force Fixation System to the ETEX recommended instruments with respect to their ability to deliver bone void filler material.

Conclusion

The N-Force Fixation System is substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and materials.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized depiction of an eagle or bird-like figure, with its wings spread and head turned to the right. The bird is rendered in a thick, black line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

Innovision, Inc. % Ms. Michelle McDonough 1331 H Steet Northwest, 12th Floor Washington, District Columbia 20005

JUL 28 2011

Re: K102528

Trade/Device Name: N-Force Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 16, 2011 Received: June 20, 2011

Dear Ms. McDonough:

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

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Page 2 - Ms. Michelle McDonough

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely vours.

Mark A. Millener,

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

Enclosure

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Indications for Use

510(k) Number (if known): K102528

Device Name: N-Force Fixation System

Beta-bsm (ETEX Corporation) .
CarriGen (ETEX Corporation) .

Prescription Use ﮯ (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ar M. Melkerson

(Division Sign-Oft) (Division Sign-On))
Division of Surgical, Orthopedic, Division of Surge
and Restorative Devices

510(k) Number K102528

Page 1 of 1

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.