The Intraosseous Fixation System consists of various size implants to stabilize and aid in the fixation of fracture, fusions, and osteotomies of the phalanges. The implants are offered in different lengths and diameters. All implants are manufactured from implant grade titanium alloy.

AI/ML Overview

The provided text is related to a 510(k) summary for the OrthoHelix Surgical Designs, Inc. Intraosseous Fixation System. This document outlines the device description, intended use, and substantial equivalence to predicate devices based on mechanical testing. It does not describe a study involving a comparison of device performance against acceptance criteria using statistical measures on a test set, nor does it refer to human readers, experts, or ground truth as would be relevant for a medical imaging or diagnostic device.

Therefore, many of the requested categories of information are not applicable to this submission.

Here is the information that can be extracted from the provided text based on your prompt:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated as acceptance criteria in the format of statistical metrics.	Mechanical 4-point bend testing was performed to establish substantial equivalence to predicate devices (New Deal K-wire (K022599) and Memometal Technologies Smart Toe (K070598)). The submission states: "No new issues of safety and effectiveness have been raised." This implies the device's mechanical performance in 4-point bend testing was comparable to predicates.

Regarding the other points, the provided text does not contain the information needed to answer them as they pertain to studies typically performed on diagnostic or AI-enabled devices.

2. Sample size used for the test set and the data provenance: Not applicable. The study was mechanical testing, not a diagnostic accuracy study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established by experts for this type of mechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. No training set was involved in this type of mechanical testing.
9. How the ground truth for the training set was established: Not applicable.

Summary

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K120/65 page 1 of 1

510(k) SUMMARY

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APR 1 7 2012

Submitter Information
Submitter's Name:Address:	OrthoHelix Surgical Designs, Inc.1065 Medina Rd, Suite 500Medina, Ohio 44256
Telephone Number:Fax Number:	330-869-9562330-247-1598
Prepared By:	Amanda Martin & Jamey Price
Contact Person:	Derek Lewis
Date Prepared:	12/30/2011
Device Information
Trade Name:	Intraosseous Fixation System
Common Name:	Fixation Device
Classification Name:	Pin, Fixation, Smooth
Device Classification:	Pin, Fixation, Smooth (Class II per 21 CFR 888.3040)Panel: Orthopedic, Product Code: HTY
Predicate Device:	The Intraosseous Fixation System is equivalent to current legallymarketed devices.
Material Composition:	Titanium Alloy
Device Description:	The Intraosseous Fixation System consists of various size implants tostabilize and aid in the fixation of fracture, fusions, and osteotomies ofthe phalanges. The implants are offered in different lengths anddiameters. All implants are manufactured from implant gradetitanium alloy.
Intended Use:	The Intraosseous Fixation System is intended to stabilize and aid in thefixation of fractures, fusions, and osteotomies of the phalanges.
Substantial Equivalence:	The Intraosseous Fixation System is substantially equivalent to theNew Deal K-wire (K022599) and Memometal Technologies Smart Toe(K070598). Mechanical 4 point bend testing was performed toestablish substantial equivalence. No new issues of safety andeffectiveness have been raised.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three lines instead of one.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

OrthoHelix Surgical Designs, Incorporated % Mr. Derek Lewis Vice President of Research and Development 1065 Medina Road, Suite 500 Medina, Ohio 44256

APR 1 7 2012

Re: K120165

Trade/Device Name: Intraosseous Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: March 16, 2012 Received: March 19, 2012

Dear Mr. Lewis:

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2 - Mr. Derek Lewis

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 yours,

Erin Keith

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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K 120/65 page 1 of 1

Indications for Use

510(k) Number (if known):

Device Name: Intraosseous Fixation System

Indications for Use:

The Intraosseous Fixation System is indicated to stabilize and aid in fixation of fractures, fusions, and osteotomies of the phalanges.

Over-The-Counter-Use Prescription Use ___ AND/OR × (Part 21 CFR 801 Subpart D) (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)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120605

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.