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 or PEEK.

AI/ML Overview

This document is a 510(k) premarket notification summary for the "Intraosseous Fixation System" by Tornier, OrthoHelix Surgical Designs, Inc. It details the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not describe an acceptance criteria table, a study proving device performance against such criteria, or any of the other specific items requested in your prompt (sample size, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set details).

This type of submission primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, often relying on mechanical testing to show similar performance characteristics to the predicate, rather than clinical efficacy studies with specific acceptance criteria as you've outlined.

Therefore, I cannot extract the requested information from the provided text. The document does not contain the details for:

A table of acceptance criteria and the reported device performance: This document reports mechanical testing (4-point bend, axial pull-out, insertion/removal torque, torque to failure) to establish substantial equivalence, but it doesn't present these as "acceptance criteria" for a specific study, nor does it provide the exact performance values against such criteria.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study with ground truth establishment is described.
Adjudication method for the test set: Not applicable.
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, as this is a physical medical device, not an AI or imaging diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with the head tilted upwards.

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

August 21, 2014

Tornier, OrthoHelix Surgical Designs, Inc. Mr. Brian Hockett Director of Research and Development 1065 Medina Road, Suite 500 Medina, Ohio 44256

Re: K141004

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: August 4, 2014 Received: August 6, 2014

Dear Mr. Brian Hockett:

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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Page 2 - Mr. Brian Hockett

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.

Lori A. Wiggins -S

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

Enclosure

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Indications for Use

K141004 510(k) Number TBD:

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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________

(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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510(k) SUMMARY

Submitter Information

Submitter's Name:	OrthoHelix Surgical Designs, Inc.
Address:	1065 Medina Rd, Suite 500
	Medina, Ohio 44256
Telephone Number:	330-869-9562
Fax Number:	330-247-1598
Prepared By:	Amanda Martin and Simon Sjovold
Contact Person:	Brian Hockett
Date Prepared:	8/20/2014

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
Material Composition:	Titanium Alloy and Polyetheretherketone (PEEK)
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 or PEEK.
Intended Use:	The Intraosseous Fixation System is intended to stabilize and aid in thefixation of fractures, fusions, and osteotomies of phalanges.
Substantial Equivalence:	The Intraosseous Fixation System is substantially equivalent to theOrthoHelix Intraosseous Fixation System (K120165), MMI Smart Toe(K070598), OrthoHelix MaxLock Extreme Extremity Plating Systemwith Variable Angle Technology (K100618), Extremity MedicalHammerFiX IP Fusion System (K133636), Bioretec ActivaPin (K061164)and Arthrex Bio-Pin (K050259). Mechanical 4 point bend, axial pull-out, insertion and removal torque and torque to failure testing wereperformed to establish substantial equivalence. No new issues ofsafety and effectiveness have been raised.

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.