The OIC External Fixation system is intended to be used in adult and pediatic patients for provisional fixation of open and or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of periarticular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

Device Description

The device is used for the external stabilization of bone fractures. It consists of: Carbon fiber composite bars, 11mm diameter, 100mm to 600mm lengths Titanium and aluminum combination clamp. 5 & 8 hole pin clamp Aluminum straight and angled posts Stainless steel 4mm and 5mm pins, blunt tip and threaded 150mm lengths, 15mm through 120mm thread lengths. Stainless steel 5mm transfixing pin, 250mm length Stainless steel instruments for implantation The pins are implanted into bone and then they are connected using the clamps, rods and posts to form a rigid construct which holds the bone fragments rigidly in place. The pins are offered in various lengths and thicknesses.

AI/ML Overview

This document describes the OIC External Fixation System, a medical device for stabilizing bone fractures. It has been cleared by the FDA under K171211. The document does not contain information about a study proving the device meets acceptance criteria related to an AI/ML product or performance metrics like accuracy, sensitivity, or specificity. Instead, the "Performance Testing" section refers to mechanical testing for external fixation systems.

Since the provided document does not pertain to an AI/ML device, many of the requested fields are not applicable.

Here's the information based on the provided text, with "N/A" for inapplicable fields:

Acceptance Criteria and Device Performance (Mechanical Testing)

While the document doesn't provide a table of acceptance criteria and reported performance in the typical sense of an AI/ML device (e.g., accuracy, sensitivity), it does discuss mechanical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Compliant with ASTM F1541-02 for clamping ability	FEA simulations conducted using methods outlined in ASTM F1541-02.
Withstand greater loads than the predicate device (mechanical static axial load)	Mechanical static axial load testing per ASTM F1541-02 determined that the device will withstand greater loads than the predicate device.

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

Sample Size: Not specified in terms of number of physical units tested, but references Finite Element Analysis (FEA) simulations and mechanical static axial load testing. These tests typically involve a defined number of test samples or simulation runs.
Data Provenance: N/A (mechanical testing, not patient data).

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

N/A (Ground truth for mechanical testing is based on engineering specifications and test standards, not expert medical opinion).

4. Adjudication method for the test set:

N/A (Not applicable to mechanical testing).

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:

N/A (This device is an external fixation system, not an AI/ML diagnostic or assistive tool).

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

N/A (Not an AI/ML algorithm).

7. The type of ground truth used:

Ground Truth Type: Engineering specifications, industry standards (ASTM F1541-02), and mechanical properties of materials.

8. The sample size for the training set:

N/A (Not an AI/ML device; no training set in the AI sense).

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

N/A (Not an AI/ML device).

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 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 image of three human profiles facing to the right, stacked on top of each other.

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

September 27, 2017

Orthopaedic Implant Company Douglas Fulton Ouality Assurance Manager 770 Smithridge Drive #400 Reno, Nevada 89502

Re: K171211

Trade/Device Name: OIC External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT Dated: August 2, 2017 Received: August 3, 2017

Dear Douglas Fulton:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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 (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE) 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.

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

510(k) Number (if known) K171211

Device Name OIC External 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)

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510(k) Summary

Prepared 8/1/2017

Name and Address of Manufacturer: The Orthopaedic Implant Company (OIC) 770 Smithridge Drive. Suite 400 Reno, NV 89502

Contact: Douglas Fulton Quality Assurance Manager Telephone: 775-636-8281 Fax: 775-636-8284 Email: doug@orthoimplantcompany.com

Device Identification: Trade Name: OIC External Fixation System Classification Name: Single/multiple component metallic bone fixation appliances and accessories Classification: Class II, 21 CFR 888.3030 Panel: Orthopedic Product Code: KTT

Indications for Use:

The OIC External Fixation system is intended to be used in adult and pediatric patients for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of peri-articular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

Device Description:

Comparison of Technological Characteristics (Substantial Equivalence): Predicate devices: K110965 Renovis T 710 Large External Fixation System K072212 Jet-X Bar System Clamps, Bars and Posts - MR Conditional K952730 Hoffman II External Fixation System K061493 Apex Pins K031428 Synthes Large External Fixation Clamps The OIC External Fixation System has the following similarities to those which previously received 510(k)

concurrence: has the same indicated use, uses the same operating principle, incorporates the same design and incorporates the same or similar materials

Performance Testing:

FEA simulations were conducted using methods outlined in ASTM F1541-02 to ascertain that the clamping ability of the OIC clamps have acceptable mechanical characteristics for the intended uses. Mechanical static axial load testing performed per ASTM F1541-02 determined that the device will withstand greater loads than the predicate device.

Conclusion:

The OIC External Fixation System described in this substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.