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

The device is used for the external stabilization of bone fractures. It consists of:

Carbon fiber composite bars, 11mm diameter, 100mm to 650mm 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, 300mm 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

The provided text does NOT describe a study involving an AI/ML powered device, but rather a traditional medical device (OIC External Fixation System) used for bone fracture fixation. Therefore, most of the requested information regarding acceptance criteria and study design for an AI/ML device is not present in the document.

The document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device. This involves comparing indications for use, operating principles, design, and materials, along with performance testing relevant to the physical characteristics of the device.

Here's a breakdown of what can be extracted from the provided text, and what cannot be provided due to the nature of the device:

Information NOT APPLICABLE/AVAILABLE for this traditional medical device:

Table of acceptance criteria and reported device performance related to AI/ML metrics: There are no AI/ML metrics (e.g., sensitivity, specificity, AUC) for this device. The "performance testing" mentioned is for MRI compatibility, not diagnostic accuracy.
Sample size for the test set and data provenance: No test set for AI/ML performance.
Number of experts and qualifications for ground truth: No ground truth establishment related to diagnostic imaging or AI output.
Adjudication method for the test set: Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable, as there's no AI to assist human readers.
Standalone (algorithm-only) performance: Not applicable, as it's a physical device, not an algorithm.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML performance.
Sample size for the training set: Not applicable (no AI/ML model to train).
How the ground truth for the training set was established: Not applicable.

What is available from the document (relevant to a traditional medical device):

Device Name: OIC External Fixation System
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 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.
Performance Testing Mentioned: Magnetic resonance imaging (MRI) compatibility testing was performed on the OIC External Fixation System. Testing shows that the system has acceptable MRI characteristics for the intended uses.
Conclusion of Performance Testing (for MRI compatibility): "Testing shows that the system has acceptable MRI characteristics for the intended uses." This acts as the acceptance criterion for MRI compatibility.
Predicate Devices: K171211 OIC External Fixation System, K082650 Synthes Large External Fixation MR Conditional

If this were an AI/ML medical device, here's how the information would typically be structured:

Acceptance Criteria and Study for AI/ML Device (Hypothetical as per your request, but NOT based on the provided document)

This section outlines the acceptance criteria and the study performed to demonstrate that the hypothetical AI/ML device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criterion	Reported Device Performance
Primary Endpoints
[e.g., Sensitivity for detecting X]	[e.g., ≥ 90%]	[e.g., 92.5% (95% CI: 90.1-94.6%)]
[e.g., Specificity for detecting X]	[e.g., ≥ 80%]	[e.g., 85.2% (95% CI: 83.0-87.1%)]
Secondary Endpoints
[e.g., AUC]	[e.g., ≥ 0.90]	[e.g., 0.93]
[e.g., Negative Predictive Value]	[e.g., ≥ 95%]	[e.g., 96.1%]
[e.g., Time to diagnosis reduction]	[e.g., ≤ 10% reduction in read time]	[e.g., 12% reduction]

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: [e.g., 500 cases (e.g., 200 positive, 300 negative for the condition)]
Data Provenance: [e.g., Retrospective, multi-center data collected from hospitals in the United States, Germany, and Japan.]

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: [e.g., 3 independent expert radiologists per case]
Qualifications: [e.g., All radiologists were board-certified with at least 5 years of experience in reading [relevant imaging modality, e.g., chest X-rays] and specialized in [relevant area, e.g., pulmonary imaging]. Additional experts included two board-certified pathologists with 10+ years of experience.]

4. Adjudication Method (for the test set)

Method: [e.g., 2+1 adjudication. Initial reads by two independent experts. If disagreement, a third senior expert (adjudicator) provided the final consensus. Alternatively: 3+1 (three readers, then a fourth tie-breaker), or Unanimous Consensus, or Majority Vote.]

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

Was it done? [Yes/No]
- If Yes:
  - Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance:
    - [e.g., Human readers using AI assistance demonstrated a statistically significant increase in diagnostic accuracy by X% (e.g., 5.3 percentage points, p < 0.001) compared to unassisted reads. Specific metrics, e.g., average AUC increased from 0.85 to 0.90.]
    - [e.g., Sensitivity increased from A% to B%, and Specificity from C% to D% when using AI assistance vs. without.]
    - [e.g., Reduced false positive rate by Y% or reduced false negative rate by Z%.]

6. If a Standalone (Algorithm-Only) Performance was Done

Was it done? [Yes/No]
- If Yes:
  - Description of standalone performance metrics provided in Section 1 (Table of Acceptance Criteria).

7. The Type of Ground Truth Used

Type: [e.g., Expert Consensus: established by a panel of [number] experts based on clinical data, imaging, and follow-up. OR Pathology: confirmed by histopathological analysis from biopsy or surgical specimens. OR Outcomes Data: confirmed by long-term patient follow-up or established clinical endpoints (e.g., survival data, resolution of symptoms).]

8. The Sample Size for the Training Set

Sample Size: [e.g., 100,000 cases (e.g., 40,000 positive, 60,000 negative)]

9. How the Ground Truth for the Training Set was Established

Method: [e.g., Automated labeling based on EMR codes and structured reports, reviewed by a single clinical expert for common conditions. Or labeled by primary clinical readers and then cross-checked for consistency based on pre-defined criteria. For more critical cases, a subset was reviewed by expert consensus (similar to the test set ground truth establishment).]

Summary

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

Indications for Use

510(k) Number (if known) K183682

Device Name

OIC External Fixation System

Indications for Use (Describe)

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.

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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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.

April 8, 2019

Orthopaedic Implant Company Douglas Fulton Quality Assurance Manager 770 Smithridge Dr. #400 Reno, Nevada 89502

Re: K183682

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: March 11, 2019 Received: March 12, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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

Enclosure

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510(k) Summary

Prepared 4/4/2019

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 Common Name: External fixation components 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:

Device Description:

The device is used for the external stabilization of bone fractures. It consists of:

Carbon fiber composite bars, 11mm diameter, 100mm to 650mm 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, 300mm length

Stainless steel instruments for implantation

Comparison of Technological Characteristics (Substantial Equivalence):

Predicate devices: K171211 OIC External Fixation System, K082650 Synthes Large External Fixation MR Conditional 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:

Magnetic resonance imaging (MRI) compatibility testing was performed on the OIC External Fixation System. Testing shows that the system has acceptable MRI characteristics for the intended uses.

Conclusion:

The OIC External Fixation System described in this submission is, in our opinion, 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.