The OrthoPro Ankle Trauma system is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone, The OrthoPro Ankle Trauma system is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the system.

Device Description

The OrthoPro Ankle Trauma system is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of lones and bone fragments. The plates include straight, right, and left configurations. The system also includes bone screws. Manual surgical instruments are supplies with the system to facilitate implantation.

AI/ML Overview

The provided text is for a medical device (The OrthoPro Ankle Trauma System) that is a metallic bone fixation appliance. The acceptance criteria and the study performed for this type of device are primarily focused on non-clinical performance benchmarks, demonstrating substantial equivalence to predicate devices, rather than clinical performance measures or AI-driven diagnostic accuracy.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" will largely pertain to biomechanical testing and comparison with legally marketed predicate devices, and not to a clinical study involving human readers, AI assistance, or diagnostic accuracy metrics typically seen in AI/ML medical devices.

Here's the breakdown based on the provided text, addressing the points where information is available or applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are typically defined by demonstrating substantial equivalence in performance to predicate devices through standardized biomechanical testing. The performance is reported as meeting or exceeding the predicate.

Acceptance Criteria	Reported Device Performance
Plate Biomechanical Performance: Demonstrated substantial equivalence to predicate devices under ASTM F382-99 (Standard Specification and Test Methods for Metallic Bone Plates).	The OrthoPro plate was found to be substantially equivalent to the predicate device. In most cases, device function performed with superiority.
Screw Biomechanical Performance: Demonstrated substantial equivalence to predicate devices under ASTM F543-07 (Standard Specification and Test Metallic Bone Screws).	The screws from the Ankle Trauma System were found to be substantially equivalent to the predicate device.
Materials: Use of Titanium alloy (Ti 6Al 4V ELI) per ASTM F136.	The device uses Titanium alloy (Ti 6Al 4V ELI) per ASTM F136, matching or being substantially equivalent to predicate device materials (Titanium and/or stainless steel).
Indications for Use: Comparable to predicate devices.	The Indications for Use are substantially equivalent to the predicate devices.
Design and Function: Comparable to predicate devices.	The design and function are substantially equivalent to the predicate devices.

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

The text explicitly mentions tests conducted on "the worse case plate" and "the screws" from the Ankle Trauma System. This implies a limited number of physical samples for mechanical testing, not a large test set of clinical data from patients. The provenance of these physical samples would be the manufacturing facility, representing the device itself.

Sample Size: Not explicitly stated as a numerical count, but refers to "the worse case plate" and "the screws," indicating physical samples for destructive testing. Typically, biomechanical testing involves a statistically significant number of samples of the device and predicate to demonstrate equivalence; however, specific numbers are not provided in this summary.
Data Provenance: Not applicable in the context of clinical data. The "data" comes from in vitro biomechanical testing of the manufactured devices.

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

This question is not applicable to the non-clinical testing described. "Ground truth" in this context would refer to the established standards and methodologies of the ASTM documents (ASTM F382-99 and ASTM F543-07), which are developed by expert consensus within the field of biomaterials and medical devices. There are no "experts used to establish ground truth for the test set" in the sense of clinical reviewers or annotators, as this is a non-clinical, mechanical performance study.

4. Adjudication Method for the Test Set

Not applicable. This refers to methods for resolving discrepancies among multiple expert reviewers in clinical studies. No such adjudication was performed as this was non-clinical biomechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

No. This type of study is performed for diagnostic imaging devices, often involving AI. This device is a metallic bone fixation appliance, and no such clinical or AI-related study was performed. The document explicitly states: "No clinical studies were performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This question is relevant for AI/ML medical devices. This device is a physical implant, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical study is established by:

Standardized Biomechanical Testing Methods: ASTM F382-99 (Standard Specification and Test Methods for Metallic Bone Plates) and ASTM F543-07 (Standard Specification and Test Metallic Bone Screws).
Performance of Predicate Devices: The measured mechanical performance of the legally marketed predicate devices serves as the benchmark against which the new device's performance is compared for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable, as there is no training set for this device.

Summary

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K122936

510(k) Summary

for The OrthoPro Ankle Trauma System In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for The OrthoPro Ankle Trauma system

FEB 2 8 2013

Date Prepared: September 21, 2012 Date Updated: January 28, 2013

1. Submitter: OrthoPro LLC 3450 Highland Drive, Ste 302 Salt Lake City, UT 84106
  Contact Person: Brock Johnson OrthoPro LLC 3450 Highland Drive, Ste 302 Salt Lake City, UT 84106 Telephone: 801-746-0208 ext 109

Trade Name: Common Name:

Classification Name:

The OrthoPro Ankle Trauma System bone plate Single/Multiple Component Metallic Bone Fixation Appliances and Accessories 21 CFR § 888.3030 HRS Class II

Predicate or legally market devices which are substantially equivalent: 3.

· LCP One-Third Tubular Plate - K011335 (Synthes)

· T-3.5mm LCP T-Plate - K000684 (Synthes)

· LCP Distal Tibia Plate - K013248 (Synthes)

4. Description of the device:

Materials:

Titanium alloy (Ti 6Al 4V ELI) per ASTM F136

Indications for Use:

The OrthoPro Ankle Trauma system is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, particularly in osteopenic bone, The OrthoPro Ankle Trauma system is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the system.

દ. Comparison of the technological characteristics of the device to predicate and legally marketed devices: The OrthoPro Ankle Trauma system is substantially equivalent to the Synthes devices: One-Third Tubular Plate, T-3.5mm LCP T-Plate, LCP Distal Tibia Plate in terms of intended use, design, and

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materials used. The table below compares the features and characteristics of Ankle Trauma System to these predicate devices.

DeviceName/Items	OrthoPro AnkleTrauma System	Synthes LCP One-Third Tubular Plate	Synthes T-3.5mmLCP T-Plate	Synthes LCP DistalTibia Plate
Sponsor	OrthoPro LLC	Synthes (USA)	Synthes (USA)	Synthes (USA)
DeviceClassificationName	Single/Multiplecomponent metallicfixation appliances andaccessories	Single/Multiplecomponent metallicfixation appliancesand accessories	Single/Multiplecomponent metallicfixation appliances andaccessories	Single/Multiplecomponent metallicfixation appliances andaccessories
Product code	HRS	HRS	HRS	HRS
Regulation #	888.3030	888.3030	888.3030	888.3030
Classification	Class II	Class II	Class 11	Class II
510(k)Number	K122936	K011335	K000684	K013248
Indications forUse	The OrthoPro AnkleTrauma system isintended for fixation offractures, osteotomies,and non-unions of theclavicle, scapula,olecranon, humerus,radius, ulna, pelvis, distaltibia, and fibula,particularly in osteopenicbone, The OrthoPro AnkleTrauma system isintended for fixation ofcomplex intra- and extra-articular fractures andosteotomies of the distaltibia and other smallbones as a part of thesystem.	Synthes DynamicCompression LockingPlate System isintended for fixationof fractures,osteotomies, and non-unions of the clavicle,scapula, olecranon,humerus, radius, ulna,pelvis, distal tibia, andfibula, particularly inosteopenic bone aspart of the SynthesSmall Fragment DCLSystem	Fixation of fractures,osteotomies, and non-unions of the clavicle,scapula, olecranon,humerus, radius, ulna,pelvis, distal tibia,fibula particularly inosteopenic bone.	The Synthes LockingCompression Plate (LCP)is intended for fixation offractures, osteotomies,and non-unions of theclavicle, scapula,olecranon, humerus,radius, ulna, pelvis, distaltibia, and fibula,particularly in osteopenicbone, The Synthes LCPDistal Tibia Plates areintended for fixation ofcomplex intra- and extra-articular fractures andosteotomies of the distaltibia and other smallbones as a part of thesystem.
Material	Titanium	Titanium andstainless steel	Titanium andstainless steel	Titanium andstainless steel
Configuration	Straight, Cloverleaf	Straight	Straight, T,cloverleaf, T obliqueangle, curved	Cloverleaf
Profile	Scalloped	Straight	Straight, Scalloped	Straight
Screws	Locking and Non-locking	Locking and Non-locking	Locking and Non-locking	Locking and Non-locking
Sterility	Non-sterile	Sterile/Non-sterile	Sterile/Non-sterile	Sterile/Non-sterile

7. Nonclinical Test Summary:

The worse case plate from the Ankle Trauma System was tested against the predicate device using the standard ASTM F382-99 Standard Specification and Test Methods for Metallic Bone Plates. The OrthoPro plate was found to be substantially equivalent to the predicate device. The screws from the Ankle trauma system were tested against the predicate device using the standard ASTM F543-07 Standard Specification and Test Metallic Bone Screws. The screws from the Ankle Trauma System were found to be substantially equivalent to the predicate device.

1. Clinical Test Summary:
  No clinical studies were performed.

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K122936

9. Conclusions Nonclinical and Clinical:

The OrthoPro Ankle Trauma System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function; in most cases with respect to device function performed with superiority.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

February 28, 2013

OrthoPro, LLC % Mr. Brock Johnson Vice President Operations 3450 Highland Drive Salt Lake City. Utah 84106

Re: K122936

Trade/Device Name: The OrthoPro Ankle Trauma System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: January 28, 2013 Received: February 8, 2013

Dear Mr. Johnson:

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

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Page 2 - Mr. Brock Johnson

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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin जिलिंth

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 Statement

510(K) Number (if known): K122936

Device Name: The OrthoPro Ankle Trauma system

Indications for Use:

Prescription Use_X_ (Part 21 CFR 801.109) AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Division of Orthopedic 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.