The OIC Variable Angle Small Fragment Locking Plate System is indicated for the fixation of fractures, mal-unions, nonunions or osteolomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.

Device Description

The OIC Variable Ande Small Fragment Locking Plate System consists of titanium plates for the Distal Radius. Clavice. Proximal Humerus, Tibia and Distal Fibula, bone screws and instruments for implantation. The platety of sizes and are pre-contoured to match the anatomy of the patient and 3.5mm bone screws. The bone screws are available in two diameters (2.5mm) and range in length from 6mm to 130mm. The bone screws are available with both threaded (locking) and non-threaded (non-locking) heads.

The OIC Variable Angle Small Fragment Locking Plate System implants are made of titanium alloy or cp titanium in compliance with ASTM F136 or ASTM F67.

AI/ML Overview

The provided text describes a medical device submission (K140357) for the OIC Variable Angle Small Fragment Locking Plate System. However, it does not contain information regarding traditional acceptance criteria or a study proving the device meets said criteria in the context of clinical performance or diagnostic accuracy.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through engineering and material testing, rather than clinical trials with patient outcomes or AI-driven performance studies.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Here's an attempt to answer based on the available information, with clear indications where the information is not present:

Acceptance Criteria and Device Performance Study for K140357: OIC Variable Angle Small Fragment Locking Plate System

The provided 510(k) summary for the OIC Variable Angle Small Fragment Locking Plate System does not detail specific acceptance criteria or clinical performance studies related to diagnostic accuracy or human-in-the-loop improvements for an AI device. Instead, the document focuses on demonstrating substantial equivalence through mechanical testing and material compliance.

The "acceptance criteria" can be inferred from the standards the device conforms to and the evaluation methods used to demonstrate substantial equivalence, which are primarily related to mechanical properties and materials.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from standards/methods)	Reported Device Performance
Material Compliance	Conformance to ASTM F136 or ASTM F67	Implants made of titanium alloy or cp titanium in compliance with ASTM F136 or ASTM F67.
Bone Screw Standards	Conformance to ASTM F543-07	Device conforms to ASTM F543-07.
Metallic Bone Plate Standards	Conformance to ASTM F382	Device conforms to ASTM F382.
Mechanical Characteristics	Acceptable mechanical characteristics for intended uses, similar to predicate devices.	The screws, plates, locking interfaces, and behavior were evaluated using Finite Element Stress/Strain Analyses (FEA). They were "found to have acceptable mechanical characteristics for the intended uses." Each component and construct showed "similar mechanical performance compared to similar devices used for the same indications as identified via a literature review."
Sterilization	Provided non-sterile, suitable for steam sterilization.	The device is provided non-sterile and is steam-sterilized by the medical facility prior to implantation.
Substantial Equivalence	No significant differences from predicate devices affecting safety and effectiveness.	"The new device is substantially equivalent to the predicate devices in regards to intended use, materials, and function. There are no significant differences... Any minor differences have no effect on safety and effectiveness."

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

Sample Size: Not applicable/not provided. The evaluation was primarily based on engineering analyses (FEA) and literature review, not a test set of data in the context of AI or clinical outcomes.
Data Provenance: Not applicable/not provided. The document refers to "literature review" for comparative mechanical performance, but does not specify the origin of this literature.

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

Not applicable. The ground truth for mechanical performance was established via engineering analyses and comparisons to published standards and literature, not expert consensus on a test set of cases.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI-assisted interpretation, which is not the nature of this orthopedic implant submission.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a physical orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

The 'ground truth' for this 510(k) submission relates to engineering standards, material specifications, and documented mechanical performance characteristics established through finite element analysis and literature review. It is not clinical pathology, outcomes data, or expert consensus on patient cases.

8. The Sample Size for the Training Set

Not applicable. This device is an orthopedic implant, not an AI algorithm requiring a training set. The "training" for its design and evaluation would come from established engineering principles, material science, and the design of predicate devices.

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

Not applicable, as there is no "training set" in the context of this orthopedic implant. The benchmarks for performance (comparable mechanical properties, material compliance, etc.) were established through recognized ASTM standards, the performance of predicate devices, and engineering analyses (FEA).

Summary

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K140357 - page 1 of 2

510(k) Summarv

Prepared 06/03/2014

Name and Address of Manufacturer

The Orthopaedic Implant Company (OIC) 316 California Ave #701 Reno, NV 89509

Contact

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

Device Identification

Trade Name: OIC Variable Angle Small Fragment Locking Plate System Common Name: Plate, fixation, bone Screw, fixation, bone Classification Name: Single/Multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Classification: Class II, 21 CFR 888.3030, 888.3040 Panel: Orthopedic Product Code: HRS, HWC

Indications for Use

The OIC Variable Ande Small Fragment Locking Plate System is indicated for the fixation of fractures, mal-unions, nonunions or osteolomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.

Device Description

The OIC Variable Angle Small Fragment Locking Plate System implants are made of titanium alloy or cp titanium in compliance with ASTM F136 or ASTM F67.

The devices conform to the following standards:

ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws ASTM F382, Standard Specification and Test Method for Metallic Bone Plates
The OIC Variable Angle Small Fragment Locking Plate System is provided non-sterile and is steam-sterilized by the medical facility prior to implantation.

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Substantial Equivalence

. 1

Predicate devices: K001170 Synthes 2.7mm LC-DCP, 3.5mm Profile (Limited Contact - Dynamic Compression Plate) K033669 Smith & Nephew Locking Bone Plate System K050646 Synthes (USA) 3.5 / 4.5mm LCP Medial Proximal Tibia Plates K051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity K061352 Peri-Loc Periaticular Locked Plating System - Locking Bone Plates & Screws for the Upper Extremity K071184 Synthes Variable Angle - Locking Compression Plate (VA-LCP) Distal Radius System K071563 Peri-Loc Periarticular Locked Plating System - VLP Locking Bone Plates & Screws K071715 Acumed Congruent Bone Plate System K080522 Synthes 3.5mm LCP Distal Tibia T Plates K083032 PERI-LOC Bone Plating and Screw System K123832 OlC Distal Radius Plating System, OlC Proximal Humerus Plating System, OlC Clavicle Plating System

The new device is substantially equivalent to the predicate devices in regards to intended use, materials, and function. There are no significant differences between the OIC Variable Angle Small Fragment Locking Plate System and the predicate devices listed above. Any minor differences have no effect on safety and effectiveness.

The screws, the plates, the locking interfaces and the behavior of the OIC Variable Angle Small Fragment Locking Plate System were evaluated using finite element stress/strain analyses (FEA). The screws, the plates and the plate-screw constructs were found to have acceptable mechanical characteristics for the intended uses. Similarly, each screw design, plate design and each locked screw-plate sub-construct was found to have similar mechanical performance compared to similar devices used for the same indications as identified via a literature review.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 9, 2014

The Orthopaedic Implant Company Mr. Douglas Fulton Quality Assurance Manager 316 California Avenue, Suite 701 Reno, Nevada 89509

Re: K140357

Trade/Device Name: OIC Variable Angle Small Fragment Locking Plate 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: May 19, 2014 Received: May 21, 2014

Dear Mr. 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 enclosurc) 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 1 ou may, anteres 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 or any . 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

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Page 2 - Mr. Douglas Fulton

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 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/ResourcesforYou/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins

for 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140357

Device Name

OIC Variable Angle Small Fragment Locking Plate System

Indications for Use (Describe)

The OIC Variable Angle Small Fragment Locking Plate System is indicated for the fixation of fractures, non-unions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metalarsal.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

THE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FO Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Elizabeth 詞腳ank -S

Division of Orthopedic Devices

FORM FDA 3881 (1/14)

Page 1 of ]

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.