The OsteoMed ExtremiLOCK Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device.

The OsteoMed ExtremiLOCK Foot Plating System implants are intended for single use only.

Device Description

The 14 MTP Primary and Transfix plates are designed as part of the OsteoMed ExtremiLOCK Foot Plating System. The system consists of plates of various shapes and sizes featuring compression, locking, elongated or compression elongated holes, angulated locking, non-locking and cannulated screws, implantable K-Wires, washers, and appropriate instrumentation. Modifications to plates of the subject system include increasing the thickness of the plates, material changes, and addition of features.

The implants of the OsteoMed ExtremiLOCK Foot Plating System are made from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136). Surgical instrumentation is provided to facilitate modification. insertion. and removal of implants. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.

AI/ML Overview

The provided text describes a Special 510(k) Summary for the OsteoMed 1st MTP Primary and Transfix plates, which are part of the OsteoMed ExtremiLOCK Foot Plating System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of AI/software performance.

Therefore, many of the requested sections (2-9) regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies are not applicable or cannot be extracted from this type of regulatory submission. This document is for a physical medical device (bone fixation plates) and not an AI/software device.

However, I can extract the acceptance criteria and the reported device performance as much as possible from the provided text, while noting the limitations.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Strength for Intended Use: Design features must meet required mechanical strength criteria.	The 1st MTP Primary and Transfix plates underwent "verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use." Performance equivalence was shown through "verification comparison to the predicate devices."
Biocompatibility: Materials must be biocompatible.	ExtremiLOCK implants are manufactured from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136), which are "the same materials used in the manufacture of the predicate devices. These materials are biocompatible."
Substantial Equivalence: Similarities in intended use, material, function, performance, design, technology, operational principles, and sterilization to the predicate device (OsteoMed ExtremiLOCK Foot Plating System, K131445).	A "design, dimensional, and performance comparison was performed to establish substantial equivalence" to the predicate. The "basis of substantial equivalence for this device is based on similarities in intended use, material, function, performance, design, technology and operational principles to the OsteoMed ExtremiLOCK Foot Plating System (K131445)." Specifically for the 1st MTP plates, the basis is "similarities in design, technology, material, function, sterilization, and intended use." "Non-clinical evaluation demonstrate that the device is as safe and effective as the predicate devices."

Explanation of the Study and its Context (based on the provided text):

The "study" described here is a premarket notification (510(k)) submission to the FDA for a physical medical device. The primary goal of this submission is to demonstrate substantial equivalence to an already legally marketed predicate device (OsteoMed ExtremiLOCK Foot Plating System, K131445) rather than to prove performance against specific clinical efficacy endpoints in a new clinical study.

The "study" involved:

Verification Evaluation: This refers to in-house testing (likely mechanical and material testing) to ensure the modified plates (1st MTP Primary and Transfix plates) meet required mechanical strength criteria and material specifications.
Comparison to Predicate Device: A detailed comparison of design, dimensions, materials, function, performance, technology, and operational principles between the new plates and the predicate.

Missing Information (Due to the nature of the document being a 510(k) for a physical device, not an AI/software study):

For the following points, the information is either not relevant to this type of submission or not provided in the document:

Sample size used for the test set and the data provenance: Not applicable in the context of an AI/software test set. The "test set" here would refer to the physical samples of the plates that underwent mechanical and material testing, but specific sample sizes are not detailed in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical properties is established through engineering standards and testing, not expert consensus in the way an AI model's output would be.
Adjudication method (e.g., 2+1, 3+1, none) 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 not an AI-assisted device for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device and not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" for its performance would be established through engineering specifications, material standards (e.g., ASTM F-67, ASTM F-136), and mechanical testing results against predetermined pass/fail criteria.
The sample size for the training set: Not applicable, as this is not a machine learning/AI device.
How the ground truth for the training set was established: Not applicable, as this is not a machine learning/AI device.

In summary, the document describes a regulatory filing for a physical medical device, focusing on demonstrating equivalence to an existing product through engineering and material comparisons rather than a clinical study or AI performance evaluation.

Summary

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Special 510(k) Summary

Name of Submitter: OsteoMed

	3885 Arapaho RoadAddison, Texas 75001Phone: (972) 677-4600Fax: (972) 677-4601
Contact Person:	Blesson Abraham	DEC 0 2 2013
Date Prepared:	November 5, 2013.
Device Proprietary Name:	1st MTP Plate
Device Common Name:	Foot Plate
Classification Name:	21 CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessories
Product Code:	HRS
Predicate Devices:

OsteoMed ExtremiLOCK Foot Plating System, K131445

Classification Name: Single/multiple component metallic bone fixation appliances and accessories (21CFR 888.3030, Product Code HRS)

Device Class: II

Summary:

Device Description:

Intended Use:

The OsteoMed Extremil.OCK Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device.

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The OsteoMed ExtremiLOCK Foot Plating System implants are intended for single use only.

Technological Characteristics:

The OsteoMed ExtremiLOCK Foot Plating System is recommended for fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle or other bones appropriate for the size of the device.

ExtremiLOCK implants are manufactured from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136), the same materials used in the manufacture of the predicate devices. These materials are biocompatible.

Performance/Clinical Data:

The 1ª MTP Primary and Transfix plates were compared to the OsteoMed ExtremiLOCK Foot Plating System, K131445, plates. The implants underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use. The intended use of the OsteoMed ExtremiLOCK implants remains the same with the addition of the 1st MTP Primary and Transfix plates.

Performance equivalence was shown through the verification comparison to the predicate devices.

Clinical Testing is not required to support substantial equivalence.

Substantial Equivalence:

A design, dimensional, and performance comparison was performed to establish substantial equivalence to the legally marketed predicate devices listed in this summary. The basis of substantial equivalence for this device is based on similarities in intended use, material, function, performance, design, technology and operational principles to the OsteoMed ExtremiLOCK Foot Plating System (K131445).

The basis of substantial equivalence of the 18 MTP Primary and Transfix plates to the OsteoMed ExtremiLOCK Foot Plating System, K131445. is based on the similarities in design, technology, material, function, sterilization, and intended use. OsteoMed believes that the non-clinical evaluation demonstrate that the device is as safe. and effective as the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gible Silver Spring, MI) 20993-0002

December 2, 2013

OsteoMed Ms. Blesson Abraham Regulatory Affairs Specialist 3885 Arapaho Road Addison, Texas 7500 !

Re: K133437

Trade/Device Name: OstcoMed ExtremiLOCK Foot Plating 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 Dated: November 5, 2013 Received: November 7, 2013

Dear Ms. Abraham

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Ms. Blesson Abraham

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 Small Manufacturers. International and Consumer Assistance at its tollfree 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/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.

Sincercly vours.

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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Indications for Use

510(k) Number (if known): K133437

Device Name: OsteoMed ExtremiLOCK Foot Plating System

Indications for Use:

The OsteoMed ExtremiLOCK Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device.

The OsteoMed ExtremiLOCK Foot Plating System implants are intended for single use only.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

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.