· skeletal osteosynthesis of small bone fragments, which were damaged due to trauma or require reconstruction or arthrodesis
· primary or revision tibio-talar and tibiotalo-calcaneal fusion especially in the presence of osteopenic bone, hindfoot deformity and bone loss
· post-traumatic surgery.

Device Description

The Normed ANKLE FIX and ANKLE FIX + Systems 4.0 are titanium plate and screw systems intended for internal fracture fixation of the ankle. The pre-contoured plates are anatomically designed for optimal screw positioning. This trauma system offers lateral plates for fusion of the tibiotalar (ANKLE FIX) and tibiotalo-calcaneal (ANGLE FIX +) bones as well as medial, posterior (hindfoot), posterior tibia and anterior plates as needed for the ankle for stability.

AI/ML Overview

Here is an analysis of the provided text regarding the acceptance criteria and study for the Normed® ANKLE FIX and ANKLE FIX + Systems 4.0:

The provided text describes a medical device, the Normed® ANKLE FIX and ANKLE FIX + Systems 4.0, which are titanium plate and screw systems for internal fracture fixation of the ankle. The document, a 510(k) Premarket Notification summary, focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical (mechanical) testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Based on Standards)	Reported Device Performance
Plates:
Static and dynamic 4-point bending tests as per ASTM F382-99	Meets performance requirements as defined by Design Control activities; similar to predicate devices in safety and efficacy.
Screws:
Torsional properties as per ASTM F543-07	Meets performance requirements as defined by Design Control activities; similar to predicate devices in safety and efficacy.
Driving torque as per ASTM F543-07	Meets performance requirements as defined by Design Control activities; similar to predicate devices in safety and efficacy.
Axial pull-out strength as per ASTM F543-07	Meets performance requirements as defined by Design Control activities; similar to predicate devices in safety and efficacy.

Explanation: The "acceptance criteria" here are the performance requirements set by the specified ASTM standards for orthopedic implants. The "reported device performance" is a general statement that the device "meets performance requirements as defined by Design Control activities" and is "substantially equivalent to the predicate devices in terms of safety and efficacy." Specific numerical performance values are not provided in this summary.

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

Sample Size for Test Set: The document does not specify the exact number of plates or screws tested for each mechanical test. It mentions "worst case" testing for both plates and screws, implying a selection of configurations that would represent the most challenging scenarios.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): The data provenance is from non-clinical (mechanical) testing performed by the manufacturer, Normed® Medizin-Technik GmbH, which is located in Tuttlingen, Germany. This is a prospective test design for device performance, not related to patient data.

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

Not Applicable. This is a non-clinical (mechanical) testing study of medical devices (plates and screws), not a study involving human subjects or interpretation of medical images. Therefore, clinical "ground truth" established by experts is not relevant to this specific type of study. The ground truth for mechanical testing is established by the specifications of the ASTM standards themselves and the objective measurements obtained.

4. Adjudication Method for the Test Set

Not Applicable. As this is mechanical testing, there is no need for human adjudication of results in the way it would be for a clinical study involving subjective interpretation (e.g., radiological reads). The results are objective measurements against defined standards.

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

Not Applicable. This is a 510(k) premarket notification for a physical medical implant (bone plates and screws). It is a mechanical performance study, not an AI or imaging diagnostic device, and therefore, no MRMC study or AI assistance evaluation was conducted.

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

Not Applicable. This is not an algorithm or AI-based device.

7. The Type of Ground Truth Used

For the non-clinical (mechanical) testing, the "ground truth" is defined by the specifications and methodology of internationally recognized ASTM standards (ASTM F382-99 for plates and ASTM F543-07 for screws). The measurements obtained from the physical testing are then compared directly to the requirements outlined in these standards.

8. The Sample Size for the Training Set

Not Applicable. This is not a study that involves machine learning or AI models with training sets.

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

Not Applicable. There is no training set for this type of device and study.

Summary

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510(k) Summary Pursuant to 21 CFR 807.92

General Company Information

Company Name:	Normed® Medizin-Technik GmbH
Company Address:	Ulrichstrasse 7D-78532Tuttlingen, Germany
Company Telephone:	+ (011) 49 7461 93 43 0+ (011) 49 7461 93 43 20
Contact:	David Furr, MSFDC Services, LLCUS Agent	AUG 0 2 2013
Contact Address:	8708 Capehart CoveAustin, Texas 78733(512) 906-9654
Date:	August 2, 2013
Device Trade Name:	Normed® ANKLE FIX and ANKLE FIX +Systems 4.0
Common Name:	bone plates and bone screws
Classification Nameand Reference:	HRS- 888.3030, single/multiple componentmetallic bone fixation appliances andaccessoriesHWC-888.3040, Smooth or threaded,metallic bone fixation fastener
Predicate Device:	Normed Titanium Calcaneus Plating withLocking Screw System - K022324, cleared9/17/02

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510(k) Premarket Notification Normed ANKLE FIX System and Normed ANKLE FIX Plus System 4.0 VLP Foot Talus and Percutaneous Calcaneus Bone Plates, VLP Bone Screws: Peri-Loc Ankle Fusion Bone Plates and Instruments - K110670, cleared 7/12/11 Ascension Ankle Fusion Plate System -K100176, cleared 6/16/10 Device Description: The Normed ANKLE FIX and ANKLE FIX + Systems 4.0 are titanium plate and screw systems intended for internal fracture fixation of the ankle. The pre-contoured plates are anatomically designed for optimal screw positioning. This trauma system offers lateral plates for fusion of the tibiotalar (ANKLE FIX) and tibiotalo-calcaneal (ANGLE FIX +) bones as well as medial, posterior (hindfoot), posterior tibia and anterior plates as needed for the ankle for stability. Intended Use: The ANKLE FIX and ANKLE FIX + System 4.0 are intended to support normal bone healing for osteotomies, fractures and reconstruction. The systems are indicated for: skeletal osteosynthesis of small bone . fragments, which were damaged due to trauma or require reconstruction or arthrodesis primary or revision tibio-talar and . tibiotalo-calcaneal fusion especially in the presence of osteopenic bone. hindfoot deformity and bone loss post-traumatic surgery.

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510(k) Premarket Notification Normed ANKLE FIX System and Normed ANKLE FIX Plus System 4.0

Testing and Technological
Characteristics:	The technological characteristics of thisankle system are similar to its predicates byhaving the similar intended use, material,lengths, thickness and overall design.The implants are provided sterile and non-sterile. They are for single use orthopaedicsurgical application. The instruments arenon-sterile and reusable.
	Non-clinical testing demonstrated for theNormed ANKLE FIX and ANKLE FIX +Systems 4.0 meets performancerequirements as defined by DesignControl activities and are substantially

Device	Testing	Standard
Plates	Static and dynamic 4 point bending tests were performed on the worst case	ASTM 382-99
Screws	Torsional properties, driving torque, and axial pull-out strength tests were performed on the worst case	ASTM F543-07

equivalent to the predicate devices in terms

of safety and efficacy.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

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

Normed® Medizin-Technik GmbH % FDC Services, LLC Mr. David C. Furr Principle Consultant, US Agent 8708 Capehart Cove Austin, Texas 78733

August 2, 2013

Re: K123347

Trade/Device Name: Normed® ANKLE FIX and ANKLE FIX PLUS Systems 4.0 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: June 18, 2013 Received: July 3, 2013

Dear Mr. Furr:

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

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Page 2 - Mr. David C. Furr

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 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 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/Resourcesfor You/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/McdicalDevices/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 vours.

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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510(k) Premarket Notification Normed ANKLE FIX System 4.0 and Normed ANKLE FIX Plus System 4.0

Indications for Use Statement

K123347 510(k) Number:

Device Name: ANKLE FIX and ANKLE FIX Plus Systems 4.0

Indications For Use:

く

ANKLE FIX and ANKLE FIX + Systems 4.0 are indicated for:

· skeletal osteosynthesis of small bone fragments, which were damaged due to trauma or require reconstruction or arthrodesis
· primary or revision tibio-talar and tibiotalo-calcaneal fusion especially in the presence of osteopenic bone, hindfoot deformity and bone loss
· post-traumatic surgery.

Prescription Use	X
(per CFR 801.109)
or
Over-the-counter use

Concurrence of CDRH

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.