The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.

Device Description

The RECON system is a plate and screw system intended for internal fracture fixation. The system consists of the following plates:

Reconstruction Plates 3.5, ●
Medialis Plates 3.5, ●
Universal Plates 3.5
Universal Plates 3.5, H-shaped .
USG Plates 3.5 ●
Interpositioning Arthrodesis Plates ●
Lapidus Plates ●
. Dwyer Plates

screws and washers of different sizes and designs.

The plates, screws, and washers are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).

The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable.

AI/ML Overview

The provided text describes the RECON system, a plate and screw system for internal fracture fixation, and its substantial equivalence to predicate devices, as reviewed by the FDA in a 510(k) submission. However, this document does not contain acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner described in your request for a medical AI/software device evaluation.

The information provided is typical for a 510(k) submission for a physical medical device (implants), which primarily focuses on demonstrating substantial equivalence to already legally marketed predicate devices through material testing and performance comparison, rather than human-in-the-loop or standalone algorithm performance for AI/software.

Here's an breakdown of why the information you requested cannot be fully extracted and what can be said based on the provided text:

1. Table of acceptance criteria and the reported device performance

Not Applicable in the provided text. The document describes a physical medical device (implants), not an AI/software device. Therefore, there are no "acceptance criteria" related to AI performance metrics (like accuracy, sensitivity, specificity, AUC) or "reported device performance" in that context.
Instead, the "performance" demonstrated is mechanical:
- Biocompatibility: Passed all testing per ISO 10993-1.
- Mechanical Properties (Plates): Cross sectional engineering analysis, proof load, bending strength, bending stiffness, equivalent bending stiffness, and fatigue strength were "similar" to predicate devices.
- Mechanical Properties (Screws): Self-tapping performance, driving and removal torque, to failure, and axial pullout were "similar" to predicate devices.
- Washers: Substantially equivalent to previously cleared washers.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes mechanical testing of physical implants, not a clinical study or a study involving a "test set" of patient data for an AI. The "samples" would be the physical plates, screws, and washers subjected to mechanical loads. The document does not specify the number of individual components tested but states "all testing passed" for biocompatibility and that analysis resulted in "similar mechanical properties and performance" for the other tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no "ground truth" establishment by experts in the context of an AI/software evaluation for this device. The "ground truth" for mechanical testing would be the physical properties and performance measured by engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is described because there's no expert interpretation of data relevant to AI performance.

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

No, an MRMC study was not done. This is a physical implant, not an AI-powered diagnostic or assistive device.

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

Not applicable. There is no algorithm to perform a standalone performance evaluation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Mechanical testing standards and measurements. For a physical device, the "ground truth" is typically defined by established engineering and material science standards (e.g., ASTM, ISO). The results of the mechanical tests (e.g., tensile strength, fatigue life) are compared against these standards or against predicate device performance.

8. The sample size for the training set

Not applicable. No AI "training set" is relevant to this device.

9. How the ground truth for the training set was established

Not applicable. No AI "training set" or corresponding ground truth establishment is relevant to this device.

Summary of what the document does provide regarding "performance":

The study described is a non-clinical performance evaluation comparing the RECON System's mechanical properties and biocompatibility to predicate devices.

Tests Conducted:
- Biocompatibility (ISO 10993-1)
- Cross sectional engineering analysis of plates
- Proof load, bending strength, bending stiffness, equivalent bending stiffness, fatigue strength of plates
- Self-tapping performance, driving and removal torque, to failure, axial pullout of screws
Results: All tests indicated "similar mechanical properties and performance" or that the device "passed." This led to the conclusion of "substantial equivalence" to the predicate devices.
Clinical Data: No clinical testing was required as the device's indications for use are equivalent to predicate devices with a proven safety and efficacy record on the market for many years.

In conclusion, your request focuses on criteria relevant to the evaluation of AI/software as a medical device. The provided FDA 510(k) document is for a physical orthopedic implant (RECON System) and thus addresses mechanical and biocompatibility testing, not AI performance metrics.

Summary

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August 12, 2015

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

Normed Medizin-Technik GmbH Mr. Arne Briest RA/QA Manager Ulrichstrasse 7 D-78532 DE Tuttlingen Germany

Re: K151407 Trade/Device Name: RECON 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, HTN Dated: June 16, 2015 Received: June 18, 2015

Dear Mr. Arne Briest:

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

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Page 2 - Mr. Arne Briest

(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 (OS) 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/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 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.

Sincerely yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

510(k) Number (if known)

K151407

page 1 of 1

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017

See PRA Statement below.

Device Name RECON system

Indications for Use (Describe)

The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.

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.

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/2 description: The image is a logo for NORMED, a Zimmer company. The logo features the text "NORMED" in a bold, sans-serif font, with a globe graphic incorporated into the letter "O". Above the text is the tagline "The specialist for small bones". Below the text is the text "A ZIMMER COMPANY" with a stylized Z to the left.

510(k) Summary

9611091

Submission Sponsor and Correspondent 1.

Normed Medizin-Technik GmbH Ulrichstrasse 7 D-78532 Tuttlingen Germany

Phone:	+ 49 7461 93 43 0
Fax:	+ 49 7461 93 43 20
Contact:	Mr. Arne Briest

FDA Establishment Registration #:

2. Date Prepared

Date Prepared: July 22, 2015

3. Device Identification

Trade/Proprietary Name: Regulation Name:

Classification Regulation Product Code:

Device Class: Classification Panel

RECON system

Single/Multiple Component Metallic Bone Fixation Appliances and Accessories 21CFR 888.3030 HRS HWC HTN Class II Orthopedic

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Image /page/4/Picture/2 description: The image is a logo for NORMED, a Zimmer company. The logo features the word "NORMED" in a bold, stylized font, with a globe graphic incorporated into the first letter. Above the logo, the text "The specialist for small bones" is written in a smaller font. Below the logo, the text "A ZIMMER COMPANY" is written in a smaller font.

4. Legally Marketed Predicate Device

K143165 - Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw

K063303 - Universal Locking Plate System 2.7, Plates and Screws, manufactured by Zimmer Inc., cleared November 22, 2006

K060710 - Universal Locking Plate System 3.5, Plates and Screws manufactured by Zimmer Inc., cleared April 26, 2006

K022325 - Normed Titanium Osteotomy Plating System, manufactured by Normed Medizin-Technik GmbH, cleared September 9, 2009

K022231 - Normed Distal Radius Reconstruction System, manufactured by Normed Medizin-Technik GmbH, cleared September 13, 2002

K143066 - Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS Plate Line Extensions, Sterile/Non-sterile ZPS Screws and Washers manufactured by Zimmer Inc., cleared November 28, 2014

K090675 - VLP Medial Column Fusion Plate - manufactured by Smith & Nephew Inc., cleared June 4. 2009

K121651 - Ortholoc 3DI Midfoot/Flatfoot System - manufactured by Wright Medical Technology, Inc. cleared October 12, 2012

K141784 - UltOS Plating System - manufactured by Ortho Solutions Limited, cleared July 23, 2014

K111678 - Ortho Solutions - Extremity Fixation Implants for Osteosynthesis- manufactured by Ortho Solutions Limited, cleared February 7, 2012

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Image /page/5/Picture/2 description: The image shows the logo for NORMED, a Zimmer company. The logo is black and white, with the word "NORMED" in large, bold letters. Above the word "NORMED" is the text "The specialist for small bones". Below the word "NORMED" is the text "A ZIMMER COMPANY" in a smaller font.

5. Device Description

The RECON system is a plate and screw system intended for internal fracture fixation. The system consists of the following plates:

Reconstruction Plates 3.5, ●
Medialis Plates 3.5, ●
Universal Plates 3.5
Universal Plates 3.5, H-shaped .
USG Plates 3.5 ●
Interpositioning Arthrodesis Plates ●
Lapidus Plates ●
. Dwyer Plates

screws and washers of different sizes and designs.

The plates, screws, and washers are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).

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Image /page/6/Picture/2 description: The image shows the logo for NORMED, a Zimmer company. The logo is black and white and features the word "NORMED" in large, bold letters. Above the word "NORMED" is the text "The specialist for small bones". Below the word "NORMED" is the text "A ZIMMER COMPANY".

6. Indications for Use

The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.

7. Substantial Equivalence Discussion

The RECON system has the same intended use, similar performance characteristics, is manufactured from similar materials and is similar in design to the predicate devices.

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Image /page/7/Picture/2 description: The image is a logo for NORMED, a Zimmer company. The logo features the text "NORMED" in a bold, sans-serif font, with the "O" replaced by a globe graphic. Above the logo, the text "The specialist for small bones" is written in a smaller font. Below the logo, the text "A ZIMMER COMPANY" is written in a smaller font, accompanied by the Zimmer logo.

8. Non-Clinical Performance Data

-Biocompatibility - Biocompatibility testing on the plates, screws, and washer material was conducted and evaluated per ISO 10993-1. All testing passed
-Cross sectional engineering analysis of the plates, proof load, bending strength, bending stiffness, equivalent bending stiffness and fatigue strength of the RECON System -plates and the predicate devices, the Zimmer Universal Locking System (ULS) Plates and Screws (K063303 and K060710) , resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.
-Self-tapping performance, driving and removal torque, to failure and axial pullout of the RECON System -screws and the predicate devices, the Zimmer Universal Locking System (ULS) Plates and Screws (K063303 and K060710) and Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw (K143165), resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.
-The subject washers are substantially equivalent to the washers cleared in K143066

9. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device.

10. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the difference between the RECON system and the predicate devices do not raise any questions regarding its safety and effectiveness.

Performance testing and compliance with voluntary standards, demonstrate that the RECON system are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.

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Image /page/8/Picture/2 description: The image shows the logo for NORMED, a Zimmer company. The logo is black and white and features the word "NORMED" in a stylized font. Above the word "NORMED" is the text "The specialist for small bones". Below the word "NORMED" is the text "A ZIMMER COMPANY".

The RECON system is determined to be substantially equivalent to the referenced 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.