The Magna-FX Cannulated Bone Screws are indicated for fractures of: The intracapsular hip, femoral condyles, tibial condyles, ankle, acetabulum, pelvis, and other areas where accurate screw placement is required. The screw can also be applied to slipped capital femoral epiphysis if image intensification fluoroscopy is used to ascertain the proper position of the screw.

The Mini Magna-FX Cannulated Bone Screws are indicated for: Fractures of the medial malleolus, distal tibia, distal radius, calcaneus, talus, patella, and pelvis. It can also be used in the reduction of small bone fragments and reduction and fixation with cerclage wire, and the fixation of bone prominences.

Device Description

The Magna-FX Cannulated Screw Fixation System consists of a line of cannulated bone screws that are self- reaming and self-tapping and an associated washer. Magna-FX screws are designed to provide rigid fixation for various fractures.

AI/ML Overview

This document describes a 510(k) premarket notification for the Magna-FX® Cannulated Screw Fixation System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study as requested, based on the provided text:

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/algorithm-based medical device. Instead, it is a traditional FDA 510(k) clearance letter and summary for a physical medical device (bone screws).

Therefore, many of the requested categories for AI/algorithm performance studies cannot be answered from this provided text.

However, I can extract the information relevant to non-clinical performance for this physical device:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the "acceptance criteria" for a physical device like these screws are typically defined by recognized standards (e.g., ASTM) and demonstrated through testing. The "reported device performance" are the results of these tests.

Acceptance Criteria / Test Standard	Reported Device Performance (as stated in the document)
Non-Clinical Performance
Shelf Life (Accelerated aging)	10 years
Biocompatibility (ISO 10993-1, 21 CFR 58)	All testing passed
Screw Torsional Properties (ASTM F543)	Results demonstrate safety, effectiveness, and substantial equivalence to predicate devices.
Axial Pull-out Strength (ASTM F543)	Results demonstrate safety, effectiveness, and substantial equivalence to predicate devices.
Clinical Performance	Not needed for these devices to show substantial equivalence.

Regarding the other requested points, the document states the following, or the information is not applicable/provided for this type of device submission:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable or not provided. The performance testing refers to physical tests on the screws (e.g., mechanical testing, biocompatibility), not a "test set" of patient data as would be used for an AI device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to the defined parameters of the mechanical or biocompatibility tests, not expert consensus on medical images or data.
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. This is for a physical bone screw, not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" would be the established scientific and engineering principles and the predefined pass/fail criteria according to standards like ASTM and ISO.
The sample size for the training set: Not applicable. There is no concept of a "training set" for physical device testing in this context.
How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) clearance for a physical medical device (bone screws) and details non-clinical performance testing against recognized standards. It does not contain information related to AI or algorithm-based device studies, which would typically involve "acceptance criteria" and "studies" as described in your prompt for such technologies.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other. The profiles are connected by a flowing, ribbon-like shape that extends from the bottom of the first profile to the bottom of the third. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

October 3, 2014

Zimmer, Incorporated Mr. Stephen H. McKelvey, MA, RAC Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K142442

Trade/Device Name: Magna-FX® Cannulated Screw Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC. NDG Dated: August 29, 2014 Received: September 2, 2014

Dear Mr. McKelvey:

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

{1}------------------------------------------------

Page 2 - Mr. Stephen H. McKelvey, MA, RAC

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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.

Ronald###ean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

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

510(k) Number (if known) K142442

Device Name

Magna-FX Cannulated Screw Fixation System

Indications for Use (Describe)

The Magna-FX Cannulated Bone Screws are indicated for fractures of:

· The intracapsular hip, femoral condyles, ankle, acetabulum, pelvis, and other areas where accurate screw placement is required.

· The screw can also be applied to slipped capital femoral epiphysis if image intensification fluoroscopy is used to ascertain the proper position of the screw.

The Mini Magna-FX Cannulated Bone Screws are indicated for:

· Fractures of the medial malleolus, distal tibia, distal radius, calcaneus, talus, patella, and pelvis.

· It can also be used in the reduction of small bone fragments and fixation with cerclage wire, and the fixation of bone prominences.

Type of Use (Select one or both, as applicable)

2 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."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo features a blue circle with a stylized white "Z" inside. Below the circle, the word "zimmer" is written in lowercase blue letters.

510(k) Summary
----------------

Sponsor:	Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Contact Person:	Stephen H. McKelvey, MA, RAC Senior Project Manager, Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 372-4605
Date:	September 22, 2014
Trade Name:	Magna-FX® Cannulated Screw Fixation System
Common Name:	Screw, Fixation, Bone Washer, Bolt, Nut, Non-Spinal, Metallic
Classification Names and References:	Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040, HWC) Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030, NDG)
Classification Panel:	Orthopedics/87
Predicate Device(s):	Cannulated Screws and Washers, manufactured by Smith & Nephew, Inc., K111994, cleared October 11, 2011. Synthes 6.5 mm Cannulated Screw, manufactured by Synthes, K021932, cleared September 6, 2002.
Purpose and Device Description:	The Magna-FX Cannulated Screw Fixation System consists of a line of cannulated bone screws that are self- reaming and self-tapping and an associated washer. Magna-FX screws are designed to provide rigid fixation for various fractures.

{4}------------------------------------------------

Intended Use:	The Magna-FX Cannulated Bone Screws are indicated forfractures of: The intracapsular hip, femoral condyles, tibialcondyles, ankle, acetabulum, pelvis, and other areas whereaccurate screw placement is required. The screw can alsobe applied to slipped capital femoral epiphysis if imageintensification fluoroscopy is used to ascertain the properposition of the screw.
	The Mini Magna-FX Cannulated Bone Screws areindicated for: Fractures of the medial malleolus, distaltibia, distal radius, calcaneus, talus, patella, and pelvis. Itcan also be used in the reduction of small bone fragmentsand reduction and fixation with cerclage wire, and thefixation of bone prominences.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:
	• Shelf Life - Accelerated aging testing conductedshows that the sterile devices included in thissubmission have a shelf life of 10 years.
	• Biocompatibility – Biocompatibility testing of thesubject devices was conducted per ISO 10993-1 andGood Laboratory Practices (21 CFR 58). All testingpassed.
	• Performance Testing – Testing performed includedevaluation of screw torsional properties and axial pullout strength per ASTM F543. The results of non-clinical performance testing demonstrate that thedevices are safe and effective and substantiallyequivalent to the predicate devices.
	Conclusions: The non-clinical performance data presentedin this submission show that the devices are substantially

substantial equivalence.

equivalent to the predicate devices. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for these devices to show

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.