The MAGELLAN™ Intramedullary Femoral Nail System is indicated for use in long bone shaft fractures of the femur which require stabilization of the axis of the bone, including subtrochanteric fractures, intertrochanteric fractures, femoral neck fractures, comminuted fractures, segmental fractures, fractures with bone loss, proximal and distal fractures, nonunions and malunions, and bone lengthening.

Device Description

The MAGELLAN™ Intramedullary Femoral Nail System is a modular system consisting of femoral nails, femoral rod inserts, nail caps, locking screws, and instrumentation for fixation. The system is made of 316 LVM stainless steel conforming to ASTM F 138. The nail is available in six outer diameters and eight lengths. The nail may be crosslocked dynamically or statically, locked antegrade, and also has reconstruction capabilities. This MAGELLAN™ Magnetic distal targeting instrumentation system is designed to locate and lock in place the distal screw holes of the Magellan Intramedullary Femoral Nail without the use of radiographic equipment. The system includes reamers for preparing the intramedullary canal for nail placement; a targeting compass and magnetic target insert that locate the distal screw holes, and targeting Steinmann pins and drill bits (two sizes) that create the proximal and distal screw holes. This instrument system is used with power equipment available from other manufacturers, and is certified by the supplier to work with the power source.

AI/ML Overview

The provided text describes the "MAGELLAN™ Intramedullary Nail System" and its intended use, but it does not detail specific acceptance criteria or a study that formally proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, it focuses on demonstrating substantial equivalence to predicate devices through mechanical testing.

Here's an analysis based on the information provided:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies an acceptance criterion of "appropriate strength for clinical usage" and performing "similarly to the Russell-Taylor System." These are qualitative rather than quantitative metrics.
- Reported Device Performance: "Testing and theoretical data show that the MAGELLAN™ nail device has appropriate strength for clinical usage, and will perform similarly to the Russell-Taylor System."

Acceptance Criteria	Reported Device Performance
Appropriate strength for clinical usage	Achieved: "appropriate strength for clinical usage"
Performance similar to Russell-Taylor System	Achieved: "perform similarly to the Russell-Taylor System"

Sample size used for the test set and the data provenance
- The document mentions "Testing and theoretical data" but does not specify a sample size for a test set. It refers to generic mechanical testing rather than a clinical study evaluating diagnostic or treatment outcomes over a patient population.
- Data provenance: Not specified, but given the nature of mechanical testing for strength, it would typically be laboratory-based rather than from specific countries or retrospective/prospective patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The "ground truth" here would relate to mechanical properties, which are typically established by engineering standards and measurements, not expert medical opinion in a clinical context.
Adjudication method for the test set
- Not applicable/Not provided. Since no clinical study or expert review for a "test set" in the context of diagnostic performance is described, adjudication methods like 2+1 or 3+1 are irrelevant to the information presented.
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. The document describes a medical device (intramedullary nail system) and an instrument system for targeting. It does not involve AI or human readers, and therefore no MRMC study or effect size related to AI assistance is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical implant and an associated instrument system, not an algorithm.
The type of ground truth used
- The "ground truth" for the performance evaluation described appears to be mechanical strength standards and comparative performance against a predicate device (Russell-Taylor System). This implies engineering benchmarks and material property measurements.
The sample size for the training set
- Not applicable/Not provided. The concept of a "training set" is relevant to machine learning algorithms. This document describes a physical medical device, not an AI model.
How the ground truth for the training set was established
- Not applicable/Not provided. As there's no mention of a training set, the establishment of its ground truth is not discussed.

In summary, the provided text is a 510(k) summary for a medical device (intramedullary nail system), which focuses on demonstrating substantial equivalence to existing predicate devices primarily through mechanical testing and theoretical data regarding strength. It does not contain the kind of detailed information about acceptance criteria or performance studies typically associated with diagnostic or AI-driven medical devices regarding sensitivity, specificity, or clinical outcomes from patient data.

Summary

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Image /page/0/Picture/0 description: The image shows a stylized letter "W" formed by two triangles. The triangles are positioned side by side, with the left triangle slightly overlapping the right one. A thin, diagonal line runs from the top left to the bottom right, creating the impression of a continuous "W" shape. A small registered trademark symbol is located at the bottom right of the image.

Image /page/0/Picture/1 description: The image shows the text "WRIGHT MEDICAL TECHNOLOGY, INC." in a bold, serif font. The words "WRIGHT" are in a larger font size than the rest of the text. Below the text is the address "5677 AIRLINE ROAD" and "ARLINGTON, TN 38002". The text is black and the background is white.

Contact Person: Date:

Cristie Manuel March 26, 1997

510(k) Summary

Trade/Proprietary Name: Common Name: Classification: Predicate Device:

MAGELLAN™ Intramedullary Nail System Intramedullary Fixation Rod and Accessories Class II MAGELLAN™ Femoral Nail manufactured by Wright Medical Technology, Inc. and the Russell-Taylor Femoral

JUN - 5 1997

Nail System manufactured by Smith and Nephew

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Description/Indicated Use

This MAGELLAN™ Magnetic distal targeting instrumentation system is designed to locate and lock in place the distal screw holes of the Magellan Intramedullary Femoral Nail without the use of radiographic equipment. The system includes reamers for preparing the intramedullary canal for nail placement; a targeting compass and magnetic target insert that locate the distal screw holes, and targeting Steinmann pins and drill bits (two sizes) that create the proximal and distal screw holes. This instrument system is used with power equipment available from other manufacturers, and is certified by the supplier to work with the power source.

Testing

Testing and theoretical data show that the MAGELLAN™ nail device has appropriate strength for clinical usage, and will perform similarly to the Russell-Taylor System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The overall design is simple and recognizable, representing the department's role in promoting the health and well-being of the nation.

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

JUN - 5 1997

Ms. Cristie Manuel Requlatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re : K971135 MAGELLAN™ Intramedullary Femral Nail System Regulatory Class: II Product Code: HSB Dated: March 26, 1997 Received: March 27, 1997

Dear Ms. Manuel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Cristie Manuel

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene orige or compliand, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
to celia
. Celia M. Witten, Ph.D., M.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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C. Indications for use of the Device

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MAGELLAN™ Intramedullary Femoral Nail System

Indications for Use:

(Please do not write below this line-continue on another page if needed)

彩米水 Concurrence of CDRH, Office of Device Evaluation (ODE)

b colla

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use_

(Optional Format 1-2-96)

000009

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.