The iMNS Medacta Navigation System is intended to be used to support the surgeon during specific orthopedic surgical procedures by providing information on bone resections, instrument and implant positioning during joint replacement.

The iMNS Medacta Navigation System provides computer assistance to the surgeon based on anatomical landmarks and other specific data obtained intra-operatively that are used to place surgical instruments.

Examples of some surgical procedures include but are not limited to: Total Knee Replacement Minimally Invasive Total Knee Replacement

Device Description

The iMNS Medacta Navigation System is a device for computer aided navigation of surgical instruments used in total knee replacement surgery. The system works on the common principle of stereotaxic technology in which passive markers are securely mounted on the patient's bones and an infrared camera is used to monitor the spatial location of those markers. This information is used to locate the anatomical landmarks such as centers of rotation of the femur head, knee and ankle intraoperatively. These measurements are displayed on a computer screen in real time. The instruments are then outfitted with the passive markers to improve the positioning of the cutting guides. The information from the system with the "navigated" instruments assists the surgeon in conducting the bone resections and positioning of the orthopedic surgical implants. The surgeon maintains control of the surgery and makes any decisions required with regard to bone resections and implant positioning but the iMNS Medacta Navigation System provides real time support and information throughout the surgery.

The iMNS Medacta Navigation System consists of the following kev components:

· An acquisition system composed of two infrared cameras equipped . with infrared light emitting diodes (LED) to track the position of the passive markers.
. A computer running the proprietary Medacta software and a monitor,
. Interface devices of a keyboard, foot pedal and optional mouse to control the system, and
Manual reusable surgical instruments. .

The software application called GMK v4.2.2 is designed to work with Medacta's GMK Total Knee System, cleared under K090988. The manual reusable surgical instruments include instruments specifically designed for navigated surgery and other standard surgical instruments needed to conduct total knee replacement.

AI/ML Overview

The Medacta iMNS Navigation System (GMK v4.2.2) is a computer-aided navigation system for total knee replacement surgery. The device was tested through a series of "design verification and validation" protocols with predefined acceptance criteria. These tests were conducted as part of the Special 510(k) submission (K100314) to demonstrate substantial equivalence to its predicate device (iMNS Medacta Navigation System v4.0, K083872).

Here's a breakdown of the requested information based on the provided text:

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

The document states that "The iMNS Medacta Navigation System was tested as part of design verification and validation to written protocols with pre-defined acceptance criteria. The testing met all acceptance criteria." However, specific numerical acceptance criteria (e.g., accuracy thresholds) and their corresponding reported device performance values are not detailed in the provided text. The tables list the Protocol IDs, Report IDs, and Titles of the verification and validation activities.

Protocol ID	Report ID	Title	Acceptance Criteria (Not Detailed)	Reported Device Performance (Not Detailed)
IL 07.09.026	EG08 and Annex 1	GUI Verification	Met	Met
	EG13 and Annex 1	GUI Verification	Met	Met
IL 07.09.028	EG09	Validation of resections planning and cutting blocks positioning	Met	Met
	EG11	Validation of resections planning and cutting blocks positioning	Met	Met
IL 07.09.029	EG12	Single Point/ Multi Point/ Directional Acquisition's Validation	Met	Met
IL 07.09.048	EG10	Functionality of the Navigation Software in Deep Stress Cases	Met	Met
IL07.09.026	GMK00	GUI Verification	Met	Met
IL07.09.027	GMK06	Mechanical axis and saggital plane reconstruction	Met	Met
IL07.09.028	GMK02	Resection planning & cutting block positioning	Met	Met
IL07.09.029	GMK03	Single point/multipoint directional acquisition	Met	Met
IL07.09.030	GMK05	Single point acquisition	Met	Met
IL07.09.031	GMK01	Geometry of knee implants & ancillaries	Met	Met
IL07.09.092	GMK04	Validation of HW & SW compatibility & relative stability	Met	Met

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

The document primarily describes internal design verification and validation activities. It mentions "Design validation was conducted on the iMNS Medacta Navigation System in a simulated user setting by a surgeon". It does not specify a sample size for a test set (e.g., number of patients or cases), nor does it provide information on data provenance (country of origin, retrospective/prospective). The testing appears to be conducted in a simulated environment rather than on patient data.

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)

The design validation was conducted "by a surgeon". The specific number of surgeons, their qualifications, or how they established "ground truth" (e.g., in a simulated environment for measurement accuracy) is not detailed beyond the mention of "a surgeon."

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

The document does not describe any adjudication method for the test set results. The validation was conducted by "a surgeon," implying a single expert evaluation for the simulated user setting.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is a surgical navigation system, not an AI diagnostic tool for human readers. It assists the surgeon directly in instrument positioning.

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

The document implies that "standalone" testing (algorithm only performance) was inherently part of the design verification and validation activities, particularly for functionalities related to "res resection planning," "single point acquisition," and "mechanical axis and sagittal plane reconstruction." These would evaluate the accuracy and functionality of the software's calculations and measurements independent of the surgeon's real-time input, though the text does not explicitly use the term "standalone performance." The "simulated user setting" test with a surgeon would combine both algorithm and human-in-the-loop.

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

Given the nature of the device (surgical navigation), the "ground truth" for the verification and validation activities likely involved predefined geometric or anatomical targets and measurements within the simulated environment. For example, for "resection planning," the system's output for bone cuts would be compared against the ideal planned cuts. For "mechanical axis and sagittal plane reconstruction," the system's computed axes would be compared against known or calculated true axes. The document does not explicitly state the type of ground truth in terms such as "expert consensus," "pathology," or "outcomes data."

8. The sample size for the training set

The document does not mention a training set or its sample size. This type of 510(k) submission generally focuses on design verification and validation of a defined software version, not on the developmental process involving a training set for machine learning. The system's core principle is "stereotaxic technology," implying pre-programmed algorithms rather than machine learning models requiring training data.

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

Since a training set is not mentioned, there is no information on how its ground truth would have been established.

Summary

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

Image /page/0/Picture/0 description: The image shows the text "K100314" at the top, followed by the word "Medacta" in a stylized font. Below "Medacta" is the word "International" on the left and a plus sign on the right. The text and symbols appear to be part of a logo.

MAR 8 1 2010

Special 510(k) Summary

Manufacturer:

MEDACTA International SA Strada Regina CH6874 Castel San Pietro Switzerland Phone (+41) 91 696 60 60 FAX (+41) 91 696 60 66

Contact Person:

Heather Neelv Director RA/QA 4725 Calle Quetzal, Suite B Camarillo, CA 93012 USA Phone: 805-886-1069 Fax: 877-550-4749 e-mail: HNeely@medacta.us.com

Date Prepared:

January 29, 2010

DEVICE INFORMATION

Trade/Proprietary Name: iMNS Medacta Navigation System Common/Classification Name:

21 CFR 882.4560 Class II Device Product Code: HAW

K083872 iMNS Medacta Navigation System Predicate Device:

Product Description:

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

regard to bone resections and implant positioning but the iMNS Medacta Navigation System provides real time support and information throughout the surgery.

The iMNS Medacta Navigation System consists of the following kev components:

· An acquisition system composed of two infrared cameras equipped . with infrared light emitting diodes (LED) to track the position of the passive markers.
. A computer running the proprietary Medacta software and a monitor,
. Interface devices of a keyboard, foot pedal and optional mouse to control the system, and
Manual reusable surgical instruments. .

Indications for Use:

Examples of some surgical procedures include but are not limited to:

Total Knee Replacement

Minimally Invasive Total Knee Replacement

Performance Testing

No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the iMNS Medacta Navigation System was conducted in accordance with design controls, international standards and FDA guidance documents.

Comparison to Predicate Device

The indications for use of the modified system remain the same as the original 510(k) K083872.

The iMNS Medacta Navigation System v4.2.2 is identical to the predicate device, iMNS Medacta Navigation System v4.0 in the following aspects: Intended Use/Indications for Use, design features, operating principle, type of optical tracking system, graphical user interface, control switch, passive locators, navigated surgery process, sterility, and biocompatibility aspects.

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

The main difference between the iMNS Medacta Navigation System v4.2.2 and the predicate device is the software application. Previously there was only one software application, Evolis Global Femur First version 4.0 (K083872) and the second software application is GMK version 4.2.2 which is the subject of this 510(k).

The manual reusable surgical instruments have changed to those required by the non-navigated GMK Total Knee System. Additionally, there are separate micrometric positioners that are specific to GMK included with the instruments for use with navigated knee surgery and the iMNS Medacta Navigation System. These manual surgical instruments are made of the same type of materials as those in the original submission and handled the same as other reusable manual orthopedic instruments for non-navigated surgery.

The iMNS Medacta Navigation System was tested as part of design verification and validation to written protocols with pre-defined acceptance criteria. The testing met all acceptance criteria. This new software version has been completely verified and validated like an initial software release. The verification and validation activities are summarized in the below.

Summary of Design Controls for Software Changes v 4.1.0 and v 4.2.1
Protocol ID	Report ID	Title
IL 07.09.026	EG08 and Annex 1	GUI Verification
	EG13 and Annex 1
IL 07.09.028	EG09	Validation of resections planning and
	EG11	cutting blocks positioning
IL 07.09.029	EG12	Single Point/ Multi Point/ Directional
		Acquisition's Validation
IL 07.09.048	EG10	Functionality of the Navigation Software in
		Deep Stress Cases

Summary of Design Controls for Software Changes v 4.2.2
Protocol ID	Report ID	Title
IL07.09.026	GMK00	GUI Verification
IL07.09.027	GMK06	Mechanical axis and saggital planereconstruction
IL07.09.028	GMK02	Resection planning & cutting blockpositioning
IL07.09.029	GMK03	Single point/multipoint directionalacquisition
IL07.09.030	GMK05	Single point acquisition
IL07.09.031	GMK01	Geometry of knee implants & ancillaries
IL07.09.092	GMK04	Validation of HW &SW compatibility &relative stability

Design validation was conducted on the iMNS Medacta Navigation System in a simulated user setting by a surgeon and demonstrated that the system meets user needs and intended uses.

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

There were no changes to the hardware and trolley with this device modification, there were no significant changes to the hardware system risk analysis or validation/verification.

Conclusion:

The data and information provided in this submission support the conclusion that the iMNS Medacta Navigation System (GMK v4.2.2) is substantially equivalent to its predicate device, iMNS Medacta Navigation System (Evolis v4.0) with respect to indications for use, operating principle, and technological characteristics.

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

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around the perimeter. In the center of the seal is a stylized depiction of a bird, which is the symbol of the HHS. The bird is shown with its wings spread, suggesting protection and care.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAR 3 1 2010

Medacta International SA % Medacta USA Ms. Heather Neely Director, RA/QA 4725 Calle Quetzal, Suite B Camarillo, California 93012

Re: K100314

Trade/Device Name: iMNS Medacta Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: March 18, 2010 Received: March 22, 2010

Dear Ms. Neely:

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

{5}------------------------------------------------

Page 2 - Ms. Heather Neely

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Sincerely yours,
Mark N Wilkerson

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

Enclosure

{6}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):

Device Name: iMNS Medacta Navigation System

Klock314 Indications for Use:

Examples of some surgical procedures include but are not limited to: Total Knee Replacement

Minimally Invasive Total Knee Replacement

Over-The-Counter Use Prescription Use _ × AND/OR (Over-The-Counter Use __
AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Ogle for mxm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K1000314

Page

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).