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 marker and and 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 optimally 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 key 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 Evolis Global Femur First is designed to work with Medacta's Evolis Total Knee System, cleared under K081023. 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 provided text describes performance testing for the iMNS Medacta Navigation System. However, it does not contain specific acceptance criteria, reported device performance metrics, or details about the study design that would allow for a comprehensive answer to all parts of your request.

Here's what can be extracted and what information is missing:

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

Acceptance Criteria	Reported Device Performance
Not specified	"The testing met all acceptance criteria."

Missing Information: Specific quantitative or qualitative acceptance criteria were not provided in the document. Therefore, actual reported performance metrics cannot be listed. The document only states that "all acceptance criteria" were met.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The document refers to "simulated user setting" and "a surgeon," but no details on the number of cases or the nature of the data (retrospective/prospective, country of origin) are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: "a surgeon" – implies at least one, but the exact number isn't quantified.
Qualifications of Experts: Only "surgeon" is mentioned. Further specific qualifications (e.g., years of experience, subspecialty) are not provided.

4. Adjudication method for the test set:

Adjudication Method: Not specified. With only "a surgeon" mentioned, it's unlikely a formal adjudication method like 2+1 or 3+1 was necessary or described for a single user evaluation.

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:

MRMC Study: No. This device is a navigation system for surgery, not an AI diagnostic tool involving human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

Standalone Performance: The description emphasizes that the system "assists the surgeon" and "the surgeon maintains control." It provides "real-time support and information throughout the surgery." This strongly indicates that it is a human-in-the-loop system, and a standalone algorithm-only performance assessment would not be relevant or described as such.

7. The type of ground truth used:

Type of Ground Truth: The context suggests that the ground truth for "design validation" was based on whether "the system meets user needs and intended uses" in a "simulated user setting." For a surgical navigation system, this would typically involve assessing the accuracy of anatomical landmarks, cutting guides, and implant positioning relative to surgical plans or anatomical references, often determined by the evaluating surgeon's assessment of surgical outcomes in the simulated environment. No pathology or outcomes data from actual patients are mentioned for this validation.

8. The sample size for the training set:

Training Set Sample Size: Not specified. The document describes "design verification" and "design validation" but does not detail a separate "training set" for a machine learning model, as this is a computer-aided navigation system based on stereotaxic technology, not a deep learning AI model that requires extensive training data in the typical sense.

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

Training Set Ground Truth Establishment: Not applicable/not specified, as the system does not appear to be a machine learning model that learns from a "training set" with established ground truth in the conventional sense. The system's functionality is based on established stereotaxic principles and proprietary software logic.

In summary, the provided document describes a computer-aided surgical navigation system and its regulatory clearance process. While it states that performance testing was conducted and all acceptance criteria were met, it lacks the detailed quantitative and qualitative results, study design specifics, sample sizes, and expert qualifications often found for AI/ML-based diagnostic devices. This is likely because the device is a navigation system based on established principles, rather than a machine learning algorithm requiring extensive data-driven validation for diagnostic accuracy.

Summary

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K083872

Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two triangles pointing upwards, followed by the word "Medacta" in a sans-serif font. Below the word "Medacta" is the word "International" in a smaller font, followed by a small square with a plus sign inside.

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
JAN 1 5 2009
Contact Person: Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: (858) 705-0350 Fax: (858) 764-9739 email: NKennel@njkconsulting.com
Date Prepared: Dec. 11. 2008

DEVICE INFORMATION

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

21 CFR 882.4560 Class II Device Product Code: HAW

K061362 PiGalileo™ Total Knee Replacement (TKR) Predicate Device: System

Product Description:

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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 optimally 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 key 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.

The iMNS Medacta Navigation System was tested as part of design verification to written protocols with pre-defined acceptance criteria. The

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testing met all acceptance criteria. 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.

Comparison to Predicate Device

The iMNS Medacta Navigation System is similar to or identical to the predicate device, the PiGalileo™ Total Knee Replacement System 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.

The main differences between the iMNS Medacta Navigation System and the predicate device are the type of computer, the lack of a motorized cutting guide, and the model of the optical tracking system. None of these differences raise any new issues of safety or effectiveness.

Conclusion:

The data and information provided in this submission support the conclusion that the iMNS Medacta Navigation System is substantially equivalent to its predicate device, Plus Orthopedics PiGalileo™ Total Knee Replacement System with respect to indications for use, operating principle, and technological characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an abstract eagle or bird-like figure with three curved lines forming its body and wings. To the left of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medacta International. SA % Underwriters Laboratories, Inc. Ms. Casey Conry 1285 Walt Whitman Road Melville, New York 11747

JAN 1 5 2009

Re: K083872

Trade/Device Name: iMNS Medacta Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO, HAW Dated: December 19, 2008 Received: December 29, 2008

Dear Ms. Conry:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Casey Conry

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Mulkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use Statement

510(k) Number (if known): K083872

Device Name: iMNS Medacta Navigation System

Indications for Use:

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

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).