The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and position sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignments and implant components relative to these axes.

Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty.

Device Description

As in the predicate, the iASSIST Knee System consists of tracking sensors ('pods'), a computer system, software, and surgical instruments designed to assist the surgeon in the placement of Total Knee Replacement components. The pods combined with the surgical instruments provide positional information to help orient and locate the main femoral and tibial cutting planes as required in knee replacement surgery. This includes means for the surgeon to determine and thereafter track each of the bones' alignment axes relative to which the cutting planes are set.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for the iASSIST™ Knee System. It details the device, its intended use, and comparisons to a predicate device. However, it does not explicitly provide a table of acceptance criteria with reported device performance statistics in the way that would typically be seen for AI/ML device performance.

Instead, the document states that "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device." The performance data section describes the types of tests conducted, rather than specific quantitative acceptance criteria and results against those criteria.

Therefore, I cannot fulfill all parts of your request with the provided information. I will, however, extract all available information about the study and acceptance criteria as described.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, a detailed table with specific quantitative acceptance criteria and corresponding reported device performance (e.g., accuracy, sensitivity, specificity, or specific error margins with numerical results) is not provided in this document. The document focuses on demonstrating that modifications to an existing device (predicate) did not introduce new safety or efficacy issues and that the device still meets its intended functionality.

The closest to "acceptance criteria" are implied by the types of tests described, indicating that the system must maintain its required functionality, robust performance, and compatibility.

Acceptance Criteria (Implied)	Reported Device Performance (Summary from text)
Required functionalities maintained or correctly updated without hazardous anomalies	Software system tests performed to ensure functionalities were maintained/updated correctly.
Performance of bone registration related functionalities verified	Performance tests performed under simulated bench test conditions and analyses.
Robustness and compatibility of added/modified instruments verified	Bench test and analyses performed.
Resistance of pods to electro-static discharges verified	Bench test and analyses performed.
Sufficiency of pod's battery expected lifetime verified	Bench test and analyses performed.
Overall system performance, usage, surgical flow, and instrument ergonomics validated	Full use simulations tests using sawbones performed.
Electrical safety certification (IEC 60601-1:2005) met	Electrical certification tests related to the update performed.

2. Sample Size Used for the Test Set and Data Provenance

The document describes "Non-clinical tests" and "simulated bench test conditions," and "Full use simulations tests using sawbones." This indicates the tests were conducted in a controlled, non-human, and likely retrospective or simulated environment, rather than on patient data.

Sample Size: Not explicitly mentioned.
Data Provenance: Simulated bench tests and sawbone simulations. This is not patient data; therefore, "country of origin" is not applicable in the typical sense. It implies lab or manufacturing environment testing.
Retrospective/Prospective: Not applicable, as it's not patient-level data. The tests would have been performed prospectively during the development and modification phases.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. Since the tests were primarily engineering and functional verification on simulated or bench setups (e.g., software, hardware, mechanical components, sawbones), "ground truth" would likely be established by engineering specifications, calibration standards, and comparison to the predicate device's known performance, rather than clinical expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as "adjudication" typically refers to resolving discrepancies between human readers or ground truth experts for clinical data. The tests described are engineering validations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned. The document primarily focuses on verifying that device modifications do not introduce new safety or efficacy concerns compared to its own predicate, rather than comparing its performance against humans or quantifying human improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is described as a "computer assisted stereotaxic surgical instrument system to assist the surgeon." This inherently implies a "human-in-the-loop" system. While the software and hardware components were tested individually ("Software system tests," "Performance tests were performed...to verify the implementation of the performance of the bone registration related functionalities"), these tests were to ensure the components functioned correctly for the purpose of assisting a surgeon. A standalone performance without a human interaction is not the intended use and therefore not explicitly evaluated in isolation as a primary performance metric in the way an AI diagnostic tool might be.

7. The Type of Ground Truth Used

For the engineering tests:

Software tests: Likely against defined software requirements and specifications.
Performance tests (bone registration): Likely against known, calibrated physical measurements or established mathematical models for bone alignment.
Robustness/Compatibility/Battery life/ESD: Against engineering specifications, industry standards, and predicate device performance.
Sawbone simulations: Likely against established surgical techniques and expected outcomes for total knee arthroplasty, possibly with objective measurements of alignment.

8. The Sample Size for the Training Set

This device is not described as an AI/ML device that undergoes "training" in the typical sense of a deep learning model. It's a computer-assisted surgical instrument system using predefined algorithms and sensors. Therefore, a "training set" as understood in machine learning is not applicable here. The software development would involve traditional software engineering and testing cycles.

9. How the Ground Truth for the Training Set Was Established

As explained above, there isn't a "training set" in the AI/ML context for this device. The algorithms are likely based on biomechanical principles, geometry, and surgical protocols, with "ground truth" derived from engineering specifications and clinical understanding of proper implant positioning.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

September 11, 2014

ZIMMER CAS Mr. Christopher Mclean Quality and regulatory Affairs Associate Director 75 QUEEN STREET, SUITE 3300 MONTREAL, Canada H3C 2N6

Re: K141601

Trade/Device Name: iASSIST™ Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: August 11, 2014 Received: August 12, 2014

Dear Mr. Mclean:

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}------------------------------------------------

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" (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 vours.

Mark N. Melkerson -S

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

Enclosure

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

Indications for Use

K141601

Device Name iASSIST Knee System

Indications for Use (Describe)

Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty.

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}------------------------------------------------

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS iASSIST™ KNEE SYSTEM

Applicant: Zimmer CAS 75 Queen Street, suite 3300 Montreal, Quebec Canada, H3C 2N6 Tel.: 514 861 4074 Fax: 514 866 2197

Contact Person: Christopher McLean

Date Summary Prepared: June 12, 2014

Device Trade Name: iASSIST™ Knee System

Device Classification Name: Orthopedic Stereotaxic Instrument (product code OLO): 21 CFR & 882.4560

Predicate Device:

i ASSIST Knee System, from Zimmer CAS, 510(k) # K122326, cleared Nov. 30th, 2012

Device Description:

Indications for Use / Intended Use:

This is unchanged from the predicate:

Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty.

Technological Comparisons to the Predicates:

The fundamental scientific technology of the predicate is unchanged including the operating principle and control mechanism.

The changes involved altering the system to allow for an alternate surgical flow requiring only 2 pods as compared to the predicate 4 pod method. This involved the introduction of a new 2 pod kit along with software adjustments to allow for the altered step sequence.

In addition, general system improvements and updates have been implemented in the predicate. These involved secondary engineering changes and improvements. They did not involve

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

changes to the intended and indication for use and did not raise any new issues of safety and effectiveness. These included the following:

-Update of the pod electrical certification to latest IEC 60601-1:2005 electrical safety standard
Removal of no longer used or redundant pod and instrument graphical symbols and mechanical interfaces
The modification or addition instruments and methods to facilitate use and improve the compatibility with implant systems
Improvements to the system software components to improve system usability, to increase the robustness of bone registration and wireless communication algorithms, to further increase the resistance to electro-static discharges, and to further ensure the pod's battery lifetime to accommodate the system changes.

Performance Data:

Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. The main tests included the following:

1. Software system tests were performed to ensure that the required functionalities were maintained or correctly updated per the changes without the introduction of hazardous anomalies. They included the hardware and user interfaces, the communication protocols. the use of pods and instruments as applicable, the response to temperature effects, and the verification of fault conditions.
1. Performance tests were performed under simulated bench test conditions and analyses to verify the implementation of the performance of the bone registration related functionalities.
1. Bench test and analyses were performed to verify the robustness and compatibility of the added or modified instruments, to verify the resistance of the pods to electro-static discharges, and to verify the sufficiency the pod's battery expected lifetime as in the predicate.
1. Full use simulations tests using sawbones were performed to verify and validate the overall system performance in terms of the system usage, surgical flow, and instrument ergonomics.
1. Electrical certification test related to the certification update.

Conclusion:

The information and data provided in this 510(k) Premarket Notification established that the modified iASSIST Knee System is substantially equivalent to its predicate version.

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).