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

The present iASSIST Knee System is designed for Total Knee Arthroplasty.

Device Description

As in the predicates, the iASSIST Knee System consists of Pods (tracking sensors), 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. The computer system and software components control and sequence the functions of the Pods per the applicable knee surgery steps via wireless communication.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria or an associated study for the iASSIST Knee System that would allow me to populate all the requested fields. The document primarily describes the regulatory submission (510(k)) and its general performance testing, but lacks the detailed quantitative data, sample sizes, and expert information typically found in a study proving acceptance criteria.

However, based on the information available, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The text generally states that the device "is safe and effective and that the performances of the iASSIST Knee System are acceptable," but does not list specific quantitative criteria or performance metrics (e.g., accuracy, precision) with corresponding reported values.

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

The text mentions "full simulated use on cadaveric specimens" for the Validation Lab. It does not specify the number of cadaveric specimens used (the sample size) or their country of origin. The study appears to be prospective in nature, as it involves actual testing on specimens.

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

Not available in the provided text.

4. Adjudication Method for the Test Set

Not available in the provided text.

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

Not applicable. The iASSIST Knee System is described as a computer-assisted surgical instrument system, not an AI diagnostic or interpretive tool that would involve "human readers" or AI assistance in the sense of image interpretation for diagnosis. Its purpose is to assist the surgeon in bone surface preparation and positioning of orthopedic implants.

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

The device is inherently designed for "human-in-the-loop" performance, assisting a surgeon intra-operatively. Therefore, a standalone performance study in the absence of a surgeon would not be relevant or meaningful for this device's intended use. The validation lab involves "full simulated use on cadaveric specimens," implying the system is used as intended with human involvement.

7. The Type of Ground Truth Used

For the "Validation Lab" testing on cadaveric specimens, the ground truth would likely be established through:

Direct measurement: Using highly accurate external instruments or established anatomical reference points to measure the actual alignment axes and cutting planes achieved by the system and surgical instruments on the cadaver bones.
Expert surgical assessment: Evaluation by experienced orthopedic surgeons to determine if the achieved bone preparation and alignment match the surgical plan and accepted orthopedic standards.

The text does not explicitly state which method was used, but given the nature of the device, it would involve objective measurements against defined surgical parameters.

8. The Sample Size for the Training Set

Not applicable. The iASSIST Knee System is a stereotaxic surgical instrument system, not a machine learning model that requires a distinct "training set" in the conventional sense of AI/ML development. The software capabilities are likely developed and refined through engineering, modeling, and iterative testing, rather than being "trained" on a large dataset of patient images or outcomes.

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

Not applicable, as described in point 8. The "ground truth" for the development of such a system would involve engineering specifications, biomechanical principles, and established surgical techniques for total knee arthroplasty.

Summary

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January 14, 2022

Orthosoft d/b/a Zimmer CAS Paul Hardy Regulatory Affairs Associate Director 75 Queen Street, Suite 3300 Montreal, Quebec H3C 2N6 Canada

Re: K213033

Trade/Device Name: iASSIST Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 20, 2021 Received: September 21, 2021

Dear Paul Hardy:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213033

Device Name iASSIST® Knee System

Indications for Use (Describe)

The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system intended to assist the surgeon in preparing the bone surfaces for the positioning of orthopedic implants intra-operatively. It involves surgical instruments and inertial sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and cut guides relative to these axes.

The present iASSIST Knee System is designed for Total Knee Arthroplasty.

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with 21 CFR $807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the iASSIST® Knee System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.

Sponsor:	Orthosoft, Inc d/b/a. Zimmer CAS
	75 Queen St., Suite 3300
	Montreal, QC, CANADA H3C 2N6
	Establishment Registration Number: 9617840
Contact Person:	Paul Hardy
	Regulatory Affairs Associate Director
	Telephone: 574-453-6739
	Paul.Hardy@zimmerbiomet.com
Date:	January 5, 2022
Subject Device:	Trade Name: iASSIST® Knee System
	Common Name: iASSIST® Knee System
	Classification Name:
	• OLO- Orthopedic Stereotaxic Instrument (21 CFR

882.4560)

Primary Predicate Device:

Manufacturer	Device Name	510(k)Number
Zimmer CAS	iASSIST Knee System	K192080

Reference Devices:

Manufacturer	Device Name	510(k)Number
Zimmer CAS	iASSIST Knee System	K141601
Zimmer CAS	SmartTools Knee System	K122326

Purpose and Device Description:

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which the cutting planes are set. The computer system and software components control and sequence the functions of the Pods per the applicable knee surgery steps via wireless communication.

Indications for Use:

The present iASSIST Knee System is designed for Total Knee Arthroplasty.

Summary of Technological Characteristics:

The rationale for substantial equivalence is based on consideration of the following characteristics:

The subject and predicate devices are intended to assist the surgeon in ● providing software defined spatial boundaries for orientation
The subject and predicate devices assist in intraoperative navigation of the patient's anatomy and are utilized to facilitate implant positioning.
. The subject and predicate device consists of the same major components including Pods, Surgical Instruments, iASSIST V2 Tablet and software components.
The software and iASSIST V2 Tablet of the subject and predicate devices are intended to sequence and to control the Pods and their user interface functions via wireless communication.
The software algorithm and instrument features of the subject and ● predicate devices are intended to determine and track the alignment axes to reference the cutting planes.
The instrument features and functions of the subject and predicate devices are intended to allow assembly of the sensors, to attach the subject bones, to register or digitize the applicable landmarks, and to adjust the alignment of provided saw guides.

Summary of Performance Data (Nonclinical and/or Clinical):

The iASSIST® Knee System has been evaluated through the following nonclinical testing in support of the substantial equivalence determination:

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Device Performance Testing:

Verification and Validation Testing for iASSIST Knee System was conducted with the following aspects:

Physical/Performance Tests- to ensure the performance of the implemented features and verify related design inputs
Engineering Analysis- to ensure the performance of the implemented ● features and verify related design inputs
Usability Engineering- addressed user interactions with the iASSIST Knee System
. Validation Lab- performed to validate that using the iASSIST Knee System is safe and effective and that the performances of the iASSIST Knee System are acceptable under full simulated use on cadaveric specimens

Software Verification and Validation Testing:

Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process). The software is considered a "moderate" level of concern, a malfunction in the device could lead to a minor injury. The testing demonstrates that the iASSIST Knee System does not raise any new issues of safety and effectiveness as compared to the predicate devices.

Substantial Equivalence Conclusion:

In summary, the subject and predicate devices have similar indications for use, the same intended use, the same principle of operation as well as similar technological characteristics. Furthermore, the information provided herein demonstrates that:

Any differences do not raise new questions of safety and effectiveness;
Verification and Validation activities demonstrate that the subject device ● is at least as safe and effective as the legally marketed predicate devices.

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).