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 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 describes the iASSIST Knee System, a computer-assisted stereotaxic surgical instrument system. While it outlines the system's purpose, design, and general testing, it does not include acceptance criteria or detailed results of a study demonstrating the device meets specific performance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text.

However, I can extract the information that is present regarding the studies and ground truth:

General Information on Performance Data:

Device Performance Testing:
- Physical/Performance Tests: Conducted to ensure performance of implemented features and verify related design inputs.
- Engineering Analysis: Conducted to ensure performance of 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 its performances are acceptable under full simulated use on cadaveric specimens.
Software Verification and Validation Testing:
- Conducted to satisfy requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304.
- The software is considered a "moderate" level of concern.
- Testing demonstrates that the iASSIST Knee System does not raise any new issues of safety and effectiveness compared to predicate devices.

Specific Study Details (based on the provided text's limitations):

Table of Acceptance Criteria and Reported Device Performance: Not provided in the text.
Sample Size used for the test set and data provenance:
- Test Set Sample Size: "cadaveric specimens" were used in the Validation Lab. The exact number is not specified.
- Data Provenance: The Validation Lab study involved "full simulated use on cadaveric specimens." No country of origin is specified for the cadavers or data. It appears to be a prospective simulation study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the text.
Adjudication method for the test set: Not specified in the text.
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 specified in the text. The device is a surgical instrument system, not an imaging interpretation AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The text mentions "computer assisted stereotaxic surgical instrument system to assist the surgeon". The validation lab involved "full simulated use on cadaveric specimens," implying human interaction is part of its intended use and testing. A "standalone" performance without human input is not described.
The type of ground truth used:
- For the "Validation Lab" testing, the ground truth would likely refer to the actual anatomical alignments or target positions in the cadaveric specimens, which would then be compared against the system's measurements and guidance. However, the exact method for establishing this ground truth is not detailed (e.g., whether it relied on pre-defined anatomical markers, precise physical measurements independent of the device, or other methods).
The sample size for the training set: Not applicable and not mentioned. This device is a surgical navigation system, not a typical machine learning algorithm that requires a separate training set in the conventional sense. The software is verified and validated, but does not appear to be "trained" on a dataset in the way an AI diagnostic tool would be.
How the ground truth for the training set was established: Not applicable (see point 8).

In summary, the provided document focuses on the regulatory submission, equivalence to predicate devices, and general categories of testing performed. It lacks the specific quantitative performance metrics, acceptance criteria, and detailed study methodologies typically required to fill out the requested table for an AI/device performance study.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Orthosoft Inc. (d/b/a Zimmer CAS) Eduardo Mendoza Senior Regulatory Affairs Specialist 75 Queen St., Suite 3300 Montreal, H3C 2N6 Ca

Re: K192080

Trade/Device Name: iASSIST Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 31, 2019 Received: August 2, 2019

Dear Eduardo Mendoza:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

November 5, 2019

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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 (OS) 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 mediation-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,

For: 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192080

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)

	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 August 12, 2005.

	Manufacturer	Device Name	510(k)Number
		●Predicate Devices:
		Classification Name:· OLO- Orthopedic Stereotaxic Instrument (21 CFR882.4560)
Subject Device:		Trade Name: iASSIST® Knee SystemCommon Name: iASSIST® Knee System
Date:		July 31th, 2019
		Alternate: Paul HardyRegulatory Affairs Sr. SpecialistTelephone: 574-372-6799
Contact Person:		Primary: Eduardo MendozaRegulatory Affairs Sr. SpecialistTelephone: 514-861-4074 ext. 312
Sponsor:		Orthosoft, Inc d/b/a. Zimmer CAS75 Queen St., Suite 3300Montreal, QC, CANADA H3C 2N6Establishment Registration Number: 9617840

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

Purpose and Device Description:

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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.

Indications for Use:

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 alignment instruments and implant components relative to these axes. Example orthopedic surgical procedures include but are not limited to: 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/System Controller and software components.
The software and iASSIST V2 Tablet/System Controller 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:

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

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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:

The new iASSIST Knee System is substantially equivalent to its predicates. The subject device has the same intended use and indications for use as the predicates. Furthermore, the subject device has similar technological and performance characteristics (including accuracy) to the predicates and the operating principle and control mechanism remain the same. Finally, the information provided herein demonstrates that the proposed and implemented modifications to the predicates:

do not raise new questions of safety and effectiveness; and
the subject device is at least as safe and effective as the legally marketed predicate device.

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).