The Naviswiss Hip Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system is only compatible with acetabular cup impactors that have a parallel and straight segment. The system aids the surgeon in performing intra-operative measurements of leg length, offset, and cup inclination/anteversion.

An example of a stereotaxic orthopedic surgical procedure includes Total Hip Arthroplasty: Lateral/Supine.

The equipment is intended for use by trained surgeons in operating theaters.

Device Description

The Naviswiss Hip Navigation System is an image-free surgical navigation system intended to assist the orthopedic surgeon during the implantation of an artificial joint (hip). The device consists of a handheld navigation device, used to register the patient's anatomy into a software platform. Subsequently the navigation system helps the surgeon maneuver the surgical instruments with precision. Thus, the surgeon can position the implant in accordance to pre-operative planning.

The Naviswiss Hip Navigation System is comprised of two major sub-systems: the Naviswiss Hip (M42) and Naviswiss Platform (M59).

The Naviswiss Hip (M42) is composed of:

. NAVItags used for reference and registration
. Ancillary instruments
. Application Software

The Naviswiss Platform (M59) is composed of:

. Computer
Camera ●
. Software

The M42 employs the base computing, power supply, and programing in the M59 Platform. The NAVItags allow the surgeon to determine anatomical landmarks or navigate an instrument.

The camera utilizes application and tracking software to guide the surgeon through a workflow process for the surgery. The camera is covered by a sterile, single use drape for use of the navigation device in a sterile environment.

AI/ML Overview

The provided text does not contain a specific table detailing acceptance criteria and reported device performance. It states broadly that "All performance tests were passed successfully" for both the subject and predicate devices.

However, based on the Summary of Testing section and the Indications for Use, we can infer some details related to accuracy and successful operation for the Naviswiss Hip Navigation System.

Here's an attempt to structure the information you requested based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Aspect	Reported Device Performance	Comments
Accuracy (General)	All requirements were met.	Verified according to ASTM F2554-18, simulating normal conditions, worst-case use, and realistic tracking disturbances.
Benchtop Accuracy	All requirements were met.	Verified using calibrated test fixtures.
Simulated Use (Anatomical Phantom) - User Needs, Intended Use, Clinical Accuracy	Satisfies user needs, intended use, and clinical accuracy requirements.	Assessed by comparing measurements with known values. Performed by orthopedic surgeons in THA procedures following a typical workflow.
Software Functional Requirements	All requirements and specifications were met.	Software verification and validation testing ensured functional requirements, algorithms, and measurement calculations were met.
Pre-operative Planning (Leg Length, Offset, Cup Inclination/Anteversion)	Aids the surgeon in performing intra-operative measurements.	Implied by Indications for Use and the system's function to provide real-time, intraoperative data on these parameters.

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

System Accuracy (ASTM F2554-18): Not explicitly stated, but the testing simulated "normal conditions, and a variety of worst-case use scenarios and realistic tracking disturbances."
Benchtop Accuracy: Not explicitly stated, but verified using "calibrated test fixtures."
Anatomical Phantom Simulated Use: Not explicitly stated how many phantom tests were conducted, but it was stated that the test was performed on a "metallic bone simulator." The data provenance is a "simulated use" scenario.
Cadaver Simulated Use: "multiple cadaver wet labs" were used. The data provenance is human cadaver specimens.
OUS Prospective Clinical Study: The study was designed to evaluate 35 patients undergoing elective THA surgery. The data provenance is prospective, clinical study data from Australia.

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

Anatomical Phantom Simulated Use: Tests were performed by "orthopedic surgeons." The number of surgeons is not specified, nor are their specific qualifications (e.g., years of experience). Ground truth for this test was "known values" from the metallic bone simulator.
Cadaver Simulated Use: Tests were performed by "trained surgeons." The number of surgeons and their specific qualifications are not specified. Ground truth for this test is implied to be the intended clinical use and performance on human specimens.
OUS Prospective Clinical Study: The primary outcome involved agreement between intraoperative data from the Naviswiss system and post-operative CT measurements. This suggests the ground truth was based on objective imaging data (CT scans), not expert consensus from the study. The surgeons were involved in using the device but not specifically for establishing ground truth post-operatively. The number of experts interpreting the CT scans is not mentioned.

4. Adjudication method for the test set

The document does not describe a formal adjudication method (like 2+1 or 3+1 expert review) for any of the performance tests. For the clinical study, the primary outcome involved comparing system measurements to post-operative CT measurements, which is an objective measurement rather than a consensus-based adjudication.

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 MRMC comparative effectiveness study, as typically understood in the context of reader performance with and without AI assistance, was not explicitly described in the provided text. The OUS Prospective Clinical Study focuses on system accuracy against CT measurements, not on comparing human reader performance with and without the system's assistance. The device assists the surgeon, but there's no study detailed on the improved performance of surgeons due to the assistance quantified as an effect size.

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

The Naviswiss Hip Navigation System is described as a "computer-controlled system intended to assist the surgeon." Its indications for use clearly state it "aids the surgeon." Therefore, it is inherently designed for human-in-the-loop performance. While "System Accuracy" and "Benchtop Accuracy" tests evaluate the algorithm and hardware, they are still within the context of a system that provides guidance to a human surgeon. A purely standalone (algorithm-only) performance evaluation independent of surgeon interaction is not described.

7. The type of ground truth used

System Accuracy (ASTM F2554-18) & Benchtop Accuracy: Verified against objective, known values provided by calibrated test fixtures and simulated conditions.
Anatomical Phantom Simulated Use: Compared measurements obtained with the system against known values of the phantom.
OUS Prospective Clinical Study: Ground truth for component positioning was established by post-operative CT measurements.

8. The sample size for the training set

The document does not explicitly mention a training set or its sample size. The tests described are primarily verification and validation studies to demonstrate the device's accuracy and performance. If there was a machine learning component for which a training set was used, it is not detailed in this summary.

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

Since a training set and its sample size are not mentioned, the method for establishing its ground truth is also not provided in this document.

Summary

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June 10, 2020

Naviswiss AG % Viky Verna Co-Founder & VP (US Office) confinis 15807 Glacier Ct Potomac, Maryland 20878

Re: K193094

Trade/Device Name: Naviswiss Hip Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 5, 2020 Received: June 8, 2020

Dear Viky Verna:

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193094

Device Name Naviswiss Hip Navigation System

Indications for Use (Describe)

An example of a stereotaxic orthopedic surgical procedure includes Total Hip Arthroplasty: Lateral/Supine.

The equipment is intended for use by trained surgeons in operating theaters.

Type of Use (Select one or both, as applicable)
Remediation Use (Part 31, GER 901 Subpart D)
On-Site Corrective Use (31 GER 903)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary

In accordance with 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

Applicant: Naviswiss AG

Submitter name: Jan Stifter Responsible person: Jan Stifter Phone: +41 61 761 85 37 E-mail: jan.stifter@naviswiss.eu

Official Correspondent:

Contact person:	Viky Verna, MS BME, MS Pharm, RAC
Phone:	786-525-9811
Email:	Viky.verna@confinis.com
Date prepared:	4 November 2019

Device Name: Naviswiss Hip Navigation System

Proprietary name:	Naviswiss Hip Navigation System
510(k) number:	To be assigned
Common name:	Orthopedic Stereotaxic Instrument
Classification name:	Orthopedic Stereotaxic Instrument
Product code:	OLO

Predicate Device:

Substantial Equivalence is claimed with the device, K162364 "intellijoint HIP Generation 2A System", manufactured by Intellijoint Surgical Inc. on the basis of equivalent intended use / indications for use, technological characteristics and principle of operation.

Device Description:

The Naviswiss Hip Navigation System is comprised of two major sub-systems: the Naviswiss Hip (M42) and Naviswiss Platform (M59).

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The Naviswiss Hip (M42) is composed of:

. NAVItags used for reference and registration
. Ancillary instruments
. Application Software

The Naviswiss Platform (M59) is composed of:

. Computer
Camera ●
. Software

The M42 employs the base computing, power supply, and programing in the M59 Platform. The NAVItags allow the surgeon to determine anatomical landmarks or navigate an instrument.

Indications for Use:

The Naviswiss Hip Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system is only compatible with acetabular cup impactors that have a parallel and straight segment. The system aids the surgeon in performing intra-operative measurements including measurements of leg length, offset, and cup inclination/anteversion.

An example of a stereotaxic orthopedic surgical procedure includes Total Hip Arthroplasty: Lateral/Supine.

The equipment is intended for use by trained surgeons in operating theaters.

Comparison of Technological Characteristics:

The substantial equivalence of the Naviswiss Hip Navigation System to the predicate is shown by similarity in intended use, indications for use and performance.

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Characteristic	Subject Device	Predicate Device
Device Name	Naviswiss Hip Navigation System	intellijoint HIP Generation 2A System
510(k) #	to be assigned	K162364
Intended use	The Naviswiss Hip Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system is only compatible with acetabular cup impactors that have a parallel and straight segment. The system aids the surgeon in performing intra-operative measurements including measurements of leg length, offset, and cup inclination/anteversion.An example of a stereotaxic orthopedic surgical procedure includes Total Hip Arthroplasty: Lateral/Supine.The equipment is intended for use by trained surgeons in operating theaters.	The intellijoint HIP Generation 2A System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified. The system is only compatible with straight acetabular cup impactors. The intellijoint HIP Generation 2A System is indicated for patients undergoing orthopaedic surgery, and where the use of stereotactic surgery is considered safe and effective. The system aids the surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning.Example orthopedic surgical procedures include, but are not limited to: Total Hip ArthroplastyMinimally Invasive Hip Arthroplasty
Technology /Scientific principle	Image-free surgical navigation system using infrared stereo cameraIdentical to predicateIdentical to predicate	Uses infrared optical technology and integrated microelectronicsintellijoint HIP® posterior and anterior applications provide real-time, intraoperative measurements to assist orthopaedic surgeons in accurate implant positioning for cup position, leg length, offset and hip center of rotation.Measure changes in leg length, offset and hip center, as well as native acetabular position and cup position (anteversion and inclination)
Device Descrip-tion	Naviswiss Hip Navigation System isan image-free surgical navigationsystem, consists of a handheld navi-gation device and a computer mod-ule	3D mini-optical navigation system,surgeon controlled surgical guidancetool
Cleaning andSterilizationShelf-Life	The reprocessing of reusable instru-ments consists of preparation, pre-cleaning, and automated cleaningfollowed by sterilization. It was veri-fied that tags are correct after the in-itial shelf life validation. The naviga-tion unit is draped and used in thesterile area.	The work station is situated outsideof the sterile field, in view of the sur-geon, while the camera and otherequipment remain within the sterilefield.
Operating Prin-ciple	The M42 employs the base compu-ting, power supply, and programingin the M59 Platform. The NAVItagsattach various objects (e.g. the fe-mur, surgical instruments, etc.) foreither determining anatomical land-marks or navigating an instrument.The camera utilizes software toguide the surgeon through a work-flow process for the surgery.	System generates positional meas-urements between a camera(mounted on the iliaccrest) and atracker than can be mounted on vari-ous objects (e.g. the femur, the ace-tabular cup impactor, etc.) duringsurgery to measure their positions.The camera detects the trackerwithin its field of view and communi-cates with a workstation, which exe-cutes the application software toguide the device workflow and dis-play measurements to the surgeon.
Performance	All performance tests were passedsuccessfully	All performance tests were passedsuccessfully

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The technological principle for both the subject and predicate devices is to provide intra-operative measurements during orthopedic surgery. It is based on the use of infrared optical technology to provide real-time, intraoperative data on leg length, offset, and cup position.

The subject and selected predicate devices are based on similar technological elements. The system generates positional measurements between a camera and a tracker that can be mounted on different objects. The camera uses the application software and the tracking software to guide the surgeon through a workflow process for the surgery.

Summary of Testing:

The following tests were performed to demonstrate the substantial equivalence of the Naviswiss Navigation Hip System to the intellijoint HIP Generation 2A System.

Biocompatibility Testing

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The biocompatibility evaluation for the Naviswiss Hip Navigation System was conducted in accordance with ISO 10993-1.

Reprocessing Validation

A reprocessing validation was conducted for the reusable instruments.

EMC Testing

Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted on the Naviswiss Hip Navigation System. The system complies with the IEC 60601-1, standard for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted to ensure functional requirements were met and the system performs as intended. Algorithms and measurement calculations were also verified in these tests. All requirements and specifications were met.

System Accuracy

The Naviswiss Hip Navigation System's accuracy was verified according to the methodology in ASTM F2554-18 - Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. Testing simulated normal conditions, and a variety of worst-case use scenarios and realistic tracking disturbances. All requirements were met.

Benchtop Accuracy

The Naviswiss Hip Navigation System's accuracy was verified using calibrated test fixtures. All requirements were met.

Anatomical Phantom Simulated Use and Clinical Accuracy

Simulated use testing was performed on a metallic bone simulator by orthopedic surgeons in THA procedures following a typical workflow. The test validated that the Naviswiss Hip Navigation System satisfies user needs, intended use, and clinical accuracy requirements. This was assessed by comparing the measurements obtained in the simulated use with known values.

Cadaver Simulated Use

Simulated use testing was performed in multiple cadaver wet labs to validate the Naviswiss Hip Navigation System satisfies clinical use requirements and performed as intended on human specimans when used in an OR environment by trained surgeons.

OUS Prospective Clinical Study

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Naviswiss is conducting a prospective clinical study in Australia. The study was designed to evaluate 35 patients undergoing elective THA surgery. The primary outcome is the agreement between intraoperative component positioning data captured by the Naviswiss Hip Navigation System compared with post-operative CT measurements.

Conclusion:

Based on equivalence of intended use / indications for use, technological characteristics and operational principle the applicant concludes, that substantial equivalence between the new and the predicate device has been demonstrated and that the new device, Naviswiss Hip Navigation System, is substantially equivalent to the legally marketed predicate device, intellijoint HIP Generation 2A System (K162364).

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).