The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated.

Example orthopedic surgical procedures include but are not limited to:

Total Knee Arthroplasty
· Unicompartmental Knee Arthroplasty: Tibial Transverse Resection
· Hip Arthroplasty

Device Description

The ARVIS® Surgical Navigation System (ARVIS® System) is to be used by orthopedic surgeons and operating room staff who perform hip and knee arthroplasty.

The ARVIS® System uses cameras to measure locations and angles between trackers mounted on the patient and trackers mounted on surgical instruments. By prompting the user through a procedurespecific workflow to register the reference tracker to anatomic landmarks, the ARVIS® Application Software calculates and displays positions of the instruments relative to the patient's anatomy.

The Eyepiece Assembly contains stereo infrared (IR) tracking cameras, a color camera, a stereo display, IR illumination, and IR laser illuminator. The Eyepiece also includes a headlight. The Eyepiece communicates with the Belt Pack via a cable connection.

The Belt Pack houses the computer module, the battery, and the power management board. The Belt Pack supplies power to the eyepiece and computer module. The computer module runs the ARVIS® Application Software.

All system instructions, prompts, alerts, and outputs are displayed to the surgeon on the Eyepiece display. The ARVIS® System Eyepiece is worn on the surgeon's head via a surgical helmet. The ARVIS® Belt Pack is worn on the surgeon's belt or waistband. No electronic hardware is applied to the patient. The surgeon stands adjacent to the patient to operate. The ARVIS® Battery Charger is intended to be used outside the operating room.

The ARVIS® System comprises the major elements listed in Table 1.

Item	Description	Purpose
1	Eyepiece Assembly	Houses display, speakers, cameras, and other sensors.
2	Belt Pack	System power management. Houses the External Batteryand Computer module.
3	Computer Module	Runs the ARVIS® Application Software.
4	External Battery	Removable/swappable. Provides power to the EyepieceAssembly and the Computer module.
5	Eyepiece Cable	Connects Eyepiece to the Belt Pack.
---	----------------------------	-----------------------------------------------------------------------------------------------------------------
6	Battery ChargingSystem	Charges External Battery when system is not in use.Intended to be used outside the operating room.
9	Instrument Set	Surgical tools, including trackers, mounts, adapters, etc.that are required to perform surgical procedures.

AI/ML Overview

The ARVIS® Surgical Navigation System has the following acceptance criteria and study data:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Cleaning process Validation: The ARVIS® Instruments can be adequately cleaned using the specified procedure provided in the Instructions for Use.	Cleaning process Validation: The ARVIS® Instruments can be adequately cleaned using the specified procedure provided in the Instructions for Use.
Sterilization Validation:	Sterilization Validation:
a. The ARVIS® Surgical Instruments are compatible with the necessary FDA-cleared reprocessing equipment.	a. The ARVIS® Surgical Instruments are compatible with the necessary FDA-cleared reprocessing equipment.
b. The reprocessing instructions are technically feasible for implementation by users.	b. The reprocessing instructions are technically feasible for implementation by users.
c. The sterilization process has been validated to attain a sterility assurance level (SAL) of 10-6.	c. The sterilization process has been validated to attain a sterility assurance level (SAL) of 10-6.
Software Verification and Validation Testing:	Software Verification and Validation Testing:
1) All requirements and specifications in the ARVIS® Software Requirements Specification were implemented and operate correctly.	1) All requirements and specifications in the ARVIS® Software Requirements Specification were implemented and operate correctly.
2) All Risk Mitigations to be implemented in software were implemented and operated correctly.	2) All Risk Mitigations to be implemented in software were implemented and operated correctly.
3) The software conforms with the user needs and intended uses of the ARVIS® device.	3) The software conforms with the user needs and intended uses of the ARVIS® device.
Electromagnetic Compatibility (EMC) testing: The ARVIS® System is compliant with applicable Standards for Electromagnetic Compatibility.	Electromagnetic Compatibility (EMC) testing: The ARVIS® System is compliant with applicable Standards for Electromagnetic Compatibility.
Electrical Safety testing: The ARVIS® System is compliant with applicable Standards for Electrical Safety.	Electrical Safety testing: The ARVIS® System is compliant with applicable Standards for Electrical Safety.
Safety and Performance Bench Testing: The ARVIS® System meets its performance specifications and is substantially equivalent to the predicate device performance.	Safety and Performance Bench Testing: The ARVIS® System meets its performance specifications and is substantially equivalent to the predicate device performance.
Simulated Clinical Validation Testing: The particular requirements for the specified intended use can be consistently fulfilled by the ARVIS® System, including validation of user requirements and navigation accuracy.	Simulated Clinical Validation Testing: The particular requirements for the specified intended use can be consistently fulfilled by the ARVIS® System, including validation of user requirements and navigation accuracy.

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

The document indicates that "Simulated Clinical Validation Testing" was conducted in a "human cadaveric setting." However, it does not specify the sample size (number of cadavers or simulated cases) used for this test set, nor does it provide details on the country of origin or whether the cadaveric data was retrospective or prospective.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the simulated clinical validation testing.

4. Adjudication method for the test set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.

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

The document does not mention an MRMC comparative effectiveness study or any effect size related to human reader improvement with AI assistance. The testing focused on device performance and accuracy in a simulated clinical setting.

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

The "Simulated Clinical Validation Testing" involved validating "user requirements and navigation accuracy," suggesting human interaction with the system. While the "Safety and Performance Bench Testing" also assessed the system's performance specifications, it's not explicitly stated if a standalone, algorithm-only performance evaluation without any human-in-the-loop was performed. The device is a "Surgical Navigation System" which inherently implies human-in-the-loop operation.

7. The type of ground truth used

For the "Simulated Clinical Validation Testing," the ground truth was likely established through precise measurements or direct observation in the human cadaveric setting to assess navigation accuracy and fulfillment of user requirements. The document does not explicitly state the specific method for establishing this ground truth (e.g., highly accurate physical measurements, known anatomical landmarks).

8. The sample size for the training set

The document does not provide information about a training set since no clinical testing was performed for the determination of substantial equivalence (as stated in Section 9.2). The device is a surgical navigation system, and the provided tests focus on verification and validation of its components and overall system performance rather than an AI model that would require a distinct training set.

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

As no training set is mentioned or implied for an AI model, the method for establishing its ground truth is not applicable or described in this document.

Summary

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July 14, 2021

Insight Medical Systems Inc. % Bob Duffy President Bob Duffy Associates. Inc. 16405 Summer Sage Rd. Poway, California 92064

Re: K203115

Trade/Device Name: ARVIS® Surgical Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 9, 2021 Received: June 11, 2021

Dear Bob Duffy:

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

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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) K203115

Device Name

ARVIS® Surgical Navigation System

Indications for Use (Describe)

Example orthopedic surgical procedures include but are not limited to:

Total Knee Arthroplasty
· Unicompartmental Knee Arthroplasty: Tibial Transverse Resection
· Hip Arthroplasty

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements established by 21 CFR 807.92.

1.	Submitter Information
	Submitter:	Insight Medical Systems, Inc.
	Address:	8601 Ranch Road 2222Building 1, Suite 104Austin, TX 78730-2304 (USA)
	Contact Person:	Nicholas R. van der WaltChief Executive OfficerPhone: (949) 468-7775Email: nvanderwalt@insightmedsys.com
	Date Prepared:	July 14, 2021
2.	Subject Device
	Trade Name:	ARVIS® Surgical Navigation System
	Common Name:	Orthopedic Stereotaxic Instrument
	Classification:	21 CFR 882.4560
	Classification Name:	Orthopedic Stereotaxic Instrument
	Product Code:	OLO
	FDA Panel:	84 - Neurology
	Class:	II
3.	Predicate Device
	510(k) Number:	K172462
	Manufacturer:	OrthAlign, Inc.
	Trade Name:	OrthAlign Plus System
	Classification:	21 CFR 882.4560
	Classification Name:	Orthopedic Stereotaxic Instrument
	Product Code:	OLO
	FDA Panel:	84 - Neurology
	Class:	II
510(k) Number:	K190929
Manufacturer:	Augmedics Ltd.
Trade Name:	Xvision Spine System (XVS)
Classification:	21 CFR 882.4560
Classification Name:	Orthopedic Stereotaxic Instrument
Product Code:	OLO
FDA Panel:	84 - Neurology
Class:	II

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4. Reference Device

5. Device Description

The ARVIS® Surgical Navigation System (ARVIS® System) is to be used by orthopedic surgeons and operating room staff who perform hip and knee arthroplasty.

The ARVIS® System comprises the major elements listed in Table 1.

Item	Description	Purpose
1	Eyepiece Assembly	Houses display, speakers, cameras, and other sensors.
2	Belt Pack	System power management. Houses the External Batteryand Computer module.
3	Computer Module	Runs the ARVIS® Application Software.
4	External Battery	Removable/swappable. Provides power to the EyepieceAssembly and the Computer module.

Table 1: ARVIS® Surgical Navigation System Components.

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5	Eyepiece Cable	Connects Eyepiece to the Belt Pack.
6	Battery ChargingSystem	Charges External Battery when system is not in use.Intended to be used outside the operating room.
9	Instrument Set	Surgical tools, including trackers, mounts, adapters, etc.that are required to perform surgical procedures.

6. Intended Use

The ARVIS® System is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components.

The Intended Use of the ARVIS® System is substantially the same as that of the predicate device. Minor differences in wording are not critical to the intended surgical use of the device, and the difference does not affect the safety and effectiveness of the device when used as labeled.

7. Indications for Use

The ARVIS® Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated.

Example orthopedic surgical procedures include but are not limited to:

. Total Knee Arthroplasty
Unicompartmental Knee Arthroplasty: Tibial Transverse Resection
. Hip Arthroplasty

8. Technological Characteristics

Table 2 provides a comparison of the technological characteristics between the ARVIS® System (Subject device) and the OrthAlign Plus System (Predicate device).

Characteristic	Subject Device	Predicate Device	Same /Different
Materials	Metal grades common to orthopedic surgical instruments. Polymer grades common to orthopedic surgical instruments. Internal electronics.	Metal grades common to orthopedic surgical instruments. Polymer grades common to orthopedic surgical instruments. Internal electronics.	Same
Characteristic	Subject Device	Predicate Device	Same /Different
BiocompatibilityCategorization(ISO 10993-1)	• External CommunicatingDevice, Tissue/Bone/DentinCommunicating, withsubsystems that have directand potential indirectcontact for a limited contactduration (< 24 hours).	• External CommunicatingDevice, Tissue/Bone/DentinCommunicating, withsubsystems that have directand potential indirect contactfor a limited contact duration(< 24 hours).	Same
Main SystemComponents	• Waist-mounted Belt Packwith non-sterile, reusablemobile computer module andsystem Battery.• Optical and inertial sensors,illumination, and display innon-sterile, reusable Head-mounted Eyepiece.• Reusable sterile mechanicalinstrument set.	• Sterile single-use computermodule with internal, non-replaceable Battery.• Inertial sensors and display insterile, single-use module.• Reusable electronic sensorwith Battery.• Reusable sterile mechanicalinstrument set.	Different
OperatingPrinciple	• Computer processor usespositional information fromtracked markers on anatomyor instruments to calculateand display measurements tothe user.	• Computer processor usespositional information fromsensors on anatomy orinstruments to calculate anddisplay measurements tothe user.	Same
TrackingTechnology	• Optical - stereo infraredcameras.• Inertial – for head trackingand measurements relative togravity.	• Inertial - accelerometer andgyroscope.• Optical - monocular camera(for hip registration probe scalereader).	Different
Registration	• Instruments placed atindicated anatomic points.• System's optical and inertialsensors used to determineposition and/or orientation ofinstruments or anatomy towhich trackers or sensors areattached.	• Instruments placed at indicatedanatomic points.• System's optical and inertialsensors used to determineposition and/or orientation ofinstruments or anatomy towhich trackers or sensors areattached.	Same
Characteristic	Subject Device	Predicate Device	Same /Different
User Interface	• Text and graphical output onLCD in Eyepiece.• Audible feedback Eyepiece-mounted internal speakers.• Eyepiece-mountedmicrophone.• Head tracking interface andvoice commands to controland navigate the applicationsoftware.	• Text and graphical output onLCD in single-use computermodule.• Audible feedback fromspeakers in single-usecomputer module.• Physical buttons on sterilesingle-use module to controland navigate the applicationsoftware.	Different
Patient Interface	• Tracking markers and cuttingguides pinned to bone.• Landmarks registered withmechanical probe tip.• No electronics applied topatient.	• Inertial sensors and cuttingguides pinned to bone.• Landmarks registered withmechanical probe tip.• Battery-powered sensorsmounted on patient.	Different
Sterilization -reusablemechanicalinstruments	• Steam sterilization forreusable mechanicalinstruments.	• Steam sterilization for reusablemechanical instruments.	Same
Sterilization -Electroniccomponents	• No sterilization required forelectronic components.	• EtO sterilization for single-usecomputer module.	Different
Energy Type	• Electronics: Battery Power.• Instruments: Mechanical(Manual).	• Electronics: Battery Power.• Instruments: Mechanical(Manual).	Same
EnvironmentalSpecifications	• Temperature: -30 to 50 °C.• Humidity: 10 to 90% RH;(non-condensing).• Pressure: 60 kPa to 106 kPa.	Specified storage and operatingenvironments for typicaltransport and surgicalenvironments.	Same

Table 2: Comparison of Technological Characteristics.

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As shown in Table 2, the following technological characteristics are the same for the ARVIS® System and the OrthAlign Plus System:

Materials a.
Biocompatibility Classification per ISO 10993-1 b.
Operating Principle C.
Registration d.
Environmental Specifications e.

As also shown in Table 2, the following technological characteristics are different between the ARVIS® System and the OrthAlign Plus System:

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1. Main System Components
1. Tracking Technology
1. User Interface
1. Patient Interface
1. Sterilization

Using a combination of Risk Management, design specifications and implementation, and verification and validation, these differences are not critical to the intended surgical use of the device, and do not affect the safety and effectiveness of the device when used as labeled.

The Augmedics Xvision is named as a Reference Device because it includes the technological characteristic of a heads-up display similar to that in the subject device.

9. Non-Clinical Performance Data

9.1. Summary of Non-Clinical Testing Performed and Conclusions Drawn

A program of non-clinical verification and validation testing was conducted that includes:

Cleaning process Validation ●
Sterilization Validation
Software Verification and Validation Testing ●
Electromagnetic Compatibility (EMC) testing ●
Electrical Safety testing ●
Safety and Performance Bench Testing ●
Simulated Clinical Validation Testing ●

Cleaning process Validation was performed to validate that the ARVIS® Instruments can be adequately cleaned using the specified procedure provided in the Instructions for Use.

Sterilization Validation was conducted to demonstrate that:

The ARVIS® Surgical Instruments are compatible with the necessary FDA-cleared a. reprocessing equipment,
The reprocessing instructions are technically feasible for implementation by users, and b.
The sterilization process has been validated to attain a sterility assurance level (SAL) of 10 °. c.

Software Verification and Validation Testing was conducted to demonstrate that:

1. All requirements and specifications in the ARVIS® Software Requirements Specification were implemented and operate correctly.
1. All Risk Mitigations to be implemented in software were implemented and operated correctly, and
1. the software conforms with the user needs and intended uses of the ARVIS® device.

Electromagnetic Compatibility (EMC) testing was conducted to demonstrate that the ARVIS® System is compliant with applicable Standards for Electromagnetic Compatibility.

Electrical Safety testing was conducted to demonstrate that the ARVIS® System is compliant with applicable Standards for Electrical Safety.

Safety and Performance Bench Testing was conducted to demonstrate that the ARVIS® System meets its performance specifications and is substantially equivalent to the predicate device performance.

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Simulated Clinical Validation Testing was conducted to demonstrate that the particular requirements for the specified intended use can be consistently fulfilled by the ARVIS® System. This testing was conducted in a human cadaveric setting and included validation of user requirements and navigation accuracy.

9.2. Clinical Testing

No clinical testing was conducted for a determination of substantial equivalence.

10. Overall Conclusion

The documentation and test results provided in this submission and comparison of intended use, principle of operation, performance data, design and the overall technological characteristics, demonstrate that the ARVIS® Surgical Navigation System is as safe, as effective, and performs as well as the 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).