Intellijoint VIEW is indicated to assist qualified healthcare professionals in preoperative planning and postoperative review of orthopedic surgery. The device allows for orthopedic implant to be overlaid on medical images for the purpose of selecting and positioning implants. The device includes tools for performing measurements and evaluating surgical treatment options. Clinical judgement and experience are required to properly use the software.

Device Description

Intellijoint® VIEW is a web-based software as a medical device (SaMD) product that assists health care professionals complete preoperative planning and postoperative review for orthopedic surgery. Preoperative planning on Intellijoint® VIEW involves the user completing measurements on medical images to inform the selection and intraoperative positioning of orthopedic implant system components. Intellijoint® VIEW also allows for postoperative image review and measurement.

Intellijoint® VIEW Templating tool allows the user to perform distance and angular measurements on scaled medical images, to inform selection of acetabular and femoral implant components.

Intellijoint® VIEW Hip-Spine Assessment allows the user to assess a patient's spinopelvic relationship for preoperative functional acetabular cup position planning. The Application overlays acetabular measurement tools on standing and sitting lateral functional patient images to inform an appropriate implant position based on the functional relationship between the hips and spine.

AI/ML Overview

The Intellijoint VIEW device's acceptance criteria and the study proving it meets these criteria are detailed below, synthesizing information from the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy of Angular Measurements: Angular measurements satisfy requirements for accuracy.	Angular measurements are displayed "to within ± 0.8° of their true value."
Accuracy of Distance Measurements: Distance measurements satisfy requirements for accuracy.	Distance measurements are displayed "to within ± 0.3 mm of their true value."
Accuracy of Resultant Position Changes (Implant Placement): Distance measurements of resultant position changes due to implant placement satisfy requirements for accuracy.	Distance measurements of resultant position changes due to implant placement are displayed "to within ± 1 mm of their true value."
Correct and Accurate Display of Implant Templates: Implant templates are displayed correctly and accurately.	Confirmed (No specific quantitative value provided beyond "Software satisfied all accuracy requirements.").
Functional Requirements and Intended Performance: The software satisfies functional requirements and performs as intended.	"Software satisfied all requirements and specifications."
Algorithm and Measurement Calculation Verification: Algorithms and measurement calculations are verified.	"Algorithms and measurement calculations were verified in these tests."
User Needs and Intended Use: Satisfies user needs and intended use.	"All user needs were met."

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

The document does not explicitly state a specific sample size (i.e., number of images or cases) used for the accuracy test set. It mentions "radiographic images" were used in the Simulated Use and Usability Validation.

Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.

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

The document states that "Simulated use testing was performed by qualified orthopedic surgeons" for the Usability Validation. It does not specify the number of surgeons involved or their years of experience. Their qualification is broadly stated as "qualified orthopedic surgeons."

For the quantitative accuracy tests (angular and distance measurements), the document does not describe the process for establishing ground truth or the involvement of experts beyond the statement that these tests provide "confirmation that distance and angular measurements satisfy requirements for accuracy" and "implant templates are displayed correctly and accurately." It implies a direct comparison to a "true value," which for software verification often means comparison against a known standard or precise reference rather than human-established ground truth.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. Given the nature of the accuracy and functional tests described (verification of calculations, measurements against true values, and simulated use), a formal adjudication process for interpreting results may not have been deemed necessary in the same way it would be for diagnostic AI.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for this Traditional 510(k)." The tests performed focused on device functionality, accuracy, and usability in a simulated environment, rather than a comparative effectiveness study with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The performance data primarily describes standalone performance in terms of accuracy of measurements and proper display of templates. The "Accuracy Test" verifies that the device's calculations and displays meet specified tolerances. This is characteristic of an algorithm-only assessment when the "true value" is a known numerical standard.

The "Simulated Use and Usability Validation" involved "qualified orthopedic surgeons" interacting with the device, which includes a human-in-the-loop component, but the goal was to validate user needs and intended use, not to evaluate human reader improvement with or without AI assistance.

7. Type of Ground Truth Used

For the quantitative accuracy tests (angular and distance measurements, implant placement changes), the ground truth appears to be based on "true value" comparisons, likely established through precise technical specifications, known inputs, or calibrated reference points, typical for software verification where outputs are numerical.

For the "Simulated Use and Usability Validation," the ground truth was established by assessing whether the software "satisfies user needs and intended use" based on expert judgment ("qualified orthopedic surgeons") during a typical workflow. This is a form of qualitative expert consensus on usability.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set size. This suggests that the device's functionality primarily involves measurement and templating tools based on pre-programmed algorithms rather than machine learning models that require extensive training data.

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

As no training set is mentioned or implied for a machine learning model, this information is not applicable and not provided in the document. The device's validation focuses on its accuracy in performing calculations and displaying information, which typically relies on internal verification against established mathematical or engineering standards rather than external ground truth data.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

Intellijoint Surgical Inc. % Katarina Jugovic Regulatory Affairs Associate 809 Wellington Street North, Unit 2 Kitchener. Ontario N2H 5L6 CANADA

November 12, 2021

Re: K211876

Trade/Device Name: Intellijoint VIEW Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 14, 2021 Received: October 15, 2021

Dear Katarina Jugovic:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K211876

Device Name Intellijoint VIEW

Indications for Use (Describe)

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

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

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Image /page/3/Picture/2 description: The image contains the logo for "Intellijoint Surgical". The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of three triangles, one blue, one light blue, and one gray. The company name is written in a sans-serif font, with the word "Intellijoint" in a larger font size than the word "Surgical".

510(k) Summary

1. Submitter Information

Submitter:	Intellijoint Surgical Inc.
Address:	809 Wellington St. N., Unit 2Kitchener, ONCanada N2H 5L6
Telephone:	(519) 342-3178
Fax:	(226) 317-0471
Contact:	Andrew Graham
Date Prepared:	7 Oct 2021

2. Device Information

Trade Name:	Intellijoint® VIEW
Common Name:	Medical Image Management and Processing System
Classification:	Class II per 21 CFR 892.2050
Product Code:	LLZ

3. Purpose of Submission

The purpose of this submission is to gain clearance for a new software as a medical device, Intellijoint® VIEW.

4. Predicate Device Information

The Intellijoint® VIEW product described in this substantially equivalent to the following predicates:

Predicate Device	Manufacturer	510(k) No.
TraumaCAD (primary)	OrthoCrat Ltd	K042816
Cuptimize	Cuptimize, Inc.	K203651

5. Device Description

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Image /page/4/Picture/2 description: The image shows the logo for "Intellijoint Surgical". The logo consists of a blue triangle on the left, with a smaller gray triangle below it. To the right of the triangles is the word "intellijoint" in gray, with the word "surgical" in a smaller font below it.

Intellijoint® VIEW Templating tool allows the user to perform distance and angular measurements on scaled medical images, to inform selection of acetabular and femoral implant components.

6. Indications for Use

Intellijoint VIEW is software indicated to assist qualified healthcare professionals in preoperative planning and postoperative review of orthopedic surgery. The device allows for orthopedic implant templates to be overlaid on medical images for the purpose of selecting and positioning implants. The device includes tools for performing measurements and evaluating surgical treatment options. Clinical judgement and experience are required to properly use the software.

7. Comparison of Technological Characteristics

The substantial equivalence of Intellijoint® VIEW to the predicates is shown by similarities in intended use, indications for use, and performance.

Property	Intellijoint® VIEW	Primary PredicateTraumaCAD(K042816)	Predicate 2Cuptimize(K203651)
510(k) No.	K211876	K042816	K203651
Classification	21 CFR 892.2050	21 CFR 892.2050	21 CFR 892.2050
Product Code	LLZ	LLZ	LLZ; HAW
		Primary Predicate	Predicate 2
Property	Intellijoint® VIEW	TraumaCAD(K042816)	Cuptimize(K203651)
Indications for Use	Intellijoint VIEW isindicated to assist qualifiedhealthcare professionals inpreoperative planning andpostoperative review oforthopedic surgery.The device allows for	The TraumaCAD programis indicated for assistinghealthcare professionals inpreoperative planning ororthopedic surgery. Thedevice allows foroverlaying of prosthesistemplates on radiologicalimages and includes toolsfor performingmeasurements on theimage and for positioningthe template. Clinicaljudgements and experienceare required to properlyuse the software.	Cuptimize is an image-processing softwareindicated to assist in thepositioning of total hipreplacement components,with a specific focus onthe acetabular component.It is intended to assist inthe precise positioning ofthe acetabularcomponent intra-operatively by measuringits position relative to thebone structures of interestprovided that the points ofinterest can be identifiedfrom radiology images.The device allows foroverlaying of digitalannotations on radiologicalimages and includes toolsfor performingmeasurements using theimages and digitalannotations. Clinicaljudgment and experienceare required to properlyuse thesoftware. The software isnot for primary imageinterpretation. Thesoftware is not for use onmobile phones.
Versions	Web version	Client/server versionStandalone versionWeb version	Web version
	PC and MAC Compatible	PC and MAC Compatible	PC and MAC Compatible
Computer	Not for use on mobilephones	Not for use on mobilephones	Not for use on mobilephones
	Not tablet compatible	iPad compatible
Operating Systems	MacOSWindows	MacOSWindows	MacOSWindows
Anatomical Locations	Hip	Hip, Knee, Upper Limb,Foot and Ankle, Trauma,Spine, Pediatric,Deformity, 3D Suite	Hip
Image Input	2D radiographs	2D radiographs	2D radiographs
	Templating
Image Measurements	Leg Length Discrepancy	Leg Length Discrepancy	N/A
Property	Intellijoint® VIEW	Primary PredicateTraumaCAD(K042816)	Predicate 2Cuptimize(K203651)
	Hip-Spine AssessmentAngular measurements(Inclination Reference,Pelvic Tilt, Sacral Slope,Pelvic Incidence, LumbarLordosis, PelvicIncidence-LumbarLordosis mismatch)	Angular measurements	Angular measurements(Inclination Reference,Pelvic Tilt, Sacral Slope,Pelvic Incidence,Spinopelvic Tilt Angle)
Output Data	TemplatingSelected ImplantsAnticipated anatomicalchanges (Leg Length,Offset, Femoral StemPositioning, AcetabularCup Position)	Selected ImplantsAnticipated anatomicalchanges (Leg Length,Offset, Femoral StemPositioning, AcetabularCup Position)	N/A
	Hip-Spine AssessmentAnatomical measurements(Pelvic Tilt, Sacral Slope,Pelvic Incidence, LumbarLordosis, PelvicIncidence-LumbarLordosis mismatch)Target Cup Position(Inclination andAnteversion)	N/A	Anatomical measurementsTarget Cup Position(Inclination andAnteversion)
Software Features	TemplatingTemplate overlaycapability, Interactivetemplate positioning,Image Scaling, Templatesupport frommanufacturers, Permitstemplate rotation	Template overlaycapability, Interactivetemplate positioning,Image Scaling, Templatesupport frommanufacturers, Permitstemplate rotation	N/A
	Hip-Spine AssessmentPreoperative cup positionanalysis.	N/A	Preoperative andintraoperative cup positionanalysis.

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Image /page/5/Picture/2 description: The image shows the logo for "Intellijoint Surgical". The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of three triangles, one dark blue, one light blue, and one gray. The company name is written in gray, with the word "surgical" in a smaller font size below "intellijoint".

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Image /page/6/Picture/2 description: The image shows the logo for "IntelliJoint Surgical". The logo consists of a blue triangle shape on the left, with the text "IntelliJoint" in a sans-serif font to the right of the triangle. Below "IntelliJoint" is the word "surgical" in a smaller font size.

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Image /page/7/Picture/2 description: The image shows the logo for "Intellijoint Surgical". The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of three triangles, one dark blue, one light blue, and one gray. The company name is written in a sans-serif font, with the word "Intellijoint" in a larger font size than the word "Surgical".

8. Performance Data

The following tests were performed to demonstrate the substantial equivalence of Intellijoint® VIEW to its predicate devices:

Test	Summary	Result
Verification
Software Functionaland Unit Tests	Verified that Intellijoint® VIEW satisfies functional requirements and performs as intended.Algorithms and measurement calculations were verified in these tests.	Software satisfied all requirements and specifications.
Accuracy Test	Provides confirmation that distance and angular measurements satisfy requirements for accuracy.Provides confirmation that implant templates are displayed correctly and accurately.	Software satisfied all accuracy requirements.
Validation
Simulated Use andUsability Validation	Simulated use testing was performed by qualified orthopedic surgeons on radiographic images following a typical workflow.This test validated that Intellijoint® VIEW satisfies user needs and intended use.	All user needs were met.

The testing demonstrated that the Intellijoint® VIEW is substantially equivalent to the legally marketed predicate devices for its intended use.

Non-Clinical Testing

Non-clinical testing was performed to assess the safety and effectiveness of the device, to demonstratethat themeasurement tools produced accurate, repeatable, and reproducible implant selection, sizing, and placement of components. Testing verified that the software application is operating according to specified design requirements. Intellijoint VIEW displays angular measurements to within ± 0.8°and distance measurements to within ± 0.3 mm of their true value. Distance measurements of resultant position changes due to implant placement, are displayed to within ± 1 mm of their true value. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate devices.

Software testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software as a Medical Device". The software application was of "moderate" level of concern because a failure or latent flaw in the software could indirectly result in minor injury to the patient through incorrect or delayed information.

Clinical Testing

Clinical testing was not necessary for this Traditional 510(k).

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Image /page/8/Picture/2 description: The image shows the logo for "Intellijoint Surgical". The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of three triangles, stacked on top of each other, in different shades of blue and gray. The company name is written in a sans-serif font, with the word "Intellijoint" in a larger font size than the word "Surgical".

9. Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate devices, Intellijoint® VIEW has been shown to be substantially equivalent to the legally marketed predicate devices identified in this submission and does not present any increased risk to safety or effectiveness.

Based on the information supplied in this 510(k), it is our conclusion that our device is safe, effective, and substantially equivalent to the primary predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).