The Intellijoint® Navigation 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 Intellijoint Navigation System is indicated for patients undergoing orthopedic surgery, and where the use of stereotactic surgery is considered safe and effective.

Intellijoint HIP aids the surgeon in performing intra-operative measurements of limb position, joint center-of-rotation, and implant component positioning.

Intellioint KNEE aids the surgeon in performing intra-operative measurements including alignmentation and bony cuts for implant component positioning.

Example orthopedic surgical procedures include, but are not limited to:

Total Hip Arthroplasty
Minimally Invasive Hip Arthroplasty
Revision Hip Arthroplasty
Total Knee Arthroplasty

Device Description

The Intellijoint® Navigation System (IINS) is an imageless optical navigation system intended for use in orthopedic surgery. The IINS consists of an infrared Camera, Camera Drape, optical tracking Spheres, a computer Workstation and associated hardware.

This submission provides the addition of Total Knee Arthroplasty (TKA) to the indications for use (cleared in K171525), allowing real-time measurements of varus/valgus angle, flexion/extension angle, and resection depth for distal femur and proximal tibia cuts during TKA procedures. The modifications include the addition of TKA-specific mechanical instruments and software. The updated product will be referred to as the Intellijoint® Navigation System throughout this submission.

AI/ML Overview

The provided text describes the Intellijoint® Navigation System, an imageless optical navigation system for orthopedic surgery, and its 510(k) clearance for Total Knee Arthroplasty (TKA). The document focuses on demonstrating substantial equivalence to predicate devices, particularly the KneeAlign 2 System (K103829) and the Intellijoint HIP Generation 2B System (K171525).

Here's a breakdown of the acceptance criteria and study information:

Key Sections Relevant to Acceptance Criteria and Study Proof:

The information regarding acceptance criteria and the study proving the device meets them is primarily found under "8. Performance Data" (pages 5-6).

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of specific numerical acceptance criteria with corresponding performance data. Instead, it provides a summary of tests performed and their general results. However, we can infer the acceptance criteria from the descriptions of the tests and the stated results.

Inferred Acceptance Criteria and Reported Device Performance:

Test	Inferred Acceptance Criteria	Reported Device Performance
Benchtop Accuracy	The Intellijoint KNEE component (and by extension, the Intellijoint® Navigation System when used for TKA) must meet predefined clinical accuracy requirements as verified using calibrated benchtop test fixtures.	"All accuracy requirements were met." This implies the system's measurements (e.g., varus/valgus angle, flexion/extension angle, resection depth) were within acceptable predefined tolerances when tested in a controlled benchtop environment.
Tracking System Accuracy and Robustness	The accuracy of Intellijoint KNEE must meet the methodology outlined in ASTM F2554-10 (Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems). The system must maintain accuracy and robustness under normal conditions, worst-case use scenarios, and realistic tracking disturbances.	"All accuracy specifications and robustness requirements were met." This suggests that the tracking system's ability to precisely locate and track anatomical structures and instruments was verified to be within specified limits, even when subjected to conditions simulating real-world surgical challenges. The standard ASTM F2554-10 implies quantitative performance metrics.
Software Functional and Unit Tests	The Intellijoint KNEE Software Application must satisfy all functional requirements, perform as intended, and accurately execute algorithms and measurement calculations.	"Software satisfied all requirements and specifications." This indicates that the software's logic, calculations for measurements (e.g., bone cuts, alignment), and overall functionality were rigorously tested and found to be free of defects and to perform correctly according to design specifications.
Mechanical Instrumentation Functional and Performance Tests	All mechanical instruments developed for the Intellijoint® Navigation System's TKA application must satisfy their functional and performance requirements.	"All functional and performance requirements met." This confirms that the physical tools used with the system (e.g., TKA-specific mechanical instruments) perform reliably and as designed, implying they are robust, precise, and fit for their intended purpose in a surgical setting.
Anatomical Phantom Simulated Use and Clinical Accuracy	The Intellijoint KNEE component must satisfy user needs, intended use, and clinical accuracy requirements when used by orthopedic surgeons in a simulated TKA procedure on bone models. Accuracy is assessed by comparing simulated measurements to ground truth values.	"All user needs and clinical accuracy requirements were met." This suggests that the system's ease of use, workflow integration, and most importantly, its ability to provide accurate measurements in a simulated surgical environment were validated. The comparison to "ground truth values" implies that the measurements taken by the system were within clinically acceptable deviation from known model values.
Cadaver Simulated Use	The Intellijoint KNEE component must satisfy clinical use requirements and perform as intended when: - Operated by a surgeon - Used on human specimens - Used in a realistic operating room environment.	"All clinical use requirements were met." This signifies that the system's practical application in a more realistic cadaveric setting (human tissue, operating room environment, surgeon interaction) was successful, verifying its reliability and performance under conditions closely mimicking actual surgery. While specific numerical accuracy isn't explicitly stated here, it builds upon the phantom accuracy tests by demonstrating real-world applicability.

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

Test Set Sample Size: The document does not specify exact numerical sample sizes for any of the tests (e.g., number of benchtop tests performed, number of simulated procedures on phantoms or cadavers). It refers to tests being performed, but not the quantity of iterations or cases.
Data Provenance: The document does not explicitly state the country of origin for the data. Given Intellijoint Surgical Inc. is based in Kitchener, ON, Canada, and the submission is to the U.S. FDA, it's reasonable to infer that testing was conducted either in Canada or the US, or both. The studies appear to be prospective in nature, as they involve performing new tests (benchtop, phantom, cadaver) specifically for this submission.

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

Number of Experts: The document states that "orthopedic surgeons" performed the simulated use testing on bone models and in cadaver labs. It does not specify the exact number of surgeons involved in these tests or the number of experts involved in establishing ground truth for the benchtop or phantom tests.
Qualifications of Experts: The experts involved in the simulated use testing are confirmed as "orthopedic surgeons." Their specific experience level (e.g., "10 years of experience") is not provided. For the benchtop and tracking system tests, the ground truth would likely be established through precise metrological instruments and validated methodologies (e.g., ASTM F2554-10), not necessarily by human experts.

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. Ground truth for benchtop and phantom tests would typically be established by highly precise measurements rather than human consensus that requires adjudication. For the simulated use tests, the comparison was between the system's measurements and the "ground truth values" (for phantoms) or its "performance as intended" (for cadavers), implying a direct comparison to established references rather than a consensus among multiple human readers of subjective data.

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

Was an MRMC study done? No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in this document. The nature of the device (a navigation system providing intra-operative measurements) does not lend itself to a typical diagnostic MRMC study where human readers interpret images.
Effect Size of Human Improvement with AI vs. Without AI Assistance: Not applicable, as no MRMC study was conducted. The device assists the surgeon by providing measurements, rather than providing an interpretation that a human would then re-interpret.

6. Standalone (Algorithm Only) Performance

Was a standalone performance study done? The document describes the "Intellijoint KNEE™ Software Application" and verifies its "functional and unit tests" where "Algorithms and measurement calculations were also verified." This implies that the core algorithms' performance in calculating measurements was assessed. The "Benchtop Accuracy" and "Tracking System Accuracy and Robustness" tests also represent standalone performance of the system's measurement capabilities. However, these are functional and accuracy tests of the device's output, not a standalone diagnostic performance in a clinical context where the algorithm on its own makes a clinical decision without human input. The device is explicitly intended to "aid in selection and positioning" for a surgeon, indicating a human-in-the-loop design.

Therefore, while the core measurement algorithms were tested for accuracy and functionality, a standalone "algorithm only without human-in-the-loop clinical performance" study (e.g., an AI diagnosing a condition) was not conducted, as that is not the device's intended use or function.

7. Type of Ground Truth Used

The document describes several types of ground truth:

Calibrated Benchtop Test Fixtures: Used for "Benchtop Accuracy" and "Tracking System Accuracy and Robustness." This implies a metrological ground truth established by precise, calibrated instruments and known physical configurations.
Known "Ground Truth Values" for Bone Models: Used in the "Anatomical Phantom Simulated Use and Clinical Accuracy" test. This is a phantom-based ground truth, where the anatomical structures and target measurements are precisely known for the models.
Functional/Performance Requirements and Specifications: Used for "Software Functional and Unit Tests" and "Mechanical Instrumentation Functional and Performance Tests." This is a specification/design-based ground truth, where the software or hardware behavior is compared against its pre-defined design and functional requirements.
Clinical Use Requirements/Intended Performance: Used in the "Cadaver Simulated Use" test. While not a "ground truth" in the same quantifiable sense as a benchtop, this involves validating the system's intended performance and clinical utility in a realistic human cadaver environment, implying successful execution of the surgical workflow and accurate provision of measurements to the surgeon as expected.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This is because the Intellijoint® Navigation System is described as an "imageless optical navigation system" with specific algorithms and mechanical components providing intra-operative measurements. It is not presented as an AI/machine learning system that requires a distinct "training set" in the conventional sense for learning patterns from data to make predictions or classifications. The verification and validation focus on the accuracy and reliability of its measurement capabilities, software functionality, and hardware performance.

9. How Ground Truth for the Training Set Was Established

As no training set is described or implied to be used for machine learning (per the description of the device), this question is not applicable.

Summary

{0}------------------------------------------------

October 1, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

Intellijoint Surgical Inc. Breanne Cuddington Regulatory Affairs Associate 60 Bathurst Drive Unit 6 Waterloo, N2V 2A9 CA

Re: K191507

Trade/Device Name: Intellijoint® Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 30, 2019 Received: September 3, 2019

Dear Breanne Cuddington:

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

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 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K191507

Device Name Intellijoint® Navigation System

Indications for Use (Describe)

Intellijoint HIP aids the surgeon in performing intra-operative measurements of limb position, joint center-of-rotation, and implant component positioning.

Intellioint KNEE aids the surgeon in performing intra-operative measurements including alignmentation and bony cuts for implant component positioning.

Example orthopedic surgical procedures include, but are not limited to:

Total Hip Arthroplasty
Minimally Invasive Hip Arthroplasty
Revision Hip Arthroplasty
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)
------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/3 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, with the top triangle being dark blue, the middle triangle being light blue, and the bottom triangle being gray. The company name is written in gray, with the word "Intellijoint" on top and the word "Surgical" on the bottom.

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:	Breanne Cuddington
Date Prepared:	30 August 2019

2. Device Information

Trade Name:	Intellijoint® Navigation System
Common Name:	Orthopedic Stereotaxic Instrument
Classification:	Class II per 21 CFR 882.4560
Classification Name:	Orthopedic Stereotaxic Instrument
Product Code:	OLO

3. Purpose of Submission

The purpose of this submission is to gain clearance for updates to the indications for use for the Intellijoint HIP Generation 2B System, which has been previously cleared in K171525. The updated product will be referred to as the Intellijoint® Navigation System throughout the submission.

4. Predicate Device Information

The Intellijoint® Navigation System described in this substantially equivalent to the following predicate devices:

Primary Predicate:

Device Name	Manufacturer	510(k) No.
KneeAlign 2 System	OrthAlign, Inc.	K103829

Additional Predicate:

Device Name	Manufacturer	510(k) No.
Intellijoint HIP Generation 2B System	Intellijoint Surgical Inc.	K171525

{4}------------------------------------------------

tellijoint

5. Device Description

6. Indications for Use

The Intellijoint® Navigation 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 Intellijoint® Navigation System is indicated for patients undergoing orthopedic surgery, and where the use of stereotactic surgery is considered safe and effective.

Intellijoint HIP® aids the surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning.

Intellijoint KNEE™ aids the surgeon in performing intra-operative measurements including alignment of instrumentation and bony cuts for implant component positioning.

Example orthopedic surgical procedures include, but are not limited to:

Total Hip Arthroplasty ।
Minimally Invasive Hip Arthroplasty ।
Revision Hip Arthroplasty -
-Total Knee Arthroplasty

7. Comparison of Technological Characteristics

The substantial equivalence of the Intellijoint® Navigation System compared to the predicate devices is based on the following technological characteristics:

Property	Intellijoint® Navigation System	Primary PredicateKneeAlign® 2 System	Additional PredicateIntellijoint HIP® Generation 2B System
510(k) No.	K191507	K103829	K171525
Tracking method	Optical	Inertial	Optical
Imaging Modality	Imageless	Imageless	Imageless
Camera System	Monocular	N/A	Monocular
RegistrationMethod	HIPSame as K171525	HIPN/A	HIPi. Camera rigidly fixed to pelvis.ii. Digitization of Anterior Pelvic Plane and/or frontal / sagittal planes.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for "IntelliJoint Surgical". The logo consists of a geometric shape on the left, resembling a stylized joint, with three overlapping triangles in different shades of blue and gray. To the right of the geometric shape is the word "IntelliJoint" in a sans-serif font, with the word "Surgical" in a smaller font size underneath.

K191507

Intellijoint®Navigation System	Primary Predicate	Additional Predicate
	KneeAlign® 2 System	Intellijoint HIP®Generation 2B System
KNEE	KNEE	KNEE
i. Bone Tracker mountedrigidly to Femur orTibiaii. Digitization of Femoralor Tibial Landmarks	i. Navigation unit mountedrigidly to Femur or Tibiaii. Digitization of Femoralor Tibial landmarks	N/A

8. Performance Data

This submission provides the addition of TKA to the indications for use cleared in 510(k) K171525 and adds the Intellijoint KNEE™ Software Application to the Intellijoint® Navigation System. Other modifications include the addition of TKA specific mechanical instruments to the Intellijoint® Navigation System.

The following tests were performed to support the addition of Intellijoint KNEE™ and to demonstrate the substantial equivalence of the Intellijoint® Navigation System to its predicate devices:

Test	Summary	Result
Verification
Benchtop Accuracy	Verified clinical accuracy requirements usingcalibrated benchtop test fixtures.	All accuracyrequirements weremet.
Tracking System Accuracy and Robustness	Accuracy of Intellijoint KNEE was verifiedaccording to the methodology in ASTM F2554-10 - Standard Practice for Measurement ofPositional Accuracy of Computer AssistedSurgical Systems. Testing simulated normalconditions, and a variety of worst-case usescenarios and realistic tracking disturbances.	All accuracyspecifications androbustnessrequirements weremet.
Software Functional and Unit Tests	Verified that the Intellijoint KNEE SoftwareApplication satisfies functional requirementsand performs as intended. Algorithms andmeasurement calculations were also verified inthese tests.	Software satisfiedall requirementsand specifications.
Mechanical Instrumentation Functional and Performance Tests	Provides confirmation that mechanicalinstrumentation satisfies functional andperformance requirements.	All functional andperformancerequirements met.

{6}------------------------------------------------

Image /page/6/Picture/3 description: The image shows the logo for "Intellijoint Surgical". The logo consists of a blue and gray triangle shape on the left, followed by the word "intellijoint" in gray. Below "intellijoint" is the word "surgical" in a smaller, lighter gray font.

Validation
Anatomical PhantomSimulated Use andClinical Accuracy	Simulated use testing was performed on bonemodels by orthopedic surgeons in a simulatedTKA procedure following a typical workflow.This test validated that Intellijoint KNEEsatisfies user needs, intended use and clinicalaccuracy requirements. Accuracy was assessedby comparing simulated use measurements withground truth values.	All user needs andclinical accuracyrequirements weremet.
Cadaver Simulated Use	Simulated use testing was also performed incadaver labs. These tests validated thatIntellijoint KNEE satisfies clinical userequirements and performs as intended when:- Operated by a surgeon- Used on human specimens- Used in a realistic operating roomenvironment	All clinical userequirements weremet.

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

9. Conclusion

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

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).