Intellijoint HIP™ is a computer-controlled, optical localizer intended to provide intraoperative measurements to a surgeon to aid in selection and positioning of orthopaedic implant system components, where a reference to a rigid anatomical structure can be identified. The system is only compatible with straight acetabular cup impactors.

Intellijoint HIP™ 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 orthopaedic surgical procedures include, but are not limited to:

Total Hip Arthroplasty -
-Minimally Invasive Hip Arthroplasty

Device Description

The intellijoint HIP™ System is an imageless optical navigation system intended for use in orthopaedic surgery. The device provides intra-operative assessment of patient leg length, offset, anterior-posterior change, hip center of rotation change, and acetabular cup angle during Total Hip Arthroplasty (THA) procedures. The system is composed of an infrared Camera, Tracker, computer workstation, software, and bone fixation instruments/hardware.

This submission is an update to the intellijoint HIP™ System previously cleared in 510(k) K133759. The updates include an acetabular cup alignment feature, modifications to the method of patient registration, and other minor design and aesthetic improvements.

AI/ML Overview

The provided document describes the Intellijoint HIP™ System, a computer-controlled, optical localizer for intra-operative measurements in orthopedic surgery. The information below is extracted based on the acceptance criteria and the study proving the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Brief Summary	Reported Device Performance/Result
Tracking System Accuracy and Robustness	The Intellijoint HIP™ System's accuracy was verified according to ASTM F2554-10 - 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 accuracy specifications and robustness requirements were met.
Benchtop Accuracy	Verified clinical accuracy requirements using calibrated benchtop test fixtures.	All accuracy requirements were met.
Bone Fixation Performance	Verified bone fixation performance requirements including functional tests, robustness, rigidity of fixation and repeatability.	All functional and performance requirements were met.
Software Functional and Unit Tests	Verified that the software application satisfies functional requirements and performs as intended. Algorithms and measurement calculations were also verified in these tests.	Software satisfied all requirements and specifications.
Electrical Safety and EMC	Compliance with ANSI / AAMI / IEC 60601-1:2005 for medical electrical equipment: - Part 1: General requirements for basic safety and essential performance - Part 1-2: Collateral standard—Electromagnetic compatibility – requirements and tests - Part 1-6: Collateral Standard: Usability	Compliance with the requirements of the standards demonstrated.
Biocompatibility Evaluation	Evaluation against the applicable requirements of ISO 10993-1:2009 – Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Part 5: Tests for in vitro cytotoxicity - Part 10: Tests for irritation and skin sensitization - Part 11: Tests for systemic toxicity	Compliance with the requirements of the standards demonstrated.
Anatomical Phantom Simulated Use and Clinical Accuracy	Simulated use testing was performed on bone models by orthopaedic surgeons in a simulated THA procedure following a typical workflow. This test validated that the Intellijoint HIP™ System satisfies user needs, intended use and clinical accuracy requirements. Accuracy was assessed by comparing simulated use measurements with ground truth values.	All user needs and clinical accuracy requirements were met.

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

The document does not specify exact sample sizes (e.g., number of bones models or simulated procedures) for the "Anatomical Phantom Simulated Use and Clinical Accuracy" test. However, it indicates that testing was performed on "bone models."

The data provenance is from simulated use testing in a lab setting, not from human patient data. Therefore, it is a prospective study in a simulated environment, rather than retrospective data. The country of origin of the data is not explicitly stated, but the company address is in Waterloo, ON, Canada.

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

The document states that the simulated use testing was performed by "orthopaedic surgeons." The specific number of surgeons and their detailed qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method for the test set results. The accuracy in simulated use was assessed by "comparing simulated use measurements with ground truth values." This implies a direct comparison rather than a multi-expert adjudication process.

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

An MRMC study was not conducted as part of this submission. The testing focused on the device's accuracy and performance in simulated scenarios, not on the comparative effectiveness of human readers with or without AI assistance. The device is an optical localizer intended to aid surgeons, not an AI for image interpretation that would typically necessitate an MRMC study to show human reader improvement.

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

The device is an "optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopaedic implant system components." It is inherently a human-in-the-loop system. While "Software Functional and Unit Tests" verified algorithms and measurement calculations, this is not equivalent to a standalone diagnostic or interpretative algorithm performance study. The "Anatomical Phantom Simulated Use and Clinical Accuracy" involved surgeons performing procedures with the system. Therefore, a purely standalone (algorithm-only) performance study was not detailed in the provided information.

7. The Type of Ground Truth Used

For the "Anatomical Phantom Simulated Use and Clinical Accuracy" test, the ground truth was established using calibrated physical measurements from "calibrated benchtop test fixtures" and "ground truth values" derived from the bone models themselves. This is analogous to a phantom-based ground truth.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or artificial intelligence. The Intellijoint HIP™ System is described as a "computer-controlled, optical localizer" and an "imageless optical navigation system," implying it relies on principles of optical tracking and geometry rather than complex machine learning models that require large training datasets. Therefore, a training set as understood in AI/ML is not applicable or detailed.

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

As no training set (in the AI/ML context) is indicated, this point is not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 28, 2015

Intellijoint Surgical, Incorporated Mr. Brandon Gingrich Ouality and Regulatory Affairs Manager 60 Bathurst Drive, Unit 1 Waterloo. Ontario Canada N2V 2A9

Re: K151364

Trade/Device Name: Intellijoint HIP™ System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: November 16, 2015 Received: November 17, 2015

Dear Mr. Gingrich:

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. 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 Parts 801): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151364

Device Name Intellijoint HIP™ SYSTEM

Indications for Use (Describe)

Intellijoint HIP is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopaedic implant system components, where a reference to a rigid anatomical structure can be identified. The system is only compatible with straight acetabular cup impactors.

Intellijoint HIP 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 orthopaedic surgical procedures include, but are not limited to:

Total Hip Arthroplasty
Minimally Invasive 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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Image /page/3/Picture/2 description: The image contains the logo for "Intellijoint Surgical". The logo consists of a blue triangle shape on the left, with the word "intellijoint" in gray text to the right of the triangle. Below the word "intellijoint" is the word "surgical" in a smaller, lighter gray font.

510(k) Summary

1. Submitter Information

Submitter:	Intellijoint Surgical Inc.
Address:	60 Bathurst Dr., Unit 1Waterloo, ONCanada N2V 2A9
Telephone:	(519) 342 – 3178
Fax:	(226) 317 – 0471
Contact:	Brandon Gingrich
Date Prepared:	December 28th 2015

2. Device Information

Trade Name:	Intellijoint HIPTM System
Common Name:	Orthopaedic Stereotaxic Instrument
Classification:	Class II per 21 CFR 882.4560
Classification Name:	Orthopaedic Stereotaxic Instrument
Product Code:	OLO

3. Purpose of Submission

The purpose of this submission is to gain clearance for updates to a previously cleared Computer-Assisted Orthopaedic Surgery System.

4. Predicate Device Information

The intellijoint HIP™ System described in this submission is substantially equivalent to the following predicates:

Predicate Device	Manufacturer	510(k) No.
intellijoint HIPTM System	Intellijoint Surgical, Inc.	K133759
NavitrackTM System – Total Hip ReplacementCT-Free	ORTHOsoft, Inc.	K041369

5. Device Description

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

6. Intended Use

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

Total Hip Arthroplasty -
-Minimally Invasive Hip Arthroplasty

7. Comparison of Technological Characteristics

The substantial equivalence of the intellijoint HIP™ System to the predicates is shown by similarity in intended use, indications for use, materials, and performance.

8. Performance Data

The following tests were performed to demonstrate the substantial equivalence of the intellijoint HIP™ System to its predicate devices:

Verification
Test	Brief Summary	Result
Tracking SystemAccuracy andRobustness	The intellijoint HIPT™ System's accuracy wasverified according to the methodology inASTM F2554-10 - Standard Practice forMeasurement of Positional Accuracy ofComputer Assisted Surgical Systems. Testingsimulated normal conditions, and a variety ofworst-case use scenarios and realistic trackingdisturbances.	All accuracyspecificationsand robustnessrequirementswere met.
Benchtop Accuracy	Verified clinical accuracy requirements usingcalibrated benchtop test fixtures.	All accuracyrequirementswere met.
Bone FixationPerformance	Verified bone fixation performancerequirements including functional tests,robustness, rigidity of fixation andrepeatability.	All functionaland performancerequirementswere met.
Software Functionaland Unit Tests	Verified that the software application satisfiesfunctional requirements and performs asintended. Algorithms and measurementcalculations were also verified in these tests.	Softwaresatisfied allrequirements andspecifications.

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Image /page/5/Picture/1 description: The image contains the logo for "intelliJoint surgical". The logo consists of a geometric shape on the left, resembling a stylized joint or bone structure, rendered in shades of blue and gray. To the right of the geometric shape is the word "intelliJoint" in gray, with the word "surgical" in a smaller font size underneath.

Electrical Safety andEMC	Compliance with ANSI / AAMI / IEC 60601-1:2005 for medical electrical equipment:- Part 1: General requirements for basicsafety and essential performance- Part 1-2: Collateral standard—Electromagnetic compatibility –requirements and tests- Part 1-6: Collateral Standard: Usability	Compliance withthe requirementsof the standardsdemonstrated.
BiocompatibilityEvaluation	Evaluation against the applicablerequirements of ISO 10993-1:2009 –Biological evaluation of medical devices- Part 1: Evaluation and testing within a riskmanagement process- Part 5: Tests for in vitro cytotoxicity- Part 10: Tests for irritation and skinsensitization- Part 11: Tests for systemic toxicity	Compliance withthe requirementsof the standardsdemonstrated.
Validation
Test	Brief Summary	Result
AnatomicalPhantom SimulatedUse and ClinicalAccuracy	Simulated use testing was performed on bonemodels by orthopaedic surgeons in asimulated THA procedure following a typicalworkflow. This test validated that theintellijoint HIP™ System satisfies user needs,intended use and clinical accuracyrequirements. Accuracy was assessed bycomparing simulated use measurements withground truth values.	All user needsand clinicalaccuracyrequirementswere met.

The testing demonstrated that the intellijoint HIP™ System is substantially equivalent to the legally marketed predicate devices for its intended use in facilitating the accurate positioning of orthopaedic implants where a reference to rigid anatomical structures can be identified relative to the anatomy.

9. Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate devices, the intellijoint HIP™ System has been shown to be substantially equivalent to the legally marketed predicate devices identified in this submission, and does not present any new issues of 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).