The Intellijoint HIP Generation 2A System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of 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.

The Intellijoint HIP Generation 2A System is indicated for patients undergoing orthopaedic surgery, and where the use of stereotactic surgery is considered safe and effective. The system aids the surgeon in performing intra-operative measurements including measurements of limb position, 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® Generation 2A System is an imageless optical navigation system intended for use in orthopaedic surgery. The device provides intra-operative assessment of patient leg length, offset, 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.

The intellijoint HIP® Generation 2A System is an update to the intellijoint HIP® System previously cleared in 510(k) K151364. The updates include revised software to support THA procedures performed using the Direct Anterior Approach, modified methods of patient registration, and leg position measurement.

AI/ML Overview

The Intellijoint HIP Generation 2A System is an imageless optical navigation system intended for intra-operative measurements to aid in the selection and positioning of orthopaedic implant system components, particularly for Total Hip Arthroplasty (THA). This 510(k) summary provides information on the device's acceptance criteria and the studies conducted to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance

The submission details three main categories of tests: Tracking System Accuracy and Robustness, Benchtop Accuracy, and Software Functional and Unit Tests under "Verification"; and Anatomical Phantom Simulated Use and Clinical Accuracy and Cadaver Simulated Use under "Validation."

Acceptance Criteria Category	Specific Criteria/Description	Reported Device Performance
Verification
Tracking System Accuracy and Robustness	Accuracy verified according to ASTM F2554-10. Testing simulated normal conditions, 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. The specific numerical accuracy targets are not provided in this summary but are implied to be part of the "clinical accuracy requirements."	"All accuracy 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.	"Software satisfied all requirements and specifications."
Validation
Anatomical Phantom Simulated Use and Clinical Accuracy	Simulated use testing on bone models by orthopaedic surgeons following a typical workflow. This test validated that the device satisfies user needs, intended use, and clinical accuracy requirements. Accuracy was assessed by comparing simulated use measurements with ground truth values. Specific numerical accuracy targets are not provided.	"All user needs and clinical accuracy requirements were met."
Cadaver Simulated Use	Simulated use testing in a cadaver lab. This test validated that the device satisfies clinical use requirements and performs as intended when operated by a surgeon, used on human specimens, and used in a realistic OR environment.	"All clinical use requirements were met."

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

Tracking System Accuracy and Robustness: The document does not specify a distinct "test set" sample size in terms of number of cases or subjects. The testing involved simulating "normal conditions, and a variety of worst-case use scenarios and realistic tracking disturbances." This implies a varied set of conditions rather than a fixed number of "samples."
Benchtop Accuracy: Not specified. Testing used "calibrated benchtop test fixtures," implying a controlled laboratory environment.
Anatomical Phantom Simulated Use and Clinical Accuracy: Not specified in terms of the number of phantom models or simulated procedures. Data provenance is implied to be laboratory-based (simulated use on bone models), likely in North America (Canada, given the company's location). This was a prospective simulation.
Cadaver Simulated Use: Not specified in terms of the number of cadavers or simulated procedures. Data provenance is implied to be laboratory-based (cadaver lab), likely in North America. This was a prospective simulation.

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

Tracking System Accuracy and Robustness: Ground truth would likely be established by a reference tracking system or measurement standard, not human experts.
Benchtop Accuracy: Ground truth would be established by "calibrated" measurement systems and fixtures, not human experts.
Anatomical Phantom Simulated Use and Clinical Accuracy: Orthopaedic surgeons performed the simulated use. Their number and specific qualifications (e.g., years of experience) are not specified. It is reasonable to assume they were experienced in THA. The "ground truth values" for accuracy comparison would not be established by these surgeons but by precision measurement tools on the phantom models.
Cadaver Simulated Use: Orthopaedic surgeons operated the system. Their number and specific qualifications are not specified. Ground truth for clinical use requirements would be determined by whether the system performed as intended under realistic conditions, likely evaluated by the surgeons and study coordinators against established protocols, rather than individual "ground truth" measurements like accuracy.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth from multiple human readers/experts. For the accuracy tests, ground truth appears to be based on objective physical measurements or comparisons to established standards. For simulated use, the assessment of "satisfaction of user needs" and "clinical use requirements" would likely be based on pre-defined criteria and possibly surgeon feedback rather than an adjudication process of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the effect size of how much human readers improve with AI vs without AI assistance?

No MRMC comparative effectiveness study is described in this summary. The Intellijoint HIP Generation 2A System is an optical navigation system that provides intra-operative measurements. It's a tool for surgeons, not an AI system that directly assists human readers (like radiologists interpreting images). Therefore, an MRMC study in the traditional sense of comparing human reader performance with and without AI assistance is not applicable to this device's reported testing. The testing focuses on the system's own accuracy and its ability to meet clinical requirements during surgery.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

The device is an "imageless optical navigation system intended to provide intra-operative measurements to a surgeon." Its function is inherently "human-in-the-loop," as it provides information to a surgeon to aid in decision-making and positioning. Therefore, a purely standalone (algorithm-only) performance evaluation would not be directly applicable to its intended use in surgery. However, the "Tracking System Accuracy and Robustness" and "Benchtop Accuracy" tests essentially evaluate the core capabilities of the system (including its algorithms for measurement and tracking) in a controlled, objective manner, which could be considered a form of standalone evaluation of its measurement accuracy, even if its ultimate application requires human interaction.

7. The Type of Ground Truth Used

Tracking System Accuracy and Robustness: Ground truth was established against reference standards according to ASTM F2554-10, likely using a highly accurate measurement system (e.g., a coordinate measuring machine or a more precise optical tracking system).
Benchtop Accuracy: Ground truth was established using "calibrated benchtop test fixtures," implying objective, known, and precise measurements.
Anatomical Phantom Simulated Use and Clinical Accuracy: Ground truth was established through "ground truth values" on the phantom models, which would have been precisely measured and known references. This is objective, physical measurement ground truth.
Cadaver Simulated Use: Ground truth for meeting "clinical use requirements" would be assessed based on the system's ability to perform its functions as intended by a surgeon in a realistic surgical environment on human specimens. This focuses more on functional performance and user satisfaction rather than a single, objective "ground truth" measurement.

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" sample size. This device is an optical navigation system with specific algorithms for measurement and tracking, not a machine learning or AI model in the sense of requiring a large, labeled training dataset for pattern recognition. The software "algorithms and measurement calculations were also verified" implying deterministic or rule-based algorithms, or algorithms trained on smaller, controlled datasets, but not a "training set" in the context of deep learning.

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

As no specific "training set" is described for machine learning, the concept of establishing ground truth for it is not applicable here. The algorithms' accuracy and functionality would be verified through rigorous engineering testing (as suggested by the "Software Functional and Unit Tests") against known mathematical principles and validated reference data, rather than a labeled training set derived from expert consensus on medical cases.

Summary

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

March 2, 2017

Intellijoint Surgical Inc. Brandon Gingrich Quality And Regulatory Affairs Manager 60 Bathurst Drive, Unit 6 Waterloo, Ontario N2V 2A9 Canada

Re: K162364

Trade/Device Name: Intellijoint HIP Generation 2A System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 27, 2017 Received: January 30, 2017

Dear Brandon 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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

Mark N. Melkerson -S

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) K162364

Device Name Intellijoint HIP Generation 2A System

Indications for Use (Describe)

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

Total Hip Arthroplasty
Minimally Invasive Hip Arthroplasty

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/1 description: The image contains the logo for "Intellijoint Surgical". The logo consists of a geometric shape on the left, resembling a stylized joint, with the company name to the right. The geometric shape is composed of blue and gray triangles, while the company name is written in gray, with the word "surgical" in a smaller font size below "intellijoint".

K162364

510(k) Summary

1. Submitter Information

Submitter:Address:	Intellijoint Surgical Inc.60 Bathurst Dr., Unit 6Waterloo, ONCanada N2V 2A9
Telephone:Fax:	(519) 342 - 3178(226) 317 - 0471
Contact:	Brandon Gingrich
Date Prepared:	January 27th, 2016

Trade Name:	intellijoint HIP® Generation 2A 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® Generation 2A System described in this submission is substantially equivalent to the following predicates:

Predicate Device	Manufacturer	510(k) No.
intellijoint HIP® Generation 2 System	Intellijoint Surgical Inc.	K151364
Navitrack™ System – Total Hip ReplacementCT-Free	ORTHOsoft, Inc.	K041369

5. Device Description

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Image /page/4/Picture/1 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 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 than the word "Surgical".

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® Generation 2A System to the predicates is shown by similarity in intended use, indications for use, and performance.

8. Performance Data

This submission is for updates to the intellijoint HIP® Generation 2 System cleared in 510(k) K151364. The following tests were performed to demonstrate the substantial equivalence of the updated intellijoint HIP® Generation 2A System to its predicate devices:

Test	Brief Summary	Result
Verification
Tracking System Accuracy and Robustness	The intellijoint HIP® Generation 2A System's accuracy was verified according to the methodology in 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.

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Image /page/5/Picture/1 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 a blue triangle on top, a light blue curved shape in the middle, and a gray triangle pointing downwards at the bottom. The company name is written in a sans-serif font, with "Intellijoint" in a larger font size and "Surgical" in a smaller font size below it.

Software Functionaland Unit Tests	Verified that the software applicationsatisfies functional requirements andperforms as intended. Algorithms andmeasurement calculations were also verifiedin these tests.	Softwaresatisfied allrequirements andspecifications.
Validation
Anatomical PhantomSimulated Use andClinical Accuracy	Simulated use testing was performed on bonemodels by orthopaedic surgeons in asimulated THA procedure following a typicalworkflow. This test validated that theintellijoint HIP® Generation 2A Systemsatisfies user needs, intended use and clinicalaccuracy requirements. Accuracy wasassessed by comparing simulated usemeasurements with ground truth values.	All user needsand clinicalaccuracyrequirementswere met.
Cadaver SimulatedUse	Simulated use testing was also performed ina cadaver lab. This test validated that theintellijoint HIP® Generation 2A Systemsatisfies clinical use requirements andperforms as intended when:- Operated by a surgeon- Used on human specimens- Used in a realistic OR environment	All clinical userequirementswere met.

The testing demonstrated that the intellijoint HIP® Generation 2A 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® Generation 2A 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).