The Intellijoint HIP Generation 2B 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 HIP Generation 2B System is indicated for patients undergoing orthopedic surgery, and where the use of stereotactic surgery is considered safe and effective. The surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning. Example orthopedic surgical procedures include, but are not limited to:

Total Hip Arthroplasty
Minimally Invasive Hip Arthroplasty
Revision Hip Arthroplasty

Device Description

The Intellijoint HIP® Generation 2B System is an imageless optical navigation system intended for use in orthopedic 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 procedures. The system is composed of an infrared Camera, Tracker, computer workstation, software, and bone fixation instruments/hardware.

The Intellijoint HIP® Generation 2B System is an update to the Intellijoint HIP® System previously cleared in 510(k) K162364. This submission provides the addition of revision hip arthroplasty (RHA) procedures to the indications for use, and the use of either linear or non-linear acetabular cup impactors. Other minor modifications made to the device are also provided.

AI/ML Overview

"The Intellijoint HIP Generation 2B System is an optical navigation system for orthopedic surgery. The manufacturer submitted a 510(k) premarket notification to the FDA to gain clearance for updates to the Indications for Use, specifically the addition of revision hip arthroplasty (RHA) procedures and the use of linear or non-linear acetabular cup impactors. Below is an outline of the acceptance criteria and the study that proves the device meets the acceptance criteria.

1. A table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria (Implied from Summary)	Reported Device Performance
Verification
Benchtop Accuracy	All accuracy requirements were met.	All accuracy requirements were met.
Software Functional and Unit Tests	Software satisfies functional requirements and performs as intended.	Software satisfied all requirements and specifications.
Bone Fixation Functional & Performance Tests	New hardware (Femoral Disc and Femoral Rod) satisfies functional and performance requirements.	All functional and performance requirements met.
Validation
Anatomical Phantom Simulated Use & Clinical Accuracy	Device satisfies user needs, intended use, and clinical accuracy requirements; accuracy assessed by comparing simulated use measurements with ground truth values.	All user needs and clinical accuracy requirements were met.
Cadaver Simulated Use	Device satisfies clinical use requirements and performs as intended.	All clinical use requirements were met.

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

The document does not explicitly state the numerical sample size for the anatomical phantom or cadaver studies regarding the number of simulated procedures or specimens used.

Anatomical Phantom Simulated Use and Clinical Accuracy: Bone models were used.
Cadaver Simulated Use: Human specimens (cadavers) were used.
The data provenance is prospective, as these were simulated use tests conducted by orthopedic surgeons. The country of origin of the data is not specified in the provided text.

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

Experts: Orthopedic surgeons were involved in the simulated use testing, both on bone models and cadavers. The number of surgeons is not specified.
Qualifications: They are referred to as "orthopedic surgeons," implying expertise in orthopedic surgical procedures. The duration of their experience is not mentioned.

4. Adjudication method for the test set:

The document does not describe an adjudication method for the test set. It states that accuracy was assessed by comparing simulated use measurements with ground truth values, but it does not specify if multiple experts independently made measurements or how discrepancies were resolved.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed. The Intellijoint HIP Generation 2B System is an optical navigation system that provides intra-operative measurements to a surgeon; it is not an AI-assisted diagnostic or interpretation tool in the typical sense that would be evaluated with an MRMC study for improved human reader performance. Its function is to provide measurement data to the surgeon, assisting with component selection and positioning.

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

The device's performance was evaluated with human-in-the-loop, as the "simulated use testing was performed on bone models by orthopedic surgeons" and "in a cadaver lab... operated by a surgeon." The system is designed to provide intra-operative measurements to a surgeon to aid in selection and positioning. Therefore, a standalone (algorithm-only) performance evaluation would not be applicable or relevant to its intended use, which is as a surgeon-assisted tool. The software functional and unit tests may have involved algorithm-only verification of calculations, but this is distinct from clinical performance assessment.

7. The type of ground truth used:

For the "Anatomical Phantom Simulated Use and Clinical Accuracy" test, ground truth values were established against which the simulated use measurements were compared. The exact method for establishing these ground truth values is not explicitly described but implies predefined, accurate measurements on the bone models.

8. The sample size for the training set:

The document describes performance testing for an update to an already cleared system. It does not provide information about a training set, as this device functions as a real-time intra-operative measurement tool rather than a machine learning model that requires a training set.

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

As no training set is described for this device's functionality, this question is not applicable."

Summary

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October 30, 2017

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

Re: K171525

Trade/Device Name: Intellijoint HIP Generation 2B System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 5, 2017 Received: October 6, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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 (DICE) 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 (DICE) 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) K171525

Device Name

Intellijoint HIP Generation 2B System

Indications for Use (Describe)

Total Hip Arthroplasty
Minimally Invasive Hip Arthroplasty
Revision Hip Arthroplasty

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

1. Submitter Information

Submitter:	Intellijoint Surgical Inc.
Address:	60 Bathurst Dr., Unit 6Waterloo, ONCanada N2V 2A9
Telephone:	(519) 342-3178
Fax:	(226) 317-0471
Contact:	Brandon Gingrich
Date Prepared:	May 23, 2017

2. Device Information

Trade Name:	Intellijoint HIP® Generation 2B 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 a previously cleared Computer-Assisted Orthopedic Surgery System.

4. Predicate Device Information

The Intellijoint HIP® Generation 2B System described in this submission is substantially equivalent to the following predicates:

Predicate Device	Manufacturer	510(k) No.
Intellijoint HIP® Generation 2A System	Intellijoint Surgical Inc.	K162364
Stryker OrthoMap Versatile Hip System	Stryker Leibinger GmbH	K162937

5. Device Description

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or non-linear acetabular cup impactors. Other minor modifications made to the device are also provided.

6. Intended Use

The Intellijoint HIP Generation 2B System is indicated for patients undergoing orthopedic 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 orthopedic surgical procedures include, but are not limited to:

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

7. Comparison of Technological Characteristics

The substantial equivalence of the Intellijoint HIP® Generation 2B 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 2A System cleared in 510(k) K162364. The following tests were performed to demonstrate the substantial equivalence of the updated Intellijoint HIP® Generation 2B System to its predicate devices:

Test	Summary	Result
Verification
Benchtop Accuracy	Verified clinical accuracy requirements usingcalibrated benchtop test fixtures.	All accuracyrequirementswere met.
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.
Bone FixationFunctional andPerformance Tests	Provides confirmation that new hardware(Femoral Disc and Femoral Rod) satisfyfunctional and performance requirements.	All functionaland performancerequirementsmet.

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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 in different shades of blue and gray. The company name is written in a sans-serif font, with the word "intellijoint" in bold and the word "surgical" in a smaller font below it.

Validation
Anatomical PhantomSimulated Use andClinical Accuracy	Simulated use testing was performed on bonemodels by orthopedic surgeons in asimulated THA procedure following a typicalworkflow. This test validated that theIntellijoint HIP® Generation 2B 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 2B Systemsatisfies clinical use requirements andperforms as intended when:- Operated by a surgeon- Used on human specimens- Used in a realistic operating roomenvironment	All clinical userequirementswere met.

The testing demonstrated that the Intellijoint HIP® Generation 2B 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 HIP® Generation 2B 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).