Intellijoint HIP™ is an infrared. computer-controlled localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implants, relative to anatomical structures and reference axes.

Intellijoint HIP™ is indicated for patients undergoing orthopedic surgery where the use of stereotactic safe and effective, and where a reference to a rigid anatomical structure, such as a long bone, can be identified relative to the anatomy. The system aids the surgeon in controlling leg length and offset discrepancies.

Example orthopedic 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 orthopedic surgery. The Intellijoint HIPTM System provides intra-operative assessment of patient leg length and offset during Total Hip Arthroplasty (THA) procedures. The system is composed of an infrared sensor, a tracked reflective marker assembly (beacon), a computer workstation, software, and bone fixation components. The infrared sensor is affixed to the patient's pelvis and the beacon is attached to the patient's femur. The system records the position and orientation of the femur relative to the pelvis prior to hip dislocations. This baseline information can then be used to track the change in leg length and leg offset during the joint replacement procedure.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Intellijoint HIP™ System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For non-clinical performance evaluation through various tests conducted as part of the 510(k) submission, the stated acceptance criterion for each test was "All [relevant] requirements were met" or "Compliance with the requirements of the standards demonstrated." The reported device performance uniformly confirms that these criteria were met.

Test	Acceptance Criteria (Implicit)	Reported Device Performance
Tracking System Accuracy	Intellijoint HIP™ software application accuracy verified according to ASTM F2554-10. All accuracy specifications to be met.	All accuracy specifications were met.
Benchtop Accuracy and Robustness	Clinical accuracy requirements verified using calibrated benchtop test fixtures, simulating normal and worst-case scenarios, and realistic tracking disturbances. All accuracy and robustness requirements to be met.	All accuracy and robustness requirements were met.
Bone Fixation Performance	Bone fixation performance requirements, including functional tests, robustness, rigidity of fixation, and repeatability, to be met.	All functional and performance requirements were met.
Software Functional and Unit Tests	Software application to satisfy functional requirements and perform as intended. Algorithms and measurement calculations to be verified.	Software satisfied all requirements and specifications.
Electrical Safety and EMC	Compliance with ANSI/AAMI ES60601-1:2005/(R)2012 for medical electrical equipment (Part 1 and Part 1-2).	Compliance with the requirements of the standards demonstrated.
Biocompatibility Evaluation	Evaluation against applicable requirements of ANSI/AAMI/ISO 10993-1:2009 (Parts 1, 5, 10, 11).	Compliance with the requirements of the standards demonstrated.
Sawbones Simulated Use and Accuracy	Non-clinical simulated use testing on bone models (sawbones) by orthopedic surgeons to validate satisfaction of user needs, intended use, and clinical accuracy requirements. Accuracy to be assessed by comparing simulated use measurements with ground truth values. All user needs and clinical accuracy requirements to be met.	All user needs and clinical accuracy requirements were met.
Cadaver Simulated Use and Accuracy	Pre-clinical simulated use testing in a cadaver lab. Validation that the system satisfies clinical use/accuracy requirements and performs as intended when operated by a surgeon, used on human specimens, and in a realistic OR environment. All clinical use and accuracy requirements to be met.	All clinical use and accuracy requirements were met.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state numerical sample sizes for the "test set" in the context of individual measurements or "cases." Instead, it describes methodologies and the types of materials used for testing:

Sawbones Simulated Use and Accuracy: "Non-clinical simulated use testing was performed on bone models (sawbones)." The number of sawbones or individual runs is not specified.
Cadaver Simulated Use and Accuracy: "Pre-clinical simulated use testing was performed in a cadaver lab." The number of cadavers or individual runs is not specified.

Data Provenance:

Sawbones: In-house simulated laboratory environment.
Cadaver: In-house simulated laboratory environment, using human specimens (cadavers).
Retrospective/Prospective: The testing described is prospective in nature, as it involves active testing and validation of the device.

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

Sawbones Simulated Use and Accuracy: "Performed ... by orthopedic surgeons." The number of surgeons is not specified, nor are their specific qualifications (e.g., years of experience).
Cadaver Simulated Use and Accuracy: "Operated by a surgeon." The number of surgeons is not specified, nor are their specific qualifications.
Ground Truth for Accuracy Tests: For both sawbones and cadaver studies, ground truth values were established for comparison using "calibrated benchtop test fixtures" or by some means that allowed "comparing simulated use measurements with ground truth values." The specific method of establishing this ground truth is not detailed beyond being "calibrated."

4. Adjudication Method for the Test Set

The provided text does not describe any adjudication method for the test set (e.g., 2+1, 3+1). The accuracy assessments appear to involve direct comparison of device measurements against a ground truth established by calibrated systems or independent measurements, rather than requiring expert consensus on the device's output.

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

The document does not describe an MRMC comparative effectiveness study involving human readers or AI assistance in the traditional sense. The Intellijoint HIP™ System is an "imageless optical navigation system" that provides intra-operative measurements. It's a tool for the surgeon during the procedure, not a diagnostic imaging AI that assists in interpreting data or making clinical decisions outside the direct surgical guidance. Therefore, a study measuring "human readers improvement with AI assistance" is not applicable to the described device and its stated purpose in this document.

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

Yes, standalone performance was assessed through several tests:

Tracking System Accuracy: Verified via "Intellijoint HIP™ software application."
Benchtop Accuracy and Robustness: Verified "clinical accuracy requirements using calibrated benchtop test fixtures."
Software Functional and Unit Tests: Verified that the "software application satisfies functional requirements and performs as intended. Algorithms and measurement calculations were verified."

These tests demonstrate the system's inherent accuracy and functionality independent of direct real-time human interpretation or decision-making in a live surgical context. While surgeons operate the system in simulated use cases, the underlying performance metrics (accuracy, functionality) are assessed directly from the device's outputs against known ground truth.

7. The Type of Ground Truth Used

The ground truth used for accuracy and performance assessments appears to be:

Calibrated Measurement Systems/Fixtures: For "Tracking System Accuracy" and "Benchtop Accuracy and Robustness," ground truth was established using "calibrated benchtop test fixtures."
Expert-Defined or Known Values: For "Sawbones Simulated Use and Accuracy," accuracy was assessed by comparing simulated use measurements with "ground truth values," implying a reference standard or known measurement. This could be pre-measured values on the sawbones or values derived from highly accurate instrumentation.
For the cadaver study, it also validated accuracy requirements, implying comparison to a reliable reference.

The primary method appears to be objective, quantitatively measured ground truth established through calibrated instruments or pre-determined values, rather than subjective expert consensus (like in imaging diagnosis) or pathology/outcomes data.

8. The Sample Size for the Training Set

The document does not mention a training set or any deep learning/machine learning components that would typically require a distinct training set. The Intellijoint HIP™ System is described as an "imageless optical navigation system" with "algorithms and measurement calculations" that were "verified" in software tests. This suggests a deterministic, rule-based or model-based system rather than a machine learning system requiring a data training phase.

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

Since no training set is mentioned, this information is not applicable based on the provided text.

Summary

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SECTION 5 - 510(k) Summary

510(k) Summary Intellijoint HIPTM System

1. Submitter Information

Submitter:Address:	Intellijoint Surgical Inc.60 Bathurst Dr., Unit 1Waterloo, ONCanada N2V 2A9
Telephone:	519.342.3178
Contact:	Brandon Gingrich
Date Prepared:	July 21st, 2014

2. Device Information

Trade Name:	Intellijoint HIPTM 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 a new Computer-Assisted Orthopedic 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.
DASH Hip System	BrainLAB AG	K110021
StealthStation Imageless Hip Module	Medtronic	K052623

5. Device Description

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marker assembly (beacon), a computer workstation, software, and bone fixation components. The infrared sensor is affixed to the patient's pelvis and the beacon is attached to the patient's femur. The system records the position and orientation of the femur relative to the pelvis prior to hip dislocations. This baseline information can then be used to track the change in leg length and leg offset during the joint replacement procedure.

6. Intended Use

Intellijoint HIP™ is an infrared, computer-controlled localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, relative to anatomical structures and reference axes.

Intellijoint HIP™ is indicated for patients undergoing orthopedic surgery where the use of stereotactic surgery is considered safe and effective, and where a reference to a rigid anatomical structure, such as a long bone, can be identified relative to the anatomy. The system aids the surgeon in controlling leg length and offset discrepancies.

Example orthopedic 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.

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8. Performance Data

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

Test	Brief Summary	Result
Verification
Tracking SystemAccuracy	The Intellijoint HIP™ System'saccuracy was verified using theIntellijoint HIP™ software applicationaccording to the methodology inASTM F2554-10 - Standard Practicefor Measurement of PositionalAccuracy of Computer AssistedSurgical Systems.	All accuracyspecificationswere met.
Benchtop Accuracyand Robustness	Verified clinical accuracy requirementsusing calibrated benchtop test fixtureswhile simulating normal use, a varietyof worse-case use scenarios andrealistic tracking disturbances.	All accuracyand robustnessrequirementswere met.
Bone FixationPerformance	Verified bone fixation performancerequirements including functional tests,robustness, rigidity of fixation andrepeatability.	All functionalandperformancerequirementswere met.
Software Functionaland Unit Tests	Verified that the software applicationsatisfies functional requirements andperforms as intended. Algorithms andmeasurement calculations were verifiedin these tests.	Softwaresatisfied allrequirementsandspecifications.
Electrical Safety andEMC	Compliance with ANSI/AAMIES60601-1:2005/(R)2012 for medicalelectrical equipment:Part 1: General requirements forbasic safety and essentialperformancePart 1-2: General requirements forbasic safety and essentialperformance - collateralstandard-Electromagneticcompatibility - requirements andtests	Compliancewith therequirements ofthe standardsdemonstrated.
BiocompatibilityEvaluation	Evaluation against the applicablerequirements of ANSI/AAMI/ISO10993-1:2009 - Biological evaluationof medical devices- Part 1: Evaluation and testingwithin a risk management process- Part 5: Tests for in vitrocytotoxicity- Part 10: Tests for irritation andskin sensitization- Part 11: Tests for systemic toxicity	Compliancewith therequirements ofthe standardsdemonstrated.
Validation
Sawbones SimulatedUse and Accuracy	Non-clinical simulated use testing wasperformed on bone models (sawbones)by orthopedic surgeons in a simulatedTHA procedure following a typicalTHA workflow. This test validated thatthe Intellijoint HIPTM system satisfiesuser needs, intended use and clinicalaccuracy requirements. Accuracy wasassessed by comparing simulated usemeasurements with ground truthvalues.	All user needsand clinicalaccuracyrequirementswere met.
Cadaver SimulatedUse and Accuracy	Pre-clinical simulated use testing wasperformed in a cadaver lab. This testvalidated that the Intellijoint HIPTMsystem satisfies clinical use/accuracyrequirements and performs as intendedwhen:- Operated by a surgeon- Used on human specimens- Used in a realistic OR environment	All clinical useand accuracyrequirementswere met.

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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 orthopedic 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.

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

July 29, 2014

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

Re: K133759

Trade/Device Name: Intellijoint HIPTM Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Product Code: OLO Regulatory Class: Class II Dated: June 25, 2014 Received: June 26, 2014

Dear Mr. Gingrich:

This letter corrects our substantially equivalent letter of July 23, 2014.

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. Iisting 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

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Page 2 - Mr. Brandon Gingrich

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

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.

Lori A. Wiggins

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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) K133759

Device Name Intellijoint НІРТм

Indications for Use (Describe)

Example orthopedic 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Casey L. Hanley, Ph.D.

Division of O

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).