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Intellijoint VIEW is indicated to assist qualified healthcare professionals in preoperative planning and postoperative review of orthopedic surgery. The device allows for orthopedic implant to be overlaid on medical images for the purpose of selecting and positioning implants. The device includes tools for performing measurements and evaluating surgical treatment options. Clinical judgement and experience are required to properly use the software.

Intellijoint® VIEW is a web-based software as a medical device (SaMD) product that assists health care professionals complete preoperative planning and postoperative review for orthopedic surgery. Preoperative planning on Intellijoint® VIEW involves the user completing measurements on medical images to inform the selection and intraoperative positioning of orthopedic implant system components. Intellijoint® VIEW also allows for postoperative image review and measurement.

Intellijoint® VIEW Templating tool allows the user to perform distance and angular measurements on scaled medical images, to inform selection of acetabular and femoral implant components.

Intellijoint® VIEW Hip-Spine Assessment allows the user to assess a patient's spinopelvic relationship for preoperative functional acetabular cup position planning. The Application overlays acetabular measurement tools on standing and sitting lateral functional patient images to inform an appropriate implant position based on the functional relationship between the hips and spine.

The Intellijoint VIEW device's acceptance criteria and the study proving it meets these criteria are detailed below, synthesizing information from the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific sample size (i.e., number of images or cases) used for the accuracy test set. It mentions "radiographic images" were used in the Simulated Use and Usability Validation.

Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.

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

The document states that "Simulated use testing was performed by qualified orthopedic surgeons" for the Usability Validation. It does not specify the number of surgeons involved or their years of experience. Their qualification is broadly stated as "qualified orthopedic surgeons."

For the quantitative accuracy tests (angular and distance measurements), the document does not describe the process for establishing ground truth or the involvement of experts beyond the statement that these tests provide "confirmation that distance and angular measurements satisfy requirements for accuracy" and "implant templates are displayed correctly and accurately." It implies a direct comparison to a "true value," which for software verification often means comparison against a known standard or precise reference rather than human-established ground truth.

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. Given the nature of the accuracy and functional tests described (verification of calculations, measurements against true values, and simulated use), a formal adjudication process for interpreting results may not have been deemed necessary in the same way it would be for diagnostic AI.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for this Traditional 510(k)." The tests performed focused on device functionality, accuracy, and usability in a simulated environment, rather than a comparative effectiveness study with human readers.

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

The performance data primarily describes standalone performance in terms of accuracy of measurements and proper display of templates. The "Accuracy Test" verifies that the device's calculations and displays meet specified tolerances. This is characteristic of an algorithm-only assessment when the "true value" is a known numerical standard.

The "Simulated Use and Usability Validation" involved "qualified orthopedic surgeons" interacting with the device, which includes a human-in-the-loop component, but the goal was to validate user needs and intended use, not to evaluate human reader improvement with or without AI assistance.

7. Type of Ground Truth Used

For the quantitative accuracy tests (angular and distance measurements, implant placement changes), the ground truth appears to be based on "true value" comparisons, likely established through precise technical specifications, known inputs, or calibrated reference points, typical for software verification where outputs are numerical.

For the "Simulated Use and Usability Validation," the ground truth was established by assessing whether the software "satisfies user needs and intended use" based on expert judgment ("qualified orthopedic surgeons") during a typical workflow. This is a form of qualitative expert consensus on usability.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set size. This suggests that the device's functionality primarily involves measurement and templating tools based on pre-programmed algorithms rather than machine learning models that require extensive training data.

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

As no training set is mentioned or implied for a machine learning model, this information is not applicable and not provided in the document. The device's validation focuses on its accuracy in performing calculations and displaying information, which typically relies on internal verification against established mathematical or engineering standards rather than external ground truth data.

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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

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.

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:

• 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.

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The Intellijoint HIP Generation 2C 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 system is only compatible with straight acetabular cup impactors.

The Intellijoint HIP Generation 2C 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

The Intellijoint HIP® Generation 2C 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.

This submission describes updates implemented to provide terminally sterile bone screws to the user, which were previously only supplied non-sterile. The intended use and fundamental scientific technology is unchanged, and remains substantially equivalent to the predicate device.

The provided text describes a 510(k) submission for the Intellijoint HIP Generation 2C System, which is an update to a previously cleared computer-assisted orthopedic surgery system. The submission focuses on changes to the sterilization and packaging processes for bone screws, rather than a clinical performance study of the device's accuracy in intra-operative measurements.

Therefore, the acceptance criteria and study detailed below relate to manufacturing, sterilization, and packaging aspects of the bone screws included with the system, not the accuracy or clinical effectiveness of the Intellijoint HIP system itself. The document states "The intended use and fundamental scientific technology is unchanged, and remains substantially equivalent to the predicate device." and "This modification does not alter the device's fundamental scientific technology in comparison to the predicate devices (K151364 and K162364) and therefore has the same technological characteristics."

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state sample sizes for each test mentioned (e.g., number of screws tested for cleaning, biocompatibility, sterilization, or packaging). The tests listed are primarily laboratory-based or engineering tests on components/packaging rather than clinical studies with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply in the context of these specific manufacturing and sterilization validation tests.

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

This information is not applicable to the types of tests described, as the ground truth is established through standardized laboratory testing procedures and specifications (e.g., gravimetric analysis for residue, cytotoxicity assays, bacterial endotoxin limits, physical testing for packaging integrity) rather than expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical or image-based studies where human interpretation or consensus is required. These methods are not relevant to the engineering and analytical tests described for manufacturing, sterilization, and packaging validation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The submission explicitly states it does not alter the device's fundamental scientific technology and the purpose is for updates to sterilization and packaging processes. Therefore, a clinical MRMC comparative effectiveness study, particularly one measuring human reader improvement with or without AI, was not conducted nor is it applicable to this type of regulatory submission. The device is an "imageless optical navigation system" and the current submission is about manufacturing/sterilization, not a new AI component requiring human reader evaluations.

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

No. The tests described are related to the manufacturing, sterility, and packaging of physical components (bone screws) of the system, not a standalone algorithm's performance in a clinical or diagnostic context.

7. The Type of Ground Truth Used

For the tests described:

• Manufacturing Cleaning Process: Measured gravimetric residue, compared against pre-defined acceptance criteria.
• Biocompatibility Analysis: Cytotoxicity levels determined via standardized assays, compared against safety limits.
• Packaging Integrity Testing: Physical measurements (e.g., seal width, strength), visual inspections, and performance under stress, compared against engineering specifications.
• Sterilization Validation Testing: Sterility assurance levels (SAL) confirmed through gamma irradiation studies, adhering to regulatory standards for medical device sterility.
• Sterile Barrier System Integrity Tests: Physical characteristics (seal width, strength), leak tests, visual inspection, compared against design specifications.
• Shelf-life/Aging Tests: Observation of material degradation and integrity over time (real-time and accelerated), compared against expected performance.
• Pyrogenicity Testing: Bacterial endotoxin levels quantified using LAL testing, compared against established endotoxin limits.

In essence, the ground truth for these tests is based on established scientific and engineering standards, validated laboratory methods, and regulatory limits applicable to medical device manufacturing and sterilization.

8. The Sample Size for the Training Set

This concept is not applicable here. The document describes validation tests for manufacturing and sterilization processes, not the development or training of an algorithm or AI model.

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

This concept is not applicable as there is no training set for an AI/algorithm described in this submission.

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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

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.

"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:

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."

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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

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.

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."

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.

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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

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.

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

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.

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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

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.

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.

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.

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