(221 days)
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
| Acceptance Criteria / Test | Brief Summary | Reported Device Performance/Result |
|---|---|---|
| Tracking System Accuracy and Robustness | The Intellijoint HIP™ System's accuracy was verified according to ASTM F2554-10 - Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. Testing simulated normal conditions, and a variety of worst-case use scenarios and realistic tracking disturbances. | All accuracy specifications and robustness requirements were met. |
| Benchtop Accuracy | Verified clinical accuracy requirements using calibrated benchtop test fixtures. | All accuracy requirements were met. |
| Bone Fixation Performance | Verified bone fixation performance requirements including functional tests, robustness, rigidity of fixation and repeatability. | All functional and performance requirements were met. |
| Software Functional and Unit Tests | Verified that the software application satisfies functional requirements and performs as intended. Algorithms and measurement calculations were also verified in these tests. | Software satisfied all requirements and specifications. |
| Electrical Safety and EMC | Compliance with ANSI / AAMI / IEC 60601-1:2005 for medical electrical equipment: - Part 1: General requirements for basic safety and essential performance - Part 1-2: Collateral standard—Electromagnetic compatibility – requirements and tests - Part 1-6: Collateral Standard: Usability | Compliance with the requirements of the standards demonstrated. |
| Biocompatibility Evaluation | Evaluation against the applicable requirements of ISO 10993-1:2009 – Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Part 5: Tests for in vitro cytotoxicity - Part 10: Tests for irritation and skin sensitization - Part 11: Tests for systemic toxicity | Compliance with the requirements of the standards demonstrated. |
| Anatomical Phantom Simulated Use and Clinical Accuracy | Simulated use testing was performed on bone models by orthopaedic surgeons in a simulated THA procedure following a typical workflow. This test validated that the Intellijoint HIP™ System satisfies user needs, intended use and clinical accuracy requirements. Accuracy was assessed by comparing simulated use measurements with ground truth values. | All user needs and clinical accuracy requirements were met. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify exact sample sizes (e.g., number of bones models or simulated procedures) for the "Anatomical Phantom Simulated Use and Clinical Accuracy" test. However, it indicates that testing was performed on "bone models."
The data provenance is from simulated use testing in a lab setting, not from human patient data. Therefore, it is a prospective study in a simulated environment, rather than retrospective data. The country of origin of the data is not explicitly stated, but the company address is in Waterloo, ON, Canada.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document states that the simulated use testing was performed by "orthopaedic surgeons." The specific number of surgeons and their detailed qualifications (e.g., years of experience) are not provided.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method for the test set results. The accuracy in simulated use was assessed by "comparing simulated use measurements with ground truth values." This implies a direct comparison rather than a multi-expert adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted as part of this submission. The testing focused on the device's accuracy and performance in simulated scenarios, not on the comparative effectiveness of human readers with or without AI assistance. The device is an optical localizer intended to aid surgeons, not an AI for image interpretation that would typically necessitate an MRMC study to show human reader improvement.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
The device is an "optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopaedic implant system components." It is inherently a human-in-the-loop system. While "Software Functional and Unit Tests" verified algorithms and measurement calculations, this is not equivalent to a standalone diagnostic or interpretative algorithm performance study. The "Anatomical Phantom Simulated Use and Clinical Accuracy" involved surgeons performing procedures with the system. Therefore, a purely standalone (algorithm-only) performance study was not detailed in the provided information.
7. The Type of Ground Truth Used
For the "Anatomical Phantom Simulated Use and Clinical Accuracy" test, the ground truth was established using calibrated physical measurements from "calibrated benchtop test fixtures" and "ground truth values" derived from the bone models themselves. This is analogous to a phantom-based ground truth.
8. The Sample Size for the Training Set
The document does not mention a training set in the context of machine learning or artificial intelligence. The Intellijoint HIP™ System is described as a "computer-controlled, optical localizer" and an "imageless optical navigation system," implying it relies on principles of optical tracking and geometry rather than complex machine learning models that require large training datasets. Therefore, a training set as understood in AI/ML is not applicable or detailed.
9. How the Ground Truth for the Training Set Was Established
As no training set (in the AI/ML context) is indicated, this point is not applicable.
§ 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).