(224 days)
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.
| 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.
§ 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).