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510(k) Data Aggregation
(117 days)
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:
| Test | Inferred Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Benchtop Accuracy | The Intellijoint KNEE component (and by extension, the Intellijoint® Navigation System when used for TKA) must meet predefined clinical accuracy requirements as verified using calibrated benchtop test fixtures. | "All accuracy requirements were met." This implies the system's measurements (e.g., varus/valgus angle, flexion/extension angle, resection depth) were within acceptable predefined tolerances when tested in a controlled benchtop environment. |
| Tracking System Accuracy and Robustness | The accuracy of Intellijoint KNEE must meet the methodology outlined in ASTM F2554-10 (Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems). The system must maintain accuracy and robustness under normal conditions, worst-case use scenarios, and realistic tracking disturbances. | "All accuracy specifications and robustness requirements were met." This suggests that the tracking system's ability to precisely locate and track anatomical structures and instruments was verified to be within specified limits, even when subjected to conditions simulating real-world surgical challenges. The standard ASTM F2554-10 implies quantitative performance metrics. |
| Software Functional and Unit Tests | The Intellijoint KNEE Software Application must satisfy all functional requirements, perform as intended, and accurately execute algorithms and measurement calculations. | "Software satisfied all requirements and specifications." This indicates that the software's logic, calculations for measurements (e.g., bone cuts, alignment), and overall functionality were rigorously tested and found to be free of defects and to perform correctly according to design specifications. |
| Mechanical Instrumentation Functional and Performance Tests | All mechanical instruments developed for the Intellijoint® Navigation System's TKA application must satisfy their functional and performance requirements. | "All functional and performance requirements met." This confirms that the physical tools used with the system (e.g., TKA-specific mechanical instruments) perform reliably and as designed, implying they are robust, precise, and fit for their intended purpose in a surgical setting. |
| Anatomical Phantom Simulated Use and Clinical Accuracy | The Intellijoint KNEE component must satisfy user needs, intended use, and clinical accuracy requirements when used by orthopedic surgeons in a simulated TKA procedure on bone models. Accuracy is assessed by comparing simulated measurements to ground truth values. | "All user needs and clinical accuracy requirements were met." This suggests that the system's ease of use, workflow integration, and most importantly, its ability to provide accurate measurements in a simulated surgical environment were validated. The comparison to "ground truth values" implies that the measurements taken by the system were within clinically acceptable deviation from known model values. |
| Cadaver Simulated Use | The Intellijoint KNEE component must satisfy clinical use requirements and perform as intended when: - 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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