(148 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of Angular Measurements: Angular measurements satisfy requirements for accuracy. | Angular measurements are displayed "to within ± 0.8° of their true value." |
| Accuracy of Distance Measurements: Distance measurements satisfy requirements for accuracy. | Distance measurements are displayed "to within ± 0.3 mm of their true value." |
| Accuracy of Resultant Position Changes (Implant Placement): Distance measurements of resultant position changes due to implant placement satisfy requirements for accuracy. | Distance measurements of resultant position changes due to implant placement are displayed "to within ± 1 mm of their true value." |
| Correct and Accurate Display of Implant Templates: Implant templates are displayed correctly and accurately. | Confirmed (No specific quantitative value provided beyond "Software satisfied all accuracy requirements."). |
| Functional Requirements and Intended Performance: The software satisfies functional requirements and performs as intended. | "Software satisfied all requirements and specifications." |
| Algorithm and Measurement Calculation Verification: Algorithms and measurement calculations are verified. | "Algorithms and measurement calculations were verified in these tests." |
| User Needs and Intended Use: Satisfies user needs and intended use. | "All user needs were met." |
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).