(21 days)
UroNav is a stereotaxic accessory for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (U/S) images and register these images with those from other imaging modalities such as Magnetic Resonance (MR). It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire, grid plate or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. Other software features include patient data management, multiplanar reconstruction. segmentation, image measurements and 2D/3D image registration.
UroNav is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue ablations and placement of fiducial markers.
UroNav System is a medical image processing system that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician. The target can be indicated either pre-procedurally or intraprocedurally using images or relative to an indicated position on the patient. As a diagnostic system, it combines pre-procedural and intraprocedural imaging to assist in locating areas of interest detected on one set of images on the other. The system provides fusion between Ultrasound (US) and different imaging modalities such as Magnetic Resonance Imaging (MR). When used as a navigation aid, it also transforms two and three-dimensional patient images (scan sets) into dynamic representations on which a medical instrument can be navigated. The system performs spatial mapping from one image space to another image space or from image space to physical space ("registration") allowing the physician to correlate scan sets with each other and to the patient. The system facilitates minimally invasive interventional procedures. Images used by UroNav can include archived image data from a CD, PACS, etc., and live images from an ultrasound system.
The UroNav system consists of an Electromagnetic Measurement System (EMMS) (including a Field Generator, System Control Unit and System Interface Unit(s)), a System Unit (including a CPU/monitor, medical-grade power supply and mobile cart), Field Generator stand, UroNav software and various instrumentation devices. The UroNav System Unit and the UroNav software utilize the keyboard, mouse and visual display to interact with the image data from a connected Ultrasound System. This interaction includes the selection of targets and associated navigation on the UroNav monitor. Targeted use areas for UroNav include hospital operating rooms, outpatient surgery centers, ultrasound suites, and procedure rooms.
The UroNav System is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, transrectal ultrasound (TRUS) probe, commercially available needle guides and needle gun combinations. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement and 3D image registration. UroNav utilizes an electromagnetic measurement system (EMMS) for identifying and tracking the location of the TRUS probe (and associated needle guides, instruments, etc.) relative to the 2D and 3D images. The EMMS Field Generator is positioned near the patient and provides an electromagnetic (EM) field for detection by a proprietary electromagnetic (EM) Sensor, which is attached to the ultrasound probe and tracks probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. The Field Generator and EM Sensor are connected to the UroNav System Control Unit and the PC running the UroNav software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of UroNav System. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, UroNav System is able to reconstruct and display a 3D image and 3D rendered surface model of the prostate.
The reconstructed 3D image can be further processed to perform various measurements including volume estimation and can be examined for abnormalities by the physician. Patient information, notes and images may be stored for future retrieval.
Locations for biopsies, needles, markers, and other devices may be selected by the physician, displayed in the 3D image and 3D rendered surface model, and stored. Previously created 3D models may be recalled and may be aligned or registered to the current live display of the prostate. The 3D model used for co-registration may be based on another series of ultrasound images or DICOM images.
The physician may also attach a commercially available biopsy needle guide to the TRUS probe and use the probe and biopsy needle to perform tissue biopsy. Whenever the ultrasound machine is turned on by the physician, the live 2D ultrasound image is displayed on the UroNav display during the biopsy. As the TRUS probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe is tracked. UroNav System is able to add, display and edit plans for target locations (e.g., biopsy sites) as well as an estimate of the probe position and needle trajectory relative to the 3D image and 3D rendered surface model of the prostate and the planned target locations. UroNav System offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure.
In addition to standard transrectal procedures, UroNav System also supports transperineal access and commercially available gridplates normally used for performing such procedures. When using transperineal mode, the UroNav EM Sensors are attached to both the TRUS probe and the transperineal gridplate within a mechanical stepper assembly. Procedure planning, segmentation, registration and navigation are performed the same as the standard transrectal procedure except that a computer rendering of the transperineal gridplate is displayed on the UroNav System display. UroNav System provides an indication of the gridplate coordinates that correspond to the identified target location.
The provided text describes the UroNav System and its substantial equivalence to a predicate device but does not contain a detailed study report that proves the device meets specific acceptance criteria with quantifiable metrics. Instead, it states that "Non-Clinical verification and or validation test results demonstrate that the UroNav System: Complies with the aforementioned international and FDA-recognized consensus standards and Meets the acceptance criteria and is adequate for its intended use."
The document focuses on establishing substantial equivalence to a predicate device (UroNav Version 3.0, K182561) rather than presenting a standalone study with specific performance outcomes.
Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from the text. The text explicitly states: "The UroNav System did not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes... Non-clinical performance testing..."
However, I can extract the information that is present regarding the non-clinical verification and validation:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with International and FDA-recognized Consensus Standards (e.g., IEC 60601-1, IEC 62304, IEC 62366, ISO 14971) | Complies with the aforementioned international and FDA-recognized consensus standards. |
| Adequacy for intended use (based on technical claims and risk management) | Meets the acceptance criteria and is adequate for its intended use. |
| Non-clinical performance (verification and validation) tests | Demonstrated substantial equivalence; results indicate acceptance criteria met. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified. The document refers to "Non-Clinical verification and or validation tests" but does not detail the methodology or sample sizes used for these tests.
- Data provenance: Not explicitly stated as retrospective or prospective clinical data, as it was a "non-clinical" study. The intent was to demonstrate substantial equivalence through technical testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was a non-clinical verification and validation study, not a study involving expert-established ground truth on medical images or patient data.
4. Adjudication method for the test set:
- Not applicable for a non-clinical verification and validation study focused on technical performance and compliance with standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The UroNav System did not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes: ... Non-clinical performance testing..."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document implies that non-clinical verification and validation tests were performed on the system's functionality, which would include algorithm-only performance for various features like image processing, segmentation, registration, and EM navigation. However, the exact details of such standalone testing (e.g., specific metrics, test cases) are not provided. The UroNav system itself is described as a medical image processing system that assists in procedures, implying a human-in-the-loop context for its intended use, even if components were tested in a standalone manner.
7. The type of ground truth used:
- For the non-clinical verification and validation tests, the ground truth would typically be established through engineering specifications, simulated data with known parameters, or phantom studies with measurable outcomes, in accordance with the mentioned consensus standards. The document does not specify the exact nature of this "ground truth" but implies it was based on functional requirements and technical accuracy.
8. The sample size for the training set:
- Not applicable. The document describes a "non-clinical verification and validation" study to demonstrate substantial equivalence, not a study involving machine learning model training.
9. How the ground truth for the training set was established:
- Not applicable, as there was no mention of a training set for a machine learning model.
§ 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).