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UroNav is a stereotaxic accessory for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance (MR), Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire, gridplate 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. multi-planar 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 biopsies, soft tissue ablations and placement of fiducial markers.

UroNav is a medical image processing workstation 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 preprocedurally or intra-procedurally using images or relative to an indicated position on the patient. As a diagnostic system, it combines pre-procedural and intra-procedural 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), Computed Tomography (CT), etc. 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.

UroNav 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, multiplanar 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. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, UroNav 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-reqistration 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 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 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 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 display. UroNav provides an indication of the gridplate coordinates that correspond to the identified target location.

The provided text is a 510(k) summary for Invivo Corporation's UroNav (Version 2.0) device. This document focuses on demonstrating substantial equivalence to pre-existing devices rather than detailing a specific clinical study with acceptance criteria and performance metrics for the UroNav device itself.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and MRMC studies are not available in this document. The document outlines general nonclinical testing and states that predetermined acceptance criteria were met but does not specify what those criteria or the exact performance results were.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The text states:

• "Nonclinical and performance testing has been performed by designated individuals as required by Invivo Corporation’s quality procedures."
• "Verification & Validation Test Plans were designed to evaluate all input functions, output functions, and actions performed by UroNav in each operational mode."
• "UroNav has been assessed and tested at the manufacturer’s facility and has passed all in-house testing criteria including validating design, function and specifications."
• "Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met."

However, the specific acceptance criteria (e.g., target accuracy, registration error thresholds) and the quantitative reported device performance against those criteria are not described in this 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The nonclinical testing mentioned appears to be internal verification and validation, not a clinical study involving a test set of patient data with a specific sample size or provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. As no clinical test set of patient data is detailed, the establishment of ground truth by external experts is not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

There is no mention of an MRMC comparative effectiveness study in this document. The UroNav system as described is an image-guided accessory and workstation, not an AI or CAD (Computer-Aided Detection) system whose effect on human reader performance would typically be measured in an MRMC study. The device provides "image-guided intervention and diagnostic information" and acts as a "navigation aid" and "medical image processing workstation."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not provided in the document, nor is it directly applicable. The device is explicitly described as an accessory for "image-guided interventional and diagnostic procedures" and an "image processing workstation." It is inherently designed for human-in-the-loop use. The document states: "Diagnosis is not performed by the UroNav system but by Radiologists, Clinicians and referring Physicians. A physician, providing ample opportunity for competent human intervention interprets the images and information being displayed and maintains control of the clinical procedure at all times."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. Since the document describes nonclinical testing, any "ground truth" would likely refer to engineering specifications or known simulated targets rather than clinical pathology or outcomes.

8. The sample size for the training set

This information is not provided in the document. The UroNav device, as described, is an image processing and navigation system, not a machine learning or AI model that relies on training data in the conventional sense.

9. How the ground truth for the training set was established

This information is not provided in the document. (See point 8).

Summary of what is provided related to performance/testing:

The document states that Invivo Corporation conducted "Nonclinical and performance testing" as per their quality procedures. These tests involved "Verification & Validation Test Plans" designed to evaluate all input/output functions and actions of UroNav in each operational mode. The manufacturer attests that these tests were passed and met "predetermined acceptance criteria."

The core of this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices (Eigen 3-D Imaging Workstation K081093, Jet Soft SRL BioJet K122329, and Philips Healthcare PercuNav K121498). The comparison table highlights that UroNav shares similar technological characteristics (e.g., Windows OS, multi-modality support, 3D rendering, live 2D ultrasound, image processing, DICOM connectivity, planning/navigation features) with its predicates. The main difference noted is the use of an Electromagnetic Measurement System (EMMS) instead of mechanical encoding for navigation in comparison to some predicates. This difference is asserted not to raise new safety risks or affect device use or effectiveness.

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