(127 days)
The BiopSee bundled system is a combination of MobileUS providing the "Medical Image Processing Workstation" which acquires and displays ultrasound images from external ultrasound scanners and the BiopSee "Image Fusion Navigation Software" which is a stereotaxic accessory for Ultrasound (US) devices.
The BiopSee system is intended to be used in clinical interventions and for anatomical structures in a clinical setting where US imaging is currently used for visualizing such procedures. It displays the simulated insertion tool such as a biopsy needle on a computer monitor that shows images of the target organs and the projected future path of the interventional instrument.
The patient population is mainly people who need prostate biopsy.
It is intended to be used mainly in the Urological departments for prostate biopsies.
The BiopSee system is not intended to be used as a standalone diagnostic image device, since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always be seen as an additional source of information.
The BiopSee system when connected with an electromagnetic tracker should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment. BiopSee is a prescription device.
The BiopSee bundled system (also called BiopSee System) is a medical image processing workstation that provides image quided instrument navigation. The hardware part (MobileUS) consists of the system unit which includes a CPU, a monitor, medical-grade keyboard, mouse and power supply and a medical trolley. It is designed to display ultrasound images from different sources. Optionally it can be equipped with an electromagnetic positioning system to track the ultrasound probe or other medical instruments.
The system is able to load different image modalities such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Positron emission tomography (PET) and allows organ delineation and planning instrument access paths within the 3D dataset. It is designed to display 2D images from commercially available ultrasound systems and either reconstruct a 3D ultrasound image or fuse the images with pre-loaded other datasets.
The BiopSee software can be installed on standard PCs under Microsoft Windows operating systems which follow the minimum requirements described in the service manual, similar to MobileUS hardware. BiopSee is designed to work in combination with an ultrasound scanner (the Ultrasound System is used in order to display the live US images) and a probe, a positioning system (to track the position of the probe) and medical navigation instruments (to track the position of the medical instruments like needles). The ultrasound scanners connected must be tested with the BiopSee System and shall be legally marketed in the US.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the BiopSee, Mobile US device, organized according to your requested points:
The provided text is a 510(k) summary, which is a premarket notification for a medical device. This document primarily focuses on establishing substantial equivalence to previously cleared devices rather than providing a detailed report of clinical study results that would typically be found in a full Clinical Study Report (CSR). Therefore, some of the information you requested may not be explicitly present or might be inferred from the context of substantial equivalence claims and non-clinical data.
1. A table of acceptance criteria and the reported device performance
The document details non-clinical performance data, primarily focusing on system accuracy and tracking quality. It doesn't explicitly state "acceptance criteria" in a tabular format but presents performance metrics.
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| System Accuracy (Needle Navigation) | Overall error better than 5 mm for software projected virtual needle position over real-time US image. | This was demonstrated using CIRS Phantoms. This suggests the system's ability to accurately display the planned needle path in relation to the live ultrasound image. |
| Tracking Quality | System can detect low sensor tracking quality and show if tracking is distorted (e.g., by metallic objects). | Verified through integration tests. The integrated "Ascension 3D Guidance trakSTAR" electromagnetic guidance system has a stated accuracy of 1.4 mm RMS, 0.5 degrees RMS by its manufacturer. This indicates the system's ability to maintain and report the integrity of its tracking. |
| 2nd Modality Image Display Overlapping Accuracy | At least 5mm overlapping accuracy, under the presumption that registration was done with an overall error better than 5mm. | This applies to the fusion of ultrasound images with other modalities like MRI or CT. The accuracy is contingent on the quality of the initial registration process. |
| Length Measurement (Ruler Function) - Ultrasound Image | 5% error, or better. | Performance for the measurement tool within the ultrasound images. |
| Length Measurement (Ruler Function) - 2nd Modality Image | 5%-10% error, or better. | Performance for the measurement tool within fused 2nd modality images. The accuracy depends on the quality of the 2nd modality dataset. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide information on the sample size for a test set in the context of clinical data. The performance data presented are from non-clinical verification and validation software tests using CIRS Phantoms. These are physical models used for testing medical imaging systems. There is no mention of human subject data, country of origin, or whether it was retrospective or prospective.
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)
Given that the testing was non-clinical and involved phantoms, there were no human experts or ground truth established in the sense of clinical diagnoses. The "ground truth" for these tests would have been the known physical properties and measurements within the CIRS phantoms, against which the device's measurements and projections were compared.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Since the testing was non-clinical and involved phantoms, there was no adjudication method involving human experts. The comparison would be against the known physical dimensions and positions within the phantom.
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
The document does not mention an MRMC comparative effectiveness study. The BiopSee system is described as an "Image Fusion Navigation Software" and a "medical image processing workstation" intended for image-guided instrument navigation, not as an AI-powered diagnostic tool for interpretation by human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to the described functions of this device in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes standalone non-clinical performance testing of aspects of the algorithm, particularly for system accuracy (needle navigation), tracking quality, 2nd modality image display, and length measurement. These tests evaluate the device's technical performance metrics without human clinical interpretation or interaction beyond setting up the test and recording results.
However, the device itself is not intended to be used as a standalone diagnostic image device and explicitly states it "shall therefore always be seen as an additional source of information." This implies it is always used with a human in the loop for clinical decision-making.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests mentioned, the ground truth was known physical properties and measurements of CIRS phantoms. For the tracking system, the manufacturer-stated accuracy of the integrated "Ascension 3D Guidance trakSTAR" (1.4 mm RMS, 0.5 degrees RMS) serves as a ground truth reference for its inherent accuracy. There is no mention of expert consensus, pathology, or outcomes data as ground truth in this submission, as it focuses on technical performance rather than clinical diagnostic accuracy.
8. The sample size for the training set
The document does not provide information on a training set. This is not a machine learning or AI algorithm submission in the sense of a predictive model that requires a labeled training set. It's a medical image processing workstation and navigation software.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned or implied for the functionalities described.
§ 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).