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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 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 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 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 diaical 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 3 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 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 3 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 quides, 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 3. 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 3 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 3 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 3 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 3 display. UroNav provides an indication of the gridplate coordinates that correspond to the identified target location.

Here's a breakdown of the acceptance criteria and study information for the UroNav 3 device, based on the provided FDA 510(k) summary:

Note: This 510(k) summary does not contain explicit acceptance criteria tables with performance metrics or detailed results of a specific clinical study for the UroNav 3. Instead, it relies on demonstrating substantial equivalence to a predicate device (UroNav Version 2.0 and PercuNav) through comparisons of technological characteristics and confirmation of nonclinical testing.

The document 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 3 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 "predetermined acceptance criteria" themselves and the breakdown of performance against those criteria are not explicitly detailed in the provided text. The safety and effectiveness are established by showing that UroNav 3 has substantially equivalent technological characteristics to the predicate devices and passed internal V&V testing according to applicable standards.

Therefore, the table below reflects what can be inferred rather than explicit numeric acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

• Instructions for use, cautions, warnings, and notes for safe/effective use.
• Risk Management procedure identifying and controlling potential hazards.
• Product (software and hardware) development process, verification, and validation testing.
• Passing all in-house testing criteria, validating design, function, and specifications. (Explicitly stated) |
  | Technological Equivalence: Identical or similar technological characteristics. | Nearly identical technological characteristics to predicate devices (UroNav 2.0 and PercuNav) in terms of: PC-based software, Windows OS, multi-modality support, 2D/3D review, live 2D ultrasound, gland segmentation, image registration (rigid/elastic), MPR, DICOM import/export, ultrasound video, standard image viewing/measurement/annotation/segmentation/reporting tools, video capture, image overlays, planning & navigation tools, electromagnetic navigation. (Detailed comparison table provided in K) |
  | Compliance to Standards: Adherence to relevant medical device standards. | Complies with IEC 60601-1:2005 Ed 3.1, IEC 60601-1-2:2014 Ed 4, ISO 14971:2007, IEC 62366:2007. (Explicitly stated) |
  | Physical Form Factor: Changes do not impact safety or effectiveness. | Differences in physical form factor (smaller enclosure, separate embedded computer vs. integrated computer/display) are stated to not impact device safety or effectiveness. (Explicitly stated) |
  | Limited Indications (vs. PercuNav): Scope of use for prostate only (vs. multiple anatomies). | The UroNav system does not include support for all anatomical locations indicated for PercuNav (e.g., liver, lung, pancreas, etc.), but this absence does not significantly affect the use of the device, nor does it raise new or additional safety risks. (Explicitly stated) |
  | Minor UI Variations (vs. PercuNav): Cosmetic user interface changes. | Minor user interface variations (GUI icons, screen colors, image viewing layouts) are cosmetic and do not significantly affect the use of the device, nor do they raise new or additional safety risks. (Explicitly stated) |

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify a sample size for a test set in a clinical or performance study of the UroNav 3. The document states that "Nonclinical and performance testing has been performed by designated individuals at the manufacturer's facility." This implies internal testing rather than a formal test set of patient data from external sites.

The data provenance is not explicitly stated beyond internal nonclinical and performance testing done at Invivo Corporation. There is no mention of country of origin, nor whether it was retrospective or prospective in the context of a clinical study for UroNav 3.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The 510(k) summary does not mention a clinical study with a test set requiring expert-established ground truth for UroNav 3. The document focuses on demonstrating substantial equivalence through comparison with predicate devices and internal validation. For the predicate devices or previous versions, this information might exist, but it is not provided for UroNav 3 in this document.

4. Adjudication Method for the Test Set

Since a specific test set requiring expert ground truth and adjudication is not described in the provided document for UroNav 3, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary for UroNav 3. The submission focuses on substantial equivalence based on technological characteristics and nonclinical testing. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The UroNav 3 is described as a "stereotaxic accessory for image-guided interventional and diagnostic procedures" and emphasizes that "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." This indicates that the device is not intended or tested for standalone (algorithm-only) performance without human-in-the-loop. Its functionality is as an aid to a physician.

7. The Type of Ground Truth Used

Given the nature of the submission (substantial equivalence based on technological characteristics and internal V&V testing), the ground truth for any internal performance testing would likely be based on engineering specifications, accuracy targets for tracking systems, and known parameters for image processing algorithms. There is no mention of clinical ground truth types such as expert consensus, pathology, or outcomes data being used in a formal study for UroNav 3 in this document.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. The UroNav 3 is a medical image processing system that integrates various functionalities (image display, registration, segmentation, navigation aid, etc.). While such systems contain algorithms, the submission doesn't describe it as a machine learning/AI device requiring a specific training set in the common sense of statistical or deep learning models needing large datasets for training. Its equivalence is based on established technological characteristics and function.

9. How the Ground Truth for the Training Set Was Established

As no training set is described, no information on how ground truth for a training set was established is provided.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetabl/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal.

The clinical environments where the EPIQ 5, EPIQ 7, Affiniti 50 Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

The proposed EPIO and Affiniti Diagnostic Ultrasound Systems, which includes EPIO 5. EPIQ 7, Affiniti 50 and Affiniti 70 systems, are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation.

The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). In addition to the physical knobs and buttons of the main control panel, the user interface consists of a touch screen with soft key controls. EPIO also has a QWERTY keyboard.

The removable transducers are connected to the system using a standard technology, multipin connectors. The proposed EPIQ and Affiniti systems use standard transducer technology, and supports phased, linear, curved linear array, TEE, motorized 3D curved linear arrays as well as non-imaging (pencil) probes.

Clinical data storage consists of a local repository as well as off-line image storage via the network, DVR, DVD, and USB storage devices. The images are stored in industry-standard formats (e.g. JPEG. AVI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA.

The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of the system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow.

The proposed EPIQ and Affiniti systems give the operator the ability to measure anatomical structures and offer analysis packages that provide information used by competent healthcare professionals to make a diagnosis. The proposed EPIQ and Affiniti systems enable image guided navigation and image fusion via the optional PercuNav feature (K121498).

The document describes the Philips EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems, and Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems. It primarily details their indications for use and compares their technological characteristics to a previously cleared predicate device (Philips EPIQ Diagnostic Ultrasound System K132304).

Based on the provided text, a "study that proves the device meets the acceptance criteria" in terms of clinical performance or specific statistical metrics is not explicitly described. The document explicitly states: "Clinical data was not required to demonstrate safety and effectiveness of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems since the proposed EPIQ or Affiniti system introduces no new indications for use, modes or features that have not been previously cleared with the predicate device EPIQ system (K132304). The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices."

Therefore, the acceptance criteria are demonstrated through substantial equivalence to a predicate device, and compliance with recognized safety and performance standards, rather than a de novo clinical study for this specific submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria (from Standards) and Reported Device Performance (Compliance Statement)

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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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DynaCAD/Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and interventional devices.

The application provides the user with patient data processing, visualization and storage functions. It allows image analysis, display and recording of simulated images of a tracked insertion tool, such as a needle guide or sleeve, on a computer monitor or other display that shows images of the target organs and the current and/or projected path of the interventional instrument.

The device is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional and/or diagnostic procedures of the prostate.

DynaCAD/Prostate Interventional (a.k.a. Dynal.OC/Prostate) is medical device software that is intended to be loaded onto a commercially available computer workstation. The DynaLOC/Prostate software application is designed for use with the DynaTRIM positioning device. The software receives DICOM images from a pre-procedure magnetic resonance (MR) study and performs calculations to assist the clinician with adjustments to the DynaTRIM positioning device. The software does not directly control the Dynall'RIM device, the interventional accessories or the MR scanner. The users must manually adjust the DynaTRIM device and confirm proper positioning of the interventional accessories via an MR verification scan. Additionally, the users must manually control the MRI scanner to obtain the correct MR data sets.

The provided text describes the DynaCAD/Prostate Interventional software, but it does not contain the specific details required to complete all sections of your request regarding acceptance criteria and a detailed study proving performance. The document focuses on the substantial equivalence discussion to predicate devices.

However, based on the limited information available, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The safety and effectiveness of the DynaCAD/Interventional software (a.k.a. DynaLOC/Prostate) for the proposed indications for use is supported by preclinical software verification and validation testing. This includes validation of the software with the DynaTRIM device is a simulated clinical use setting."

This indicates that acceptance criteria and performance were assessed during software verification and validation testing, but the specific metrics (e.g., accuracy, precision, sensitivity, specificity, user task completion rates, time savings) and their corresponding performance values are not provided in the given text. Thus, a detailed table cannot be created.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "validation of the software with the DynaTRIM device is a simulated clinical use setting." However, it does not specify the sample size for this test set (e.g., number of cases, number of simulated procedures).

The data provenance is also not specified (e.g., no mention of country of origin, or whether the data was retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

The document does not mention the use of experts to establish a ground truth for a test set, nor does it specify their number or qualifications. The validation appears to be software-centric and in a simulated environment, suggesting ground truth might have been established through engineering specifications or simulated scenarios rather than expert interpretations of clinical data.

4. Adjudication Method for the Test Set:

Given that expert involvement for ground truth is not mentioned, an adjudication method is not applicable or described in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. There is no mention of human readers improving with or without AI assistance, as the device is an "image-guidance accessory" and not an AI diagnostic tool in the sense of automating interpretation.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop):

The document primarily describes the software as an "image-guidance accessory" that "assists the clinician with adjustments" and provides "patient data processing, visualization and storage functions." The clinicians "must manually adjust the DynaTRIM device and confirm proper positioning." This strongly implies that the device is designed for human-in-the-loop use and does not provide information on a standalone performance study (i.e., algorithm only without human-in-the-loop).

7. Type of Ground Truth Used:

The document states, "The safety and effectiveness... is supported by preclinical software verification and validation testing. This includes validation of the software with the DynaTRIM device is a simulated clinical use setting." This suggests the ground truth was likely based on engineering specifications, simulated accuracy targets, and functional correctness within the simulated environment, rather than expert consensus on clinical findings, pathology, or outcomes data from real patients.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. Given that the device performs calculations and visualization for assistance rather than complex pattern recognition or diagnostic assessment typical of machine learning, a "training set" in the conventional AI sense may not be applicable or explicitly used for this type of software.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a training set, there is no information on how its ground truth might have been established.

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