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The UC-Care Navigo Workstation is an adjunctive tool for ultrasound guided procedures and is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. The Navigo Workstation offers the ability to fuse DICOM originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the other.

It also provides the ability to display a simulated image of a tracked insertion tool such as a needle, guide wire, catheter, 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.

Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3-D image registration, as well as storage and future retrieval of this information.

Navigo 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. The software is not intended to predict ablation volumes or predict ablation success.

The Navigo Workstation version 2.3, model: FPRMC00039 (hereinafter referred to as "Navigo Workstation Version 2.3") is an adjunctive tool in the management of prostate diagnostic and interventional procedures. The Navigo Workstation provides tracking, recording, and management solutions for prostate insertion tools (such as a needle, guide wire, or catheter).

The Navigo Workstation is designed to assist the physician in performing prostate diagnostic and interventional procedures by providing regional orientation information, displaying a 3D model with real-time tracking and recording of the needle location. The Navigo Workstation offers the ability to fuse DICOM-originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the other. The device includes means to compensate for the patient's body and prostate motion at any time during the procedure. In addition, the Navigo Workstation Version 2.3 supports treatment procedure by allowing the physician to plan the treatment by selecting a treatment needle with its defined properties (as declared by the manufacturer) and displaying the virtual ablation zone. The system enables the physician to segment anatomic ROIs (anatomic Regions Of Interest, e.g. surrounding organs) and present the distance measurements of the virtual treatment zone from it. The ROIs used for treatment planning can be either ROI segmented on MRI/CT images or positive pathology results updated on historic biopsy procedures performed on the Navigo.

The Navigo Workstation is used as an add-on to the ultrasound diagnostic and interventional procedures of the prostate gland. When operated in conjunction with the standard equipment in trans-rectal/trans-perineal ultrasound prostate procedure, the Navigo software may be used for the following:

• To assist the physician by transferring and displaying ultrasound images on the workstation screen
• To provide regional orientation information during prostate procedures
• To build a display and manipulate a 3D model of the prostate on a screen
• To define the physician's ROIs (Regions Of Interest) and display them on the 3D model
• To archive procedure data and report generating
• To provide data management solutions
• To track, display, and record the needle trajectory location retrieved from the ultrasound
• To display the scanning history, including pathology analyses
• To retrieve and display DICOM-compliant information
• To fuse DICOM-compliant originated regions of interest with the ultrasound 2D and 3D information
• To support the grid trajectory in Grid guided procedures
• To perform automatic or manual compensation for patient movement.
• To support treatment procedure: The module allows pre-procedure planning, real-time display of the treatment needle virtual ablation zone, accurate placement of the needle or insertion tools (such as cryoprobes) on targets, 3D tracking, and distance measurements (proximity) to anatomic ROIs.

The Navigo Workstation Version 2.3 is designed to work with standard trans-rectal/transperineal ultrasound systems and biopsy setup without changing or interfering with the physician's existing workflow. The Navigo Workstation Version 2.3 connects to the video output of the ultrasound system and by tracking the ultrasound probe's position, the recorded 2D ultrasound images are transferred to the Navigo Workstation Version 2.3 for viewing and creation of a 3D model. As with any other procedure, the Ultrasound probe is used together with a standard disposable cover sheath supplied by the user.

Two-dimensional (2D) images and the 3D model of the prostate are displayed on the Navigo Workstation Version 2.3 screen. The Navigo Workstation is equipped with tools to manipulate (rotate, pan, zoom) the model, and to archive and retrieve the information for further use.

The tracking and recording enable the display of an accurate 3D model of the prostate and to record needle locations on the model. Pathology diagnosis results may be updated on the 3D model and a color display representation provides a visual display of the pathology results.

In offline mode, the workstation allows analysis of previous procedures, updates to biopsy locations, report generation, and DICOM-based ROI definition. Offline tools support treatment planning by segmenting anatomical ROIs, displaying virtual treatment regions, and measuring distances from these regions to surrounding structures. Data from prior imaging or biopsy procedures can be utilized for planning.

The device consists of the following components and accessories: The Navigo Workstation cart, electromagnetic transmitter, probe sensor, reference sensor, grid-plate sensor, sensor fixators, reference sensor tape, and cables.

The provided document, an FDA 510(k) Clearance Letter for the Navigo Workstation 2.3, does not contain specific acceptance criteria (e.g., minimum accuracy percentages, sensitivity, specificity thresholds) or a detailed report of device performance against such criteria. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technological similarities and a summary of non-clinical performance testing.

Therefore, I cannot extract a table of acceptance criteria and reported device performance directly from this document. The document lists the types of non-clinical tests performed, but not the quantitative results or the specific acceptance thresholds for those tests.

However, I can provide information based on the listed non-clinical performance testing and general context:

Summary of Device Acceptance and Performance (Based on Provided Document)

The Navigo Workstation 2.3 demonstrated performance through a series of non-clinical (bench) tests and adherence to recognized standards. The document asserts that these tests validate the device's changes and ensure its safety and effectiveness, leading to a conclusion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" and "reported device performance" are inferred based on the statement that these tests were conducted to "validate the changes" and ensure "compliance with defined requirements," ultimately supporting the conclusion of substantial equivalence and safety/effectiveness.

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

• Test Set Sample Size: Not explicitly stated for any of the bench tests. The description of tests like "Mesh Proximity Test" or "Tests for Margin of ROIs" suggests computational validation rather than a fixed number of physical samples.
• Data Provenance: The tests are described as "Bench Testing" performed by UC-Care. This indicates a controlled, laboratory-type setting. There is no mention of country of origin for test data, but the company is based in Israel. The tests are non-clinical, so the concept of retrospective or prospective data as typically applied to patient studies does not directly apply.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned. For bench tests, ground truth would likely be established by engineering specifications, computational models, or known physical properties rather than human experts in the clinical sense.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned. It's improbable that an adjudication method like 2+1 or 3+1 would be applicable for these types of non-clinical bench tests.

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

• MRMC Study Done? No. The document explicitly states: "No clinical Study was performed for the purpose of this submission." and "Clinical performance data was not required to demonstrate safe and effective use of Navigo workstation 2.3."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done? Not directly stated as a "standalone study" with specific performance metrics (e.g., AUC, sensitivity, specificity). However, the "Non-Clinical Performance Testing" on specific software features (e.g., Mesh Proximity, Virtual Ablation Zone Display, Margin addition) inherently evaluates the algorithm's performance in a standalone manner, as it's testing the computational output of these features against defined requirements or specifications. The document doesn't provide the quantitative results of these standalone algorithmic evaluations, only that they were performed and validated the changes.

7. Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical bench tests, the ground truth appears to be based on:
  • Defined specifications/requirements: For software functionalities (e.g., accurate calculation of shortest distance, accurate margin addition, accurate display of ablation zone aligned with manufacturer specs).
  • Recognized consensus standards: For general software, electrical safety, EMC, and risk/usability (IEC 62304, IEC 60601 series, ISO 14971).
  • Internal existing test methods: Previously utilized for legally marketed devices by UC-Care.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable/not mentioned. This device is a medical image management and processing system with new software features and hardware updates, not an AI/ML device that requires a distinct "training set" in the context of machine learning model development. The document does not describe the use of a machine learning component that would necessitate a training set.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for machine learning.

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The UC-Care Navigo Workstation is an adjunctive tool for ultrasound guided procedures and is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. The Navigo Workstation offers the ability to fuse DICOM originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the other.

It also provides the ability to display a simulated image of a tracked insertion tool such as a needle, guide wire, catheter, 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. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3-D image registration, as well as storage and future retrieval of this information.

Navigo 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.

The Navigo Workstation Version 2.0 is an adjunctive tool in the management of prostate diagnostic and interventional procedures. The Navigo Workstation Version 2.0 allows prostate needle tracking, recording, and management solution. The Navigo Workstation Version 2.0 is designed to assist the physician in performing prostate diagnostic and interventional procedures by providing regional orientation information, displaying a 3D model with real-time tracking and recording of the needle location. The Navigo Workstation Version 2.0 offers the ability to fuse DICOM originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the other. The device includes means to compensate for patient body and prostate motion at any time during the procedure.

The Navigo Workstation Version 2.0 is designed to work with standard trans-rectal / transperineal ultrasound systems and biopsy setup without changing or interfering with the physician's existing workflow. The Navigo Workstation Version 2.0 connects to the video output of the ultrasound system and by tracking the ultrasound probe's position, the recorded 2D ultrasound images are transferred to the Navigo Workstation Version 2.0 for viewing and creation of a 3D model. As with any other procedure, the US probe is used together with a standard disposable cover sheath supplied by the user.

Two dimensional (2D) images and the 3D model of the prostate are displayed on the Navigo Workstation Version 2.0's screen. The Navigo Workstation Version 2.0 is equipped with tools to manipulate (rotate, pan, zoom) the model, and to archive and retrieve the information for further use.

The tracking and recording enables display of an accurate 3D model of the prostate and to record needle locations on the model. Pathology diagnosis results may be updated on the 3D model and a color display representation provides a visual display of the pathology results.

The Navigo Workstation Version 2.0 supports the display of ROIs on the 3D model and displays visual indication when the needle trajectory intersects with an ROI (Region Of Interest) is defined by the physician by segmenting a portion of the prostate on a 2D image and displaying its location on the 3D model, thereby defining a portion of the prostate as a target to direct a needle within. The 2D images for segmentation of the ROI can be either a frozen Ultrasound image or a DICOM compliant image from another imaging study completed prior to the Ultrasound procedure (e.g. MR,CT).The ROls are clearly numbered and labeled by a letter symbolizing its origin (Ultrasound or DICOM). On each image, more than one ROI may be defined (segmented).

The live 2D ultrasound image is superimposed in real-time with the 2D ROI boundaries thus allowing the physician to see the real-time advancement of the needle on the live ultrasound image with reference to ROI boundaries. The 3D model is displayed on a separate window alongside the ultrasound's live continuous images display, allowing prostate 3D orientation.

Regardless of the type of ultrasound probe used for the procedure (side-fire or end-fire) a cannula for a needle is built within the outer shell of the probe and therefore a needle can be inserted through the designated cannula. The designated cannula defines the needle path along its trajectory. The needle trajectory is displayed on the 3D model representing the potential needle route to allow the physician to direct the needle in real time into the target. When the projected path intersects with an ROI, the ROI will change indicating the needle can be directed inside the ROI if the physician ensures that the needle is inserted deep enough. In trans-perineal procedures the grid-plate sensor is placed on the grid base via a fixator; the sensor tracks the grid location during the procedure and enables the Navigo Workstation Version 2.0 to present in real time the optional trajectories locations. During the procedure, the physician may change some of the parameters on the US system or perform different actions that require the Navigo Workstation Version 2.0 to adjust. A physician may wish to freeze an image and perform measurements, label the image and save it to the report, switch between transversal and longitudinal view, or change the view of the ultrasound image. The Navigo Workstation Version 2.0 is equipped with image state algorithms to automatically detect the change in parameters and adjust itself to the new parameters. For example, if the physician freezes the US image, the Navigo Workstation Version 2.0 will automatically present additional menu option for a frozen image like measurements tools and labeling. The image state algorithm was developed to support generic ultrasound parameters and is specifically tested for each new ultrasound system model the Navigo Workstation Version 2.0 is required to support. In case of auto-detection failure, the user is informed and asked to confirm or manually change the detected parameters In order to continue.

In off-line mode, the Navigo Workstation Version 2.0 software further enables the physician to analyze previous procedures using the prostate model, update the 3D model if necessary. update the recorded biopsies' locations, generate reports, and provides a DICOM (MRI/CT) interface for ROI definition, 3D model display, and data communication.

Here is an analysis of the acceptance criteria and supporting studies for the Navigo Workstation Version 2.0, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance:

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The UC-CARE NaviGo Workstation is an adjunctive tool for ultrasound guided procedures and is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. The NaviGo™ Workstation offers the ability to fuse DICOM originated information (e.g. MRI) with the ultrasound images and thus superimpose information from one modality onto the other. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement and 3-D image registration.

The device is specifically indicated to provide information within the prostate to assist needle targeted procedures (e.g. biopsy) regions of interest display, procedures planning and, reconstruction of a 3D rendered surface model of the prostate display needle locations that have been selected by the physician, as well as storage and future retrieval of this information.

The NaviGo™ Workstation is an adjunctive tool in the management of prostate diagnostic and interventional procedures. The NaviGo™ Workstation allows prostate needle tracking, recording, and management solution. The NaviGo™ Workstation is designed to assist the physician in performing prostate diagnostic and interventional procedures by providing regional orientation information, displaying a 3D model with real-time tracking and recording of the needle location. The NaviGo™ Workstation offers the ability to fuse DICOM originated information (e.g. MRI) with the ultrasound images and thus superimpose information from one modality onto the . The device includes means to compensate for patient body and prostate motion at any time during the procedure.

The NaviGo™ Workstation is designed to work with standard trans-rectal ultrasound systems and biopsy setup without changing or interfering with the physician's existing workflow. The NaviGo™ Workstation connects to the video output of the ultrasound system and by tracking the ultrasound probe's position, the recorded 2D ultrasound images are transferred to the NaviGo™ Workstation for viewing and creation of a 3D model. As with any other procedure, the TRUS probe is used together with standard disposable cover sheath supplied by the user.

Two dimensional (2D) images and the 3D model of the prostate are displayed on the NaviGo™ Workstation's screen. The NaviGo™ Workstation is equipped with tools to manipulate (rotate, pan, zoom) the model, and to archive and retrieve the information for further use.

The tracking and recording enables display of an accurate 3D model of the prostate and to record needle locations on the model. Pathology diagnosis results may be updated on the 3D model and a color display representation provides a visual display of the biopsy results.

The NaviGo™ Workstation supports the display of ROIs on the 3D model and displays visual indication when the needle trajectory intersects with an ROI (region of interest) is defined by the physician by segmenting a portion of the prostate on a 2D image and displaying its location on the 3D model, thereby defining a portion of the prostate as a target to direct a needle within. The 2D model for segmentation of the ROI can be either an Ultrasound image frozen during the procedure or a DICOM complaint image from another imaging study completed prior to the Ultrasound procedure (e.g. MR) when selecting the fusion procedure to display the planned targets. The ROIs are clearly numbered and labeled by a letter symbolizing it origin (Ultrasound or DICOM), On each image, more than one ROI may be defined (segmented).

The live 2D ultrasound image is superimposed in real-time with the 2D ROI boundaries thus allowing the physician to see the real-time advancement of the needle on the live ultrasound image with reference to ROI boundaries. The 3D model is displayed on a separate window alongside the ultrasound's live continuous images display, allowing prostate 3D orientation.

Regardless of the type of ultrasound probe used for the procedure (side-fire or end-fire) a cannula for a needle is built within the outer shell of the probe and therefore a needle can be inserted through the designated cannula. The designated cannula defines the needle path along its trajectory. The needle trajectory is displayed on the 3D model representing the potential needle route to allow the physician to direct the needle in real time into the target. When the projected path intersects with an RQL the color of the ROI will change indicating the needle can be directed inside the ROI if the physician ensures that the needle is inserted deep enough.

During the procedure, the physician may change some of the parameters on the US system or perform different actions that require the NaviGo™ Workstation to adjust. A physician may wish to freeze an image and perform measurements, label the image and save it to the report, switch between transversal and longitudinal view, or change the view of the ultrasound image. The NaviGo™ Workstation is equipped with image state algorithms to automatically detect the change in parameters and adjust itself to the new parameters. For example, if the physician freezes the US image, the NaviGo will automatically present additional menu option for a frozen image like measurements tools and labeling. The image state algorithm was developed to support generic ultrasound parameters and is specifically tested for each new ultrasound the NaviGo™ is required to support.

In off-line mode, the NaviGo™ software further enables the physician to analyze previous procedures using the prostate model, update the 3D model if necessary, update the recorded biopsies' locations, generate report, and provides a DICOM (e.g. MRI) interface for ROI definition, 3D model display, and data communication.

The information provided focuses on the non-clinical performance data for the NaviGo™ Workstation, specifically for its fusion accuracy and illustration model performance.

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Fusion accuracy performance test:
  • Sample size: 4 phantoms, each with 3 isoechoic lesions (total 12 lesions). 34 ultrasound-guided biopsies were targeted.
  • Data provenance: Bench testing using CIRS Model 778-05 phantoms. This is a controlled experimental setting, not from patients or a specific country of origin. It is a prospective study as the testing was conducted to evaluate the device.
• Illustration model performance test:
  • Sample size: 10 prostates (presumably phantom or cadaver prostates, given it's non-clinical bench testing).
  • Data provenance: Bench testing. This is a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the document. The tests described are non-clinical (bench) tests involving phantoms. The ground truth for the fusion accuracy test was established by post-procedure CT scans, which accurately measure the needle location relative to the ROI. For the illustration model, the "full contours 3D model" served as the reference for comparison. Expert involvement in establishing the ground truth for these specific bench tests is not mentioned or implied in this summary.

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

• This information is not provided as the tests described are non-clinical bench tests comparing device output to a physical ground truth (CT scan for fusion, and a reference 3D model for illustration). Adjudication, typically involving human readers, is not relevant to these specific tests.

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:

• An MRMC comparative effectiveness study was not done as part of the non-clinical performance data described. The document focuses on standalone device accuracy and model performance, not human-in-the-loop performance.

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

• Yes, the tests described are standalone performance evaluations of the NaviGo™ Workstation's algorithms and functionalities without human interpretation or assistance in the loop for the performance metrics.
  • The "fusion accuracy performance test" assesses how accurately the system targets ROIs based on its internal calculations and guidance.
  • The "illustration model performance test" evaluates the accuracy of the system's generated 3D models.

7. The type of ground truth used:

• Fusion accuracy performance test: Post-procedure CT scan (objective imaging gold standard for physical needle placement relative to a lesion).
• Illustration model performance test: The "full contours 3D model" created by the NaviGo Workstation served as the ground truth for comparison with the "Fast 3D model." This implies that a more detailed or labor-intensive method of 3D model creation by the device itself (or potentially overseen by an operator) was considered the reference.

8. The sample size for the training set:

• This information is not provided in the document. The summary focuses on the performance evaluation of the device, not its development or training data.

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

• This information is not provided in the document, as the training set details are not mentioned.

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The UC-CARE NaviGo™ Workstation is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. Additional software features to assist biopsy procedures include patient data management, multi-planar reconstruction, segmentation, image measurementand 3-D image registration.

The device is specifically indicated to provide information on regional orientation within the prostate to assist biopsy procedures under standard ultrasound guidance, reconstruction of a 3D rendered surface model of the prostate and to display locations for biopsies that have been selected by the physician, as well as storage and future retrieval of this information.

The Navigo™ Workstation is an aiding tool in the management of prostate procedures. The Navigo™ Workstation is designed to assist the physician to transfer and display ultrasound images on the workstation screen, build, display, and manipulate a 3D model of the prostate on screen, provide regional orientation, archive the images and the 3D model, as well as provide data management solutions. The Navigo™ Workstation enables tracking, displaying and recording of the biopsy needle trajectory location retrieved from the ultrasound probe.

The Navigo™ Workstation is designed to work with standard transrectal Ultrasound system without changing or interfering with the physician's flow of work. The Navigo™ Workstation connects to the Ultrasound system and by tracking the Ultrasound probe's position, the recorded 2D Ultrasound images are transferred to the Navigo™ Workstation for viewing and 3D modeling.

The 2D images and the 3D model of the prostate are displayed on the Workstation screen. The workstation is equipped with tools to manipulate (rotate, zoom, pan) the model, to add planned biopsy locations on the model and to archive and retrieve the information for further use.

Pathology diagnosis results can be updated on the 3D model and a color display representation gives a visualized status of the prostate.

I am sorry but the provided text only contains regulatory information about the NaviGo™ Workstation, including its intended use, device description, and substantial equivalence to a predicate device. It does not include information about specific acceptance criteria or a study design to prove the device meets these criteria. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.

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The UC-CARE Warming System is indicated to transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate using cryosurgical systems that have been cleared for use on the prostate.

The UCW System is indicated to transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate. The UCW System includes a Urethral Catheter & Tubing Set and a Warming Kt

The Urethral Catheter is introduced into the bladder to outline the urethral course, and to protect the urethra during therapeutic transperineal, prostatic cryotherapy procedures. The Urethral catheter further transfers heat to the urethral tissue during cryotherapy of the prostate in order to protect the urethra from, excessive cold temperatures. The closed loop Tubing Set is connected to the catheter's inlet and outlet ports and circulates warm sterile water or saline via the Warming Kit that includes a fluid warmer and peristaltic pump.

This 510(k) summary describes a medical device, the UC-CARE Warming System, and its substantial equivalence to predicate devices. It does not present a study with acceptance criteria and reported device performance in the way a clinical trial or performance study for an AI/ML device would. Instead, it focuses on demonstrating that the new device is as safe and effective as existing, legally marketed devices.

Therefore, many of the requested fields related to AI/ML performance, ground truth, expert adjudication, and sample sizes for testing/training sets cannot be filled from the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes a "substantial equivalence" claim based on a comparison to predicate devices and adherence to relevant standards. This is not a clinical study in the typical sense of measuring specific performance metrics against predefined thresholds. Instead, it's a demonstration that the new device shares fundamental characteristics with devices already cleared by the FDA.

2. Sample size used for the test set and the data provenance:

• Not applicable. This document describes a medical device (warming system), not an AI/ML algorithm that predicts or classifies based on data. The "test set" in this context would refer to the physical device itself being tested for safety and functionality, not a dataset for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth, in the context of expert consensus, is typically for evaluating the accuracy of an AI/ML algorithm against human expert judgment. This is a physical device.

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

• Not applicable. This refers to a method for resolving discrepancies among experts when establishing ground truth for an AI/ML algorithm's performance evaluation.

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:

• Not applicable. This relates specifically to the performance of AI/ML systems in conjunction with human readers.

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

• Not applicable. This document describes a physical medical device, not an AI/ML algorithm that operates in a standalone capacity.

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

• Not applicable. This refers to the reference standard against which an AI/ML algorithm's performance is measured. For this physical device, "ground truth" would be the verified safety and functional performance of the device under various conditions, likely verified through engineering tests, biocompatibility tests, and comparison to predicate device specifications.

8. The sample size for the training set:

• Not applicable. This pertains to the data used to train an AI/ML algorithm.

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

• Not applicable. This pertains to the labeling or truth assignment of data used to train an AI/ML algorithm.

Summary of Device-Specific Information from the Provided Text:

• Device Name: UC-CARE Warming System (UCW System)
• Intended Use: To transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate using cryosurgical systems that have been cleared for use on the prostate.
• Predicate Devices:
  • Endocare Urethral Warming System (K963970)
  • SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA (PresIce™) (K060390)
• Performance Standards: Tested according to various standards and guidance documents, specifically mentioning ASTM F623-99 (2006) - Standard Performance Specification for Foley Catheter.
• Conclusion: The manufacturer believes the device is substantially equivalent to its predicate devices without raising new safety or effectiveness concerns based on the provided information.

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