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510(k) Data Aggregation
(151 days)
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert
Cercare Medical Neurosuite (CMN) and associated modules is an image processing software package to be used by trained professionals, including physicians and medical technicians.
The CMN software package runs on standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM (Digital Imaging and Communications in Medicine) compliant imaging devices. CMN provides viewing capabilities of datasets acquired with CT and MRI.
The Capillary Function module provides analysis capabilities for functional and dynamic imaging datasets acquired with MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT). The Capillary Function module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. In addition, the Capillary Function module's DWI technology is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.
The Virtual Expert module allows the calculation of regions of interest and the visual inspection of time attenuation curves. For MRI, one clinical application is to visualize the apparent blood perfusion and diffusion and to calculate ADC threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke.
For CT, one clinical application is to visualize the apparent blood perfusion and to calculate rCBF threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke.
Areas of decreased perfusion appear as areas of changed signal intensity:
- Lower signal intensity for CBF and CBV
- Higher signal intensity for TTP, MTT, and Tmax
Cercare Medical Neurosuite is a software-only device designed to streamline medical inage processing by providing for the visualization and study of medical images. CMN can be installed on a customer PC, or it can be accessed remotely using remote desktop technologies. CMN provides viewing, quantification, analysis and reporting capabilities. CMN is not intended as a dedicated PACS system for long term persistent storage of patient data.
CMN is software that is intended for use by trained professionals, including physicians and medical technicians. The software provides cerebral image processing capabilities. CMN is intended to be used as decision support software only and the clinician continues to provide all treatment decisions.
The software is intended to visualize and study neuroimaging by image viewing and registration of medical images. CMN works with MRI (Magnetic Resonance Image) and CT (computed tomography) technologies.
CMN accepts and produces data sets in the DICOM format. DICOM is a standard format for storing and transmitting medical image data in vendor neutral format and is managed by the DICOM Standards Committee.
CMN is a platform that allows for the addition of certain modules for further analysis. One of these modules included in this submission is Capillary Function.
CMN Capillary Function:
Capillary Function, when activated in the installed Cercare Medical Neurosuite, provides further functionalities for reading, writing, visualizing and studying medical images.
Capillary Function provides perfusion post-processing technologies, where dynamically acquired perfusion MRI or perfusion CT series can be processed to yield information relevant for assessment of the hemodynamic status of a patient.
Capillary Function generates hemodynamic markers, which can be used for management of diseases with possibly compromised hemodynamic function, such as ischemic stroke and tumors.
The generated output maps can be viewed by standard DICOM image viewers. In addition, Capillary Function includes the possibility for post-processing diffusion-weighted imaging (DWI) MRI data. Post-processing of DWI data results in maps reflective of local water diffusion properties. The post-processed DWI-derived maps can be viewed in standard DICOM image viewers. Capillary Function thus works with MRI and CT technologies.
CMN Virtual Expert:
Virtual Expert, when activated in the installed CMN Capillary Function, provides further functionalities for reading, writing, visualizing, and studying medical images.
Virtual Expert provides automatic delineation of regions of interest (ROI) relevant for stroke patient assessment based on perfusion and diffusion image output generated by the Capillary Function module. Specifically, diffusion MRI images are used to generate threshold masks of perceived core lesions, whereas MRI or CT perfusion images are used to generate threshold masks of perceived perfusion restriction. For CT perfusion, derived perfusion images are used to generate threshold masks of perceived core lesions. Virtual Expert thus works with MRI and CT technologies.
The generated masks can be combined into a mismatch region of interest.
Volumetric calculations and ratios can be calculated from the computed regions of interest.
The provided document describes the acceptance criteria and the study conducted for the Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert device.
Acceptance Criteria and Device Performance Study
The acceptance criteria for the CMN Capillary Function with Virtual Expert device were established through performance validation testing, encompassing both simulated digital phantoms and retrospective clinical data. The document states that "The established acceptance criteria were reached in all tests conducted" (page 10).
1. Table of Acceptance Criteria and Reported Device Performance
For the Capillary Function module, the acceptance criteria focused on quantitative comparisons using digital phantoms, ensuring accuracy under varying hemodynamic parameters and experimental conditions. For the Virtual Expert module, the acceptance criteria involved volumetric and spatial agreement for lesion identification and secondary clinical application assessments like the DEFUSE3 criteria.
| Module/Parameter | Acceptance Criteria (Implicit from Testing Method) | Reported Device Performance |
|---|---|---|
| Capillary Function Module | Performance quantified through comparison of absolute bias, correlation coefficients, and multi-scale structural similarity index between the device and known true parameters in digital phantoms. Expected to operate proficiently under various experimental conditions (motion, noise, diffusion gradient schemes). | "The established acceptance criteria were reached in all tests conducted." (page 10) This implicitly means the device demonstrated acceptable absolute bias, correlation coefficients, and structural similarity as per the defined thresholds for the phantoms. |
| Virtual Expert Module | Volumetric and spatial agreement per-patient and per-lesion in comparison testing of retrospective CT perfusion imaging. | |
| Secondary clinical application assessments based on "image-driven decision to treat analysis through the so-called DEFUSE3 criteria." | The comparison testing was "modeled by the comparison testing conducted for the Predicate Device (K230016) and in the associated published technical comparison study (Bathla et al, J. Neurointerventional Surg., 12:1028-1032 (2020))." (page 10) This implies that the device performed comparably to its predicate and the results presented in the reference study. | |
| Overall Device | Satisfies all design requirements and device specifications and is substantially equivalent to the Predicate Device and Reference Device. | "Together with software verification and validation, the performance validation demonstrated that CMN Capillary Function with Virtual Expert satisfies all design requirements and device specifications and is substantially equivalent to the Predicate Device and Reference Device." (page 10-11) |
2. Sample Size Used for the Test Set and Data Provenance
-
Capillary Function Module:
- Test Set: Included simulated digital phantoms with variations of hemodynamic parameter combinations, as well as retrospective clinical data primarily for visual inspection (page 10). No specific numbers for the retrospective clinical data sample size are provided, and no country of origin is explicitly stated, though it's typically global or multi-center for such studies. The data from digital phantoms is synthetic.
- Provenance: "retrospective clinical data" and "simulated digital phantoms" (page 10).
-
Virtual Expert Module:
- Test Set: "retrospective patient CT perfusion imaging" (page 10). The specific sample size is not stated in the provided text.
- Provenance: "retrospective patient CT perfusion imaging" (page 10). The associated published technical comparison study (Bathla et al, J. Neurointerventional Surg., 12:1028-1032 (2020)) might contain details on data provenance, but it's not present in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set. However, for the Virtual Expert module, it references a published study (Bathla et al, J. Neurointerventional Surg., 12:1028-1032 (2020)) which would typically involve expert consensus for ground truth. For the Capillary Function module, ground truth for the simulated phantoms is "known" (inherent to the phantom design), and clinical data was used for "visual inspection" which implies expert review.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). For quantitative phantom testing, adjudication is not typically needed as the ground truth is predefined. For retrospective clinical data, particularly for "visual inspection" and comparison to a published study, it is common to have multiple readers involved, but the specific adjudication protocol is not detailed here.
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 provided text does not indicate that an MRMC comparative effectiveness study was performed to evaluate human reader improvement with AI assistance versus without. The studies described are performance validation tests of the device itself (standalone or comparative to predicate/reference), not human-in-the-loop clinical utility studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance validation testing described for both the Capillary Function module (using digital phantoms and visual inspection of clinical data) and the Virtual Expert module (volumetric and spatial agreement, DEFUSE3 criteria) appears to be focused on standalone algorithm performance. The comparative testing against a predicate and reference device also implies standalone performance evaluation.
7. The Type of Ground Truth Used
- Capillary Function Module: For simulated digital phantoms, the "true parameter combinations were known" (page 10), indicating a simulation-based (synthetic) ground truth. For retrospective clinical data, it was primarily used for "visual inspection," implying a clinical expert-derived visual ground truth.
- Virtual Expert Module: For retrospective patient CT perfusion imaging, the ground truth for volumetric and spatial agreement would likely be expert consensus or highly delineated clinical ground truth based on expert review of the images. The reference to the DEFUSE3 criteria also points to clinically relevant ground truth.
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set. It focuses on the performance validation testing.
9. How the Ground Truth for the Training Set was Established
The document does not specify how the ground truth for the training set was established, as it does not elaborate on the training process or data.
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(192 days)
Cercare Medical Neurosuite
Cercare Medical Neurosute and associated modules, including the Capillary Function module, is an image processing software package to be used by trained professionals, including physicians and medical technicians.
The software package runs on standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM (Digital Imaging and Communications in Medicine) compliant imaging devices
Cercare Medical Neurosuite provides viewing capabilities, whereas the Capillary Function module provides analysis capabilities for functional and dynamic imaging datasets acquired with MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI).
The Capillary Function module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. In addition, the Capillary Function module's DWI technology is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.
The Virtual Expert module allows the calculation of regions of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and to calculate ADC threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke.
Areas of decreased perfusion appear as areas of changed signal intensity:
- · Lower signal intensity for CBF and CBV
- · Higher signal intensity for TTP, MTT, and Tmax
Cercare Medical Neurosuite is a software-only device designed to streamline medical image processing by providing for the visualization and study of medical images. CMN can be installed on a customer PC or it can be accessed remotely using remote desktop technologies. CMN provides viewing, quantification, analysis and reporting capabilities. CMN is not intended as a dedicated PACS system for long term persistent storage of patient data.
CMN is software that is intended for use by trained professionals, including physicians and medical technicians. The software provides cerebral image processing capabilities. CMN is intended to be used as decision support software only and the clinician continues to provide all treatment decisions.
The software is intended to visualize and study neuroimaging by image viewing and registration of medical images. CMN works with MRI (Magnetic Resonance Image) technology.
CMN accepts and produces data sets in the DICOM format. DICOM is a standard format for storing and transmitting medical image data in vendor neutral format and is managed by the DICOM Standards Committee.
CMN is a platform that allows for the addition of certain modules for further analysis. One of these modules included in this submission is Capillary Function.
Capillary Function, when activated in the installed Cercare Medical Neurosuite, provides further functionalities for reading, writing, visualizing and studying medical images.
Capillary Function provides perfusion post-processing technologies, where dynamically acquired perfusion MRI series can be processed to yield information relevant for assessment of the hemodynamic status of a patient.
Capillary Function generates hemodynamic markers, which can be used for management of diseases with possibly compromised hemodynamic function, such as ischemic stroke and tumors.
The generated output maps can be viewed by standard DICOM image viewers. In addition. Capillary Function includes the possibility for post-processing diffusion-weighted imaging (DWI) MRI data. Post-processing of DWI data results in maps reflective of local water diffusion properties. The post-processed DWI-derived maps can be viewed in standard DICOM image viewers. Capillary Function thus works with MRI technology.
Virtual Expert, when activated in the installed CMN Capillary Function, provides further functionalities for reading, writing, visualizing, and studying medical images.
Virtual Expert provides automatic delineation of regions of interest (ROI) relevant for stroke patient assessment based on perfusion and diffusion image output generated by the Capillary Function module. Specifically, diffusion MRI images are used to generate threshold masks of perceived core lesions, whereas perfusion MRI images are used to generate threshold masks of perceived perfusion restriction. Virtual Expert thus works with MRI technology.
The generated masks can be combined into a mismatch region of interest.
Volumetric calculations and ratios can be calculated from the computed regions of interest.
Here's a breakdown of the acceptance criteria and study information for the Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Capillary Function Module (Perfusion Biomarkers) | |
| Digital phantoms: Absolute bias | Reached in all tests conducted |
| Digital phantoms: Correlation coefficients | Reached in all tests conducted |
| Digital phantoms: Multi-scale structural similarity index | Reached in all tests conducted |
| Virtual Expert Module (Volumetric and Spatial Agreement) | |
| Per-patient volumetric agreement | Not explicitly quantified, but comparison testing was performed and modeled after the predicate device, implying acceptable performance. |
| Per-lesion volumetric agreement | Not explicitly quantified, but comparison testing was performed and modeled after the predicate device, implying acceptable performance. |
| Per-patient spatial agreement | Not explicitly quantified, but comparison testing was performed and modeled after the predicate device, implying acceptable performance. |
| Per-lesion spatial agreement | Not explicitly quantified, but comparison testing was performed and modeled after the predicate device, implying acceptable performance. |
| Overall Software Performance | |
| Meets all design requirements and specifications | Demonstrated through software performance, validation, and verification testing. |
| Provides accurate representation of key processing parameters under a range of clinically relevant parameters | Demonstrated through extensive performance validation testing. |
2. Sample Size Used for the Test Set and Data Provenance:
-
Capillary Function Module:
- Test Set: Predominantly digital phantoms. The text mentions "human-like phantom testing."
- Data Provenance: Not explicitly stated for retrospective clinical data, but the phantoms are simulated.
- Note: Retrospective clinical data was primarily used for visual inspection, not rigorous quantitative testing in this module's validation.
-
Virtual Expert Module:
- Test Set: Retrospective patient MR perfusion and diffusion imaging.
- Data Provenance: Not explicitly stated (e.g., country of origin). The data is described as "retrospective clinical data."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth for either module's test sets.
- For the Virtual Expert module, it mentions "comparison testing...in the associated published technical comparison study (Bathla et al, J. Neurointerventional Surg., 12:1028-1032 (2020))." This external publication might contain more details on expert involvement, but it's not present in this document.
4. Adjudication Method for the Test Set:
- The document does not explicitly state the adjudication method used for either module's test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size:
- No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not explicitly described in this document. The performance testing focused on the device's accuracy and agreement with ground truth or a predicate device, not on human reader improvement.
- The Virtual Expert module's secondary application assessment mentioned "image-driven decision to treat analysis through the so-called DEFUSE3 criteria," which hints at clinical relevance, but it's not a formal MRMC study of human performance improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, standalone performance testing was conducted. The entire performance data section describes the testing of the CMN Capillary Function with Virtual Expert as a software-only device. The device was compared against known parameters (digital phantoms) and retrospective clinical data (yielding volumetric and spatial agreement) without explicit mention of human-in-the-loop performance during these validation steps.
7. The Type of Ground Truth Used:
- Capillary Function Module:
- Digital Phantoms: "True parameter combinations were known." This means the ground truth was synthetically generated and precisely defined.
- Virtual Expert Module:
- Retrospective Clinical Data: Ground truth implies a reference standard or consensus derived from the clinical images themselves for volumetric and spatial agreement. The comparison was modeled after a published technical study, which may provide insight into how ground truth was typically established in such contexts (likely expert consensus or a validated reference method).
8. The Sample Size for the Training Set:
- The document does not explicitly state the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established:
- The document does not explicitly state how the ground truth for the training set was established. In fact, it doesn't mention training data at all. The description focuses on validation and verification rather than model development.
Ask a specific question about this device
(237 days)
Cercare Medical Neurosuite
Cercare Medical Neurosuited modules, including the Capillary Function module, is an image processing software package to be used by trained professionals, including physicians and medical technicians.
The software package runs on standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM (Digital Imaging and Communications in Medicine) compliant MR imaging devices.
Cercare Medical Neurosuite provides viewing capabilities, whereas the Capillary Function module provides analysis capabilities for functional and dynamic imaging datasets acquired with MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI).
The Capillary Function module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. In addition, the Capillary Function module's DWI technology is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.
Cercare Medical Neurosuite is a software-only device designed to streamline medical image processing by providing for the visualization and study of medical images. CMN can be installed on a customer PC or it can be accessed remotely using remote desktop technologies. CMN provides viewing, quantification, analysis and reporting capabilities. CMN is not intended as a dedicated PACS system for long term persistent storage of patient data.
CMN is software that is intended for use by trained professionals, including physicians and medical technicians. The software provides cerebral image processing capabilities. CMN is intended to be used as decision support software only and the clinician continues to provide all treatment decisions.
The software is intended to visualize and study neuroimaging by image viewing and registration of medical images obtained with MRI (Magnetic Resonance Image) technology.
CMN accepts and produces data sets in the DICOM format. DICOM is a standard format for storing and transmitting medical image data in vendor neutral format and is managed by the DICOM Standards Committee.
CMN is a platform that allows for the addition of certain modules for further analysis. One of these modules included in this submission is Capillary Function.
Capillary Function, when activated in the installed Cercare Medical Neurosuite, provides further functionalities for reading, writing, visualizing and studying medical images.
Capillary Function provides perfusion post-processing technologies, where dynamically acquired perfusion MRI series can be processed to yield information relevant for assessment of the hemodynamic status of a patient.
Capillary Function generates hemodynamic markers, which can be used for management of diseases with possibly compromised hemodynamic function, such as ischemic stroke and tumors.
The generated output maps can be viewed by standard DICOM image viewers. In addition, Capillary Function includes the possibility for post-processing diffusion-weighted imaging (DWI) MRI data. Post-processing of DWI data results in maps reflective of local water diffusion properties. The post-processed DWI-derived maps can be viewed in standard DICOM image viewers. Capillary Function thus works with MRI technology.
The provided text is a 510(k) summary for the Cercare Medical Neurosuite (CMN) with Capillary Function. It details the device's characteristics, indications for use, and a comparison to a predicate device (iSchemaView's RAPID). While it states that acceptance criteria were met, it does not provide specific numerical acceptance criteria or detailed results of the performance studies.
However, I can extract the information that is present and highlight what is missing based on your request.
Device: Cercare Medical Neurosuite (CMN) with Capillary Function
Indications for Use: Image processing software package for trained professionals (physicians, medical technicians) to perform image viewing, processing, and analysis of functional and dynamic MRI datasets (DWI and dynamic contrast-enhanced imaging data). Specifically, the Capillary Function module is used for visualization and analysis of dynamic imaging data to calculate parameters related to tissue flow (perfusion) and tissue blood volume, and to visualize local water diffusion properties from DWI data.
Here's the breakdown of your requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes that "The established acceptance criteria were reached in all tests conducted" but does not explicitly define these criteria or provide specific numerical results of the device performance against them. It generally states:
| Criterion Type | Acceptance Criteria (Not Explicitly Defined in Document) | Reported Device Performance (Summary) |
|---|---|---|
| Accuracy (Phantom Data) | Implicit: High correlation, low absolute bias, high multi-scale structural similarity index. | "The established acceptance criteria were reached in all tests conducted." (Bench testing with digital phantoms showed accurate representation of key processing parameters.) |
| Software Functionality | Implicit: Met all design requirements and specifications. | "Software performance, validation and verification testing demonstrated that the CMN system met all design requirements and specifications." |
| DICOM Compliance | Implicit: Full compliance with NEMA PS 3.1-3.20. | "CMN with Capillary Function complies with DICOM (Digital Imaging and Communications in Medicine)." |
| Safety | Implicit: No unacceptable risks. | "The CMN with Capillary Function performs as intended and presents no unacceptable risks to the intended patient population." |
| Substantial Equivalence | Implicit: Similar intended use, indications, technological characteristics, and principles of operation to predicate device. | "The non-clinical bench data support the safety of the device and demonstrate that CMN performs as intended in the specified use conditions. CMN is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the legally marketed Predicate device, RAPID (K172477)." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Description: The document refers to "bench testing including simulated digital phantoms and retrospective clinical data."
- Sample Size: Not specified. The exact number of digital phantoms or retrospective clinical cases used in the test set is not mentioned.
- Data Provenance:
- Country of Origin: Not specified for the retrospective clinical data.
- Retrospective/Prospective: Retrospective clinical data was used. Digital phantoms are simulated data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document mentions the retrospective clinical data was "primarily used for visual inspection," implying human expert review, but does not detail the nature or number of these experts. For digital phantoms, the "true parameter combinations were known," meaning the ground truth was inherent to the simulation design, not established by human experts.
4. Adjudication Method for the Test Set:
- Method: Not specified. For the retrospective clinical data, it states "primarily used for visual inspection," which generally implies a qualitative review, but no formal adjudication process (like 2+1 or 3+1 consensus) is described. For phantom data, ground truth was inherent to the simulation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
- MRMC Study: No, it does not appear that a formal MRMC study was done to compare human readers with and without AI assistance. The performance testing was comparative against a predicate device using bench testing (digital phantoms) and retrospective clinical data primarily for visual inspection, not assessing the impact on human reader performance.
- Effect Size: Not applicable, as no MRMC study was described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the performance data described ("bench testing including simulated digital phantoms and retrospective clinical data") appears to primarily evaluate the algorithm's performance in generating the output maps and parameters independently. The phrase "the CMN system provides accurate representation of key processing parameters" and "rigorous testing was conducted through digital phantoms where the true parameter combinations were known" suggests a standalone evaluation of the algorithm's output.
7. The Type of Ground Truth Used:
- For digital phantoms: The ground truth was known parameter combinations inherent to the simulated data. This is considered a form of "synthetic ground truth."
- For retrospective clinical data: The ground truth method is not explicitly defined for quantitative comparison, as this data was "primarily used for visual inspection due to the relative nature of most perfusion image biomarkers." This implies a qualitative assessment against an unspecified clinical or expert consensus. It does not mention pathology or outcomes data as ground truth.
8. The Sample Size for the Training Set:
- Not specified. The document focuses on the validation of the device and does not provide details about its development process, including the training set size.
9. How the Ground Truth for the Training Set was Established:
- Not specified. As the training set size is not provided, neither is how its ground truth was established.
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