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Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians (medical analysis and decision making) and medical technicians (administrative case processing). The software runs on a 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 compliant imaging devices. Rapid is indicated for use in Adults only.

Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT, CT Perfusion (CTP), CT Angiography (CTA), C-arm CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI, CT, and C-arm CT).

Rapid C-arm CT Perfusion can be used to qualitatively assess cerebral hemodynamics in the angiography suite.

The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue.

The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion - weighted MRI data.

The Dynamic Analysis 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.

Rapid CT Perfusion and Rapid MR Perfusion can be used by physicians to aid in the selection of acute stroke patients (with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery). Instructions for the use of contrast agents for this indication can be found in Appendix A of the User's Manual. Additional information for safe and effective drug use is available in the product-specific iodinated CT and gadolinium-based MR contrast drug labeling.

In addition to the Rapid imaging criteria, patients must meet the clinical requirements for thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions:

· Bolus Quality: absent or inadequate bolus.

· Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate.

· Presence of hemorrhage.

· C-Arm CTP is not to be used in the Rapid Thrombectomy indication criteria, other modalities should be consulted.

Cautions:

· C-Arm CTP provides qualitative data only, review other modalities prior to diagnosis. CBV and CBT are not absolute and CBT, CBV, MTT and Tmax are supported for qualitative interpretation of the perfusion maps only.

Rapid is a software package that provides for the visualization and study of changes in tissue using digital images captured by diagnostic imaging systems including CT (Computed Tomography) and MRI (Magnetic Image Resonance), as an aid to physician diagnosis.

Rapid can be installed on a customer's Server or it can be accessed online as a virtual system. It provides viewing, quantification, analysis and reporting capabilities.

Rapid works with the following types of (DICOM compliant) medical image data:

• CT (Computed Tomography)
• MRI(Magnetic Image Resonance) ●

Rapid acquires (DICOM compliant) medical image data from the following sources:

• . DICOM file
• DICOM CD-R ●
• Network using DICOM protocol. ●

Rapid provides tools for performing the following types of analysis:

• selection of acute stroke patients for endovascular thrombectomy ●
• volumetry of thresholded maps
• time intensity plots for dynamic time courses
• measurement of mismatch between labeled volumes on co-registered image ● volumes
• large vessel density. ●

Rapid is a Software as a Medical Device (SaMD) consisting of one or more Rapid Servers (dedicated or virtual). The Rapid Server is an image processing engine that connects to a hospital LAN, or inside the Hospital Firewall. It can be a dedicated Rapid Server or a VM Rapid appliance, which is a virtualized Rapid Server that runs on a dedicated server.

Rapid is designed to streamline medical image processing tasks that are time consuming and fatiguing in routine patient workup. Once Rapid is installed it operates with minimal user interaction. Once the CT [NCCT, CT, CTA, C-arm CT(CBCT)] or MR (MR, MRA) data are acquired, the CT or MRI console operator selects Rapid as the target for the DICOM images, and then the operator selects which study/series data to be sent to Rapid. Based on the type of incoming DICOM data, Rapid will identify the data set scanning modality and determine the suitable processing module. The Rapid Platform is a central unit which coordinates the execution image processing modules which support various analysis methods used in clinical practice today:

• Rapid CTP/MRP/C-arm CTP, DWI, Dynamic Analysis (Original: K121447, Updated ● with K172477, K182130, K213165, K233512 and K233582)
• Rapid CTA (K172477) ●
• Rapid ASPECTS (K200760, K232156)
• Rapid ICH (K193087, K221456)
• Rapid LVO (K200941, K221248)
• Rapid NCCT Stroke (K222884)
• . Rapid RV/LV (K223396)
• Rapid PETN (K220499)
• Rapid ANRTN (K230074) ●
• Rapid SDH (K232436) ●

The iSchemaView Server is a dedicated server that provides a central repository for Rapid data. All iSchemaView Server data is stored on encrypted hard disks. It also provides a user interface for accessing Rapid data. It connects to a firewalled Data Center Network and has its own firewall for additional cyber/data security. The iSchemaView Server connects to one or more Rapid Servers via WAN. Available types of connection include VPN (Virtual Private Network - RFC2401 and RFC4301 Standards) Tunnel and SSH (Secure Shell).

The provided text describes the iSchemaView Rapid device, an image processing software package. The document focuses on its 510(k) submission (K233582) and demonstrates its substantial equivalence to a previously cleared predicate device (K213165). The new submission primarily extends the device's functionality to include C-arm CT for qualitative cerebral hemodynamics assessment and qualitative analysis of perfusion parameters.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in the format typically used for performance studies with specific metrics and thresholds (e.g., sensitivity, specificity, accuracy). Instead, it states that the device was validated to provide "accurate representation of key processing parameters" and "met all design requirements and specifications."

The key performance claims and their validation are described qualitatively:

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

The document states that iSchemaView conducted "extensive phantom validation testing" and "software verification and validation testing of the Rapid system" using "the use of phantoms and case data." However, it does not specify the sample size for the test set (number of phantoms or cases).

The data provenance is stated as:

• Phantoms: Used for characterizing perfusion imaging performance.
• Case Data: Used for validating the Rapid System performance.

The document does not explicitly mention the country of origin of the data or whether it was retrospective or prospective.

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

The document does not specify the number of experts used to establish ground truth for the test set or their specific qualifications. It mentions that the device is "to be used by trained professionals, including but not limited to physicians (medical analysis and decision making) and medical technicians (administrative case processing)" and that "Rapid C-arm CT Perfusion can be used to qualitatively assess cerebral hemodynamics in the angiography suite." While this indicates the intended users, it does not explicitly detail the experts involved in establishing ground truth for the validation studies.

4. Adjudication method for the test set

The document does not mention any adjudication method (e.g., 2+1, 3+1) used for establishing ground truth in the test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The current submission focuses on demonstrating substantial equivalence and the performance of the device itself (including its new feature for C-arm CT) rather than its direct comparative effectiveness with human readers.

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

The provided text only discusses "extensive phantom validation testing" and "software verification and validation testing." The results presented ("accurate representation of key processing parameters," "met all design requirements and specifications," and "comparable with small biases") appear to be from an algorithm-only (standalone) performance assessment, particularly for the software's ability to process and represent data from phantoms and cases, and the comparability of C-arm CT processing to conventional CT. There is no mention of human-in-the-loop performance in the context of these validation studies.

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

For the "phantom validation testing," the ground truth would inherently be known physical and temporal parameters designed into the phantoms.
For the "case data," the document does not explicitly state the type of ground truth. Given the nature of a software processing and analysis system, it likely relies on a combination of:

• Established interpretations from other modalities or clinical diagnoses, particularly for "selecting acute stroke patients."
• Quantitative measurements derived from advanced imaging, which the software aims to replicate or analyze.

8. The sample size for the training set

The document does not specify the sample size for the training set. It details the device's functionality and validation rather than its development or machine learning training specifics.

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

Since the document does not mention the sample size for the training set, it also does not describe how the ground truth for the training set was established. The focus is on the validation of the developed software, which includes algorithms, some of which may be AI/ML-based as indicated by "Mixed Traditional and AI/ML" under Software in Table 1 (page 10). However, the specifics of ML model training, including data and ground truth establishment, are not detailed in this summary.

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The Rapid RV/LV software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements for adults. Rapid RV/LV analyzes cases using machine learning algorithms to identify locations and measurements of the ventricles. The Rapid RV/LV device provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.

Rapid RV/LV software device is a radiological computer-assisted image processing software device. The Rapid RV/LV device is a CTPA processing module which operates within the integrated Rapid Platform to locate and measure the right and left ventricle diameters of the human heart to ultimately provide a ratio of the right ventricle diameter to the left ventricle diameter. The RV/LV software analyzes input CTPA images that are provided in DICOM format and provides both a visual output containing a color overlay image displaying where the ventricle diameter measurements were made along with the quantitative results of the measurements and a text file output (json format) containing the quantitative measurement results (the individual right and left ventricle diameters and their corresponding ratio).

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on specific performance metrics rather than explicitly listing "acceptance criteria" in a separate table. However, the performance data section implies the following are the primary endpoints for proving the device's accuracy in measuring RV/LV ratios.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 124 CTPA cases.
• Data Provenance: The cases were mixed from different scanner manufacturers (GE, Philips, Toshiba, and Siemens), suggesting data from various sources, likely clinical institutions. The document does not explicitly state the country of origin or if it was retrospective or prospective, though the mention of "cases with ground truth established" usually implies a retrospective approach where existing data is annotated.

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

• Number of Experts: 3 experts.
• Qualifications of Experts: The document does not explicitly state the qualifications of the experts (e.g., "radiologist with 10 years of experience"). It only identifies them as "experts."

4. Adjudication Method for the Test Set

• The document states "ground truth established by 3 experts." It does not specify the adjudication method used (e.g., 2+1, 3+1, or simple consensus).

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

• The document does not indicate that an MRMC comparative effectiveness study was done to evaluate how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance of the device against expert ground truth.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The document states: "Final device validation included standalone performance validation." This indicates the algorithm's performance was evaluated by itself, without human-in-the-loop assistance.

7. Type of Ground Truth Used

• Expert Consensus: The ground truth was established by "3 experts."

8. Sample Size for the Training Set

• The algorithm development used 516 CTPA cases. The text indicates that "training included 80% of cases for validation and 20% for training." This phrasing is a bit ambiguous, as typically the larger portion is for training and a smaller set for validation during development. However, if interpreted as 20% for pure training, then the training set size would be approximately 103 cases (20% of 516). If "validation" here refers to a development-phase validation set, then 80% would be 413 cases used in that stage. Given the context of "algorithm development" and allocation for "validation and training" within the 516, it's safe to say the total "training set" (including internal validation during development) was 516 cases.

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

• The document states that the 516 CTPA cases used for algorithm development were used with a "wide range of LV diameters." It does not explicitly detail the method for establishing ground truth for the training set, but it can be inferred that it would have been established by experts, similar to the test set, given that the final validation relied on expert ground truth.

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Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf computer or as VMware, and can be used to perform image viewing, processing and analysis of images. Data and images are acquired through DICOM compliant imaging devices.

Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT, CT Perfusion (CTP), CT Angiography (CTA), and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT).

The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue.

The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion - weighted MRI data.

The Dynamic Analysis 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.

Rapid CT-Perfusion and Rapid MR-Perfusion can be used by physicians to aid in the selection of acute patients (with known ocuusion of the intracranial internal carotid artery or proximal middle cerebral artery)

Instructions for the use of contrast agents for this in Appendix A of the User's Manual. Additional information for safe and effective drug use is available in the product-specific iodinated CT and gadolinium-based MR contrast drug labeling.

In addition to the Rapid imaging criteria, patients must requirements for thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions:

• Bolus Quality: absent or inadequate bolus.
• Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate .
• . Presence of hemorrhage

Rapid is a software package that provides for the visualization and study of changes in tissue using digital images captured by diagnostic imaging systems including CT (Computed Tomography) and MRI (Magnetic Image Resonance), as an aid to physician diagnosis. Rapid can be installed on a customer's Server or it can be accessed online as a virtual system. It provides viewing, quantification, analysis and reporting capabilities.

Rapid works with the following types of (DICOM compliant) medical image data:

• CT (Computed Tomography) ●
• MRI(Magnetic Image Resonance)

Rapid acquires (DICOM compliant) medical image data from the following sources:

• . DICOM file
• DICOM CD-R
• Network using DICOM protocol ●

Rapid provides tools for performing the following types of analysis:

• selection of acute stroke patients for endovascular thrombectomy ●
• volumetry of thresholded maps
• time intensity plots for dynamic time courses ●
• measurement of mismatch between labeled volumes on co-registered image ● volumes
• large vessel density

Rapid is a Software as a Medical Device (SaMD) consisting of one or more Rapid Servers (dedicated or virtual). The Rapid Server is an image processing engine that connects to a hospital LAN, or inside the Hospital Firewall. It can be a dedicated Rapid Server or a VM Rapid appliance, which is a virtualized Rapid Server that runs on a dedicated server.

Rapid is designed to streamline medical image processing tasks that are time consuming and fatiguing in routine patient workup. Once Rapid is installed it operates with minimal user interaction. Once the CT (NCCT. CT, CTA) or MR (MR, MRA) data are acquired, the CT or MRI console operator selects Rapid as the target for the DICOM images, and then the operator selects which study/series data to be sent to Rapid. Based on the type of incoming DICOM data, Rapid will identify the data set scanning modality and determine the suitable processing module. The Rapid platform is a central control unit which coordinates the execution image processing modules which support various analysis methods used in clinical practice today:

• Rapid CTP/MRP, DWI, Dynamic Analysis (Original: K121447, Updated with K172477; ● and K182130):
• Rapid CTA (K172477); ●
• Rapid ASPECTS(K190395); ●
• Rapid ICH (K193087);
• . Rapid LVO (K200941);

The iSchemaView Server is a dedicated server that provides a central repository for Rapid data. All iSchemaView Server data is stored on encrypted hard disks. It also provides a user interface for accessing Rapid data. It connects to a firewalled Data Center Network and has its own firewall for additional cyber/data security. The iSchemaView Server connects to one or more Rapid Servers via WAN. Available types of connection include VPN (Virtual Private Network - RFC2401 and RFC4301 Standards) Tunnel and SSH (Secure Shell).

Here's a breakdown of the acceptance criteria and study details for the Rapid device, specifically focusing on the NCCT Motion Artifact AI/ML Module performance, as described in the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance (NCCT Motion Artifact AI/ML Module)

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: N=619 axial image slices.
   • Data Provenance: The text does not explicitly state the country of origin for the test set data. It mentions that samples were obtained from "Siemens, GE, Toshiba, Philips, and Neurologica" for training, and for the independent validation, "The samples were primarily from Siemens with GE mixed." This suggests a multi-vendor, and likely multi-site, collection. The study appears to be retrospective as it uses existing medical images for evaluation.

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

   • Number of Experts: 3
   • Qualifications of Experts: Described as "experienced truthers." Specific qualifications (e.g., years of experience, subspecialty) are not provided.

3. Adjudication method for the test set:

   • The document states "ground truth established by 3 experienced truthers." While it doesn't explicitly mention a 2+1 or 3+1 method, the implication of "established by" multiple experts suggests a consensus-based approach was used to determine the ground truth from these three experts. It does not state "none."

4. 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:

   • No, a multi-reader, multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported in this summary for the NCCT Motion Artifact AI/ML Module. The performance evaluation is for the standalone algorithm.

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

   • Yes, a standalone algorithm performance study was done for the NCCT Motion Artifact AI/ML Module. The reported metrics (AUC, Sensitivity, Specificity) are for the algorithm's performance in detecting motion artifacts.

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

   • The ground truth for the test set was established by expert consensus from 3 experienced truthers.

7. The sample size for the training set:

   • Training Set: 23,066 axial image slices (Positive: 1,021, Negative: 12,877).
   • Training Validation Set: 5,906 axial image slices (Positive: 422, Negative: 5,484).

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

   • The document does not explicitly detail how the ground truth for the training data was established. However, given the context of medical image analysis and the subsequent use of "experienced truthers" for independent validation, it's highly probable that human expert review and labeling were also used to establish the ground truth for the training and training validation sets.

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iSchemaView's RAPID is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing and analysis of brain images. Data and images are acquired through DICOM compliant imaging devices.

iSchemaView's RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT).

The DWI Module is used to visualize local water diffusion properties from the analysis of diffusionweighted MRI data.

The Dynamic Analysis 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.

RAPID is a software package that provides for the visualization and study of changes of tissue perfusion and diffusion in digital images captured by CT (Computed Tomography) and MRI (Magnetic Image Resonance). RAPID can be installed on a customer PC or it can be accessed online as virtual system. It provides viewing, quantification, analysis and reporting capabilities.

RAPID works with the following types of (DICOM compliant) medical image data:

• · CT (Computed Tomography)
• · MRI (Magnetic Image Resonance)

RAPID acquires (DICOM compliant) medical image data from the following sources:

• · DICOM file
• · DICOM CD-R
• · Network using DICOM protocol

RAPID provides tools for performing the following types of analysis:

• · volumetry of threshold maps
• · time intensity plots for dynamic time courses
• measurement of mismatch between labeled volumes on co-registered image volumes

RAPID is a software-only device consisting of one or more RAPID Servers (dedicated or virtual and an iSchemaView Server). The RAPID Server is an image processing engine that connects to a hospital LAN, inside the Hospital Firewall. It can be a dedicated RAPID Server or a vmRAPID appliance, which is a virtualized RAPID Server that runs on a dedicated hospital server. Where available, the RAPID Server is placed logically in the demilitarized zone (DMZ) of the hospital's network to facilitate bidirectional secure connection between the (local) RAPID Server and the centralized iSchemaView Server.

The RAPID Server is configured to connect to applicable DICOM devices (PACS, Imaging Modalities, Research Workstations) via the hospital LAN and to receive diffusion and perfusion (DICOM) data directly and automatically from imaging modalities as they become available. It processes acquired data and delivers postprocessed images directly back to imaging modalities, local PACS and/or workstations, again using DICOM communication. It also transmits data to the iSchemaView Server for storage, retrieval and viewing.

The iSchemaView Server is a dedicated server that provides a central repository for RAPID data. All iSchemaView Server data is stored on encrypted hard disks. It also provides a user interface for accessing RAPID data. It connects to a firewalled Data Center Network and has its own firewall for additional data security. The iSchemaView Server connects to one or more RAPID Servers via WAN. Available types of connection include VPN (Virtual Private Network - RFC2401 and RFC4301 Standards) Tunnel and SSH (Secure Shell).

The provided 510(k) summary for iSchemaView, Inc.'s RAPID does not include specific acceptance criteria or an explicit study proving performance against them. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Olea Sphere) through a comparison of technological characteristics and a general statement about performance validation testing.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria or specific reported device performance metrics against such criteria. The closest information is a comparison of technological characteristics between RAPID and its predicate device, Olea Sphere, to demonstrate substantial equivalence.

Performance Statement:
The document states: "iSchemaView conducted extensive performance validation testing and software verification and validation testing of the RAPID system. This performance validation testing demonstrated that the RAPID system provides accurate representation of key diffusion and perfusion processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. Software validation and verification testing demonstrated that the RAPID system met all design requirements and specifications."

This is a general statement about the existence of testing, but it does not detail specific acceptance criteria (e.g., "accuracy must be > 95% for parameter X against ground truth Y") nor does it provide quantitative results.

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

The document does not specify the sample size used for any test set or the provenance (e.g., country of origin, retrospective/prospective) of the data used for performance validation.

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

The document does not mention using experts to establish ground truth for a test set, nor does it specify the number or qualifications of any such experts.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for a test set.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it mention any effect size of how much human readers improve with AI vs. without AI assistance. The focus is on the device's standalone processing capabilities, not its impact on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the implied performance validation is focused on the standalone algorithm. The statement "This performance validation testing demonstrated that the RAPID system provides accurate representation of key diffusion and perfusion processing parameters" suggests algorithmic accuracy and reliability, rather than human-in-the-loop performance. However, specific details of this standalone performance (e.g., accuracy metrics, specific parameters tested) are not provided in this 510(k) summary.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any validation. It broadly refers to showing "accurate representation of key diffusion and perfusion processing parameters," which implies comparison against some reference standard, but doesn't specify if this was expert consensus, pathology, outcomes data, a phantom, or another method.

8. The Sample Size for the Training Set

The document does not mention any training set or its sample size. This 510(k) summary is for a software package that processes images based on established physiological models for diffusion and perfusion, rather than a machine learning or AI model that typically requires a discrete training set.

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

As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established.

In summary: The provided 510(k) summary focuses almost exclusively on demonstrating substantial equivalence to a predicate device by comparing technical specifications and intended use. It describes the device's functionality and its role in processing medical images based on established scientific principles. It states that performance validation testing was conducted and that the system met design requirements, but it does not provide any specific quantitative acceptance criteria, details of the study design (e.g., sample size, data provenance), ground truth methodology, or reader study results. This type of summary for software performing calculations based on known physical models often relies on verification and validation against those models, rather than clinical efficacy studies with ground truth derived from pathology or expert consensus.

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