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Arterys MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers and on monitors/screens that meet appropriate technical specifications for image diagnosis.

Arterys MICA includes an optional Cardio AI module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (MR) imges. It provides clinically relevant and reproducible, quantitative data, and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners.

Arterys MICA includes an optional Oncology AI module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions.

Arterys MICA software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.

Arterys MICA, already cleared as per the predicate, is a dedicated software application used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. Pre-existing DICOM images, such as CT or MR, are uploaded into Arterys MICA from a PACS or a scanner. Arterys MICA is completely hosted in the cloud and is accessed using a compatible web browser by navigating to the following https://app.arterys.com. Cloud servers are provided by Amazon Web Services (AWS) and service is accessible globally.

The Viewer AI application of Arterys MICA is designed around a modular architecture of separate components that make up a basic image viewer. These include the Studylist, from which studies are selected and opened, the image display (2D, 3D, MIP, etc), view synchronization, metadata information, and various navigational, measurement, and other action tools.

Functionality provided by the Viewer AI is extended by the additional Cardio AI and Oncology AI application modules which add support for specific clinical workflows:

• Cardiac Workflow Module: Evaluates multi-slice and multi-phase velocity-encoded . cardiovascular magnetic resonance (MR) images to quantify blood flow and ventricular function. In addition, perfusion and delayed enhancement datasets are analyzed and quantified, and for parametric mapping, T1, T2, and T2* values are obtained to assess tissue changes in the myocardium, as well as ECV calculations.
• Arterys MICA includes an optional Oncology AI module which provides analytical tools ● to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence or presence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions.

Arterys MICA uses many deep learning algorithms to reduce many tedious, time-consuming manual steps, such as segmentation, landmark identification, etc. The results of these AI models are available on-screen to the user for further review and editing. The software does not perform any functions that could not be accomplished by a trained user with a manual method; the purpose of the automation is to save time and automate potential error-prone manual tasks, while allowing the results to be reviewed as per the normal clinical workflow.

NOTE: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of images. Artervs MICA software is a complement to these standard procedures.

The provided text describes the Arterys MICA device and its regulatory submission (K203744). While it mentions some validation efforts and performance data, it does not contain a dedicated table of acceptance criteria paired with reported device performance results for a specific clinical study set up to prove the device meets these criteria. The information is fragmented and generally describes software verification and validation, along with a brief mention of a "standalone performance assessment" for the T1 workflow.

However, based on the provided text, I can extract and infer some information relevant to your request.

Here's an attempt to address your request based on the provided document, highlighting where information is present and where it is lacking:

Acceptance Criteria and Device Performance (Inferred/Extracted)

As explicitly requested, a direct "table of acceptance criteria and the reported device performance" is not present in the provided document. However, the document alludes to certain performance expectations and a specific assessment for the T1 workflow.

Inferred Acceptance Criteria / Performance Study Highlights:

Detailed Information on the Study Proving Device Meets Acceptance Criteria:

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

   • As shown above, an explicit table is not provided in the document. The performance information is embedded within text describing the validation process. The closest to quantitative acceptance criteria are the accuracy requirements for T1 and T2 values (30 ms and 4 ms, respectively), and the stated performance "within predefined accuracy requirements."

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

   • T1 Workflow Standalone Assessment: "90 Cardiac T1 Mapping MRI short axis (SAX) scans from 16 studies."
   • Data Provenance: Not explicitly stated (e.g., country of origin, multiple sites). It's not specified if this was retrospective or prospective data. The general context of "validation assessment" often implies retrospective data, but it's not confirmed.

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

   • Information Not Provided: The document does not specify the number of experts or their qualifications (e.g., radiologist with X years of experience) used to establish ground truth for any of the described tests.

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

   • Information Not Provided: The document does not mention any adjudication method for establishing ground truth for the test sets.

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:

   • No MRMC Study Described: The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is generally described as a "support tool" and that "the clinician retains the ultimate responsibility for making the pertinent diagnosis." The studies mentioned focus on quantitative accuracy and standalone performance of the AI components.

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

   • Yes: A standalone performance assessment was explicitly done for the T1 workflow: "A standalone performance assessment was performed on 90 Cardiac T1 Mapping MRI short axis (SAX) scans from 16 studies."
   • Additionally, the T1 and T2 value accuracy assessment implies a comparison of the algorithm's output to some "expected" value, which suggests a standalone component of evaluation.

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

   • For T1/T2 Accuracy: Ground truth was "the average intensity value obtained in a similar ROI delineated in OEM vendor generated inline maps." This implies a comparison to a known, perhaps previously validated, standard or reference.
   • For T1 Workflow Contours: Ground truth was referred to simply as "ground-truth contours." It's not specified how these "ground-truth contours" were established (e.g., expert manual segmentation, consensus).

8. The sample size for the training set:

   • Information Not Provided: The document does not disclose the sample size used for training the deep learning models.

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

   • Information Not Provided: The document does not specify how the ground truth for the training set was established.

Summary of Gaps in Information:

The provided document, being an FDA 510(k) summary, focuses on demonstrating substantial equivalence rather than providing a detailed clinical study report. Key information typically found in a comprehensive clinical validation study, such as details about human experts, adjudication methods, detailed ground truth establishment (especially for training data), and full MRMC study results, are largely absent. The document emphasizes software verification and validation, and a specific standalone AI assessment for a component of the device (T1 workflow contours) and quantitative accuracy for T1/T2 values.

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Arterys MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers and on monitors/screens that meet appropriate technical specifications for image diagnosis.

Arterys MICA includes an optional Cardio AI module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (MR) images. It provides clinically relevant and reproducible, quantitative data, and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners.

Arterys MICA includes an optional Oncology AI module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions.

Arterys MICA software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.

Arterys MICA, already cleared as per the predicate, is a dedicated software application used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. Pre-existing DICOM images, such as CT or MR, are uploaded into Arterys MICA from a PACS or a scanner. The software has two components: i) client, and ii) server. The client software (i) can be used in a Chrome desktop web browser. The server software (ii) runs on the Linux operating system.

The Viewer application of Arterys MICA is designed around a modular architecture of separate components that make up a basic image viewer. These components include the Worklist, from which studies are selected and opened, the Uploads list that displays all uploaded studies for the current organization, and the basic image display itself, which allows for viewing and working with 2D and 3D images.

Functionality provided by the Viewer is extended by the additional Cardio AI and Oncology AI (Oncology AI: Lung AI and Oncology AI: Liver AI) application modules which add support for specific clinical workflows:

• Cardiac Workflow Module: evaluates multi-slice and multi-phase velocity-encoded cardiovascular MR images to quantify blood flow and ventricular function.
• Oncology Workflow Module: supports the oncological workflow by helping the user confirm the absence or presence of lesions including evaluation, quantification, follow-up and documentation of any such lesions within MR or CT images.

The provided text does not contain specific acceptance criteria or a detailed study proving that the device meets such criteria. It primarily focuses on the FDA 510(k) clearance process, stating that the device is substantially equivalent to a predicate device and has undergone software verification and validation.

However, based on the information provided, we can infer some details and highlight the missing information according to your request.

Here's a breakdown of the requested information, with an emphasis on what is present and what is absent in the provided document:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics. It generally states that "Hundreds of software verification and validation tests, including the display quality of mammography images and a performance test comparison to Medis MR-CT VVA, were repeatedly conducted throughout the software development effort." It also mentions that the Cardio AI module "provides clinically relevant and reproducible, quantitative data, and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners." However, no precise metrics, thresholds, or results are presented.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set(s), nor does it describe the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide information on the number of experts used to establish ground truth or their qualifications.

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

The document does not describe any adjudication method used for 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 indicate that a multi-reader, multi-case (MRMC) comparative effectiveness study was performed to evaluate human reader improvement with AI assistance. The focus is on the device as a "support tool" that "does not directly generate any diagnosis or potential findings," implying it's not a direct comparative AI-assisted vs. non-AI-assisted reader study for diagnostic accuracy.

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

The document states that the Cardio AI module "provides clinically relevant and reproducible, quantitative data, and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners." This implies a form of standalone performance evaluation for its quantitative data generation. However, it does not provide specific metrics for this standalone performance. The Oncology AI module is described as providing "analytical tools to help the user assess and document changes," suggesting its role is primarily assistive and not a standalone diagnostic algorithm.

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

The document does not explicitly state the type of ground truth used for validation. Given the description of the AI modules, it could involve:

• Cardio AI: Comparison of quantitative measurements (e.g., blood flow, ventricular function) against a gold standard or established clinical methods, possibly involving expert review of MR images.
• Oncology AI: Comparison of lesion detection, evaluation, quantification, and follow-up against expert consensus readings or potentially pathology/outcomes data where applicable for confirmable lesions.
  However, these are inferences, as the document does not specify the ground truth methodology.

8. The sample size for the training set

The document does not provide any information regarding the sample size of the training set for the AI modules.

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

The document does not provide any information on how the ground truth for the training set was established.

Summary of what is present and missing:

The provided FDA 510(k) clearance letter and summary primarily address the substantial equivalence of Arterys MICA to a predicate device, focusing on its intended use, technological characteristics, and general software validation processes (IEC 62304, ISO 14971, FDA Guidance documents). It explicitly states that "Arterys MICA software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings."

Crucially, the document lacks the specific technical details of the AI module's performance evaluation as requested, such as numerical acceptance criteria, specific performance metrics, sample sizes for test and training sets, details of ground truth establishment (number/qualifications of experts, adjudication methods), and results of MRMC studies. This type of detailed study information is often found in the full 510(k) submission, not typically summarized in the public clearance letter or a brief 510(k) summary.

Ask a specific question about this device

Arterys® MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data, with the exception of mammography. It provides the capability to store images and patient information, and perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers.

Arterys MICA includes an optional Cardio Al module which is used to analyze the heart and its major vessels using multi-slice, multi-phase, and velocity-encoded cardiovascular magnetic resonance (MR) images. It provides clinically relevant and reproducible, quantitative data, and has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners.

Arterys MICA includes an optional Oncology AI module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations. It is a tool used to support the oncological workflow by helping the user confirm the absence of lesions, including evaluation, quantification, follow-up, and documentation of any such lesions.

Arterys MICA software is intended to be used as a support tool by trained healthcare professionals to aid in diagnosis. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/ or diagnosis, but it does not directly generate any diagnosis or potential findings.

Arterys MICA is a dedicated software application used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. Arterys MICA can also be used for analyzing multi-slice and multi-phase computed tomography (CT) or magnetic resonance (MR) image. Pre-existing CT or MR images are uploaded into Arterys MICA in a DICOM format from PACS or a scanner. The software has two components: i) client, and ii) server. The client software (i) can be used in a Chrome desktop web browser. The server software (ii) runs on the Linux operating system.

The basic image Viewer application of Arterys MICA is designed around a modular architecture of separate components that make up the basic image Viewer. These components include the Worklist, from which studies are selected and opened, the Uploads list that displays all uploaded studies for the current organization and the basic image Viewer itself, which allows for viewing and working with 2D and 3D images.

Functionality provided by the basic image Viewer is extended by additional Cardio Al and Oncology AI application modules and can add support for specific clinical workflows. The Cardio module adds support for flow-4D studies and provides additional functionality specific to cardiac studies. The Oncology module adds functionality specific to evaluating and measuring lesions, including lung and liver lesions/nodules.

The provided text is a 510(k) summary for the Arterys MICA device. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain detailed acceptance criteria or a study that proves the device meets those criteria.

The "Performance Data" section (Section 5) on page 7 states: "Safety and performance of Arterys MICA has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing." However, it does not provide the specific acceptance criteria, reported performance values, or any details about the studies conducted, such as sample size, data provenance, expert consensus details, or results.

Therefore, I cannot provide the requested information in the structured format because it is not present in the given document.

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