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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.

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Arterys Cardio DL consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by Arterys Cardio DL is intended to support qualified cardiologist, radiologist, or other licensed professional healthcare practitioners for clinical decision-making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.

Arterys Cardio DL is a web-accessible image post-processing analysis software device used for viewing and quantifying cardiovascular MR images. The device is intended to visualize and quantify MRI data in DICOM format. Manual and semi-automatic border detection forms the basis for analysis. The software has features for loading, saving, generating screen displays, and aggregating quantitative data from cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL is intended for use in both pediatric (neonate, infant, child and adolescent) and adult populations.

Here's an analysis of the acceptance criteria and study information for the Arterys Cardio DL device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary (K163253) for Arterys Cardio DL does not explicitly list specific quantitative acceptance criteria or their corresponding reported device performance values in a table format.
Instead, it indicates that "Safety and performance of Arterys Cardio DL has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing." The submission focuses on demonstrating substantial equivalence to predicate devices (Arterys Software v2.0 and Medis Imaging QMass) by comparing technological characteristics and asserting that it "raises no new questions of safety and effectiveness."

The "Features/Functions" table (pages 5-6) compares the proposed device's capabilities to its predicates but does not include quantitative performance metrics or acceptance criteria for those metrics.

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

The document does not specify the sample size used for the test set.
Data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated for any test data.

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

The document does not provide information regarding the number of experts used to establish ground truth or their specific qualifications for any test set.

4. Adjudication Method for the Test Set

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

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

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study investigating human readers' improvement with AI assistance. The focus is on the device's standalone performance and substantial equivalence to predicates.

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

Yes, a standalone study (algorithm-only performance) appears to have been done. The statement "Safety and performance of Arterys Cardio DL has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing" (page 7) implies that the software's inherent capabilities were tested and validated. The entire submission focuses on the algorithm's functionality and its output.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for validation. While the device provides "clinically-relevant and reproducible, quantitative data," it doesn't specify if this was validated against expert consensus, pathology, or outcomes data. Given that it's a post-processing analysis software intended to quantify existing MR images, it's highly probable that some form of expert consensus or highly accurate manual measurements served as ground truth for quantitative validation (e.g., comparing algorithm-derived volumes or flow measurements to manually delineated ones). However, this is not stated.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set.

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

The document does not provide information on how the ground truth for the training set was established. Given the "DL" (Deep Learning) in the product name, it's implied that machine learning was used, which would typically involve a training set with established ground truth, but the details are absent.

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