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McKesson Cardiology™ is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images and information from other data sources.

McKesson Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and distributed locations and may be part of a larger PACS configuration.

McKesson Cardiology™ offers support for third-party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting.

McKesson Cardiology™ is intended to assist trained professionals in the viewing and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease.

The version of McKesson Cardiology, subject of this 510(k), allows for the provision of additional information from expanded data sources to assist trained healthcare professionals throughout the healthcare facility and distributed locations in diagnosing and treating cardiac and vascular diseases.

McKesson Cardiology™ is an image processing system. The device consists of the following components and accessories: software application; database server; application server; image and document storage server and media; long-term archive and disaster recovery media; and client application workstation.

The version of McKesson Cardiology, subject of this 510(k) includes enhancements and new features including those for supporting dictation and streamlining user workflow for documenting, charting and trending procedural related data for Cath and other reporting; Statistical data collection of non-invasive features use for adoption considerations; Security; DICOM display view; Storage and archival enhancements; Support for stress modalities XML data import; EP modalities data import and reporting; and, importing lab results and exporting procedure medications using standard HL7.

Here's an analysis of the provided text regarding the acceptance criteria and study information for McKesson Cardiology™.

It's important to note that the provided document is a 510(k) summary for a Picture Archiving and Communication System (PACS) related to cardiology, and therefore, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a diagnostic algorithm.

Based on the document, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Formal acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, AUC) for a diagnostic output are not provided in this document. The "performance" described is centered around functional verification and validation of a medical imaging and information system.

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

The document does not specify a "test set" in the context of a diagnostic performance study. The testing described (verification, validation, usability, DICOM conformance) would typically involve internal data or simulated data to ensure system functionality, not a clinical dataset for evaluating diagnostic accuracy.

• Sample size for test set: Not applicable/not provided for diagnostic performance.
• Data provenance: Not applicable/not provided for diagnostic performance.

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

This information is not provided as the submission is not for a diagnostic algorithm requiring ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not provided as the submission is not for a diagnostic algorithm requiring adjudicated ground truth.

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

• No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were necessary to support substantial equivalence." This type of study demonstrates improved human reader performance with AI assistance, which is not relevant for this PACS device's substantial equivalence claim.
• Effect size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. The device (McKesson Cardiology™) is described as an "integrated multimodality image and information system" intended to "assist trained professionals in the viewing and diagnostic interpretation of images and other information." It is not presented as a standalone diagnostic algorithm.

7. Type of Ground Truth Used

• Not applicable in the context of a diagnostic performance study. The ground truth for the verification and validation tests would be the expected functional behavior or standard compliance as defined by the design specifications and regulatory standards (e.g., DICOM standard conformance).

8. Sample Size for the Training Set

• Not applicable. This device is a PACS, not an AI/ML algorithm that requires a training set. The "development" of such a system involves software engineering and system integration, not machine learning model training.

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

• Not applicable. As there is no training set mentioned for an AI/ML model, the ground truth establishment is irrelevant in this context.

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McKesson Cardiology ECG Mobile is a software application used for accessing and displaying ECG data and related patient information previously stored, analyzed or retrieved by the Horizon Cardiology ECG Management device. The McKesson Cardiology ECG Mobile software application is intended to be used from a mobile device to perform the following:

• View ECG test results, such as waveforms, synopsis measurements and diagnosis statements, as well as other relevant current or historical patient information originally stored, analyzed or retrieved by the Horizon Cardiology ECG Management device.
• View the ECG lead traces using different display settings.
• . Compare the results of current ECG tests with any previous ECG test results stored on the Horizon Cardiology ECG Management device.
• . Perform ECG-related measurements and edit synopsis measurement values stored on the Horizon Cardiology ECG Management device.
• Enter new diagnosis statements and/or modify diagnosis records stored on the Horizon . Cardioloģy ECG Management device.
• . Confirm ECG procedures and results.
• . Communicate information with the Horizon Cardiology ECG Management device such as login credentials and user settings.

The McKesson Cardiology ECG Mobile application is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators.

The McKesson Cardiology ECG Mobile application is not intended for real-time monitoring.

McKesson Cardiology ECG Mobile provides secure access to ECG records and related information contained on the Horizon Cardiology ECG Management device. The McKesson Cardiology ECG Mobile software functions as an accessory to the Horizon Cardiology ECG Management device, and requires a WiFi or cellular connection to a pre-installed and properly configured Horizon Cardiology ECG Management device. Through providing remote access to the ECG data stored on the McKesson Cardiology ECG Management device, the user is able to review current and previous ECG tests results, perform measurements on the ECG waveforms, and edit and confirm the ECG test results. McKesson Cardiology ECG Mobile does not store ECG or patient related information on the mobile device, does not directly communicate with cardiographs or other waveform acquisition devices, and does not use any automatic electronic data processing and pattern recognition methods to derive measurements (e.g. intervals and amplitudes) or provide diagnostic statements from the ECG data. The device does not allow modification of the original ECG traces (waveforms) stored on the Horizon Cardiology ECG Management device.

The McKesson Cardiology ECG Mobile application is not intended to replace the functionalities provided by the Horizon Cardiology ECG Management desktop client but to extend those to make selected functionalities described above available via mobile devices.

The McKesson Cardiology ECG Mobile functions as a non-real time system and is not intended for real time monitoring.

McKesson Cardiology ECG Mobile can be used both inside of medical facilities except in areas where cellular phone or wireless device use is prohibited.

McKesson Cardiology ECG Mobile is intended to operate on Apple®iPad running iOS mobile operating system from Apple Inc.

This 510(k) summary describes the McKesson Cardiology™ ECG Mobile, a software application designed to provide remote access to ECG data and related patient information from a mobile device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly define quantitative acceptance criteria for the McKesson Cardiology™ ECG Mobile. Instead, the performance data focuses on qualitative outcomes and ensuring the device functions as intended and is substantially equivalent to predicate devices.

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

• Clinical Qualification Testing: Sample cases were "selected by a clinician based on technical characteristics and relevancy to the intended function." The exact number of samples is not specified.
• Usability Testing (Human Factors): Conducted by "three (3) U.S. medical facilities." The number of individual users involved in this testing is not specified, but it implies a prospective approach within the US.
• Data Provenance: The usability testing was conducted in "U.S. medical facilities," indicating prospective data collection from the US. The origin of the sample cases for clinical qualification is not explicitly stated but implies relevance to clinical practice.

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

• Clinical Qualification Testing: "Sample cases selected by a clinician." The number of clinicians is not specified. Their qualifications are not explicitly detailed beyond being a "clinician."
• Usability Testing: The document mentions "users with varying qualifications" without specifying if these users were deemed "experts" for ground truth establishment. The focus of usability testing is on human factors and device interaction rather than establishing medical ground truth.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "clinical qualification" involved a clinician selecting sample cases and assessing the device's display and measurement capabilities against "the original data as presented by Horizon Cardiology ECG Management." This suggests a direct comparison against a reference system rather than a consensus-based adjudication among multiple experts.

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

No multi-reader, multi-case (MRMC) comparative effectiveness study is mentioned. The device is purely for viewing and editing existing ECG data, not for independent diagnostic interpretation or AI-assisted interpretation, therefore, comparing human readers with and without AI assistance is not applicable to its intended use.

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

This device is a software application for viewing and editing ECG data previously stored and analyzed by another device (Horizon Cardiology ECG Management). It "does not use any automatic electronic data processing and pattern recognition methods to derive measurements (e.g. intervals and amplitudes) or provide diagnostic statements from the ECG data." Therefore, a standalone performance study of an algorithm without human-in-the-loop performance is not applicable to this device, as it does not contain such algorithms.

7. Type of Ground Truth Used

The ground truth used for performance assessment (specifically clinical qualification) was "the original data as presented by Horizon Cardiology ECG Management." This implies that the Horizon Cardiology ECG Management system serves as the reference standard for waveforms and data representation.

8. Sample Size for the Training Set

The document does not mention a "training set" as the device does not employ machine learning or AI algorithms that would require such data.

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

Not applicable, as there is no training set for this device.

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McKesson Cardiology™ Hemo is intended for complete physiological/hemodynamic monitoring. clinical data acquisition, medical image and data processing, and analytical assessment.

McKesson Cardiology™ Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, storing, storing, carrying, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices.

McKesson Cardiology™ Hemo is intended for use in the areas of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other areas where patient/procedural data management is needed.

User-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous occurrences and facilitate timely responses.

Use of the system is not intended for unattended patient monitoring or in situations where arrhythmia detection is required.

The McKesson Cardiology™ Hemo device is a hemodynamic monitoring system for monitoring vital signs, performing measurements and calculations, documenting procedure and patient data and interfacing to other systems and devices during and after procedures in the areas of in the areas of: cardiology, cardiac catheterization, electrophysiology, invasive radiology, and other areas where patient/procedural data management is needed.

McKesson Cardiology™ Hemo also acquires patient information from other hospital information systems and makes hemodynamic information available to them. It facilitates seamless interfacing with hospital information systems and cardiac image management, archiving and reporting systems.

McKesson Cardiology™ Hemo incorporates the FDA cleared the ARGUS PB vital signs monitoring device (K012226), manufactured by Schiller AG, which provides patient monitoring via:

• ECG leads .
• Invasive Blood Pressure (non-McKesson transducers) .
• SpO2 sensor .
• Non-invasive blood pressure (NIBP) cuff .
• . Temperature probe
• . Thermal Dilution Cardiac output temperature probe (connected to a non-McKesson Cardiac Output catheter)
• . CO2 (connected to non-McKesson cannulas or intubation tubes)

Disposables and accessories (transducers, cannulas and intubation devices) are not part of the McKesson Cardiology™ Hemo system, but are supplied by the end user facility as required.

McKesson Cardiology™ Hemo is composed of:

• A control and documentation unit (Information System) that is used for administration, . performing measurements, recording full disclosure, taking samples and entering procedure notes and overall data input and management of the patient and procedure data.
• A Clinical Unit that incorporates the 'Clinical System' and the 'Front-End' unit (which . incorporates the Schiller Argus PB device - K012226). The clinical unit is responsible for acquiring, analyzing and displaying patient vitals and other pertinent clinical data. The data is displayed on monitors.

The provided 510(k) summary for McKesson Cardiology™ Hemo does not contain detailed acceptance criteria or a specific study designed to prove the device meets such criteria in terms of analytical or clinical performance metrics. Instead, it focuses on general verification and validation and demonstrating substantial equivalence to predicate devices.

Here's an analysis based on the provided text, addressing your specific points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) for the device's functions. Therefore, a table for this cannot be created from the provided text.

The closest statement regarding performance is:
"Verification and validation testing was performed on McKesson Cardiology™ Hemo to ensure it met all specifications. The device was further validated to ensure that it performs as intended. Performance testing was conducted to verify compliance with specified design requirements and relevant safety standards such as: IEC 60601-1, IEC 60601-2-49 and IEC 60601-1-8. In all instances, McKesson Cardiology™ Hemo functioned as intended and the observed results demonstrate substantial equivalence with the predicate devices."

This indicates general functional and safety compliance but does not provide quantitative performance data against specific acceptance criteria.

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

The document does not specify any sample sizes for test sets (e.g., number of patients, cases, or data points) or the provenance of any data used for testing (e.g., country of origin, retrospective or prospective). The performance data section broadly mentions "verification and validation testing."

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

The document does not mention using experts to establish ground truth for a test set. This type of information is usually associated with clinical performance studies or algorithm validation, which are not detailed here.

4. Adjudication Method for the Test Set

Since there is no mention of experts or a specific test set requiring ground truth establishment, there is no information on any adjudication method.

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

The document does not mention an MRMC comparative effectiveness study, nor does it discuss comparing human reader performance with or without AI assistance. The device is a physiological/hemodynamic monitoring system, not primarily an AI diagnostic tool that would typically undergo such a study for human reader improvement.

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

The document does not describe a standalone performance study in terms of specific algorithm outputs. The device is described as a system for monitoring, data acquisition, processing, and analytical assessment, implying a human user interacts with and interprets the displayed information. Its core function is to present data, not to make autonomous diagnostic decisions.

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used for any performance evaluation. Given the nature of the device (hemodynamic monitoring), ground truth would typically refer to validated physiological measurements, but no details are provided.

8. The Sample Size for the Training Set

The document does not mention a training set size. This indicates that the device might not heavily rely on machine learning or AI models that require distinct training and testing sets in the conventional sense for performance claims, or this information was not deemed necessary for this type of 510(k) submission focused on substantial equivalence to predicate devices that are also likely traditional monitoring systems.

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

Since there is no mention of a training set, there is also no information on how ground truth for a training set was established.

Summary of Device Evaluation Approach as described in the 510(k):

The McKesson Cardiology™ Hemo 510(k) relies primarily on demonstrating substantial equivalence to existing predicate devices (Medcon Ltd.'s Windsurfer and WITT BIOMEDICAL CORP Philips Xper Flex Cardio Physiomonitoring System/ Xper Information Management System).

The "Performance Data" section states: "Verification and validation testing was performed on McKesson Cardiology™ Hemo to ensure it met all specifications. The device was further validated to ensure that it performs as intended. Performance testing was conducted to verify compliance with specified design requirements and relevant safety standards such as: IEC 60601-1, IEC 60601-2-49 and IEC 60601-1-8. In all instances, McKesson Cardiology™ Hemo functioned as intended and the observed results demonstrate substantial equivalence with the predicate devices."

This indicates that the "study" proving the device meets acceptance criteria was a general verification and validation (V&V) testing program focused on:

• Meeting design specifications.
• Functioning as intended.
• Complying with relevant safety standards (IEC 60601 series).
• Demonstrating that its technological characteristics and performance are comparable to the identified predicate devices, raising no new safety or effectiveness concerns.

Specific analytical or clinical performance metrics (e.g., accuracy of a specific measurement, diagnostic performance) and the details of studies to establish these are not provided in this summary. The FDA's clearance is based on the determination of substantial equivalence, implying that accepted methods for physiological monitoring are used and that the device performs comparably to already cleared devices.

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Horizon Cardiology™ ECG Management is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.

Horizon Cardiology™ ECG Management allows analysis of resting ECGs and provides preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology ECG Management can also provide a serial comparison of resting ECG data to facilitate review of a patient's current ECG with previous ECGs of the same patient.

Horizon Cardiology™ ECG Management is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators in a hospital or facility providing patient care. Horizon Cardiology ECG Management is not intended for real-time monitoring.

Horizon Cardiology™ ECG Management is a standard ECG management system for importing ECG waveform data, reviewing, performing measurements, diagnosis and comparison of ECG procedures and storing them for future review and management.

Horizon Cardiology™ ECG Management functions as a non-real time system. It receives ECG procedure files after the cessation of the ECG procedure, which can originate from any one of a variety of manufacturer's cardiographs, Stress ECG machines, Holter recording devices or Holter analysis and review stations. Horizon Cardiology™ ECG Management acquires the ECG waveforms through a network connection or via a diskette, and normalizes them to a common format. If the ECG cart has made an ECG procedure analysis, Horizon Cardiology™ ECG Management presents it and utilizes the Glasgow University Interpretive Algorithm to perform its own measurements, diagnosis and serial comparison without changing the raw waveform data.

Horizon Cardiology™ ECG Management acquires the Stress and Holter ECG files in PDF format through a network connection, modem or via a portable media (diskette, SD card, etc.) or wireless device and stores them in their original format without changing the file.

Horizon Cardiology™ ECG Management uses an intuitive interface, which provides tools to edit measurements and procedure diagnoses and enables the physician to seamlessly review numerous ECG procedures. Horizon Cardiology™ ECG Management complies with HL7 standards for export to the Hospital Information System (HIS) to provide billing information. Horizon Cardiology7™ ECG Management supports final ECG report distribution by printing, faxing, e-mailing and automatic export to other systems. The Horizon Cardiology™ ECG Management database complies with the requirements of HIPAA through robust password security, record access security and file allocation in a secure and managed server.

Horizon Cardiology™ ECG Management allows access to ECG records from web-enabled PC's throughout a network and enables authorized clinical users to access the system from remote locations.

The provided text describes McKesson Israel Ltd.'s Horizon Cardiology™ ECG Management system. It is a software application designed to import, display, store, analyze, distribute, and manage information related to ECG procedures. The analysis component uses the Glasgow University Interpretive Algorithm.

However, the provided document does not contain acceptance criteria for specific performance metrics (like sensitivity, specificity, accuracy, or reader improvement). It states that "Verification and validation testing was performed on Horizon Cardiology™ ECG Management to ensure it met all specifications. The device was further validated to ensure that it performs as intended. In all instances, Horizon Cardiology™ ECG Management functioned as intended and the results observed demonstrate substantial equivalence with the predicate devices."

This indicates that the study focused on demonstrating substantial equivalence to predicate devices (Medcon Ltd.'s Horizon Cardiology ECG (K061905) and GE Healthcare's GE MUSE® Cardiology Information System (K110132)). Substantial equivalence claims generally rely on demonstrating that the new device has the same intended use, similar technological characteristics, and principles of operation, and does not raise new issues of safety or effectiveness. This is often achieved through comparative analysis of features and functionality rather than rigorous statistical performance testing against predefined criteria for diagnostic accuracy.

Therefore, many of the requested details about acceptance criteria and specific study designs are not present in this 510(k) summary.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified.
• Data Provenance (country of origin, retrospective/prospective): Not specified.

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

• Not specified. The document states the system "provides preliminary data for editing and confirmation by an over-reading physician," implying physician review but not detailing its role in establishing formal ground truth for validation.

4. Adjudication Method for the Test Set

• Not specified.

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

• Was an MRMC study done? No, an MRMC study focused on comparing human readers with and without AI assistance is not described. The validation focuses on the system itself and its equivalence to predicate devices.
• Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable, as no such study is described.

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

• Was a standalone study done? The document indicates that the device performs its own measurements, diagnosis, and serial comparison using the Glasgow University Interpretive Algorithm. It "provides preliminary data for editing and confirmation by an over-reading physician." This implies a standalone diagnostic output that is then subject to physician review. However, the document does not present specific performance metrics for this standalone output against a ground truth. The "performance data" section focuses on meeting specifications and substantial equivalence rather than diagnostic accuracy.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated for performance evaluation. For the system's intended use, the "over-reading physician" is expected to confirm or edit the preliminary analysis, suggesting physician consensus or final readings as the de facto clinical ground truth. However, for the validation study, the specific method of establishing ground truth for performance metrics is absent.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The document describes a system that utilizes the Glasgow University Interpretive Algorithm, an established algorithm, rather than a de novo machine learning model trained on a specific dataset. Therefore, there isn't a "training set" in the context of training a novel AI algorithm.

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

• How Ground Truth for Training Set was Established: Not applicable, as the device uses an established algorithm rather than a newly trained AI model.

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Horizon Cardiology™ is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images.

Horizon Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and may be part of a larger PACS configuration.

Horizon Cardiology™ offers support for third party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting.

Horizon Cardiology™ is an image processing system. The device consists of the following components and accessories: software application; database server; web server; application server; image and document storage server and media; long term archive and disaster recovery media; and client application workstation.

The provided 510(k) summary for McKesson Israel Ltd.'s Horizon Cardiology™ does not contain specific acceptance criteria or a study that evaluates the device against such criteria in terms of clinical performance or accuracy beyond confirming its intended functionality.

Instead, the submission focuses on substantial equivalence to predicate devices based on intended use, technological characteristics, and principles of operation. The "Performance Data" section states that "Verification and validation testing was performed on Horizon Cardiology™ to ensure it met all specifications. The device was further validated to ensure that it performs as intended. In all instances, Horizon Cardiology™ functioned as intended and the results observed demonstrate substantial equivalence with the predicate devices." This suggests internal testing for functionality and specifications, but no detailed clinical performance study with defined acceptance criteria is presented.

Therefore, the requested information cannot be fully extracted from the provided text. However, based on the information given, here's what can be inferred and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of the provided document. The document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy for a specific diagnostic task). The "performance" discussed broadly refers to the device functioning as intended in comparison to predicate devices, not against specific, measurable clinical outcomes.

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

Not specified. The document mentions "Verification and validation testing" but does not detail the nature of this testing, the size of any test sets (clinical or technical), or the provenance (country of origin, retrospective/prospective) of any data used.

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

Not applicable/Not specified. Since no clinical performance study with a test set and ground truth establishment is described, this information is not present.

4. Adjudication Method for the Test Set

Not applicable/Not specified. As no clinical performance study with a test set is described, there is no mention of an adjudication method.

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

No. The document does not describe a MRMC comparative effectiveness study where human readers' performance with and without AI assistance is evaluated.

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

No. The device is described as an image and information system for import, export, storage, archival, review, analysis, quantification, reporting, and database management. It's a system to support cardiovascular imaging workflows, not a standalone AI algorithm designed for automated diagnostic tasks. Therefore, a standalone performance study in the sense of an "algorithm only" evaluation is not relevant or described.

7. Type of Ground Truth Used

Not applicable/Not specified. Without a clinical performance study, there is no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The "ground truth" for the device's functionality would likely be adherence to technical specifications and successful execution of its stated features.

8. Sample Size for the Training Set

Not applicable/Not specified. As this is not presented as an AI/machine learning diagnostic device in the sense of a predictive algorithm, there is no mention of a training set or its size.

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

Not applicable/Not specified. Similar to the above, without a training set for an AI algorithm, there is no information on how its ground truth would be established.

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