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Indications for Use Statement for ResolutionMD:

ResolutionMD® software is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports.

ResolutionMD is intended for use as a diagnostic, review, and analysis tool by trained healthcare professionals to drive clinical management. When interpreted by a trained physician, reviewed images may be used to aid in diagnosis. When used on a mobile device, ResolutionMD is not intended to replace full radiology workstations.

ResolutionMD is not to be used for primary mammography diagnoses.

Indications for Use Statement for ResolutionMD with Vessel Analysis module:

ResolutionMD® software is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports.

ResolutionMD incorporates a Vessel Analysis module which is used as a post-processing diagnostic review and analysis application for images viewed from ResolutionMD. It is a tool for use by trained healthcare professionals to review, edit, analyze and report findings of vascular anatomy. Clinicians can semi-automatically determine contrasted lumen boundaries and stenosis measurements, and evaluate maximum lumen diameters and length measurements.

ResolutionMD is intended for use as a diagnostic, review, and analysis tool by trained healthcare professionals to drive clinical management. When interpreted by a trained physician, reviewed images may be used to aid in diagnosis. When used on a mobile device, ResolutionMD is not intended to replace full radiology workstations.

ResolutionMD is not to be used for primary mammography diagnoses.

ResolutionMD® software is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports.

ResolutionMD incorporates a Vessel Analysis module which is used as a post-processing diagnostic review and analysis application for images viewed from ResolutionMD. It is a tool for use by trained healthcare professionals to review, edit, analyze and report findings of vascular anatomy.

The provided text is a 510(k) summary for the ResolutionMD software and its Vessel Analysis module. It describes the device, its indications for use, and claims substantial equivalence to previously cleared ResolutionMD devices. However, the document does not contain specific acceptance criteria or the details of a study that proves the device meets such criteria.

The available information regarding testing is general:

• Software Verification and Validation Testing: "Verification testing consisting of more 2000 separate tests, each executed multiple times by different testers, was performed for this device. Testing included functional, smoke and regression tests and was also complemented by beta tests performed by Calgary Scientific's distribution partners. The vast majority of tests passed our testing criteria. Any defects found or reported were either fixed or logged in the Unresolved Anomalies report included with this submission and annotated as to any impact on safety or effectiveness including applicable workarounds. Validation testing based on typical clinical workflows was performed by trained radiology personnel. Validation includes usability assessment and consistency across all client platforms."

This general description of verification and validation testing, while stating that a "vast majority of tests passed our testing criteria," does not provide a table of acceptance criteria, reported device performance metrics against those criteria, or the details of a study as requested in your prompt.

Therefore, it is not possible to provide the detailed information requested in your prompt based on the provided text. The document serves as an FDA 510(k) submission summary, which typically focuses on demonstrating substantial equivalence rather than presenting granular study results that might be found in a clinical investigation report.

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ResolutionMD™ Mobile is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0-compliant medical images as well as reports on the mobile device.

ResolutionMD Mobile provides wireless and portable access to medical images. The device is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians and technologists. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.

ResolutionMD Mobile is not to be used for mammography.

The ResolutionMD™ Mobile software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and highresolution Apple Inc. iOS and Google Inc. Android OS-based wireless mobile devices for the display and advanced visualization of medical image data. It provides for communication, storage, processing, rendering on the server and the display of DICOM 3.0 compliant image data on the mobile device.

Here's an analysis 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 acceptance criteria are not explicitly stated in a quantifiable manner (e.g., "accuracy must be >90%"). Instead, the primary acceptance criterion for the clinical testing appears to be agreement among radiologists that the mobile devices running ResolutionMD Mobile provide image quality and diagnostic confidence equivalent or comparable to a predicate PACS workstation for clinical use across various modalities, leading to the same diagnosis.

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

• Sample Size for Test Set: The document mentions "a series of typical yet challenging X-ray, ultrasound, PET and SPECT cases." The exact number of cases is not specified, only that there were "individual cases" for which agreement was reached.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It just refers to "typical yet challenging X-ray, ultrasound, PET and SPECT cases."

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

• Number of Experts: Nine (9) board-certified radiologists.
• Qualifications of Experts: Board-certified radiologists in the United States. No further detail on experience (e.g., "10 years of experience") is provided, but board-certification implies a certain level of expertise.

4. Adjudication method for the test set

The adjudication method appears to be a form of consensus or agreement. The study states, "All nine radiologists agreed that the iOS and Android mobile devices... were either 'equivalent' or 'comparable'..." and "For all the individual cases, there was agreement by all reviewers that the same diagnosis would be made..." This suggests a process where all radiologists had to concur, but the specific mechanics (e.g., independent review followed by discussion, or a sequential review) are not detailed. It is not explicitly a 2+1 or 3+1 method where disagreements are resolved by an additional reader.

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

• MRMC Comparative Effectiveness Study: Yes, a comparative assessment was done. The study specifically compared diagnostic confidence on mobile devices with ResolutionMD Mobile to a predicate PACS workstation. This constitutes a comparison of human readers using different display/interpretation systems.
• Effect Size of Human Readers Improvement with AI vs. without AI Assistance: This device is a PACS (Picture Archiving and Communication System) viewer for mobile devices, not an AI-powered diagnostic assist tool. Therefore, the study does not evaluate improvement with AI assistance. It evaluates the equivalence of a mobile viewing platform to a full workstation. The "effect size" is expressed qualitatively as being "equivalent" or "comparable" to the predicate PACS workstation.

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

No, a standalone (algorithm only) performance study was not done for diagnostic interpretation. ResolutionMD Mobile is a display and communication system, intended for use by trained professionals, not to autonomously interpret images. The clinical testing specifically involved human radiologists making diagnoses using the device.

7. The type of ground truth used

The ground truth was established by expert consensus among the panel of nine board-certified radiologists. They made comparative assessments and agreed on the diagnostic equivalence between the mobile device and the predicate PACS workstation for the tested cases. There is no mention of pathology or outcomes data being used as the definitive ground truth reference.

8. The sample size for the training set

The document does not provide information on a "training set" for the ResolutionMD Mobile software in the context of diagnostic interpretation. As a PACS viewer, it's not a machine learning model that is "trained" on images in the same way an AI algorithm for disease detection would be. The software is developed and verified through standard software engineering practices.

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

Not applicable, as there is no mention of a training set for the diagnostic function of the device in the context of machine learning. The "ground truth" for the software's functionality would be adherence to DICOM standards, performance metrics (like luminance), and usability, as confirmed by verification and validation testing, rather than medical ground truth established from labeled medical images for training purposes.

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The ResolutionMD™ Mobile software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0-compliant CT and MR medical images as well as reports on the mobile device.

The ResolutionMD Mobile provides wireless and portable access to medical images. The device is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians and technologists. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.

The ResolutionMD Mobile is not to be used for mammography.

The ResolutionMD™ Mobile 3.1 software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and highresolution Apple Inc. iOS and Google Inc. Android OS-based wireless mobile devices for the display and advanced visualization of medical image data. It provides for communication, storage, processing, rendering on the server and the display of DICOM 3.0 compliant image data derived from CT and MRI on the mobile device.

The ResolutionMD Mobile 3.1 is a software-based Picture Archiving and Communication System (PACS) intended for use as a diagnostic, review, and analysis tool for CT and MR medical images on specific mobile devices. It is not intended to replace full workstations and should not be used for mammography.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA submission for ResolutionMD Mobile 3.1 (K123186) primarily focuses on establishing substantial equivalence to a predicate device (ResolutionMD Mobile, K111346). The acceptance criteria for the new version, specifically supporting Android devices, revolve around demonstrating that the image quality and diagnostic confidence achieved on Android platforms are comparable to the previously cleared iOS platforms (predicate device) and adequate for clinical use.

• The Android mobile devices (smartphone and tablet) were comparable to the predicate iPhone and iPad devices.
• The devices were of adequate quality for clinical use.
• They were comfortable with the diagnoses made on the Android mobile devices using the ResolutionMD Mobile software.
• The overall clinical image display quality on the Android devices was equivalent to the iOS devices for the identification of clinically-relevant pathology.
• Comments on image contrast and sharpness included "very comparable" and "is diagnostic."
• No image artifacts were noted by the reviewers.
• The software and devices provide acceptable quality for regular use, and they were comfortable reviewing images. |

Study Proving Acceptance Criteria:

The study combined Performance Testing and Clinical Testing to demonstrate the device meets the acceptance criteria.

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

• Performance Testing Test Set: The sample size for the display performance tests was two mobile devices: an Android smartphone and an Android tablet.
  • Data Provenance: The tests were conducted by an ISO 17025-certified third party, implying controlled laboratory conditions and objective measurements. The data is "prospective" in the sense that the tests were specifically designed and executed to evaluate the new device's performance. The country of origin of the data is not explicitly stated, but the ISO certification and NIST traceability suggest an internationally recognized standard of testing.
• Clinical Testing Test Set: Not explicitly stated, but it involved a "series of typical CT and MR cases."
  • Data Provenance: The cases were reviewed by a panel of radiologists in the United States. The specific nature (retrospective/prospective) of the "series of typical CT and MR cases" is not detailed, but it likely involved retrospective cases from clinical archives for evaluation.

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

• Performance Testing: Ground truth was established by adherence to the AAPM Assessment of Display Performance for Medical Imaging Devices (2005) document. The "experts" in this context are the authors and contributors of the AAPM document, representing a consensus of medical physics and imaging professionals on display performance standards. The testing was carried out by an ISO 17025-certified third party, ensuring expertise in calibration and measurement.
• Clinical Testing: Three board-certified radiologists in the United States. Their specific years of experience are not mentioned, but "board-certified" indicates a recognized high level of expertise in diagnostic radiology.

4. Adjudication Method for the Test Set

• Performance Testing: The adjudication method was based on whether the devices "passed all of the tests" as defined by the AAPM document. This implies a pass/fail threshold for each of the nine display performance tests.
• Clinical Testing: The adjudication method was based on consensus among all three radiologists. The document repeatedly states "All three radiologists agreed that..." and refers to their collective findings. This indicates a form of unanimous consensus. There's no mention of a 2+1 or 3+1 rule; rather, it appears all three came to the same conclusion directly.

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, an MRMC comparative effectiveness study was not done in the context of AI assistance. This submission is for a PACS visualization device, not an AI diagnostic algorithm. The clinical testing was a comparative assessment between human readers using the Android mobile devices vs. human readers using the predicate iOS devices to establish equivalence in image display quality and diagnostic confidence. It did not involve comparing human readers with and without AI assistance to measure an effect size related to AI improvement. The device itself is a display and analysis tool, not an AI-powered diagnostic aid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone (algorithm-only) performance was not done. This device is a software-based PACS for image display and review by trained professionals. Its intended use inherently involves a "human-in-the-loop" for interpretation and diagnosis. The performance testing focused on the display capabilities of the device, and the clinical testing assessed human readers' diagnostic confidence and image quality perception when using the device.

7. The Type of Ground Truth Used

• Performance Testing: The ground truth was based on established technical standards and objective measurements as outlined in the AAPM Assessment of Display Performance for Medical Imaging Devices (2005). The test equipment and calibration were certified traceable to NIST, further solidifying the objectivity of the ground truth.
• Clinical Testing: The ground truth for comparative image quality and diagnostic confidence was expert consensus among the three board-certified radiologists comparing the Android display to the predicate iOS display for "clinically-relevant pathology." While the "clinically relevant pathology" implies there was a true pathological state in the cases, the primary "ground truth" for the equivalence assessment was the radiologists' agreement on the adequacy of the display for identifying that pathology.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. This submission primarily addresses the substantial equivalence of a new version of a PACS viewing software on Android devices to a previously cleared version on iOS. It describes the software's design and testing relative to established display standards and clinical usability. There is no mention of machine learning or AI components that would require a distinct "training set" in the traditional sense. The software's development would involve standard software engineering practices, verification, and validation, rather than a machine learning training phase.

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

• Not Applicable / Not Provided. As there's no mention of a distinct "training set" for a machine learning algorithm, there's no information on how a ground truth for such a set was established.

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The ResolutionMD(TM) is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

The ResolutionMD software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application. Calgary Scientific recommends that users of the ResolutionMD software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.

ResolutionMD Web 2.9 is not to be used for mammography.

Calcium Scoring module: The ResolutionMD device incorporates a Calcium Scoring module which is used to identify and quantify calcified plaque within the coronary arteries. This protocol is performed on non-contrast enhanced cardiac CT data sets.

Coronary Analysis module: The ResolutionMD device incorporates a Coronary Analysis protocol which is used to visually identify and measure stenoses in the coronary arteries. This protocol is performed on contrast-enhanced cardiac CTA data sets.

Vessel Analysis module: ResolutionMD Web 2.9 incorporates a Vessel Analysis module which is used as a postprocessing diagnostic review and analysis application for images viewed from ResolutionMD™, a PACS workstation or DICOM image viewer. It is a tool for use by trained professionals such as physicians, technologists and surgeons to review, edit, analyze and report findings of vascular anatomy. Clinicians can semi-automatically determine contrasted lumen boundaries and stenosis measurements, and evaluate maximum and minimum lumen diameters and length measurements.

The ResolutionMD(TM) is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the ResolutionMD Web 2.9 PACS system and its various modules (Calcium Scoring, Coronary Analysis, Vessel Analysis), outlining its intended use and regulatory classification. It does not include details on performance metrics, sample sizes, expert qualifications, or study methodologies.

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The ResolutionMD™ Mobile software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0-compliant CT and MR medical images as well as reports on the mobile device.

The ResolutionMD Mobile provides wireless and portable access to medical images. The device is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians and technologists. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.

The ResolutionMD Mobile is not to be used for mammography.

The ResolutionMD™ Mobile software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0-compliant CT and MR medical images as well as reports on the mobile device.

The provided text describes ResolutionMD Mobile, a PACS software, but it does not contain the detailed information required to answer all the questions about specific acceptance criteria and study details. The text is primarily an FDA 510(k) clearance letter and an Indications for Use statement.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

The document states that the device is intended for "diagnostic, review, and analysis" and emphasizes that it "is not intended to replace full workstations and should be used only when there is no access to a workstation," and also "is not to be used for mammography." These are related to the intended use and limitations, but not specific performance metrics or acceptance criteria as would be found in a clinical study report.

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The ResolutionMD™ 2.1 is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

The ResolutionMD™ 2.1 device incorporates a Calcium Scoring module which is used to identify and quantify calcified plaque within the coronary arteries. This protocol is performed on noncontrast enhanced cardiac CT data sets. It also includes the Coronary Artery Analysis protocol which is used to visually identify and measure stenoses in the coronary arteries. This protocol is performed on contrast-enhanced cardiac CTA data sets.

The ResolutionMD™ 2.1 software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application. Calgary Scientific recommends that users of the ResolutionMD™ 2.1 software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

The ResolutionMD™ 2.1 is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. The ResolutionMD™ software takes advantage of dedicated graphics hardware to speed the creation 3D rendered images.

The ResolutionMD™ 2.1 is available in a Microsoft Windows version, a Microsoft .NET software development kit version (SDK), a Linux Web server version and in a Macintosh OS version. All versions offer similar functionality. Available functions include DICOM communication, display of 2D images in original planes, computation and display of rendered 3D images and maximal intensity projection (MIP) and multiplanar reconstruction images (MIP/MPR), 2D and 3D image measurements, calcium scoring, and coronary artery analysis. The user controls these functions with a system of interactive menus and tools.

The provided text describes the ResolutionMD™ 2.1, a software-based Picture Archiving and Communication System (PACS) for displaying and visualizing medical image data. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or quantitative performance metrics.

The document is a 510(k) summary submitted to the FDA, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not specify any quantitative acceptance criteria for device performance (e.g., accuracy, precision, processing speed) or a study reporting such performance against those criteria. It focuses on functional equivalence to predicate devices.

2. Sample Size for the Test Set and Data Provenance

Not available. The document does not describe a test set, its sample size, or its data provenance. It mentions "extensive testing on supported platforms by members of the development and quality control team" and "Beta testing by trained cardiology professionals and potential customers" but provides no details on these tests.

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

Not available. Since no specific test set or performance evaluation study is described, there is no information on ground truth establishment or expert involvement for such a study. The document mentions "trained professionals such as physicians, technologists, and nurses" as intended users, and "trained cardiology professionals" for beta testing, but not for ground truth establishment.

4. Adjudication Method for the Test Set

Not available. No test set or corresponding adjudication method is described.

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

Not available. The document does not mention an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is a PACS system with visualization and analysis tools, not an "AI" in the sense of an automated diagnostic algorithm that would typically be evaluated in an MRMC study for improved reader performance.

6. Standalone (Algorithm Only) Performance Study

Not available. The document describes a PACS system with various imaging and analysis functionalities (2D/3D imaging, measurements, calcium scoring, artery analysis). It doesn't detail a standalone performance study of any specific algorithm within the system. The focus is on the integrated system's functionality being substantially equivalent to predicate devices.

7. Type of Ground Truth Used

Not available. No specific performance study is detailed, therefore no ground truth type (e.g., expert consensus, pathology, outcome data) is specified.

8. Sample Size for the Training Set

Not available. The document does not mention any "training set" as it describes a software product, not a machine learning model that would typically require a training set.

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

Not available. As there is no mention of a training set, there is no information on how its ground truth might have been established.

Summary of what is present:

The document primarily serves as a 510(k) application, focusing on:

• Device Description: ResolutionMD™ 2.1 is a software-based PACS for display and 3D visualization of medical image data (CT, MRI), with features like 2D/3D imaging, measurements, MIP/MPR, segmentation, calcium scoring, and coronary artery analysis.
• Intended Use: Diagnostic, review, and analysis tool for trained professionals. Images reviewed by a trained physician may be used as an element for diagnosis.
• Substantial Equivalence: Demonstrated against Vital Vitrea2™ and Vital Connect 4.1 in terms of platform, DICOM compliance, access, imaging features, measurement tools, and intended users.
• Hazard Analysis: Conducted and classified as minor.
• Testing: "Extensively tested on supported platforms" by development and QC teams, followed by "Beta testing by trained cardiology professionals and potential customers." However, no details on the scope, methodology, or results of this testing are provided beyond general statements about passing critical safety tests and demonstrating acceptable performance.

In conclusion, this document explicitly states that "The release version of the software will be required to pass all tests considered critical in terms of patient safety and demonstrate an overall acceptable performance for release as determined by the predefined release criteria." However, it does not provide the specific "predefined release criteria" or the results of the study that proves the device meets them.

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The ResolutionMD™ Cardiac Product Family is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

The ResolutionMD™ Cardiac Product Family is intended for use as a diagnostic, review. and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

The ResolutionMD™ Cardiac Product Family is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. The ResolutionMD™ software takes advantage of dedicated graphics hardware to speed the creation 3D rendered images.

The ResolutionMDTM Cardiac Product Family is available in a Microsoft Windows version and in a Macintosh OS version. Both versions offer similar functionality. Available functions include DICOM communication, display of 2D images in original planes, computation and display of rendered 3D images and maximal intensity projection (MIP) images, 2D and 3D image measurements, calcium scoring, and coronary artery analysis. The user controls these functions with a system of interactive menus and tools.

A hazard analysis has been conducted and the level of concern has been classified as minor. The ResolutionMD™ Cardiac Product Family software will be extensively tested on supported platforms by members of the development and quality control team prior to beta testing. Beta testing by trained cardiology professionals and potential customers will be completed prior to product release. The release version of the software will be required to pass all tests considered critical in terms of patient safety and demonstrate an overall acceptable performance for release as determined by the predefined release criteria.

The provided 510(k) summary for the ResolutionMD™ Cardiac Product Family does not contain specific acceptance criteria or a dedicated study demonstrating the device's performance against such criteria. Instead, it focuses on establishing substantial equivalence to a predicate device (Vitrea2) based on functional and technical similarities.

However, based on the information provided, we can infer some aspects and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, processing time, etc.). The "performance" described is largely a comparison of features and capabilities with the predicate device.

Missing Information: There are no quantitative performance metrics such as accuracy for calcium scoring, precision of measurements, speed of rendering, or comparison of diagnostic outcomes using the device versus the predicate or traditional methods.

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

The document mentions "beta testing by trained cardiology professionals and potential customers" as part of the validation process. However, it does not provide any details regarding:

• The sample size of medical images or patient cases used in this testing.
• The data provenance (e.g., country of origin of the data, retrospective or prospective nature of the beta testing data).

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

The document states that "beta testing by trained cardiology professionals" will be completed. However, it does not specify:

• The number of experts involved in establishing ground truth for the test set.
• The qualifications of these experts (e.g., "radiologist with 10 years of experience" is not mentioned, only "trained cardiology professionals").

4. Adjudication Method:

The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set during beta testing or any other validation.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance, as this is a PACS software and not strictly an AI-driven diagnostic aid in the modern sense.

6. Standalone Performance Study:

Since this is a PACS system designed for human-in-the-loop use by trained professionals, a standalone (algorithm only) performance study in the sense of an AI algorithm making a diagnosis without human intervention is not applicable or mentioned. The "device performance" relies on the trained professional's interpretation using the software.

7. Type of Ground Truth Used:

While "beta testing by trained cardiology professionals" implies a form of expert review, the exact "type of ground truth used" (e.g., expert consensus, pathology, outcomes data) for validating the software's features like calcium scoring or artery detection is not explicitly stated. It's likely that established clinical reporting for calcium scores and visual assessment for artery detection would serve as the implicit ground truth.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. This is expected as the device, introduced in 2007, is a PACS software for visualization and analysis, not an AI/machine learning model in the contemporary sense that typically requires a large training set. Its development would have focused on engineering robust algorithms for image processing and rendering, rather than learning from data.

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

As there is no mention of a "training set" in the context of machine learning, the question of how ground truth was established for a training set is not applicable. The underlying algorithms for features like calcium scoring would be based on established clinical methodologies (e.g., Agatston method) rather than being "trained" on data with ground truth.

Ask a specific question about this device

ResolutionMD™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

ResolutionMD™ is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

ResolutionMD™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. The ResolutionMD™ software takes advantage of dedicated graphics hardware to speed the creation 3D rendered images.

ResolutionMDTM is available in a Microsoft Windows version and in a Macintosh OS version. Both versions offer similar functionality. Available functions include DICOM communication, display of 2D images in original planes, computation and display of rendered 3D images and maximal intensity projection (MIP) images, and 2D and 3D image measurements. The user controls these functions with a system of interactive menus and tools.

The provided text describes a 510(k) summary for the ResolutionMD™ software, a Picture Archiving and Communication System (PACS). However, it does not contain information about specific acceptance criteria for a study proving device performance, nor details of such a study.

The text focuses on the device description, its intended use, a comparison to predicate devices, and the FDA's clearance letter acknowledging its substantial equivalence.

Therefore, for aspects related to acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, and comparative effectiveness studies, the provided document does not contain the requested information.

Here's what can be extracted and what is explicitly not available from the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

• The document states: "The release version of the software passed all tests considered critical in terms of patient safety and demonstrated an overall acceptable performance for release as determined by the predefined release criteria."
• No specific acceptance criteria (e.g., quantifiable metrics like sensitivity, specificity, or error rates) or reported device performance data are provided. The comparison table lists features and functionality against predicate devices, not performance metrics.

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

• Not available. The document states "ResolutionMD™ software has been extensively tested on a variety of platforms by both members of the development and quality control team and by potential customers serving as beta testers." This describes testing activities but does not provide details about a formal test set, its sample size, or data provenance.

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

• Not available. There is no mention of ground truth establishment methodology or the use of experts for this purpose in the context of performance evaluation.

4. Adjudication Method for the Test Set

• Not available.

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

• Not available. No mention of an MRMC study or an effect size for human readers with and without AI assistance is present. As this is a PACS viewing and processing software, not an AI diagnostic tool, such a study would generally not be expected.

6. Standalone (Algorithm Only) Performance Study

• Not available. The document describes a software PACS for display and visualization, which inherently involves human interaction, so a "standalone" algorithm-only performance might not be directly applicable in the same way it would for an AI-driven diagnostic algorithm. The testing described is focused on the software's functionality and safety.

7. Type of Ground Truth Used

• Not available.

8. Sample Size for the Training Set

• Not available. This device is a PACS viewing software, not an AI model that typically requires a 'training set' in the machine learning sense. The software's development likely involved standard software engineering and quality assurance practices, rather than machine learning training.

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

• Not available. (See point 8)

Summary of available information related to validation:

• Testing Philosophy: The software underwent testing by development, quality control teams, and beta testers. A hazard analysis was conducted, classifying the level of concern as "minor."
• Outcome of Testing: The release version "passed all tests considered critical in terms of patient safety and demonstrated an overall acceptable performance for release as determined by the predefined release criteria."
• Substantial Equivalence: The ultimate proof of the device's acceptability for market clearance is its "substantial equivalence" to legally marketed predicate devices (Lucion™, Plug 'n View 3D™, Vitrea 2™), based on intended use and technological characteristics. The provided table highlights functional similarities (e.g., DICOM compliance, 2D/3D imaging, measurement tools, MIP).

In conclusion, while the document confirms the device passed internal tests and was deemed substantially equivalent, it lacks the detailed quantitative performance data and study methodologies typically found in submissions for AI-powered diagnostic devices or those requiring specific performance metrics against a clinical ground truth. This is consistent with a PACS software device submission from 2006, where the focus would be more on functionality, safety, and equivalence to existing cleared devices rather than a detailed clinical performance study comparing against ground truth in a large cohort.

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