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Autoplaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.

Autoplaque is a workstation-based post processing application. It is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques and luminal stenoses.

The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present.

Autoplaque must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications.

Typical users of Autoplaque are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Autoplaque 3.0. a stand-alone software, performs post-processing of coronary Computed Tomography Angiography (CTA) images and measurements of components of images using computerized algorithms.

Autoplaque 3.0 aids the physician with measurement of coronary artery stenosis and provides measurements for coronary plaque and coronary artery remodeling. Autoplaque 3.0 does not replace standard clinical practice or clinician decision making.

Autoplaque 3.0 allows for standardized characterization of plaque and stenosis from DICOM image data (loaded from the local computer hard drive) and includes the following features:

• Review of heart and coronary vessels in Multiplanar Reformatting (MPR), curved MPR, and straightened MPR views:
• Measurement of vessel diameter and area;
• Characterization and measurement of plaque parameters; and
• Measurement of lumen diameter, area, and luminal stenosis.

Autoplaque 3.0 includes automated vessel, plaque and lumen segmentation, which is reviewed and can be edited, if necessary, by the clinician.

Autoplaque 3.0 can run on Windows or Mac computer platforms. The minimum hardware specifications are specified in the user manual.

Here's an analysis of the acceptance criteria and the studies conducted for Autoplaque 3.0, based on the provided text:

Acceptance Criteria and Device Performance for Autoplaque 3.0

The acceptance criteria for Autoplaque 3.0 focused on establishing concordance and agreement for various plaque and stenosis measurements compared to expert reader measurements and the predicate device. The primary statistical measures used were the intraclass correlation coefficient (ICC) and correlation coefficient. While specific numerical thresholds for "excellent agreement" or "excellent correlation" are not explicitly stated as acceptance criteria, the studies report achieving this level of agreement.

1. Table of Acceptance Criteria and Reported Device Performance

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Autoplaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.

Autoplaque is a post processing application option for the ORS Visual platform (K100335). It is a non-invasive diagnostic reading software add-on intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques.

The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present.

ORS Visual software (K100335) and the Autoplaque add-on must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications.

Typical users of ORS Visual (K100335) and Autoplaque are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Vessel Analysis is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.

Vessel Analysis is a post processing application option for the ORS Visual (K100335) platform family of products and can be used in the analysis of 2D/3D CT Angiography images/data derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular and vascular disease assessment. This software is designed to support the physician in assessment of stenosis analysis, pre/post stent procedure and directional vessel tortuosity visualization.

Vessel Analysis automatic visualization tools provide the users with the capabilities to facilitate segmentation of bony structures for accurate identification of the vessels. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a coronary artery, measure areas of abnormalities within a vessel.

The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present.

ORS Visual software (K100335) and the Vessel Analysis add-on must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Typical users of Vessel Analysis and ORS Visual (K100335) are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

The Autoplaque add-on for medical device ORS Visual (K100335) is a post processing analysis software package designed to assist Radiologists, Cardiologists, and other clinicians in the evaluation and assessment of coronary lesions.

Autoplaque is a software post-processing package for the ORS Visual application (K100335). It provides analysis of the vessel lumen and wall and makes it easier to detect findings in the coronary vessels.

The Autoplaque add-on 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. A hazard analysis has been conducted and the level of concern has been classified as moderate. 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.

The Vessel Analysis add-on (Vessel Analysis) for medical device ORS Visual (K100335) is a post processing analysis software package designed to assist Radiologists, Cardiologists, and other clinicians in the evaluation and assessment of vascular anatomy.

Vessel Analysis is a software post-processing package for the ORS Visual application (K100335). It is an additional tool for the analysis of 2D/3D CT Angiographic images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels which include but are not limited to stenosis analysis, thrombus, pre/post stent procedures and directional vessel tortuosity visualization.

The Vessel Analysis add-on 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. A hazard analysis has been conducted and the level of concern has been classified as moderate. 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.

The provided text describes two add-on software packages for the ORS Visual medical device: Autoplaque and Vessel Analysis. However, it does not contain information about acceptance criteria or specific studies demonstrating that the devices meet such criteria. It primarily focuses on device descriptions, intended use, and substantial equivalence to predicate devices, along with general statements about hazard analysis and testing.

Therefore, many of your requested points cannot be answered from the provided text.

Here is what can be inferred or explicitly stated based on the given information:

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." (Sections 5.510(k) SUMMARY (AUTOPLAQUE) and 5.510(k) SUMMARY (VESSEL ANALYSIS)).

However, the specific "predefined release criteria" or quantitative performance metrics are not detailed in the provided text. Therefore, a table of acceptance criteria and reported device performance cannot be generated.

Study Information

The document does not describe any specific clinical studies with quantitative results, sample sizes, or ground truth establishment relevant to demonstrating the device's performance against detailed acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria: Not specified in the provided text.
   • Reported Device Performance: Not specified in the provided text.

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "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."

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

   • Not specified. The document does not describe a process for establishing ground truth on a test set.

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

   • Not specified.

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:

   • Not explicitly mentioned or described. The document focuses on the software assisting radiologists and cardiologists but does not provide details of an MRMC study comparing human performance with and without AI assistance or any effect sizes.

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

   • Not explicitly mentioned or described. The device is described as an "interactive tool" designed to "assist Radiologists, Cardiologists, and other clinicians," implying human-in-the-loop use.

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

   • Not specified.

8. The sample size for the training set:

   • Not specified.

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

   • Not specified.

Summary of what is present in the document:

• Intended Use: Autoplaque aids in evaluating and assessing coronary lesions, determining the presence and extent of coronary plaques. Vessel Analysis aids in analyzing vascular anatomy and pathology, stenosis analysis, pre/post stent procedures, and directional vessel tortuosity visualization.
• Technological Characteristics: Both are post-processing software packages for ORS Visual, compliant with DICOM 3.1, providing 2D/3D imaging, measurement tools, MIP, and MPR. Autoplaque specifically quantifies plaque burden, coronary remodeling, and characterizes lesions (calcified/non-calcified).
• Substantial Equivalence: The devices are claimed to be substantially equivalent to other commercial products (Philips' CCA Plaque, Vitrea with SUREPlaque for Autoplaque; GE Advanced Vessel Analysis II, Vital Images Vitrea 4.0 for Vessel Analysis). Tables compare features, noting similarities ("same") to predicate devices.
• Software Development and Risk: Both follow documented processes for software design and verification testing. A hazard analysis classified the "Level of Concern" as Moderate, stating no hardware/software failure in a properly configured environment would be expected to result in patient death or injury.
• Testing: "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."
• Limitations/Warnings: Not intended to replace the skill/judgment of a qualified medical practitioner. Users should be trained. Awareness that interpolated data might appear as healthy tissue where pathology near/smaller than scanning resolution may be present.

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