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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.

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.

Device Description

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.

AI/ML Overview

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.

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.
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."
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.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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.
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.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified.
The sample size for the training set:
- Not specified.
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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K Number

K100335

Device Name

ORS VISUAL

Manufacturer

OBJECT RESEARCH SYSTEMS, INC.

Date Cleared

2010-04-08

(62 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The ORS Visual is a software-based Picture Archiving and Communication System (PACS) for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and analysis of medical image data from various sources including CT and MRI.

The ORS Visual 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 are intended to be used to aid in diagnosis. It is the users' responsibility to ensure that the software is installed on appropriate hardware and that image quality is sufficient for the clinical application. Object Research Systems (ORS) recommends that users of the ORS Visual software consult the appropriate American College of Radiology (ACR) guidelines for the clinical setting and pathology being studied.

Mammographic and compressed images are not supported for viewing.

The software is not intended to replace the skill and judgment of a qualified medical professional. Users should be appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views, and on the 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 pathological conditions or limited original data set resolution may be present.

ORS Visual software must be installed on a suitable commercial computer platform. It is the users' responsibility to ensure that the hardware and display configurations are consistent with the clinical applications.

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

Device Description

AI/ML Overview

This a 510(k) premarket notification for ORS Visual, a Picture Archiving and Communication System (PACS). No clinical study was performed to justify substantial equivalence. Since this is for a PACS device, the FDA often does not require specific clinical study data as they are not typically diagnostic devices themselves but rather display and communication systems for medical images. The substantial equivalence is therefore claimed using legally marketed predicate devices, as stated in the letter.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable in this context. The document does not describe performance criteria based on a clinical study for the ORS Visual device. Its substantial equivalence is based on its similarity to previously cleared PACS devices.

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

Not applicable, as no specific test set or clinical study for performance was conducted or reported in this 510(k) submission.

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

Not applicable, as no specific test set or ground truth establishment process is described for performance evaluation.

4. Adjudication Method for the Test Set:

Not applicable, as no specific test set or adjudication process is described for performance evaluation.

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

No. An MRMC comparative effectiveness study was not performed or reported in this document. The device is a PACS system for displaying and visualizing medical images, not a diagnostic AI algorithm that would typically undergo such a study to quantify human reader improvement.

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

Not applicable. The ORS Visual is described as a "software-based Picture Archiving and Communication System (PACS)" intended for use "as a diagnostic, review, and analysis tool by trained professionals." It is explicitly stated that "The software is not intended to replace the skill and judgment of a qualified medical professional." This indicates it's a human-in-the-loop system, and a standalone algorithm-only performance study would not be relevant for this type of device.

7. Type of Ground Truth Used:

Not applicable. There is no mention of a ground truth being established for the performance evaluation of the ORS Visual device.

8. Sample Size for the Training Set:

Not applicable. As no independent clinical study was performed for the performance evaluation of the ORS Visual, there is no mention of a training set or its size.

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

Not applicable, as there is no mention of a training set or ground truth establishment for it.

Summary based on the document:

The provided document is a 510(k) clearance letter for a PACS device (ORS Visual). It highlights that the device is substantially equivalent to legally marketed predicate devices. The review process for such devices often focuses on functional equivalence, technical specifications, and safety, rather than extensive clinical performance studies with acceptance criteria, ground truth, and expert adjudication, which are more common for diagnostic algorithms. The document explicitly states that the device is "not intended to replace the skill and judgment of a qualified medical professional," reinforcing its role as a tool rather than an autonomous diagnostic system.

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