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510(k) Data Aggregation
(26 days)
The R2 Breast Imaging Workstation is intended for the manipulation and display of x-ray images, including the primary reading of mammograms. It can show images from different acquisition/scanning devices and interfaces to various image storage and printing devices using DICOM or similar interface standards. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians and assistants.
Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
The R2 Breast Imaging Workstation is a combination of dedicated computer software and hardware. The workstation consists of a commercially available imaging workstation and the R2 plug-in software application, which is compatible with the workstation through a Clinical Application Interface (CAI).
The provided document is a 510(k) Premarket Notification for the R2 Breast Imaging Workstation. It outlines the device's intended use, comparison to predicate devices, and the FDA's decision regarding its substantial equivalence. However, it does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or clinical study methodologies.
The "Studies" section {0} explicitly states: "The R2 Breast Imaging Workstation will undergo design verification tests for conformance with specifications." This indicates that at the time of this filing, the plan was to conduct such tests, but the results of those tests or any clinical studies are not included in this document.
Therefore, I cannot provide the requested information from the given text.
The closest relevant information from the document are:
- Intended Use: The R2 Breast Imaging Workstation is intended for the manipulation and display of x-ray images, including the primary reading of mammograms. It can show images from different acquisition/scanning devices and interfaces to various image storage and printing devices using DICOM or similar interface standards.
- Comparison with Predicate Devices: The submission device and the predicate device (Sectra Imaging Workstation IRS5/mx.net, K033712) have the same intended use and equivalent technological specifications. All devices support DICOM protocol for communication of images and other medical imaging devices.
These points indicate that the acceptance criteria would likely revolve around demonstrating that the workstation can effectively display and manipulate mammographic images for primary reading, similar to the predicate device, and support standard imaging protocols like DICOM. However, the specific performance metrics and the study data to prove conformance are not present.
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(14 days)
The family of R2 Image Display Units with UDS software is intended to display low resolution, non-diagnostic medical images with annotations such as precomputed regions-of-interest or pre-computed CAD marks from medical scanning devices.
The R2 family of Image Display Units are a combination of dedicated computer software and hardware. The System uses an off-the-shelf personal computer with Windows-based CPUs, a hard drive, and various sizes of off the shelf monitors. Despite the variability in physical dimensions, all monitor display units have the identical functional specifications. R2 Uniform Image Display Software (UDS) is provided with all R2 image display units. This version of display software provides an updated user interface and CAD mark display features
The provided text for K050667, a 510(k) Premarket Notification for the R2 Family of Image Display Units with Uniform Display Software (UDS), does not contain information regarding detailed acceptance criteria or a study proving the device meets specific performance criteria.
The 510(k) summary explicitly states:
"The family of Image Display Units with UDS Software will undergo design verification tests for conformance with specifications."
This indicates that design verification tests are planned or will be conducted to ensure the device meets its specifications, but the results or details of these tests are not provided within this document. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological specifications, rather than presenting a performance study with detailed acceptance criteria.
Therefore, many of the requested sections (Table of acceptance criteria, sample size, ground truth, MRMC study, standalone performance) cannot be filled with information from the provided document.
Here's a summary of what can be extracted based on the provided text, and where information is missing:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the provided document.
- Reported Device Performance: Not reported in the provided document, as performance studies are not detailed.
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable as a formal performance test set is not described.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as a formal performance test set with expert-established ground truth is not described.
4. Adjudication method for the test set
- Not applicable as a formal performance test set with adjudication is not described.
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 or at least not described in this document. The device is an "Image Display Unit" intended to display images and CAD marks, not to provide AI assistance for diagnostic interpretation that would typically necessitate such a study in 2005.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study was not done or at least not described in this document. The device's intended use is to display images and pre-computed CAD marks, implying it's a display tool, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable as a formal performance test set with ground truth is not described.
8. The sample size for the training set
- Not applicable as the document does not describe the development or training of any algorithm within the "Image Display Unit" beyond its display functionality. It is a display unit for pre-computed marks.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as above.
Conclusion:
The K050667 submission primarily focuses on demonstrating "substantial equivalence" of the R2 Image Display Units with UDS to existing predicate devices based on their intended use (displaying low-resolution, non-diagnostic medical images with annotations or CAD marks) and technological specifications. It states that design verification tests will be conducted for conformance with specifications, but the results, specific acceptance criteria, or any clinical performance studies are not detailed within this 510(k) summary. This type of submission relies on the similarity to legally marketed devices rather than extensive new clinical performance data.
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(14 days)
The ImageChecker CT Software Package with Filling Defect Indicator (FDI) is used during the review of contrast-enhanced computed tomography (CT) images of the chest. This software tool enables the radiologist to view and analyze regions of the image containing low density within vascular structures that may be indicative of filling defects or other intravascular abnormalities.
The software is designed to assist the radiologist in characterization and classification of these suspicious candidate thoracic abnormalities in terms of density, size, dimension, shape and position, thus aiding in the patient management care decision process.
The ImageChecker CT Software Package with Filling Defect Indicator (FDI), the subject of this notification, is a thoracic image visualization and analysis tool. This tool offers an extended functionality of the ImageChecker CT Workstation, utilizing segmentation techniques similar to the two above-mentioned predicates. Based on physician request, the FDI tool automatically segments locations in the vasculature of the chest containing low densities that typically correlate with filling defects. The process is based on simple segmentation methodology applied to contrast-opacified CT images of the chest segmentation methouorogy appels below a certain HU (Hounsfield Unit) threshold. fuentifying region is highlighted by placing a triangle on the region of the vascular structure of interest. This extended software functionality is designed for use with the structure of interesent on the R2 ImageChecker CT Workstation (K023003) and on other CT workstations that utilize the ImageChecker CT Workstation software tools. The FDI tool contains modifications to the Workstation with a special workflow based on automated segmentation for the visual identification of possible lung filling defects.
Here's an analysis of the provided text regarding the ImageChecker CT Software Package with Filling Defect Indicator:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) premarket notification does not contain any specific acceptance criteria or quantitative performance data on the device's ability to detect filling defects. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological similarities.
Instead, the document states: "The Filling Defect Indicator tools package will undergo design verification tests for conformance with specifications." This indicates that the performance data was likely to be generated after this document was submitted or in a separate report, and not included in this summary.
2. Sample Size Used for the Test Set and Data Provenance
No information is provided regarding the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in a study report, which is not present in this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
No information is provided regarding the number of experts, their qualifications, or how ground truth was established for a test set.
4. Adjudication Method for the Test Set
No information is provided regarding any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is made. The document does not describe any study comparing human readers with AI assistance versus human readers without AI assistance, nor does it provide any effect sizes.
6. Standalone Performance Study
No information is provided regarding a standalone (algorithm only) performance study. The 510(k) states the device is "an adjunctive device that assists the radiologist in the review of CT images of the chest." This implies it's intended for human-in-the-loop use, but no standalone performance data is presented.
7. Type of Ground Truth Used
No information is provided regarding the type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for the Training Set
No information is provided regarding the sample size for any training set.
9. How the Ground Truth for the Training Set Was Established
No information is provided on how ground truth was established for any training set.
Summary of the Information Provided in the 510(k):
The provided 510(k) Premarket Notification is a regulatory document focused on demonstrating substantial equivalence to predicate devices. It describes the device's intended use ("adjunctive device that assists the radiologist in the review of CT images of the chest"), its technical functionality (segmentation based on Hounsfield Unit threshold to identify low-density regions), and its relationship to existing R2 Technology and Siemens products.
Crucially, it does not include the details of any performance studies, acceptance criteria, or clinical validation data that would typically be found in a separate study report or a more comprehensive submission. The statement "The Filling Defect Indicator tools package will undergo design verification tests for conformance with specifications" indicates that performance testing was planned or ongoing, but the results are not present in this document. Therefore, based solely on the provided text, the specific information requested about acceptance criteria and study details cannot be extracted.
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(14 days)
The Comprehensive Chest Analysis Tools (C-CAT) package consists of software that enables radiologists to view, analyze, register and compare new and previous series of thoracic CT images. The software package assists the radiologists by calculating volume change and doubling time of selected segmented candidate thoracic abnormalities, such as pulmonary and pleural nodules and lesions, found on these images.
The software is designed to assist the radiologists in characterization and classification of these suspicious candidate thoracic abnormalities in terms of size, dimension, shape and position and thus aid in the patient management care decision process.
The C-CAT software is dedicated to assist the radiologist in assessing multiple CT case studies as well as any selected abnormal thoracic regions of interest (ROI's), such as pulmonary lesions, nodules, etc. It enables:
- a) a detailed visualization and analysis of the CT slices using tools such as Multi-Planar Reformat and Sliding Maximum Image Projection;
- b) a comparative analysis of the aligned, simultaneously presented current and previous CT images with findings and selected ROIs with their size (volumetric and diameter) measurement displayed for assessment of volume change and doubling time; and
- c) review of software-generated comparative reports that present information such as development of new lesions, prior lesion's progression and doubling time. This software tools package is designed for use with the ImageChecker CT Workstation (K023003, cleared 11/20/02) and other CT workstations that utilize the ImageChecker CT Workstation software tools.
The provided text is a 510(k) summary for R2 Technology's Comprehensive Chest Analysis Tools (C-CAT). It describes the device, its intended use, comparison with predicate devices, and the FDA's clearance letter. However, it does not contain details about specific acceptance criteria or the study that proves the device meets those criteria, or any of the detailed information requested in the prompt.
The document only states: "The Comprehensive Chest Analysis Tools package will undergo design verification tests for conformance with specifications." This indicates that such tests were planned or conducted, but no results, methodology, or specific acceptance criteria are presented in this summary.
Therefore, I cannot provide the requested table and information based on the given input, as the study details are explicitly missing.
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(72 days)
The ImageChecker-CT is indicated for use as a general imaging workstation, and is intended to be used to acquire, store, transmit and display images from medical scanning devices.
Specific indications for use for the ImageChecker-CT Workstation are the display of a composite view of 2D cross-sections, and 3D volumes of chest CT images, including findings or regions of interest ("ROI") identified by the radiologist or Computer Assisted Detection ("CAD") findings.
The general indications for use of the ImageChecker-CT Workstation are as a general imaging workstation to assist radiologists in reviewing digital computed Tomography (CT) images of the chest.
Specific indications for use for the ImageChecker-CT Workstation are the display of a composite view of 2D cross-sections, and 3D volumes of chest CT images, including findings or regions of interest ("ROI") identified by the radiologist or Computer Assisted Detection ("CAD") findings.
The ImageChecker-CT System is a combination of dedicated computer software and hardware. The System uses an off-the-shelf personal computer with Windows and Linux-based CPUs, a hard drive, and a single monitor.
The provided document, K023003 for the ImageChecker-CT Workstation, does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
Instead, the document primarily focuses on establishing substantial equivalence to predicate devices. This means that instead of presenting a stand-alone performance study with acceptance criteria, the manufacturer is arguing that their device is as safe and effective as other legally marketed devices with similar intended use and technological characteristics.
Therefore, many of the requested details cannot be extracted from this specific 510(k) summary. I can only provide information directly mentioned or inferable from the document regarding the type of evaluation conducted.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not specify performance acceptance criteria or report device performance metrics in the way a clinical performance study would for a new device. The "Studies" section states, "The ImageChecker-CT Workstation will undergo design verification tests for conformance with specifications." This implies internal testing against design specifications, not necessarily clinical performance metrics.
2. Sample size used for the test set and the data provenance
Not applicable. The document describes a comparison to predicate devices for substantial equivalence, not a performance study with a distinct test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a performance study involving ground truth establishment by experts.
4. Adjudication method for the test set
Not applicable. No test set or expert adjudication is described for a performance study.
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. The document makes no mention of an MRMC study or any assessment of human reader improvement with AI assistance. The device is described as a "general imaging workstation" that can display CAD findings, but its effectiveness with CAD is not studied here.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
No. The document describes a workstation for displaying images and CAD findings, but it does not report on the standalone performance of any algorithm. The 510(k) focuses on the workstation itself, not the performance of a specific CAD algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No performance study with ground truth is described.
8. The sample size for the training set
Not applicable. The document does not describe the development or training of an algorithm.
9. How the ground truth for the training set was established
Not applicable. The document does not describe the development or training of an algorithm.
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