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510(k) Data Aggregation
(161 days)
CT Colonography is a CT image analysis software package which allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of supine & prone data sets, and an object oriented endoluminal display. In comparison to colonoscopy, this tool has an advantage of depth penetration due its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive, print, and distribute colon image studies.
CT Colonography is an image analysis software package that includes all the required software that allows the user to study the inside, wall, and outside of the colon using CT-acquired helical images. The tool is laid out to facilitate the detection of colonic lesions. CT Colonography is an advanced visualization software option that provides endoluminal views of anatomical structures. The flexibility of this software allows the user to move interactively from air paths to inner vessels visualization and thus, it is not limited to inner navigation of structures as lungs and sinuses. Volume Analysis (includes both. CT/MR Windows Workstation, K913770 and 3D & Dentascan for Windows K923077) provides the base for Colonography, CTC/Nav2 and Nav2 alone, which allows an increase in the ease of use and productivity. Colonography, CTC/Nav2 and Nav2 alone, also use some options of Volume Rendering (AW Volume Render Option K972399), which allows the user to quickly isolate structure of interest and render volumetric data in three dimensions.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving that the device meets those criteria. Instead, it focuses on establishing substantial equivalence to previously cleared devices.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or provide a table of reported device performance metrics against such criteria. The "Conclusions" section in {1} states: "The CT Colonography option (K023943) does not result in any new potential safety risks and performs as well as devices currently on the market." This suggests that the performance standard is to be equivalent to the predicate devices, rather than meeting specific numerical thresholds.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention a specific test set, its sample size, or its data provenance (e.g., country of origin, retrospective or prospective nature). The safety and effectiveness claim is based on substantial equivalence to predicate devices, implying that their established performance is sufficient.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided. Since no specific test set or study validating device performance is described, the process of establishing ground truth for such a set is not detailed.
4. Adjudication Method for the Test Set:
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
The document does not indicate that an MRMC comparative effectiveness study was conducted. The focus is on demonstrating that the CT Colonography software provides similar functionality and safety as the predicate devices.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document does not explicitly state whether a standalone algorithm performance study was done. The device is described as an "image analysis software package" intended for "Radiologists, Clinicians, and referring Physicians to process, render, review, archive, print, and distribute colon image studies," implying it is used with human interaction, not as a standalone diagnostic tool.
7. The Type of Ground Truth Used:
The document does not specify the type of ground truth used for any performance evaluation, as no such evaluation is detailed. Given the nature of CT Colonography for lesion detection, a typical ground truth would likely involve colonoscopy with biopsy/histopathology or surgical pathology.
8. The Sample Size for the Training Set:
The document does not mention a training set or its sample size.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided, as no training set is discussed.
Summary of Device Acceptance Rationale:
The core of the acceptance for the "CT Colonography" (K023943) device is its substantial equivalence to two predicate devices:
The manufacturer, GE Medical Systems, asserts that their CT Colonography option "does not result in any new potential safety risks and performs as well as devices currently on the market." This suggests that the acceptance criteria are met by demonstrating that the new device shares fundamental technological characteristics, intended use, and performance characteristics (as understood from the predicate devices) without raising new questions of safety and effectiveness. The "Conclusions" section acts as the primary statement on how the device meets "acceptance criteria" by equating its performance to already cleared devices.
The FDA's clearance letter (pages {2} and {3}) confirms this approach, stating they "have determined the device is substantially equivalent... to legally marketed predicate devices." This regulatory pathway does not typically require extensive new clinical studies to prove performance against novel acceptance criteria, but rather a demonstration of similarity to existing safe and effective devices.
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(15 days)
The Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis.
Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as a basis for a diagnosis.
The AW 4.1 is positioned to be the system of choice for all users of CT, MR. Vascular Xray, Cardiac Xray, Digital Xray, PET or even PET/CT systems, MG, NM, US, SR.
The provided text is a 510(k) summary for the GE Advantage Workstation 4.1. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove their fulfillment is not explicitly present in this document.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The document states that the Advantage Workstation 4.1 "provides images comparable to the predicate device." However, it does not provide a table of quantitative acceptance criteria or reported performance metrics against those criteria. The primary "acceptance" criteria for this 510(k) appears to be substantial equivalence to the predicate device, K960613 (Advantage Windows Review Workstation).
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicit) | Reported Device Performance | Comments |
|---|---|---|
| Substantial Equivalence to Predicate Device (Advantage Windows Review Workstation, K960613) | Achieved (as determined by FDA's 510(k) clearance) | The FDA's letter (K020483) states that the device is "substantially equivalent...to legally marketed predicate devices." This is the core "acceptance" for this regulatory filing. |
| Provision of "images comparable to the predicate device." | Stated in Section 7: "Advantage Workstation 4.1 provides images comparable to the predicate device." | No quantitative comparison or study details are provided to support this claim within the document. |
| Integration into Radiology Department Workflow | Stated in Section 7: "Advantage Workstation 4.1 brings additional features in order to integrate seamlessly into the Radiology Department Workflow." | This is a qualitative claim. No specific metrics or studies are provided. |
| Hazard analysis/Risk Management Summary | Completed (mentioned in Section 7) | No details of the summary or specific risk acceptance criteria are provided. |
| Software development and validation process | Completed (mentioned in Section 7) | No details of the process or validation results are provided. |
| Software verification plan | Completed (mentioned in Section 7) | No details of the plan or verification results are provided. |
Study Details
The document does not describe a specific clinical or technical study designed to prove the device meets quantitative performance acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a previously cleared device.
- Sample size used for the test set and the data provenance: Not applicable. The document does not describe a test set or study involving patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.
- Adjudication method for the test set: Not applicable.
- 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 applicable. This document predates widespread AI in medical imaging interpretation and does not describe such a study. The device is a workstation for image review, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a workstation for human review, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. The device is not an AI model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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(14 days)
Advanced Lung Analysis (ALA-1) is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lessons etc.) form a set of computed Tomography (CT) images. The analysis is performed on the Advantage Windows Workstation (K913770). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. This may aid the physician in characterization of suspicious nodules and thus, patient management care decision process.
Advanced Lung Analysis-1 (ALA-1) is an image analysis software package that provides support to the medical professional in assessing abnormalities such as lesions and nodules and changes in their growth over time. This software allows volumetric estimation of a lesion or nodule size over time. It contains productivity tools such as the book marking tool to keep a record of previously found nodules/lesions, the comparator tool to allow 'synchromized' comparison of nodule/lesion over time, database of all the nodules/lesions detected and enhanced speed and efficiency of the review process.
The provided document (K013381 - Advanced Lung Analysis-1) describes the device and its intended use, but it does not contain any data from a study demonstrating specific acceptance criteria or device performance measurements, nor does it detail acceptance criteria themselves.
The document states that ALA-1 "performs as well as devices currently on the market" and that "GE considers features of the ALA-1 to be equivalent to those of Tissue Volume (K963345)". This suggests a claim of substantial equivalence based on functional similarity rather than a detailed performance study with specific acceptance criteria.
Therefore, many of the requested details cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria or report specific performance metrics from a study (e.g., accuracy, sensitivity, specificity, or volume measurement deviation). It only states that the device is "substantially equivalent" to a predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention any specific test set, sample size, or data provenance for a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be provided. The document does not describe the establishment of a ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No adjudication method is described as there's no mention of a test set with expert review.
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
- Cannot be provided. The document does not describe any MRMC comparative effectiveness study or any study where human readers' performance with and without AI assistance was evaluated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. There is no mention of a standalone performance study. The description of the device ("provides support to the medical professional") implies a human-in-the-loop context, but no study details are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. As no performance study with a defined ground truth is mentioned, the type of ground truth is not specified.
8. The sample size for the training set
- Cannot be provided. There is no information regarding a training set or its sample size.
9. How the ground truth for the training set was established
- Cannot be provided. As there is no information about a training set, how its ground truth was established is also not mentioned.
Summary from the document:
The product, Advanced Lung Analysis-1 (ALA-1), is an image analysis software package for Computed Tomography (CT) images. Its purpose is to assist medical professionals in assessing lung abnormalities like lesions and nodules, tracking their changes over time, and estimating volume doubling time. It includes productivity tools for bookmarking, synchronized comparison, and database management. The FDA granted 510(k) clearance based on its substantial equivalence to the predicate device, "Tissue Volume" (K963345), manufactured by General Electric Medical Systems. The clearance letter confirms that ALA-1 can be marketed subject to general controls, as it does not pose new safety risks and performs comparably to existing devices. However, no specific performance metrics or study details (like sample sizes, ground truth methodology, or expert qualifications) are provided in this summary.
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(15 days)
CT Colonography/Navigator2 is an image analysis software package that contains CT Colonogarphy and Navigator2.
CT Colonography allows the user to study the inside, wall and outside of the colon. It provides the user with an ability to view datasets from both, prone and supine positions, facilitating detection of colonic lesions. In comparison to colonoscopy, this tool has an advantage of non-invasive depth penetration due to its 3D presentation capability.
Navigator2 provides endoluminal views of anatomical structures. Navigator2 is designed to enhance and modify current image quality, tools, speed and user interface of Navigator for improved productivity. Navigator2 provides a visualization tool to investigate structures (such as polyps, tumors, stones, calcification etc.) within anatomy, airways and organs. Thus. its viewing capability of the inner and outer surfaces of organs as well as within their walls provides additional supplemental information, complementing endoscopy/colonoscopy, to support interpretation and treatment planning. Navigation2 is applicable to X-ray as well as CTMR.
CT Colonography/Navigator2 (CTC/Nav2) is an image analysis software package that allows the user to study the inside, wall, and outside of the colon using CT-acquired helical images. The tool is laid out to facilitate the detection of colonic lesions. CT Colonography requires Navigator2 for its operation however, Navigator2 can also be utilized as a stand-alone option. Navigator2 is an advanced visualization software option that provides endoluminal views of anatomical structures. The flexibility of this software allows the user to move interactively from air paths to inner vessels visualization and thus, it is not limited to inner navigation of structures as lungs and sinuses. Volume Analysis (includes both, CT/MR Windows Workstation, K913770 and 3D & Dentascan for Windows K923077) provides the base for CTC/Nav2 and Nav2 alone, which allows an increase in the ease of use and productivity. CTC/Nav2 and Nav2 alone, also use some options of Volume Rendering (AW Volume Render Option K972399), which allows the user to quickly isolate structure of interest and render volumetric data in three dimensions.
While the document describes the device, its intended use, and its equivalence to a predicate device, it does not contain information regarding specific acceptance criteria for a study or the results of such a study proving the device meets those criteria.
The document is a 510(k) summary for regulatory clearance, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study data against defined acceptance criteria.
Therefore, I cannot provide the requested information. The sections you asked for (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are not present in the provided text.
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(71 days)
The CT Coronary Artery Calcification Scoring Option for Advantage Windows is intended to be used by a trained physician for the review and analysis of CT images as an aid in cardiac analysis. It runs on Advantage Windows independent workstations (K913770).
A software productivity package that semi-automatically quantified cardiac calcifications by a weighted number instead of manually calculating area of Regions of Interest (ROIs) and the density within each ROI.
The provided text is a K982004 510(k) summary for the GE Medical Systems' CT Coronary Artery Calcification Scoring Option for Advantage Windows. It outlines the device's purpose and its substantial equivalence to a predicate device but does not contain information about specific acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and basic device description rather than performance metrics or a detailed study report.
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(89 days)
The Advantage Windows Volume Rendering Option is intended to provide volume visualization of three dimensional structures imaged with computed tomography (CT), or magnetic resonance (MR). It reconstructs and displays translucent 3D models to be used for diagnosis confidence or planning surgical treatment. The images are reconstructed and displayed on the CT/MR Advantage Windows Diagnostic Workstation (K913770).
The device is a soltware package to be used on the same software as used for Advantage Windows 3D (VoxTool) and will operate on the Advantage Windows Operating System. The workstation hardware required for operation will be the Sun Spar 20, Mod 40, or higher. The images used to provide these 3D reconstructions can be captured by any CT or MR system and transferred to Advantage Windows workstation by DICOM or Ethernet.
The provided documents do not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics.
Instead, this is a 510(k) submission for the "Advantage Windows Volume Rendering Option" which focuses on demonstrating substantial equivalence to already marketed devices. The document highlights the device's intended use, description, and states its substantial equivalence in design, construction, principle of operation, and features to the predicate devices.
Therefore, many of the requested details about acceptance criteria, detailed performance studies, sample sizes, and ground truth establishment are not present in this type of regulatory submission. The goal of this submission is not to prove specific performance metrics against pre-defined acceptance criteria, but rather to show that the new device is as safe and effective as a legally marketed predicate device.
Here's a breakdown of what can be extracted or inferred from the provided information, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety | No adverse affects on health reported. Package itself will not have any adverse effects. |
| Effectiveness | Enhances current Advantage Windows 3D package by providing depth and position of overlapping structures. |
| Intended Use | Provides fast, easy volume visualization of 3D structures from CT/MR. Dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning. Reconstructs and displays translucent 3D models for diagnosis confidence or planning surgical treatment. |
| Substantial Equivalence | Substantially equivalent to Advantage Windows 3D (K923077), Advantage Windows 3D with Navigator Option (K954355), and Advantage CT (9800 Quick) 3D (K871859) in design, construction, principle of operation, and features. |
Missing:
- Specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, processing speed targets, image quality ratings) are not provided.
- Clearly defined numerical acceptance criteria for any performance aspect are not stated.
2. Sample size used for the test set and the data provenance
Missing: The document does not describe a formal "test set" or specific study involving patient data to evaluate the performance of this device. The assessment is based on substantial equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing: As there's no described performance study or test set, there is no information on experts establishing ground truth.
4. Adjudication method for the test set
Missing: No test set or adjudication method is 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
Missing: No MRMC study is mentioned. This device is a volume rendering tool, not an AI-assisted diagnostic tool in the modern sense that would typically involve a "human readers improve with AI vs without AI" comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing: No standalone performance study based on specific metrics is described. The device's function is to reconstruct and display models for operator interpretation, inherently involving a human-in-the-loop.
7. The type of ground truth used
Missing: No specific ground truth methodology is described as there isn't a performance study evaluating diagnostic accuracy.
8. The sample size for the training set
Missing: This device predates the widespread use of large-scale machine learning and deep learning models that typically require large "training sets." The device's functionality appears to be based on established algorithms for volume rendering, not a learned model from a training set in the contemporary sense.
9. How the ground truth for the training set was established
Missing: Not applicable, as there's no indication of a training set for a machine learning model.
Summary of the Study (or lack thereof, in the typical sense):
The provided information is a 510(k) summary for an accessory device (software) for CT/MR systems. The "study" described herein is the process of demonstrating substantial equivalence to predicate devices already on the market. This involves:
- Identification of Predicate Devices: Advantage Windows 3D (K923077), Advantage Windows 3D with Navigator Option (K954355), and Advantage CT (9800 Quick) 3D (K871859).
- Comparison of Device Features and Principles of Operation: The submitter argues that the new Volume Rendering Option "enhances the current Advantage Windows 3D package by providing showing depth and position of overlapping structures" but is "substantially equivalent... in design, construction, principle of operation, and features."
- Assessment of Safety: The document states that "The package itself will not have any adverse affects on health."
- Intended Use Statement: Clearly defines how the device is to be used.
The FDA's letter (K972399) confirms that they have reviewed the submission and determined that the device is substantially equivalent to predicate devices for the stated indications for use. This regulatory pathway does not typically require extensive clinical performance studies or a detailed breakdown of acceptance criteria and performance data as would be seen for devices seeking a PMA or those involving novel AI algorithms.
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(53 days)
Advantage Windows Tisue Volume Option is intended to calculate the volume of any three dimensional structure from a set of CT images. The images are displayed and measured on the CT/MR Advantage Windows Diagnostic Workstation (K913770). The Tissue Volume Option will automate manual measurements and estimates that are currently made regarding the measure of volume of anatomy and pathology imaged with computed tomography.
The device is a software package to be used on the Advantage Windows Workstation (K913770).
Design: The design is based on the same software platform as used for Advantage Windows 3D (VoxTool) and will operate on the Advantage Windows Operating System. The workstation hardware required for operation will be the Sun Sparc 20, Mod 40 or higher. The images used to measure volume can be captured by any CT scanner and transferred to Advantage Windows workstation by DICOM or Ethernet.
Energy Source and Exposure Levels: There is no energy source associated with this package in and of itself. However, the energy source used to make the image being analyzed is the same used to take standard CT diagnostic images.
Principals of Operation: The same as Advantage Windows 3D.
Features: To calculate the volume of areas of a CT image selected by the operator.
Accessories: None
This document, K963345, is a Summary of Safety & Effectiveness for the Advantage Windows Tissue Volume Option. It is a pre-market notification (510(k)) and largely focuses on substantial equivalence to a previously cleared device (K913770, Advantage Windows 3D).
Based on the provided information, it is not possible to fully answer all the questions regarding acceptance criteria and studies that prove the device meets them. This document is a 510(k) summary, not a detailed study report. 510(k) submissions primarily focus on demonstrating substantial equivalence, and often don't include detailed performance studies with acceptance criteria in the same way a PMA (Pre-Market Approval) or a clinical trial report would.
Here's a breakdown of what can be gleaned and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states: "The Advantage Windows Tissue volume Option enhances the current Advantage Windows 3D package by automaiting volumetric measurements that are currently being made manually using the measure distance tools of the 3D package. It is substantially equivalent to the Advantage Windows 3D package in design, construction, principle of operation, and features."
This statement indicates a reliance on substantial equivalence to an existing device (Advantage Windows 3D, K913770), rather than presenting new performance data against specific acceptance criteria for a novel functionality. There are no explicit acceptance criteria or reported performance metrics (like accuracy, precision, sensitivity, specificity, etc.) for the new "Tissue Volume Option" presented in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No information on a specific test set, its size, or data provenance is mentioned. The submission relies on the established performance of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No ground truth establishment for a test set is discussed. The device "automates manual measurements and estimates that are currently made" implying that the manual measurements by an operator (presumably a clinician) would be the reference, but no formal ground truth process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication method is 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 explicitly done or reported. The device is described as an "option" to automate current manual measurements. While it might assist human readers by automating volume calculation, a formal MRMC study comparing human performance with and without this specific AI-driven automation is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- A standalone performance study focused on the algorithm is not explicitly reported in this summary. The document describes the device as a "software package to be used on the Advantage Windows Workstation" and emphasizes that "The oulining is in the hands of the operator who can choose to accept or reject the outlined region." This indicates a human-in-the-loop process where the operator's input (outlining) is crucial, implying it's not a purely standalone algorithm making diagnostic decisions. It assists in measuring after operator input.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implicitly, the ground truth would be the manual measurements and estimates currently made by operators. The device aims to "automate manual measurements and estimates." However, there's no mention of a formal process to establish this ground truth for validation purposes in this document.
8. The sample size for the training set
- Cannot be provided. No information on a training set or its size is mentioned. Given the device's description as automating "manual measurements and estimates," its "training" might be more aligned with software development principles rather than machine learning model training on a large dataset in the modern sense. It's likely a rule-based or image processing algorithm based on established methods, rather than a deep learning model.
9. How the ground truth for the training set was established
- Cannot be provided. No training set or ground truth establishment process is mentioned.
In summary: This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device. It describes a software feature that automates an existing manual task (volume calculation). It does not present detailed performance studies, specific acceptance criteria, or robust validation datasets (test and training sets) as would be expected for a novel AI/ML device submission today. The lack of this information is typical for many 510(k) submissions from this era (1996) that relied heavily on substantial equivalence to existing technologies.
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(77 days)
The GF: Advantage Windows Review Workstation is a two dimensional review station which allows selection and review of DICOM images from Computed Tomography (CT), Magnetic Resonance (MR), X-Ray (XR), Computed Radiography (CR) and Secondary Capture (SC) modalities.
The GE Advantage Windows Review Workstation consists of a Sun Microsystems Spare 4, 5, 20 or UltraSparc Unix workstation or equivalent with 32 to 128 MBytes of RAM, 1 to 4 GBytes of mass storage memory, an Ethernet or ATM networking interface and 1 to 4 color landscape or high resolution monochrome monitors. The GE Advantage Review Windows software application is designed and produced by GE Medical Systems. Earlier versions of this software were included in previous 510(k) Premarket Notification submissions (K913770, K942120).
This document is a 510(k) summary for a GE Medical Systems device modification (K960613). It focuses on the GE Advantage Windows Review Workstation. Based on the provided text, the document describes a device modification and primarily discusses its substantial equivalence to previously cleared devices.
Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the detailed study specifics requested in your prompt.
The "Summary of Studies" section only states: "In addition to system design verification tests to assure conformance with the design specifications, the design has or will undergo further validation to assure overall user satisfaction." This indicates that design verification tests were done to meet specifications and that further validation for user satisfaction was planned or ongoing. It does not provide any detailed results or acceptance criteria relating to clinical performance.
Therefore, I cannot populate the requested sections based on the provided text. The document is a regulatory submission focused on demonstrating substantial equivalence, not a detailed technical or clinical study report.
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