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The EasyVision Workstation Release 6 is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. The Easy Vision Workstation Release 6 software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.

The device is a software package able to run on "off the shelf" hardware components. The system operating software is a standard Windows XP Professionel operating system. The application software can be divided in view, print, store and link functions. Communication with modalities such as MRI and CT and with archive systems, operates via a standardised DICOM protocol on top of a TCP/IP network.

This 510(k) submission for the Philips EasyVision Workstation Release 6 focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance data. Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not explicitly present in the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not describe specific acceptance criteria or quantitative performance metrics for a study to prove the device meets those criteria. The submission is a claim of substantial equivalence to a predicate device.

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

Not applicable. No specific test set or study data is described in this submission. The "test" in this context refers to demonstrating the equivalence in functionality and safety to the predicate device, not in a traditional clinical performance study with a test set of cases.

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

Not applicable. No ground truth establishment or expert review process for a test set is described.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is not mentioned or described in the provided document.

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

No. This device is an image processing workstation software package, which inherently involves human interaction for viewing, manipulation, and quantification. It is not an AI algorithm intended for standalone diagnostic performance.

7. The Type of Ground Truth Used

Not applicable. The submission does not describe a performance study where ground truth would be established for diagnostic accuracy. The ground truth for proving substantial equivalence would be the established functionality and safety profile of the predicate device.

8. The Sample Size for the Training Set

Not applicable. The document does not mention any machine learning or AI components that would require a "training set" in the context of algorithm development.

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

Not applicable. As no training set is mentioned, the method for establishing its ground truth is also not applicable.

Summary of Relevant Information from the Provided Document:

• Device Type: Image processing workstation software package.
• Purpose: Receives image data from medical scanning devices (CT, MRI) or archives, and performs viewing, image manipulation, communication, printing, and quantification of images.
• Intended Use Statement: "The EasyVision Workstation Release 6 is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. The Easy Vision Workstation Release 6 software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images."
• Regulatory Pathway: 510(k) premarket notification.
• Predicate Device: Philips EasyVision Workstation (K920950).
• Substantial Equivalence Claim: The Philips Easy Vision Workstation Release 6 is substantially equivalent to the Easy Vision Workstation systems (K920950).
• Safety Information: "No new hazards are introduced by the development of Easy Vision Workstation Release 6. Hazards known during the lifecycle of the Easy Vision Workstations are again considered and measurements are taken."

In essence, this 510(k) submission is a declaration that the new device has the same intended use, technological characteristics, and safety profile as a previously cleared device, rather than a clinical study evaluating its performance against specific acceptance criteria.

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The BOLD Analysis option for the EasyVision is intended for use in analyzing images created using the BOLD function of a Gyroscan NT system. The BOLD Analysis option is useful in quantifying small susceptibility changes in the human brain, created by the execution of specific tasks.

The BOLD Analysis package supports the visualization and analysis of dynamic MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast. The image contrast differs over dynamic scans as a result of the variation of blood oxygenation through task performance by the subject (e.g. finger tapping). BOLD data can be processed with the BOLD Analysis package to provide data analysis based on standard statistical methods.

The provided text is a 510(k) Summary for the Philips Easy Vision Family Workstation Option BOLD Analysis Package. It describes the device's intended use and safety information, as well as the FDA's clearance letter. However, this document does not contain any information about acceptance criteria, device performance metrics, or any studies proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document focuses on regulatory clearance based on substantial equivalence to a predicate device rather than detailed performance studies.

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The Quantitative MT Analysis option on the Easy Vision is intended for use in quantifying the Magnetization Transfer in tissue. The ratio image enhances the image contrast of MT sensitive tissue by the elimination of the T1 and T2 (spin-lattice and spin-spin relaxation time) effect. Visualization of Magnetization Transfer effects in sensitive tissue can improve lesion conspicuity, e.g., in white matter and cartilage.

The Quantitative MT Analysis option uses MTC images created by an MR system and transferred to the EasyVision. The image contrast can be changed by calculating the ratio (based on (MT image- non-MT image)/MT image)) of the scans with and without the MT effect. The resultant image represents the percentile MT effect. The image contrast therefore becomes independent of the T1 (spin-lattice) and T2 (spin-spin) relaxation times and is defined by the MT effect alone.

The provided text does not contain information regarding acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Philips Easy Vision Family Workstation Option Quantitative MT Analysis Package, primarily focusing on its description, intended use, and substantial equivalence to a predicate device, as determined by the FDA.

Therefore, I cannot provide the requested information in the specified format from the given text.

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The CT/MR Quantitative Analysis Package is intended for use where visualization and analysis of CT and MR dynamic studies, showing changes in contrast over time, are useful or necessary.

The quantitative analysis package supports the visualization and analysis of CT and MR dynamic studies which show changes in contrast over time. In a dynamic study, a time series of scans is acquired over a single or multiple slice location. The image contrast variations over time will be displayed in "Time Intensity Diagrams (TID)". These TIDs enable analysis of time dependent behavior per individual pixel, Region of Interest (ROI), or Volume of Interest (VOI). TIDs feature user definable intensity and time axes in combination with curve smoothing and curve fitting to determine modality dependent functional parameters. The functional parameters will be presented numerically and a selection of the functional parameters will be visualized as functional images. Subtraction of time series of contrast enhanced images from non-contrast enhanced images to provide the enhanced contrast only is also a function provided by the package.

The provided document, K971965, is a 510(k) Summary of Safety and Effectiveness for the "Philips Easyvision Family Workstation Option Quantitative Analysis Package". This document does not describe acceptance criteria or a study proving the device meets those criteria.

The document focuses on:

• Intended Use: Visualization and analysis of CT and MR dynamic studies showing changes in contrast over time.
• System Description: Details how the package supports visualization and analysis of dynamic studies, including "Time Intensity Diagrams (TID)", curve smoothing, curve fitting, and computation of functional parameters (e.g., maximum intensity, wash in, wash out, time to max, regional Cerebral blood flow, time to peak, mean transit time). It also mentions the creation of functional images.
• Predicate Devices: Philips Gyroview HR (K921219) and GE Advantage Windows with FuncTool Option (K960265).
• FDA Clearance Letter: Confirms substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as it is not present in the provided text.

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EasyCorrect is intended for use in situations where digital images acquired from fluoroscopic imaging systems without distortion are required. The corrected images may be either hard-copy or soft-copy. Examples of (but not limited to) such situations are: making stereotactic measurements for Radiation Treatment Planning Systems or reconstructing digital spotfilm series into composite (survey) images.

The EasyCorrect package is an option to the Vascular Analysis Package. EasyCorrect will support the creation of images acquired by a digital image intensifier based system that can be compared to conventional acquired images (cassette film). Thereby the same measurements can be performed on the digital acquired image as on the conventional acquired image. The EasyCorrect package will correct images for distortion through the following process: Calibration and clinical images are acquired according to acquisition protocols described in documentation delivered with the system. The calibration image will be acquired with a grid phantom included in the package. The software will compare the geometric characteristics of the calibration image (taken with the grid) with the actual geometrical characteristics of the grid. The difference(s) in geometrical characteristics between the two images is a measure of the distortion(s) in the digital acquired image. By applying the result of this calculation of distortion to clinical images taken under the same conditions as the calibration grid image, the clinical images can be corrected for the distortion(s) introduced by the digital technique.

The provided text is a 510(k) summary for the Philips EasyVision Family Workstation Option (EasyCorrect). It describes the device, its intended use, and the regulatory approval process, but it does not contain explicit acceptance criteria or a detailed study report demonstrating how the device meets specific performance metrics.

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

Inferred Acceptance Criteria and Reported Device Performance (Based Solely on the Provided Text)

Missing Information (Not Available in the Provided Text)

The provided document is a 510(k) summary, which typically focuses on substantial equivalence and intended use. It does not contain the detailed study information requested. Therefore, the following points cannot be answered from the given text:

2. Sample size used for the test set and the data provenance: No information on the number of images or cases used for demonstrating the correction capability, nor their origin (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or their qualifications involved in evaluating the corrected images.
4. Adjudication method: Not discussed.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No information on human reader studies or comparison with/without AI assistance. The device is a correction tool, not necessarily an AI interpretation tool in the modern sense.
6. Standalone performance (algorithm only without human-in-the-loop performance): While the description details how the algorithm works, there are no reported quantitative performance metrics (e.g., distortion reduction percentage, accuracy of measurements on corrected images) that would typically be part of a standalone performance study.
7. Type of ground truth used: The "ground truth" for distortion is inherently the known geometry of the grid phantom. However, how the effectiveness of the correction was validated against a ground truth (e.g., pathology, clinical outcomes, or expert consensus on linearity/measurement accuracy) is not detailed.
8. Sample size for the training set: Not applicable or not described, as the correction method relies on a calibration image (grid phantom) and a calculation from that, rather than a large "training set" in the machine learning sense.
9. How the ground truth for the training set was established: As above, the "ground truth" for the calibration is the known, ideal geometry of the grid phantom.

Summary of What the Document Provides vs. What it Lacks:

The Philips 510(k) summary provides a high-level description of the EasyCorrect device, its mechanism for distortion correction using a grid phantom calibration, and its intended use. It emphasizes that the corrected images can be used for measurements typically done on conventional images. However, it does not delve into the detailed performance metrics, validation studies, sample sizes, expert involvement, or statistical analyses that would typically be required to fully address the requested points regarding acceptance criteria and proof of their fulfillment. The document's purpose is to establish substantial equivalence for regulatory clearance, not to provide a comprehensive technical performance report.

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The Vascular Analysis Package is intended for off-line image processing and manipulation of digitally acquired datasets from Integris systems. The use of the Vascular Analysis package is comparable with that on the Integris operator console (the algorithms used with the Easyvision are identical to those already used on the Integris systems, although the user interface is different).

With the Vascular Analysis package the user can optimize images and perceived image quality for vascular application specific purposes.

The vascular analysis package supports the postprocessing on Digital Subtraction Angiography (DSA) images done to perform diagnosis. In a vascular study series of images are acquired either with or without contrast media. These contrast media can be iodine or CO2, and they make the vasculature visible in the image. The features in the vascular package allow for optimizing these images in the following way. Subtraction is a common used technique in DSA . Two images representing the same part of the anatomy (one with contrast media and one without contrast media) are subtracted from each other. The resulting image is an image that displays the vascular anatomy/pathology only, due to the fact that all equal anatomical structures in the two images are subtracted from each other. Thereby leaving only visible the vascular structures filled with contrast media. Run subtraction is identical to subtraction but now the subtraction process is applied to two series of images wherein image 1 of series 1 correlates w.r.t anatomy/position to image 1 in series 2.

Landmarking will allow to bring back some of the anatomical structure back into the image as to relate vascular pathology to anatomical position. Sometimes there can be a mismatch between two images that are subtracted from each other due to patient movement. To correct for this movement pixel shift is applied to the image pair, where the mask image (image without the contrast) is shifted in horizontal and/or vertical axis compared to the contrast image. This will enhance the visibility of the vascular structure only.

This can either be done:

• Manually, the user shifts in a Region Of Interest (ROI) to have an optimal result. The . shift result in the ROI will be applied to the whole image.
• Split Screen, to allow different shifts in one subtracted pair. The image is either divided . by a horizontal or vertical line into two areas. In each of those two areas different values of shift can be applied.
• . AutoWarp, a means of enhancing a pair of subtracted images by adapting regions in the mask image to regions in the contrast image.

The provided 510(k) summary for the Philips Easy Vision Family Workstation Option, Vascular Analysis, states that "The algorithms used with the Easyvision are identical to those already used on the Integris systems, although the user interface is different." This implies that the device's acceptable performance is benchmarked against the predicate Integris systems, and the FDA's clearance is based on this substantial equivalence. However, the document does not describe specific acceptance criteria or an independent study detailing the device's performance against such criteria for the new workstation.

The 510(k) summary focuses on demonstrating that the Easy Vision Vascular Analysis package is substantially equivalent to the predicate Philips Integris systems and Siemens systems. It describes the intended use and system description, detailing the image processing and manipulation functions for Digital Subtraction Angiography (DSA) images, such as subtraction, run subtraction, landmarking, and pixel shift methods (manual, split screen, and AutoWarp).

Without a dedicated performance study for the Easy Vision workstation or explicitly stated acceptance criteria in the provided text, the specific details requested in the prompt cannot be fully extracted for this particular device. The information below reflects what can be inferred or is directly stated regarding the predicate device's performance and the basis for substantial equivalence, rather than a separate study for the Easy Vision workstation itself.

Here's an attempt to answer the questions based on the available information, noting the gaps:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for a dedicated test set for the Easy Vision workstation. The claim of "identical algorithms" suggests reliance on prior validation of the Integris systems.
• Data Provenance: Not specified.

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)

• Not specified. Given the reliance on substantial equivalence, any prior validation on the Integris likely involved expert review, but details are not provided for the Easy Vision.

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 specified. This is a workstation that provides tools for image manipulation, rather than an AI-assisted diagnostic tool in the modern sense. The "AI" (AutoWarp) mentioned is a specific image processing algorithm.

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

• While the algorithms themselves function without human interaction once initiated (e.g., AutoWarp), the document describes a "Workstation" and "Vascular Analysis package" where a user ("the user can optimize images") interacts with the system. The focus is on the tools available to the user for post-processing, implying human-in-the-loop performance is inherent to its intended use. No standalone evaluation of the algorithms separate from the workstation in a user context is described.

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

• Not specified. For a system processing DSA images, the "ground truth" for evaluating image optimization would typically involve expert assessment of image quality, clarity of vascular structures, and accuracy of anatomical representation after processing, likely against clinical or expert-interpreted images.

8. The sample size for the training set

• Not applicable as this document focuses on a 510(k) submission based on substantial equivalence, not a de novo algorithm development and training. The algorithms are stated to be "identical to those already used on the Integris systems," implying they were previously developed and validated.

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

• Not applicable for the same reasons as above.

Summary of Gaps and Inferences:

The provided 510(k) summary primarily asserts substantial equivalence to predicate devices (Philips Integris, Siemens) by stating that the algorithms used in the Easy Vision Vascular Analysis package are "identical" to those already in use on the Integris systems. This means that the regulatory acceptance is built upon the prior demonstrated safety and effectiveness of the predicate devices. The document does not detail new, independent performance studies with specific acceptance criteria, sample sizes, expert qualifications, or ground truth establishment for the Easy Vision workstation itself. Instead, the "study" proving the device meets acceptance criteria is essentially the assertion and FDA's acceptance of the "identical algorithms" claim.

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The MR Cardiac Analysis Package is intended for use in processing cardiac or cardiovascular MR images, resulting in quantitative and/or qualitative data that can be used to estimate cardiac or cardiovascular function.
The MR Cardiac Analysis Package is indicated for use in association with cardiac and cardiovascular examinations where it is useful or necessary to perform qualitative or quantitative analysis.

The MR Cardiac Analysis Package provides off-line viewing and processing functions for cardiac and cardio-vascular examinations, acquired with Magnetic Resonance, to simplify the process. Historically the user had to outline the end-systolic and end-diastolic ventricle areas in one or all slices. To reduce the time required for the analysis, the MR Cardiac Analysis Package provides a facility for computer assisted detection of the heart boundaries of the left ventricle. The user may edit the computer generated boundary and must always approve the selection. The right ventricle boundary must still be detected manually. To use the MR Cardiac Analysis Package, MR images of the heart are acquired with dedicated MR sequences at multiple slices and different phases of the heart cycle and transferred to the Easyvision Workstation. Processing these images provides data that can be used to estimate various quantitative parameters, e.g., ejection fraction, stroke volume, diastolic and systolic volume, ventricular mass, and wall thickness. It can also provide a display of cardiac functional parameters and permits correction for errors caused by papillary muscle. All quantitative results can be printed in a dedicated, user definable, print layout for cardiac analysis, where analysis data (statistical and graphical) can be reported in combination with the image data. The package will also provide viewing capabilities such as direct access to images, defined by slice location or heart phase, and synchronized movies for the different heart phases and/or slices.

The provided text (K972103) describes the Philips MR Cardiac Analysis Package, an image processing system for cardiac and cardiovascular MR images. However, it does not include a detailed study or specific acceptance criteria with reported device performance metrics. Instead, it focuses on the device's intended use, system description, and regulatory clearance (510(k)).

Therefore, I cannot provide the requested information in a table format with specific performance metrics or detailed study characteristics because that information is not present in the provided document.

Here's what I can infer from the document regarding the study aspects, assuming a study would have been conducted to support substantial equivalence, even if the details aren't explicitly given in this summary:

1. A table of acceptance criteria and the reported device performance:

   • Not provided. The document does not specify quantitative acceptance criteria (e.g., accuracy, precision, F1-score) or present a table of reported device performance metrics against such criteria. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, which often relies on functional similarity and intended use rather than head-to-head performance comparisons with specific numerical outcome targets.

2. Sample size used for the test set and the data provenance, number of experts for ground truth and their qualifications, and adjudication method:

   • Not provided. The document does not mention any specific test set size, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth for any performance evaluation. It describes the output of the device (quantitative data like ejection fraction, stroke volume, etc.) and highlights its computer-assisted boundary detection feature, but not how the accuracy of these outputs was tested or validated against
     a defined ground truth.

3. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

   • Not provided. There is no mention of an MRMC study or any comparison of human reader performance with or without AI assistance. The device is described as "computer-assisted," where the user can edit and must approve the computer-generated boundary, suggesting a human-in-the-loop approach, but no formal study of its impact on human reader effectiveness is described.

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

   • Partially addressed indirectly. The system provides "computer assisted detection of the heart boundaries of the left ventricle." However, it explicitly states, "The user may edit the computer generated boundary and must always approve the selection." This indicates that a pure standalone (algorithm only) performance, without human intervention, is not the intended or described mode of operation. Therefore, a standalone performance study as typically understood (algorithm output without any human correction) would not be directly relevant to its described use, and no such study is mentioned.

5. The type of ground truth used:

   • Not provided. The document does not specify how ground truth would be established for quantitative parameters like ejection fraction, stroke volume, etc., in the context of any validation study. Given the device's output, potential ground truth could involve expert manual measurements, but this is not stated.

6. The sample size for the training set:

   • Not provided. The document does not mention any training set or its size. While the device utilizes "computer assisted detection," it does not explicitly state that it employs machine learning or a training phase in the modern sense.

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

   • Not applicable / Not provided. As no training set or machine learning approach is explicitly described, the method for establishing its ground truth is also not mentioned.

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Not Found

optional package: SPINE

I apologize, but the provided text is a 510(k) summary (K963980) from Philips Medical Systems for an optional "SPINE" package for their Easy Vision X-Ray workstations, submitted in 1996.

This document does not contain the detailed technical study information, acceptance criteria, or performance data that you have requested. It is a very high-level summary stating that the device is safe and effective based on past experience with predicate devices.

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

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample sized used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method: Not present.
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 present. This document is from 1996, well before "AI assistance" in the modern sense was a standard clinical or regulatory consideration for X-ray workstations.
6. If a standalone performance was done: Not present.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The document is purely an administrative summary for a 510(k) submission, confirming the submission of information for safe and effective use, and referencing predicate devices. It does not go into the specifics of performance studies or ground truth establishment.

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Not Found

optional package: CT/MR MATCHING

This document is a 510(k) summary for Philips Medical Systems' "CT/MR MATCHING for use in PHILIPS EasyVision CT/MR workstations." It focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a dedicated study demonstrating the device meets such criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily makes high-level claims about safety and effectiveness based on past experience and user information, rather than detailing a specific performance study with acceptance criteria and results.

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