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The CARESTREAM Vue PACS is an image management system whose is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, retrieve and display images and data from all hospital modalities and information systems. The system is to be used by trained professionals including, but not limited to, physicians and medical technicians.

The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.

The system contains a Perfusion module with interactive tools to analyze and compare Computed Tomography Perfusion (CTP) and MR Perfusion (MRP) images of adult patients. Blood perfusion parameters are automatically calculated and displayed as a set of perfusion maps and perfusion tables include the calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

The system contains a Diffusion Module with interactive tools to ease the process of analyzing and comparing MR Diffusion Weighted images (DWI) and MR Diffusion Tensor Imaging (DTI) of adult patients. This module is used to visualize local water diffusion properties from the analysis of diffusion- weighted MRI data.

The system supports Subtractive tools to aid with the analysis of Digital Subtraction Angiography (DSA) images in both interventional radiology and cardiology. Subtraction automatically subtracts a mask from contrast frames of an X-Ray Angiography study for visualization of vascular anatomy and pathology of adult patients.

CARESTREAM Vue PACS is an image management system. It provides functionality to allow remote site access to image and patient data enabling diagnostic reading through industry standard interfaces. The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images.

The modification to the Vue PACS device described in this submission includes the addition of the MR Perfusion and Diffusion Module.

The provided document describes the Carestream Vue PACS system, specifically focusing on the addition of MR Perfusion and Diffusion Modules. It outlines the performance testing conducted to demonstrate substantial equivalence to a predicate device (Olea Sphere v3.0). However, the document primarily discusses high-level details of the study rather than providing specific, granular acceptance criteria and detailed performance results with numerical thresholds.

Below is a structured attempt to answer your questions based on the provided text, supplemented with interpretations where specific details are missing (and noted as such).

Acceptance Criteria and Device Performance

The document states, "Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device." However, the exact, quantifiable acceptance criteria are not explicitly listed. The study objective was to "compare the similarity of the parametric maps," implying that the acceptance criterion was a qualitative or quantitative measure of this similarity, but no specific threshold (e.g., a certain correlation coefficient, a maximum allowed difference) is provided.

Given the available information, the table would look like this, with the understanding that specific numerical criteria are not provided in the text:

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not specified. The document only mentions "A Clinical study was performed."
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

   • This was a comparative study between an investigational device and a predicate device, focusing on the "similarity of the parametric maps." It doesn't appear to establish a ground truth through expert consensus in the traditional diagnostic sense (e.g., identifying disease vs. no disease). Instead, the "ground truth" seems to be conceptually based on the output of the predicate device.
   • Therefore, the number of experts and their qualifications for establishing ground truth are not applicable/not mentioned in the context of this study as described.

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

   • Adjudication methods are typically used when multiple human readers interpret cases and their agreement or disagreement needs to be resolved to establish a "ground truth" or consensus. Since this study focused on comparing the algorithmic output (parametric maps) of two systems, and not on human interpretation needing resolution, adjudication methods are not applicable/not mentioned.

4. 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 study assessing human reader improvement with AI assistance was not done based on this document. The study explicitly states its objective was to "compare the similarity of the parametric maps of MR DSC-Perfusion (Perfusion Module), MR DWI (Diffusion Module) and MR DTI (Diffusion Module) in Carestream Vue PACS ("investigational device") to the Olea Sphere PACS with Perfusion and DWI Modules ("predicate device")." This describes a comparison of the software's output, not a human reader performance study.

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

   • Yes, the primary clinical study described was effectively a standalone comparison between the investigational device's algorithmic output and the predicate device's algorithmic output. It focused on the "similarity of the parametric maps" generated by the respective modules, which implies direct algorithmic comparison rather than assessing human-in-the-loop performance.

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

   • As interpreted above, the "ground truth" in this comparative study was essentially the outputs (parametric maps) generated by the predicate device (Olea Sphere v3.0). The study aimed to show that the investigational device's outputs were "similar" or "substantially equivalent" to those of the legally marketed predicate. This is not a ground truth derived from pathology, expert consensus on disease, or outcomes data.

7. The sample size for the training set:

   • The document describes a "Clinical study" for validation and "non-clinical (bench) testing" for verification. It does not mention a training set or details about the development of the algorithms. The focus is purely on the validation of the integrated modules. Therefore, the sample size for the training set is not provided.

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

   • Since the document does not mention details about the training set or algorithm development, how ground truth for the training set was established is not provided.

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The CARESTREAM Vue PACS is an image management system whose is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, retrieve and display images and data from all hospital modalities and information systems.

The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D), CT Perfusion (CTP), and Digital Subtraction Angiography (DSA) images. It is a single system that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.

The system contains a Perfusion module with interactive tools to ease the process of analyzing and comparing Computed Tomography Perfusion (CTP) images of adult patients. The Arterial Input Function (AIF), Venous Output Function (VOF), and Brain Centerline are automatically detected with the ability for manual correction by the user. Blood perfusion parameters are automatically calculated and displayed as a set of user friendly perfusion maps and perfusion tables summarizing the results. The perfusion maps include relative Cerebral Blood Volume (rCBV), relative Cerebral Blood Flow (rCBF), Mean Transit Time (MTT), Time to Peak (TTP), and Time to maximum impulse response function (TMAX). The perfusion tables include the calculation of parameters related to tissue blood volume.

The system supports Subtractive tools to aid with the analysis of Digital Subtraction Angiography (DSA) images in both interventional radiology and cardiology. Subtraction automatically subtracts a mask from contrast frames of an X-Ray Angiography study for visualization of vascular anatomy and pathology of adult patients.

The Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, medical data, and medical images for different modalities including CR, DR, CT, MR, NM, ECG, and US.

Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile device is not intended to replace full workstations and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography.

CARESTREAM Vue PACS is an image management system. It provides functionality to allow remote site access to image and patient data enabling diagnostic reading through industry standard interfaces. The modification to the Vue PACS device described in this submission includes the addition of the following modules:

• 1. Perfusion Module The calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
• 2. Subtraction Feature Subtraction of two images representing the same part of the anatomy (one with contrast media and one without contrast media) resulting in an image that displays the vascular anatomy/pathology only.

The provided text describes a 510(k) premarket notification for the CARESTREAM Vue PACS, which includes a Perfusion Module and a Subtraction Feature. The document aims to demonstrate substantial equivalence to predicate devices rather than fulfilling specific acceptance criteria in the form of numerical performance targets. Therefore, a direct "acceptance criteria" table with numerical performance metrics isn't explicitly stated in the document as would be typical for an AI performance study with strict thresholds.

However, based on the information provided, we can infer the acceptance criteria and study findings in relation to establishing substantial equivalence.

Here's an attempt to structure the information as requested, acknowledging the nature of a 510(k) submission focused on substantial equivalence:

Inferred Acceptance Criteria and Reported Device Performance

Detailed Study Information:

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

   • Perfusion Module: The document mentions a "clinical study" but does not specify the sample size (number of cases or patients) used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
   • Subtraction Feature: The document mentions "Engineering Tests" using "XA test pattern and XA clinical images." It does not specify the number of clinical images used or their provenance.

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

   • Perfusion Module: The document mentions "radiologist evaluation of key metrics" in the clinical study. It does not specify the number of radiologists involved or their specific qualifications (e.g., years of experience, subspecialty).
   • Subtraction Feature: The document mentions "quantitative and visual tests" in the Engineering Tests. It does not specify if experts with specific qualifications were used to establish ground truth, nor the number of such experts.

3. Adjudication Method for the Test Set:

   • The document does not explicitly describe any formal adjudication method (e.g., 2+1, 3+1) for either the Perfusion Module or the Subtraction Feature studies. For the Perfusion Module, "radiologist evaluation" is mentioned, but the method of consensus or independent assessment is not detailed.

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

   • Perfusion Module: A "clinical study" was performed comparing the investigational device with a predicate device through "radiologist evaluation." This could imply a comparative study involving human readers, but the details (e.g., if readers used both systems, if it was a reader performance study) are not provided.
   • Effect Size: The document does not provide any effect size or quantitative measure of how much human readers improve with AI vs. without AI assistance. The focus is on demonstrating "equivalent clinical quality" between the investigational device and the predicate, not on human reader improvement with AI assistance. The device itself is a PACS module, providing interactive tools for analysis, rather than an AI for a diagnostic task.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Perfusion Module: The Perfusion Module automatically calculates parameters. While the "radiologist evaluation" assesses the output of the module, the study focuses on the clinical quality of the results rather than a standalone algorithmic diagnostic performance. The document describes the module as providing "interactive tools" and automatic detection with "ability for manual correction by the user," suggesting a human-in-the-loop design. No standalone performance metrics for the algorithm are provided.
   • Subtraction Feature: This feature "automatically subtracts" images. The "Engineering Tests" assessed its correct application and function. This suggests an evaluation of the algorithm's output, but it's not presented as a standalone diagnostic performance study.

6. Type of Ground Truth Used:

   • Perfusion Module: "Radiologist evaluation of key metrics" applicable to CTP images was used for comparison. This implies expert consensus or expert interpretation served as the reference for clinical quality. It does not explicitly state pathology or outcomes data.
   • Subtraction Feature: The ground truth for the Engineering Tests involved "XA test pattern" (likely known, manufactured patterns) and "XA clinical images." The correctness was assessed through "quantitative and visual tests," implying a comparison against expected outcomes or expert visual inspection for clinical images.

7. Sample Size for the Training Set:

   • The document does not provide any information regarding a training set size. As a 510(k) submission for a PACS module with specific functionalities (perfusion calculations, image subtraction), the development might involve rule-based algorithms or models trained on data, but this information is not disclosed in the summary.

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

   • As no training set information is provided, there is no information on how its ground truth was established.

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The CARESTREAM Vue PACS is an image management system whose intended use is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.

The Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, and medical images for diagnosis from different modalities including CR. DR, CT, MR, NM and US.

Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by the FDA for mammography.

CARESTREAM Vue PACS is an image management system whose intended use is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

It is a software only solution that contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians.

Vue PACS provides functionality to allow remote site access to image and patient data enabling diagnostic reading through industry standard interfaces. It is designed using an open architecture that allows for various proprietary and off the shelf software components to be integrated with off the shelf hardware components and configured meeting the user's specific needs in a single-site or multi-site environment.

CARESTREAM Vue Motion is a Light Viewer designed to provide wireless and portable access to medical images for remote reading or referral purposes from web browsers including enterprise distribution of the radiology images and related data. The needs to provide real time imaging results and imaging related data to the enterprise users' commands that imaging solutions have a simple distribution mechanism through simple and broadly used technology. The patient portfolio is made available to physicians from their offices within their EMR. from home on local PC's or remotely through tablet and other devices. With integration into EMR systems, Vue Motion helps hospital users and healthcare facilities enhance patient care, by bringing the complete patient imaging record and supporting data into the healthcare enterprise. Image storage, viewing and distribution becomes a seamless part of the EMR.

A "patient search page", including smart Google-like search capabilities is also available for users that have no local EMR/HIS integration.

Vue Motion is offered as an option for the PACS, Vue Archive (onsite or via Vue Cloud) or The Carestream Vendor Neutral Archive and provides a zero footprint imaging viewer that can be deployed on the fly and accessible by the right user from anywhere, over virtually any operating system or over virtually any browser enabled device. The software technology uses HTML5 which allows any browser enabled device to run the software application.

CARESTREAM Vue Motion has a simpler GUI for viewing including zoom, pan, windowing, basic measurements, cine etc. It works on any operating system and with virtually any browser enabled device such as PC's, iPad, mobiles etc. It is selfdeployable and performs well over low bandwidth networks. It supports collaboration with other users through the sticky notes mechanism.

The provided text describes the CARESTREAM Vue PACS v11.4 Vue Motion, an image management system with mobile access capabilities. It outlines the product's description, intended use, and technological characteristics, as well as its substantial equivalence to a predicate device.

However, the document does not explicitly state specific acceptance criteria in a quantitative or pass/fail manner, nor does it detail a formal study with a defined test set, ground truth establishment, or expert involvement. Instead, it broadly describes testing activities.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria are not explicitly stated, the table below presents the types of performance aspects tested and the overall reported outcome.

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

• Sample Size for Test Set: Not explicitly stated as a numerical count of cases or images. The document refers to "each of the devices" (Apple iPad2, Apple iPhone 4S, Galaxy S3, and Galaxy Note 10.1) being tested.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "Vue Motion images of diagnostic quality" were used but doesn't detail their source or type.

3. Number of Experts and Qualifications for Ground Truth Establishment

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It only states that "Clinical Assessments" were performed, implying involvement of medical professionals, but their number and specific qualifications (e.g., radiologists, years of experience) are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The document does not describe any multi-reader review or consensus process for clinical assessment.

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

• MRMC Study Done: No. The document does not mention an MRMC study comparing human readers with and without AI assistance. The focus is on demonstrating that the device itself can display images of diagnostic quality and is equivalent to the predicate PACS.
• Effect Size of Human Readers Improvement with AI vs. without AI: Not applicable, as no MRMC study was performed.

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

• Standalone Performance Done: This device is an image display and management system, not primarily an AI algorithm for diagnostic interpretation. Its performance is tied to its ability to render medical images accurately on specified mobile devices. The "Bench Testing" and "Functional QA testing" could be considered components of standalone performance for the software/device combination, but not in the context of an AI diagnostic algorithm's standalone accuracy. The "Clinical Assessments" evaluate the display capabilities for human diagnostic use, rather than an algorithm's diagnostic output.

7. Type of Ground Truth Used

• Type of Ground Truth: For the "Clinical Assessments," the implicit ground truth seems to be the widely accepted understanding of "diagnostic quality" for medical images when viewed on the tested devices, presumably benchmarked against a full diagnostic workstation (the predicate PACS). This is not an explicit ground truth like pathology reports or patient outcomes data, but rather a qualitative assessment of display fidelity suitable for diagnosis by human users.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document describes a PACS and mobile viewer, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" here would refer to the software development and quality assurance processes.

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

• Ground Truth for Training Set: Not applicable, as it's not an AI/ML system with a conventional training set. The "ground truth" for the software development and testing would be the functional requirements and specifications of the PACS and mobile viewer, ensuring it correctly processes, transmits, and displays DICOM images in accordance with industry standards and clinical needs.

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The CARESTREAM Vue PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians.

The Lesion Management Application is a module that works with CARESTREAM Vue PACS for measurement of lesions or regions of interest identified by trained users; tabulation of measurements, categorization of tumor response in accordance with user-selected standards, and follow-up record of findings. Lesion Management Application is not to be used for mammography.

The CARESTREAM Vue PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians.

The Lesion Management Application is a module that works with CARESTREAM Vue PACS for measurement of lesions or regions of interest identified by trained users; tabulation of measurements, categorization of tumor response in accordance with user-selected standards, and follow-up record of findings. Lesion Management Application is not to be used for mammography.

This FDA 510(k) clearance letter pertains to the CARESTREAM Vue PACS system, including its Lesion Management Application. The document itself does not contain specific acceptance criteria or details of a study proving device performance against such criteria.

The letter confirms that the FDA has reviewed the premarket notification and found the device substantially equivalent to legally marketed predicate devices. This means that, based on the information provided by the manufacturer, the FDA believes the device is as safe and effective as a device already on the market.

Information NOT present in the provided document:

The provided document (an FDA 510(k) clearance letter) does not include any of the requested information regarding acceptance criteria, device performance results, study design, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Explanation of the document's content:

• Page 0 & 1: These pages are the official FDA clearance letter. They state:

  • The device name: CARESTREAM Vue PACS.
  • Regulation Number and Name: 21 CFR 892.2050, Picture archiving and communications system.
  • Regulatory Class: II.
  • Product Code: LLZ.
  • The crucial statement that the device is "substantially equivalent" to legally marketed predicate devices. This equivalence is the basis for its clearance, not a new performance study proving acceptance criteria.
  • General regulatory requirements for devices.

• Page 2: This page outlines the "Indications for Use" for the CARESTREAM Vue PACS, including the Lesion Management Application.

  • The PACS system is intended for archiving, distributing, retrieving, and displaying images and data from hospital modalities.
  • The Lesion Management Application is described as a module for "measurement of lesions or regions of interest identified by trained users; tabulation of measurements, categorization of tumor response in accordance with user-selected standards, and follow-up record of findings."
  • Crucially, it explicitly states: "Lesion Management Application is not to be used for mammography."
  • It also confirms that it is a prescription-use device.

To answer your request, one would need to refer to the original 510(k) submission document (K122523) filed by Carestream Health, Inc., which would contain detailed information on performance testing, comparison to predicate devices, and any specific acceptance criteria used for that comparison. The clearance letter itself is the FDA's decision based on that submission, not the submission's content.

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