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CADstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream supports evaluation of dynamic MR data acquired during contrast administration. CADstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats).

CADstream also includes user-configurable features for reporting on findings in breast or general MRI studies. Additionally, CADstream assists users in planning MRI guided interventional procedures.

When interpreted by a skilled physician, this device provides information that may be used for screening, diagnosis, and interventional planning. Patient management decisions should not be made based solely on the results of CADstream.

CADstream may also be used as an image viewer of multi-modality, digital images, including ultrasound and mammography. CADstream is not intended for primary interpretation of digital mammography images.

CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.

CADstream receives DICOM magnetic resonance images from a PACS of directly from the MRI scanner. As they are received, CADstream processes and displays the results on the CADstream server or a client personal computer.

Available features support:

• . Visualization (standard image viewing tools, MIPs, and reformats)
• Analysis (registration, subtractions, coil inhomogeneity correction, kinetic curves, parametric image maps, apparent diffusion coefficient maps, automatic and manual segmentation and 3D volume rendering)
• Reporting of user-selected findings and assessment
• Interventional planning
• Workflow efficiency ■
• 예 Communication and storage (DICOM import/export, query/retrieve, and study storage)

The CADstream system consists of proprietary software developed by Merge Healthcare installed on an off-the-shelf computer.

The provided 510(k) summary for CADstream Version 5 (K092954) states that the device modification primarily involves adding capabilities for calculating and presenting apparent diffusion coefficient (ADC) maps and values. It emphasizes that this change is consistent with previously cleared indications for use and does not alter the fundamental scientific technology.

Therefore, the performance testing described focuses on demonstrating that the new ADC functionality meets acceptance criteria related to its implementation and the existing functionalities.

1. Table of Acceptance Criteria and Reported Device Performance

• Correct calculation and presentation of ADC maps and values.
• Integration into existing CADstream workflow.
• No adverse impact on previously cleared functionalities. | The submission states: "The potential hazards of adding the ADC map functionality have been studied and controlled as part of the product development process, including risk analysis and design considerations." and "The successful completion of verification testing has demonstrated conformance to design controls, user needs, and intended use, and that the device is safe and effective." |
  | Overall Device Safety and Effectiveness (for the modified device):
• Continues to meet intended use as an image processing system for visualization, analysis, and reporting of MRI studies.
• Maintains safety and effectiveness as demonstrated by the predicate devices. | The submission concludes: "Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate devices." |

2. Sample size used for the test set and the data provenance

The document states "verification testing was completed" but does not provide details regarding the sample size of the test set, or the specific provenance (country of origin, retrospective/prospective nature) of the data used for this testing.

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

The 510(k) summary does not specify the number of experts or their qualifications used to establish ground truth for the verification testing. Given that the modification is primarily software-based for a calculation and presentation feature (ADC maps), the "ground truth" for this specific modification would likely relate to the accuracy of the algorithm's output compared to expected mathematical results or established reference methods, rather than expert interpretation of a diagnostic outcome. The general indications for use, however, mention interpretation by a "skilled physician."

4. Adjudication method for the test set

The document does not specify any adjudication method used for the test set.

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 MRMC comparative effectiveness study was done or reported in this 510(k) summary. The modification described is focused on the technical implementation of ADC calculation and presentation, not on evaluating human reader performance with or without AI assistance.

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

The provided information indicates that "verification testing was completed," but does not explicitly detail whether standalone algorithm-only performance testing was conducted for the ADC functionality. Given the nature of ADC calculation, it is highly probable that the verification testing involved evaluating the algorithm's output accuracy against known inputs or established methods, which can be considered a form of standalone performance evaluation for that specific feature. However, the document does not break down the testing in this way.

7. The type of ground truth used

For the specific modification (ADC map functionality), the ground truth would likely be mathematical accuracy and fidelity to established methods for calculating ADC values. This would involve comparing the device's calculated ADC maps and values against highly accurate reference calculations or values derived from well-defined input MRI sequences. The document does not explicitly state the type of ground truth beyond "conformance to design controls, user needs, and intended use."

8. The sample size for the training set

The 510(k) summary does not mention a training set sample size or details about any machine learning training for this specific modification. The change described (ADC map calculations) suggests a deterministic algorithmic implementation rather than a machine learning model that would require a distinct training set.

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

As no training set is mentioned, this information is not applicable and not provided in the document.

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CADstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream supports evaluation of dynamic MR data acquired during contrast administration. CADstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats).

CADstream also includes user-configurable features for reporting on findings in breast or general MRI studies. Additionally, CADstream assists users in planning MRI guided interventional procedures.

When interpreted by a skilled physician, this device provides information that may be used for screening, diagnosis, and interventional planning. Patient management decisions should not be made based solely on the results of CADstream.

CADstream may also be used as an image viewer of multi-modality, digital images, including ultrasound and mammography. CADstream is not intended for primary interpretation of digital mammography images.

CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.

CADstream receives DICOM magnetic resonance images from a PACS or directly from the MRI scanner. As they are received, CADstream processes and displays the results on the CADstream server or a client personal computer.

Available features support:

• Visualization (standard image viewing tools, MIPs, and reformats)
• Analysis (registration, subtractions, coil inhomogeneity correction, kinetic curves, parametric image maps, and 3D volume rendering)
• Reporting of user-selected findings and assessment
• Interventional planning
• Workflow efficiency
• Communication and storage (DICOM import/export, query/retrieve, and study storage)

The CADstream system consists of proprietary software developed by Confirma installed on an off-the-shelf computer.

Here's a breakdown of the acceptance criteria and study information for the CADstream Version 5 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative measures of visualization/analysis improvement). Instead, the performance testing is described in a more general sense, focusing on verification and validation against requirements and substantial equivalence to predicate devices.

Therefore, the table will reflect the general statements made about performance rather than specific, measurable criteria.

• Visualization (standard image viewing tools, MIPs, reformats, 3D volume rendering)
• Analysis (registration, subtractions, coil inhomogeneity correction, kinetic curves, parametric image maps)
• Reporting of user-selected findings and assessment
• Interventional planning
• Workflow efficiency
• Communication and storage (DICOM import/export, query/retrieve, and study storage) |

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

• Sample Size for Test Set: The document does not specify the sample size (number of patients or cases) used for the "clinical validation testing."
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: The document does not specify the number of experts used to establish ground truth for the test set.
• Qualifications of Experts: The document does not specify the qualifications of any experts involved in establishing ground truth. The "Indications for Use" section mentions interpretation "by a skilled physician," but this is a general statement about clinical use, not a description of ground truth establishment during testing.

4. Adjudication Method for the Test Set:

• The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

• The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human readers' improvement with or without AI assistance. The focus is on device features and general validation, not comparative reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• The document describes "Performance Testing" including "extensive verification testing," "bench validation testing," and "clinical validation testing." While these tests would involve evaluating the algorithm's functionality, the document does not explicitly state that a standalone performance study comparing the algorithm's diagnostic accuracy against a ground truth was conducted without a human in the loop. The device is described as an "image processing system designed to assist," implying a human-in-the-loop context for its intended use and evaluation.

7. The Type of Ground Truth Used:

• The document does not explicitly state the type of ground truth used for any testing (e.g., expert consensus, pathology, outcomes data). It broadly refers to "user needs and intended uses" for clinical validation.

8. The Sample Size for the Training Set:

• The document does not mention a training set or its sample size. This is typical for 510(k) submissions of this era for image processing systems, as they often leverage established algorithms or feature sets rather than reporting on deep learning model training.

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

• Since a training set is not mentioned, the document does not describe how ground truth for a training set was established.

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The Confirma Breast MRI Interventional Components are intended to be used in conjunction with a magnetic resonance scanner and the Confirma Access Breast Coil designs to permit MRI-guided interventional procedures, such as breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.

The Confirma Breast MRI Interventional Components provide a grid system to immobilize the breast in an Access Breast Coil device. The grid system allows the physician to perform a biopsy through a needle block inserted in the grid plate. The system supports a standard medial-lateral approach using the Access Breast Coil. The design of the interventional components focuses on ease of patient positioning and set-up by the clinician, and patient ergonomics for enhanced comfort during interventional procedures. The design allows for unilateral or bilateral access, and offers maximum access to aid the physician in MRguided interventional procedures such as breast biopsy and localization of lesions, providing lateral and medial access to the breast. The components are provided non-sterile and are non-disposable. The components must be sterilized at the beginning of each procedure. The components are manufactured from Ultem 1000 polyetherimide which can be autoclaved or sterilized with formaldehyde. The compression plate and grid plate system incorporate locking mechanisms that secure the components once positioned. These locks provide stability during the interventional procedure. The compression and grid plates are bidirectional, allowing them to be placed in either a medial-facing or lateral-facing position. This allows the clinician to perform the interventional procedure from the medial or lateral side. For unilateral breast intervention, the system uses one grid plate and one compression plate. For bilateral breast intervention, the system uses 2 grid plates and 2 compression plates. The components are made of medical grade plastic materials, which are fire rated and have high impact and tensile strength.

The provided text describes the Confirma Breast MRI Interventional Components, a device intended for MRI-guided interventional procedures such as breast biopsy and lesion localization. However, it does not contain any information regarding acceptance criteria, reported device performance, or any studies conducted to prove the device meets specific criteria.

The document is a 510(k) summary for a premarket notification to the FDA, focusing on demonstrating substantial equivalence to legally marketed predicate devices. It discusses:

• Device Description: How the device functions as a grid system for breast immobilization and allows for biopsy.
• Comparison with Legally Marketed Devices: Lists several predicate devices and states that the Confirma device is substantially equivalent to them in terms of functionality and access for interventional procedures.
• Conclusions: Reiterates substantial equivalence and mentions that potential hazards were studied and controlled during product development, including risk analysis, test, and design considerations, and planned verification and validation testing processes. However, no results of these planned tests are provided.
• Indications for Use: Specifies the intended use of the device in conjunction with MRI scanners and specific breast coils for MRI-guided procedures.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about specific studies, as this data is not present in the given text.

To directly answer your specific points based only on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the text. The document focuses on substantial equivalence rather than performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the text. No specific test sets or study data are mentioned.
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 provided in the text. No ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the text.
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 performed/not relevant. This device is an interventional component, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not performed/not relevant. This device is a physical component for interventional procedures, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the text.
8. The sample size for the training set: Not applicable/Not provided in the text. This is not an AI/algorithm-focused device requiring a training set.
9. How the ground truth for the training set was established: Not applicable/Not provided in the text.

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The Access Breast Coil 4/SMS is a 4-channel, phased array, receive-only RF coil used in conjunction with a magnetic resonance imager (MRI) to produce diagnostic and interventional images of the breast, chest wall and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in acquiring diagnostic breast MRI studies and interventional breast MRI studies for localization of lesions, biopsies and other interventional procedures.

Access Breast Coil 4/SMS is a 4-channel, phased array breast coil optimized for parallel imaging of the chest wall, breast, and axillary tissue. This device is a dual purpose coil, offering both diagnostic imaging and flexibility in interventional access. The coil's open design allows for flexibility in performing interventional procedures with lateral, medial and cranial-caudal access.

The design of the Access Breast Coil 4/SMS focuses on patient ergonomics, allowing for enhanced comfort during both diagnostic and interventional exams. Positioning accessories, including a headrest, armrest and torso pad, help to relieve pressure on the sternum and provide customized patient positioning during the acquisition of diagnostic and interventional breast MR1 studies.

The coil consists of a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength.

The bilateral, open breast coil design offers optimized imaging capabilities and maximum access to aid the physician in localization of lesions during interventional procedures, providing lateral, medial and cranial-caudal access to the breast.

Acceptance Criteria and Study for Access Breast Coil 4/SMS

This document describes the acceptance criteria and the study that demonstrates the Access Breast Coil 4/SMS meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Access Breast Coil 4/SMS does not explicitly state quantitative acceptance criteria or a dedicated performance study with specific metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are inferred from the comparison points used to establish substantial equivalence, and the "reported device performance" is a qualitative statement of its comparability.

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

The 510(k) summary does not describe a specific clinical test set with a particular sample size for demonstrating performance. The submission relies on a comparison to a legally marketed predicate device (MRI Devices Corporation's Model OBC-63 Breast Array Coil, K022488) to establish substantial equivalence.

Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a performance test set.

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

Since no specific clinical test set is described, there is no information provided regarding the number or qualifications of experts used to establish a ground truth.

4. Adjudication Method for the Test Set

As there is no described clinical test set, there is no adjudication method mentioned.

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

The provided 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Its focus is on demonstrating substantial equivalence of the device's technical specifications and intended use to a predicate device, rather than measuring human reader improvement with or without AI assistance. The device is an RF coil, not an AI diagnostic tool.

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

This is not applicable as the Access Breast Coil 4/SMS is an RF coil, a hardware component for an MRI system, not a standalone algorithm. Its performance is inherent in the image quality it delivers, which is then interpreted by a human physician.

7. Type of Ground Truth Used

Given that the submission relies on substantial equivalence to a predicate device and there is no described clinical performance study, there is no mention of a specific type of ground truth used (e.g., expert consensus, pathology, outcomes data). The "ground truth" implicitly assumed is the established performance and safety of the legally marketed predicate device.

8. Sample Size for the Training Set

The provided 510(k) summary does not describe a training set as this is a hardware device (an RF coil) and not a machine learning or AI-driven diagnostic system that requires training data.

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

As there is no training set described, this point is not applicable.

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The Access Breast Coil is a 7-channel, phased array, receive-only RF coil, used in conjunction with a magnetic resonance scanner to produce diagnostic and interventional images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in MR-guided breast biopsy, localization of lesions, and interventional procedures, providing lateral, medial and cranial-caudal access to the breast.

Access is a 7-channel, phased array breast coil optimized for parallel imaging of the chest wall, breast and axillary tissue. Access is a dual purpose coil, offering both diagnostic imaging and flexibility in interventional access. The coil's open design allows for flexibility in performing interventional procedures with lateral, medial and cranial-caudal access.

The design of the Access breast coil focuses on patient ergonomics, allowing for enhanced comfort during both diagnostic and interventional exams. Positioning accessories, including a headrest, armrest and torso pad, help to relieve pressure on the sternum and provide customized patient positioning during the acquisition of breast MRI studies and interventional procedures.

The coil consists of a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength.

The bilateral, open breast coil design offers optimized imaging capabilities and maximum access to aid the physician in MR-guided breast biopsy, localization of lesions, and interventional procedures, providing lateral, medial and cranial-caudal access to the breast.

Features of the Access Breast Coil:

Imaging

• 7-channel phased array design uses multiple elements that surround . the breast tissue
• t Optimized for parallel imaging applications
• Supports both unilateral and bilateral imaging exams .
• Compatible with Siemens 1.5T MRI systems .
• 40 cm field of view .
• Extensive coverage of chest wall and axilla ●
• High SNR t

Ergonomics

• Large apertures to accommodate a major percentage of patient . population
• Ergonomically designed for patient comfort to minimize motion . artifact

Interventional Access

• Coil design allows lateral, medial and cranial-caudal interventional . access
• Lighting is integrated into the coil for interventional procedures . that demand a well lit area
• Compatible with SureLoc software to support interventional MRI .

This document describes a 510(k) submission for the "Access Breast Coil" and primarily focuses on establishing substantial equivalence to existing legally marketed devices, rather than a detailed study proving the device meets specific acceptance criteria in the way a new AI/software device would. Therefore, many of the requested data points are not directly available or applicable in the provided text.

Based on the nature of this submission (a medical device coil for MRI), the "acceptance criteria" discussed are largely related to safety, performance comparable to predicate devices, and meeting regulatory standards for a Class II magnetic resonance diagnostic device. The "study" mentioned is more accurately described as a validation process during development and comparison to predicate devices.

Here's an analysis based on the provided text, addressing the points where information is available or inferable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of human subject data or image datasets with a defined sample size for performance evaluation. The submission relies on engineering validation, verification, and comparison to predicate devices. There is no mention of a clinical study with a specific sample size of patients or images used to prove the device's diagnostic or interventional performance in a statistical sense beyond what is assumed by comparison to predicate devices. Therefore, sample size for a test set and data provenance (country, retrospective/prospective) are not provided.

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

This information is not provided as the submission does not detail a formal study involving expert review of a test set. The interpretation of images from the device is stated to be by a "trained physician," but this is a general statement about usage, not a specific ground truth establishment for a study.

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

This information is not provided, as there is no described test set or expert ground truth establishment and review process that would involve adjudication.

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. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for evaluating AI/software performance with human readers. This submission is for an MRI coil, a hardware device, and thus does not involve AI or human reader improvement with AI assistance.

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

No. This is a hardware device (an MRI coil), not an algorithm or software. Therefore, a standalone performance evaluation of an algorithm without human-in-the-loop is not applicable.

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

The document does not describe a specific type of ground truth used for a formal performance study in the way one would for evaluating a diagnostic algorithm. The implicit "ground truth" for demonstrating equivalence is that the images produced by the Access Breast Coil are considered "comparable to the predicate devices" when interpreted by a trained physician, which suggests a general equivalence of image quality and diagnostic utility, rather than a specific clinical validation against pathology or outcomes.

8. The sample size for the training set

This information is not applicable/not provided. This is a hardware device, not a machine learning model, so there is no training set in that context.

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

This information is not applicable/not provided. As a hardware device, there is no training set that requires ground truth establishment.

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CADstream is a computer aided detection (CAD) system intended for use in analyzing magnetic resonance imaging (MRI) studies. CADstream automatically registers serial patient image acquisitions (in 2D or 3D) to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps, referred to as angiogenesis maps), and provides quantitative measurements of morphological features of the segmented tissues. CADstream performs other user-defined post-processing functions (image subtractions, multiplanar and oblique reformats, maximum intensity projections, image averaging, removal of cardiac artifact).

CADstream also can be used to provide accurate and reproducible measurements of the segmented tissues volumes (volumes of interest (VOI)). These measurements include longest diameter, longest in-plane diameters, volume measurement (reported in cc), ratio of breast volume to VOI, distance of VOI to anatomical landmarks, and 3D renderings of the VOI.

The system includes an optional remote image viewer (CADalyst™), optimized for viewing breast MR studies processed by CADstream. CADalyst also displays and telecommunicates images from a number of other medical modalities, including ultrasound and digitized mammographic images, processed data from FDA-cleared third party image processing systems, and FDA-approved systems for computer-aided detection and advanced image processing. The ultrasound and digitized mammographic images displayed on the CADalyst remote image viewer must not be used for primary diagnostic interpretation.

CADstream™ includes software to support the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures (SureLoc™). Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion.

CADstream also includes the option to add annotations based on the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS®) Breast Imaging Atlas.

When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of CADstream analysis.

The CADstream device relies on the assumption that pixels having similar MR signal intensities represent similar tissues. The CADstream software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification. CADstream is designed to analyze dynamic breast MRI studies.

The CADstream system consists of proprietary software developed by Confirma installed on off-the-shelf personal hardware. The CADstream System consists of the following key components:

• A PC Server: a desk-side or rack-mount PC capable of running the . Server software, Client User Interface software, and Study Viewer software
• Server software: performs CADstream analysis and processing .
• . Client User Interface software: an administrative web page hosted on the Server
• Study Viewer software (CADalyst): an Image Viewer component, . optimized for viewing breast MR studies processed by CADstream
• . Archive System: a PC with a combination CD/DVD burner and printer

To initiate CADstream analysis and processing, images are acquired and pushed to the CADstream system from the MR scanner. CADstream is configured to automatically process the images and create additional series. In this configuration, CADstream forwards the processed and original images to the existing softcopy reading station.

CADstream Version 4.0 includes the following software features:

• CADstream™, which allows the user to select a study to view, define . settings for CADstream processes, process and export CADstream results, and perform administrative tasks.
• CADalyst™ (the study viewer), which allows the user to view . CADstream results, interact with the volumes, curves, and AngioMap overlays, and print and save a CADstream Portfolio. This component can be accessed from a standalone CADstream workstation, a remote computer connected to the same network as the CADstream server, such as a PACS, or a PC.
• . CADalyst includes multi-modality viewing capabilities, allowing the user to view ultrasound and digitized mammographic images. The ultrasound and digitized mammographic images displayed on the CADalyst remote image viewer must not be used for primary diagnostic interpretation.
• SureLoc™ is a guidance tool that assists the user in calculating target ● coordinates for biopsy, wire localization, or other interventional procedures.
• DICOM query/retrieve and print, which allows retrieval of DICOM . data from any DICOM-compliant device that is configured for CADstream query and retrieval.

The provided text is a 510(k) summary for the CADstream™ Version 4.0 device. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

The document outlines:

• Submitter and product identification
• Device description and features
• Indications for Use
• Comparison with predicate devices for substantial equivalence
• A letter from the FDA confirming substantial equivalence and allowing the device to be marketed.

Key regulatory aspects are discussed, but performance metrics, clinical study design, sample sizes, ground truth establishment, or expert involvement are not detailed. The document focuses on establishing substantial equivalence to existing devices for regulatory approval, rather than presenting a performance study against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text as it is not present.

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CADstream™ is a Computer Aided Detection (CAD) system intended for use in analyzing magnetic resonance imaging (MRI) studies. CADstream automatically registers serial patient image acquisitions (in 2D or 3D) to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps, referred to as angiogenesis maps), and performs other userdefined post-processing fimage subtractions, multiplanar reformats, maximum intensity projections).

CADstream also can be used to provide accurate and reproducible measurements of the longest diameters and volume of segmented tissues. including automated determination of volumes of interest (VOI), calculation of the longest diameter in X, Y and Z dimensions, the areas of VOI, the volume measurements of VOI (reported in cc), and 3D renderings of VOI.

The system includes an optional remote image viewer (CADalyst™), optimized for viewing breast MR studies processed by CADstream.

CADstream™ includes software to support the use of breast interventional coils and MR stereotactic localization devices to perform breast interventional procedures (SureLoc™). Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion.

When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of CADstream analysis.

The CADstream device relies on the assumption that pixels having similar MR signal intensities represent similar tissues. The CADstream software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification. CADstream is designed to analyze dynamic breast MRI studies.

The CADstream system consists of proprietary software developed by Confirma installed on an off-the-shelf personal computer and a monitor configured as a CADstream display station.

The CADstream System consists of the following key components:

• . A PC Server: a desk-side or rack mount PC capable of running the Server software, Client User Interface software, and Study Viewer software
• . Server software: performs CADstream analysis and processing
• Client User Interface software: an administrative web page hosted on the Server .
• Study Viewer software (CADalyst): an optional Image Viewer component. . optimized for viewing breast MR studies processed by CADstream
• Archive System: a PC with CD burner and printer .

In all cases, images are acquired and pushed to the CADstream system from the MR scanner. CADstream is configured to automatically process the images and create additional series. In this configuration, CADstream forwards the processed and original images to the existing softcopy reading station.

Here's a summary of the acceptance criteria and study information for the CADstream™ Version 3.1 device, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for the CADstream™ Version 3.1 device. Instead, it relies on successful completion of internal testing and comparison to predicate devices, focusing on the functionality and safety aspects. The performance is broadly described as:

• Segments and labels tissue types based on enhancement characteristics (parametric image maps / angiogenesis maps).
• Performs user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections).
• Provides accurate and reproducible measurements of the longest diameters and volume of segmented tissues including: automated determination of volumes of interest (VOI), calculation of the longest diameter in X, Y and Z dimensions, the areas of VOI, the volume measurements of VOI (reported in cc), and 3D renderings of VOI.
• Provides automatic calculation of the location and depth of the targeted region of interest (e.g., lesion) using MR images and fiducial coordinates for interventional procedures (SureLoc™). |
  | Software Development | - Designed, developed, tested, and validated according to written procedures.
• Successfully completed required integration and verification testing. |
  | Safety | - Assessment performed throughout the design development process in accordance with internal procedures and IEC 601-1-4.
• Potential hazards studied and controlled as part of product development, risk management, test, and design considerations, and planned verification and validation testing. |
  | Clinical Performance | - Performance testing of features successfully completed utilizing clinical datasets.
• Requirements for features have been met. |

Study Details:

The 510(k) summary provided describes the validation and verification processes for the device, rather than a specific clinical study with detailed statistical outcomes for acceptance criteria.

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

   • Sample Size: The document states that "Performance testing of the features described in the user manual has been successfully completed utilizing clinical datasets." However, it does not specify the sample size (number of cases or patients) of these clinical datasets used for testing.
   • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "clinical datasets."

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

   • The document does not provide details on the number of experts used to establish ground truth or their specific qualifications for the test set. It mentions the device provides information that "may be useful in screening and diagnosis" when "interpreted by a skilled physician," but this is a general statement about usage, not about the ground truth establishment for testing.

3. Adjudication method for the test set:

   • The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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:

   • A MRMC comparative effectiveness study is not described in this 510(k) summary. The document focuses on the device's functional performance and its substantial equivalence to predicate devices, without assessing human reader improvement with or without AI assistance.

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

   • The document implies standalone performance testing to verify the algorithm's capabilities. It states, "CADstream automatically processes the images and creates additional series" and "CADstream also can be used to provide accurate and reproducible measurements...". The "Performance testing of the features described in the user manual has been successfully completed utilizing clinical datasets" suggests testing of the algorithm's output. However, it does not explicitly detail a standalone performance study with specific metrics like sensitivity or specificity.

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

   • The document does not specify the type of ground truth used for the "clinical datasets" mentioned in the performance testing section.

7. The sample size for the training set:

   • The document does not specify the sample size for any training set. It describes the software development and testing process but does not provide details on a training phase with associated data.

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

   • Since no training set details are provided, the document does not mention how ground truth for any potential training set was established.

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CADstream is a Computer Aided Detection (CAD) system intended for use in analyzing magnetic resonance imaging (MRI) studies. CADstream automatically registers serial patient image acquisitions to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections).

When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. CADstream can also be used to provide accurate and reproducible measurements of the longest diameters and volume of segmented tissues. Patient management decisions should not be made based solely on the results of CADstream analysis.

The CADstream device relies on the assumption that pixels having similar MR signal intensities represent similar tissues. The CADstream software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification.

The CADstream system consists of proprietary software developed by Confirma installed on an off-the-shelf personal computer and a monitor configured as an CADstream display station.

The provided document is a 510(k) summary for the CADstream Version 2.0 MRI Image Processing Software. It does not contain detailed information about specific acceptance criteria or an explicit study proving performance against such criteria. The document focuses on the device's intended use, description, software development processes, and regulatory substantiation.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Them

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "Performance testing of the features described in the user manual has been successfully completed utilizing clinical datasets" and "Software beta testing also has been completed, validating that the requirements for these features have been met." However, it does not explicitly list the acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, precision of measurements) or the quantitative results of these tests.

The document describes the device's functions:

• Automatically registers serial patient image acquisitions to minimize motion impact.
• Segments and labels tissue types based on enhancement characteristics (parametric image maps).
• Performs user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections).
• Provides accurate and reproducible measurements of the longest diameters and volume of segmented tissues.

Without explicit acceptance criteria and corresponding performance metrics, a table cannot be constructed.

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

The document states "Performance testing... has been successfully completed utilizing clinical datasets." However, it does not specify the sample size (number of cases or patients) used for this testing. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature).

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

The document does not provide details about the number of experts, their qualifications, or how ground truth was established for the clinical datasets used in performance testing.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1 consensus) used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance, nor does it specify any effect size or improvement. The "Intended Use Statement" notes that "When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis" and "Patient management decisions should not be made based solely on the results of CADstream analysis," implying human oversight but not a formal comparative study of reader performance.

6. Standalone (Algorithm Only) Performance Study:

The document describes the device's features and states "CADstream automatically registers... segments and labels... and performs other user-defined post-processing functions... CADstream can also be used to provide accurate and reproducible measurements..." This implies standalone algorithmic capabilities. However, it does not present a dedicated standalone performance study with quantitative metrics (e.g., sensitivity, specificity, F1-score) in isolation from human interpretation. The primary use case described involves interpretation by a skilled physician.

7. Type of Ground Truth Used:

The document refers to "clinical datasets" but does not specify the type of ground truth used (e.g., expert consensus, pathology reports, follow-up outcomes data) for evaluating the device's performance.

8. Sample Size for the Training Set:

The document does not specify the sample size of the training set used for developing the multivariate pattern recognition methods.

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

The document states that "CADstream software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification." However, it does not describe how the ground truth for training these methods was established.

In summary, the provided document is a high-level regulatory submission that attests to developmental processes and general performance testing but lacks the specific quantitative details typically found in a clinical study report regarding acceptance criteria, sample sizes, expert involvement, and explicit performance metrics.

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ACCENT™ is a computerized tissue segmentation device intended for use in conjunction with magnetic resonance (MRI) imaging data to identify similar tissue types. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. ACCENT can also be used to provide accurate and reproducible measurements of the longest diameter and volume of identified tissue. Patient management decisions should not be made based solely on the results of ACCENT analysis.

The ACCENT device relies on the assumption that pixels having similar MR signal intensities represent similar tissues. The ACCENT software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification.

The ACCENT system consists of proprietary software developed by Confirma installed on an off-the-shelf personal computer and a monitor configured as an ACCENT display station.

This is a 510(k) premarket notification for the ACCENT device, which means the device is seeking substantial equivalence to existing predicate devices rather than proving de novo safety and effectiveness. As such, the submission primarily focuses on comparing the new device's intended use, design, function, and performance characteristics to those of predicate devices already on the market.

Therefore, the provided text does not contain information about a dedicated study proving that the device meets specific acceptance criteria. The document states that the software has been designed, developed, tested, and validated according to internal procedures, and a hazard analysis was performed. However, it does not explicitly detail a clinical or performance study with defined acceptance criteria and corresponding results.

Here's a breakdown of the information that is present, and what is missing, based on your request:

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

This information is not provided in the document. The submission is a 510(k) aiming for substantial equivalence to predicate devices, not a demonstration of meeting predefined performance acceptance criteria through a specific study in the detailed manner you've requested.

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

This information is not provided in the document. No specific test set or data provenance is mentioned.

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)

This information is not provided in the document. Since no specific test set is detailed, there's no mention of experts establishing ground truth.

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

This information is not provided in the document. No adjudication method is mentioned as there is no detailed test set 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

There is no mention of an MRMC comparative effectiveness study in the provided text. The device's intended use states it "provides information that may be useful in screening and diagnosis" and "Patient management decisions should not be made based solely on the results of ACCENT analysis," implying it's an assistive tool, but no study on human reader improvement is presented.

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

This information is not explicitly stated as a formal standalone performance study with specific metrics. The device is described as "computerized tissue segmentation device" that "simultaneously analyzes the pixel signal intensities... and applies multivariate pattern recognition methods to perform tissue segmentation and classification." While this describes the algorithm's function, there's no dedicated study or reported performance metrics for its standalone accuracy without human intervention.

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

This information is not provided in the document. No specific ground truth methodology is described.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

In summary: The provided 510(k) submission for the ACCENT device focuses on establishing substantial equivalence to predicate devices rather than detailing a specific performance study with acceptance criteria, expert adjudication, or ground truth establishment. Therefore, most of the requested information regarding experimental design, sample sizes, and performance metrics is absent from this document.

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