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The iCAD Breast Interventional Planning Software supports the use of interventional breast coils and MR stereotactic localization devices to perform magnetic resonance (MR) guided breast interventional procedures. 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 relative to the interventional device.

The iCAD Breast Interventional Planning Software (BIPS) is intended to extract certain image information and display them to a user. The software allows the user to select a target lesion in the breast as well as fiducial markers, and get accurate information about the optimal positioning of the biopsy needle or other interventional device, including visualization of the appropriate position, distances and other applicable settings. iCAD's BIPS is a software tool, which can assist the radiologist in planning and performing MRI guidance of percutaneous breast biopsies and other interventional procedures. When interpreted by a skilled physician, this device provides information that may be useful in interventional planning and monitoring.

The BIPS is a DICOM 3.0 compliant post-processing software package for viewing magnetic resonance imaging (MRI) data sets and supporting interventional breast coils and MR stereotactic localization devices when performing MRI-guided breast interventional procedures.

The provided document, K090223, primarily serves as a 510(k) summary for the iCAD Breast Interventional Planning Software. It establishes substantial equivalence to predicate devices and outlines the device's intended use and technological characteristics.

Crucially, this document does not include detailed information about specific acceptance criteria, a standalone performance study with metrics, or an MRMC comparative effectiveness study. The regulatory submission focuses on demonstrating equivalence to previously cleared devices rather than presenting novel performance data against predefined criteria.

Therefore, many of the requested items cannot be extracted directly from this document. However, I can provide the information that is available and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary states that "Test data was supplied that met the requirements of the Software Test Plan and Software Unit Test Plan," but it does not specify what those requirements (acceptance criteria) were or what the actual test data showed in terms of quantitative performance (e.g., accuracy of calculations, efficiency gains, etc.).

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

This information is not provided in the document. The document mentions "Test data was supplied," but it does not specify the size of the test set or the origin of the data (e.g., country, retrospective/prospective).

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

This information is not provided in the document. The document refers to the device assisting a "skilled physician" but does not detail any expert involvement in establishing ground truth for testing.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided in the document. The regulatory submission primarily focuses on the device's technical equivalence and functionality rather than comparative effectiveness studies with human readers.

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

A standalone performance study with specific metrics is not explicitly described in the document. The submission states that testing was done to meet software test plan requirements, implying some form of standalone validation of the software's calculations and features, but no detailed performance report is included.

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

This information is not provided in the document for any testing.

8. The Sample Size for the Training Set

This information is not provided in the document. Given the description focusing on calculations based on user-selected points and fiducial markers, it's possible the software relies on deterministic algorithms rather than a machine learning model that would require a "training set" in the conventional sense. If machine learning was used, the training set size is not disclosed.

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

This information is not provided in the document. (Please see point 8 regarding the potential absence of a traditional "training set.")

Summary of Device and Regulatory Context (Based on Provided Document):

• Device Name: iCAD Breast Interventional Planning Software (BIPS)
• Purpose: Assists radiologists in planning and performing MRI-guided percutaneous breast biopsies and other interventional procedures. It extracts image information, allows users to select target lesions and fiducial markers, and calculates optimal positioning (location and depth) for interventional devices.
• Regulatory Path: 510(k) Premarket Notification (K090223).
• Predicate Devices: CADstream™ Version 4.0 (Confirma, Inc.), DynaCAD™ V1.0 (MRI Devices Corporation), MICS Intervention Aid (Machnet BV).
• Basis for Clearance: Substantial equivalence to these predicate devices, based on same intended use, principles of operation, and characteristics, with differences primarily in visual interface design that do not raise new questions of safety or efficacy.
• Safety and Effectiveness Concerns Addressed: Risk management via risk analysis, controls through software development, verification, and validation testing.
• Performance Data Mentioned: "Test data was supplied that met the requirements of the Software Test Plan and Software Unit Test Plan." This indicates internal validation, but the details of the performance are not public in this filing.

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Z3D Contrast Acuity (z3D) version 2.1 is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic CT and MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from CT and MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.

The software displays the temporal variation in dynamic data as a surface map that enhances visualization of pixel intensity and time/intensity changes extracted from CT and MR temporal data sets. The results may be displayed as either a grayscale enhancement or a color overlay overlay over the selected image.

z3D may perform additional functions to aid in the analysis and viewing of dynamic studies, including registration of serial MR and CT acquisitions, labeling of tissue types based upon user specified enhancement characteristics, visualization and quantification of lesion morphology in 310. segmentation of tissues, multiplanar and oblique reformats, maximum intensity projections, image, averaging, subtraction and blinking of images acquired at different time noints to help visualize enhancement.

23D also may be used to perform post-processing analysis of multi-modality, digital images, including MR, CT, X-Ray, PET, and Nuclear Medicine images. The software analysis tools may be anplied to image subtractions, reformatted images, multiplanar reformats, and maximum intensity projections.

The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization.

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 z3D analysis. The z3D software is contraindicated for automated sole interpretation of digital mammography images.

z3D Contrast acuity (z3D) Version 2.1 is a software package designed to assist the radiologist in interpretation of multi-modality, digital radiology images, including dynamic CT and MR image data sets. The software applies standard 2D and 3D image processing techniques on a pixel-bypixel basis to analyze grayscale data and perform visual enhancement of user-selected images. The software may be applied to image subtractions, reformatted images, multiplanar reformats, and Maximum Intensity Projections (MIP). Single or multi-slice data sets may be used as input.

The software consists of several modes that can be enabled or disabled depending upon the specific configuration purchased/implemented. These modes include 2D image review, 2D mass morphology, 3D mass characterization.

The results of the analysis are displayed as a surface man, parametric map, Maximum Intensity Projection (MIP), subtraction, registered subtraction, or 3D display that enhances visualization of pixel intensity data provided by the image. The results may be displayed in grayscale enhancement or as a color overlay. The software includes standard workflow tools that allow the radiologist to manipulate, rotate and fly-through images for enhanced visualization of the digital output. Additionally, the software package allows the radiologist to visually inspect time sensitive contrast agent intensity curves and to make mass measurements.

The software application consists of proprietary software developed by Clario and is a Windows 2000/XP, DICOM-compatible platform. The software is designed to be distributed as a plug-in for OEM imaging systems, PACS, workstations, or embedded in software applications cleared for use in medical imaging.

The z3D user interface is designed to follow typical workflow patterns to process, review, and analyze digital images.

The provided 510(k) summary for the z3D Contrast Acuity device does not include a detailed study proving the device meets specific acceptance criteria.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices (MedIQ/K052963 and CADstream/K043216) based on similar indications for use, technological characteristics, and performance.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document.

However, I can extract information related to the device description and the claim of substantial equivalence.

Here's a breakdown of what can be inferred and what is not provided based on the input:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the z3D Contrast Acuity device itself. The primary criterion for this 510(k) submission is substantial equivalence to the predicate devices.
• Reported Device Performance: The document claims similar functionality to predicate devices. It describes what the software does (e.g., visual enhancement, 3D characterization, display of parametric maps, image manipulation tools) but does not provide quantitative performance metrics like sensitivity, specificity, accuracy, processing speed, or any clinical outcomes.

• Post-processing of multi-modality digital images (dynamic CT and MR)
• Provides image display, supplemental info, visual enhancement of time/intensity changes
• Displays results as surface map, parametric map, MIP, subtraction, registered subtraction, or 3D display
• Enhances visualization of pixel intensity data
• Includes workflow tools for image manipulation, rotation, fly-through
• Allows visual inspection of time-sensitive contrast agent intensity curves
• Enables mass measurements
• Performs similar functions to MedIQ (view/manipulate images in 3D, 3D surface shading)
• Performs similar functions to CADstream (measurements on images) |
  | Safety & Effectiveness | - Intended to provide supplemental information and enhanced visual analysis.
• "Patient management decisions should not be made based solely on the results of z3D analysis."
• "Contraindicated for automated sole interpretation of digital mammography images." |

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. The document does not describe any specific testing with a dedicated test set in terms of patient data. The evaluation appears to be a comparison of functionalities and indications for use against predicate devices.

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 applicable/Not provided. Since a specific test set with ground truth isn't described for performance evaluation, this information is absent. The "ground truth" for the submission is the functional comparison against established predicate devices.

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

• Not applicable/Not provided. No adjudication method is described for a 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, an MRMC comparative effectiveness study was not done or at least not described in this document. This submission focuses on feature equivalence and not on measuring reader improvement.

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

• Not explicitly described as a formal validation study. The device is described as "post-processing, productivity software designed to assist radiologists," implying human-in-the-loop use. It is explicitly stated that "Patient management decisions should not be made based solely on the results of z3D analysis" and it is "contraindicated for automated sole interpretation of digital mammography images," which further indicates it is not a standalone diagnostic tool.

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

• Not directly applicable for a performance study of the z3D device itself. The "ground truth" in this submission relates to the established functions and indications of the predicate devices against which z3D Contrast Acuity is being compared for substantial equivalence.

8. The sample size for the training set

• Not provided. The document describes proprietary software but does not mention any machine learning or AI models requiring a training set in the modern sense. It refers to "standard 2D and 3D image processing techniques" and "user-specified processing of algorithms."

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

• Not applicable/Not provided. As no training set is mentioned for AI/ML development, ground truth establishment for such a set is not discussed.

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