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breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere 3.0 software package. It is intended to be used by trained breast imaging physicians and trained MRI technologists.

breastscape V1.0 includes a software module (BreastApp) that supports the visualization, analysis, and reporting of lesions measurements and analysis. breastscape V1.0 supports the evaluation of dynamic MR data acquired during contrast administration and the calculation of parameters related to the uptake characteristics.

breastscape V1.0 performs other user selected processing functions (such as image subtraction, multiplanar and oblique reformats, 3D renderings).

The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image.

breastscape V1.0 can also be used to provide measurements of the segmented tissue volumes (volumes of interest) based on uptake characteristics. These measurements include volume measurement, distances of volumes of interest to anatomical landmarks, 3D longest diameter and 2D long and short axis.

breastscape V1.0 includes the option to add annotations based on the fifth edition of the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS®) Breast Imaging Atlas.

breastscape V1.0 may be used as an image viewer of multi-modality digital images, including ultrasound and mammography. breastscape V1.0 is not intended for primary interpretation of digital mammography images.

breastscape V1.0 includes a software module (BreastLoc) to assists users in planning MR guided breast interventional procedures. Using information from MR images, regarding userspecified target lesion and fiducial location coordinates, the software gives calculation of the targeted region of interest (such as suspected lesion) depth.

When interpreted by a skilled physician, breastscape V1.0 provides information that may be used for screening, diagnosis, and interventional planning.

Patient management decisions should not be based solely on the results of breastscape V1.0.

breastscape V1.0 is an optional PACS software tool that is intended for use with the Olea Sphere V3.0 software package, cleared under K152602. The software accesses image series in DICOM format through Olea Sphere V3.0, which is a software package used to perform image viewing, processing and analysis of medical images.

breastscape V1.0 is made of two software modules: BreastApp and BreastLoc.

1. BreastApp
   BreastApp is designed to assist in the visualization, analysis and reporting of Magnetic Resonance Imaging (MRI) breast studies. This module supports the evaluation of dynamic MR breast data acquired during contrast administration (DCE-MRI), and the calculation of parameters related to the lesion uptake characteristics. This module provides semi-automatic segmentation of volumes of interest, distance measurements and lesion volume measurements.

BreastApp provides the features below:

• Visualization of registered MR image series. It includes well-established to standard image viewing, MIPs, reformats and 3D volume rendering.
• Visualization of Mammography and Ultrasound image series for display purpose only.
• Evaluation of dynamic MR breast data acquired during contrast administration. It includes:
  • The computation of image subtractions (subtractions of each time point/phase image of the dynamic series with the 1st time point (baseline) image to highlight tissue with contrast enhancement).
  • The display of time intensity signal curves (kinetics curves) showing tissue contrast enhancement evolution over time.
  • The detection and display of the kinetics curve showing the worst kinetics behavior (most important washout among pixels having peak enhancement superior at 50% enhancing threshold).
  • The computation of semi-quantitative kinetics maps that are derived from the time intensity signal curves and showing uptake characteristics (e.g., Time to Maximum contrast Enhancement, Wash in, Washout, etc.).
• Automatic detection of breast morphological structures. It includes the automatic detection of nipple position, chest and skin border. The user can further adjust them if needed.
• Semi-automatic lesion segmentation. It includes:
  • Highlighting tissues showing significant contrast agent uptake based on an uptake threshold.
  • Semi-automatic segmentation of the suspected lesion identified by the user. The user can further adjust the segmentation if needed or even manually segment the suspected lesion.
  • Automatic computation of the suspected lesion 2D/3D diameter and lesion volume.
• Automatic computation of distances between the suspected lesion and the morphological structures (distances to nipple, chest and skin). The user can further adjust the distances if needed.
• Reporting of user-selected findings and assessment through a dedicated breast report. It includes the option to add annotations based on the Fifth Edition of American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS®) Breast Imaging Atlas. The software automatically reports the localization of the suspected lesion on a dedicated breast sector map. The position can be further adjusted by the user if needed.
• Follow-up for multiple (more than two) studies from same patient. It includes tools to enhance the visualization and analysis of patient follow-up studies through the same layout.

2. BreastLoc

The BreastLoc module is designed to assist users in planning MR-guided breast interventional procedures. Based on user-specified target lesion and fiducial location coordinates, BreastLoc is used to compute and display the following features:

• Needle insertion block position within the grid diagram;
• Needle insertion point activation in the block;
• Depth of introducer, representing the graduation value where to put the depth stop on the introducer sheath;
• Needle insertion path display on native images.

The provided text describes Olea Medical's breastscape V1.0 and its substantial equivalence to predicate and reference devices. However, it does not explicitly state "acceptance criteria" or provide a detailed "study that proves the device meets the acceptance criteria" in the format requested.

The document focuses on demonstrating substantial equivalence through various validation and verification tests, software functionality comparisons, and a general statement about clinical performance. It mentions "performance evaluation support that the minor difference in the technological characteristics do not raise different questions of safety and effectiveness" and "software validation testing demonstrates that the device operates as safely and effectively as its predicate device and does not raise different questions of safety and effectiveness."

While the document indicates that the device's performance was evaluated, it does not provide the specific quantitative acceptance criteria or the detailed results of a study designed to prove the device met those criteria in a structured manner.

Therefore, the following information is extracted and inferred from the text provided. Many points cannot be fully answered due to the absence of specific details in the input text.

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated in the document. The document asserts that validation testing confirms product specifications are met and that the device operates as safely and effectively as its predicate.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "anonymized images from a cohort of patients" were used for additional validation testing to compare breastscape V1.0 with the predicate and reference devices. The size of this cohort is not specified.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

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

Not explicitly stated. The document mentions "direct manual measurements (ground truth)" were used for BreastApp™, but it does not specify the number or qualifications of the experts who performed these measurements. The device is intended for use by "trained breast imaging physicians and trained MRI technologists."

4. Adjudication method for the test set

Not explicitly stated.

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 explicitly stated. The document mentions "additional validation testing to compare the results of breastscape V1.0 with the predicate and reference devices," but this test appears to be focused on comparing the device's output to the predicate/reference rather than assessing human reader performance with and without AI assistance.

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

Yes, in part. The document states that "direct manual measurements (ground truth)" were used to evaluate "automatically calculated metrics and parametric maps" for BreastApp™. This suggests an evaluation of the algorithm's output against a ground truth without human interpretation in the loop for that specific aspect. Further, the primary validation and verification tests for the software modules themselves would be standalone algorithm performance tests.

7. The type of ground truth used

• For BreastApp™: "Direct manual measurements (ground truth)" and "Kinetics plugin, viewing tools, follow-up feature, breast dedicated report, mammography loading and visualization, measurements modifications within Olea Sphere V3.0" were used. This indicates a combination of expert-derived manual measurements and reference to the established functionality of other cleared systems or modules.
• For BreastLoc™: It was compared against MultiView™ MR Breast V4.0.3.2 (Hologic®) to evaluate "performance of the MR guided breast intervention procedural planning." This implies the predicate device's accepted output served as a reference for ground truth or comparison.

8. The sample size for the training set

Not explicitly stated. The document focuses on validation and verification rather than detailing the training of potential AI/ML components (though "parametric image maps" and "semi-automatic segmentation" may involve such components).

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

Not explicitly stated.

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