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Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. Vitrea has the following additional indication:

The Endovascular Stent Planning Software application is intended for use with CT (computed tomography) images to assist medical professionals in the analysis, treatment and follow-up of aortic vascular disorders that may require a stent procedure. The software provides 3D segmentation of the aorta and initializes stent measurements based on a template provided by the stent manufacturers. The user can review the 2D and 3D images, verify and correct the results of the segmentation and initialization, and generate a report with the stent measurements.

The Endovascular Stent Planning software is intended for use with CT (computed tomography) images to assist medical professionals in the analysis, treatment and follow-up of aortic vascular disorders that may require a stent procedure. The endovascular stent planning application module enables visualization and measurements of the aortic vessel for evaluation, treatment and follow up for aortic vascular disorders that may require a stent procedure. The software performs automated 3D segmentation of the aorta and initializes stent measurements based on a template provided by the stent manufacturers. The physicians can review the 2D and 3D images, verify and correct the results of the segmentation and initialization, and generate a report with the stent measurements, in a fast and efficient manner.

The software provides imaging information as an assist to the physician. The software does not provide diagnostic information or determine recommended medical care. In summary, the software provides:

• Automated segmentation of the aortic vessel, including thrombus with centerline . and contour editing tools
• . Stent-graft templates for abdominal and thoracic aortic aneurysms
• User-quided workflow with automated identification of anatomical landmarks and automated initialization of endovascular measurements (diameters, lengths, angles, volumes) based on the stent template selection, with easy centerline and contour editing tools
• Auto-populated reporting worksheet with selected stent template measurements ●
• Key measurements that helps medical professionals to identify location of . fenestrations to support fenestrated stent planning by adding the clock angle tool and the clock angle overlay functionality
• . Create new, add/or modify, stent planning templates with the Custom Device Template Editor
• Data tables export results to CSV ●
• Multi-study support for longitudinal comparison ●
• 3D measurement overview for streamlined communication of results ●
• Volume measurements for pre and post aneurysmal size measurement ●
• Workflows for pre-treatment (stent, surgery) planning and post-treatment follow ● up, including a side-by-side comparative review layout and longitudinal measurements

The provided documentation is a 510(k) Summary for the Endovascular Stent Planning Software (K143079), which is primarily an update to an already cleared device (K091498) to add a "Clock Angle" tool. As such, the document focuses on demonstrating substantial equivalence rather than presenting a full de novo study with detailed performance metrics against acceptance criteria.

The document does not explicitly list acceptance criteria in a table format with corresponding reported device performance metrics for the "Endovascular Stent Planning Software" as a whole. Instead, it describes a process of verification and validation to show that the new feature (Clock Angle tool) does not negatively impact the previously cleared device's safety and effectiveness.

Here's an analysis based on the provided text for the new Clock Angle tool and the overall software:

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

The document does not provide a table with explicit acceptance criteria and quantitative performance metrics for the Clock Angle tool or the overall device in the way a typical clinical study would. The non-clinical testing focuses on demonstrating that the software operates "according to its requirements" and that the modifications do not raise new questions of safety or effectiveness.

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

• Test Set Sample Size: The document mentions "previously acquired medical images" for verification and validation but does not specify a sample size for the test set used for validating the software, or specifically the Clock Angle tool.
• Data Provenance: Not specified. It refers to "previously acquired medical images," but no details on country of origin, whether it was retrospective or prospective, or patient demographics are provided.

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)

• Number of Experts: The "External Validation" section states that "experienced medical professionals evaluated the application." The plural "professionals" suggests more than one, but an exact number is not specified.
• Qualifications of Experts: They are described as "experienced medical professionals." No further details on their specific qualifications (e.g., specialty, years of experience) are provided.

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

The document does not describe a formal adjudication method for ground truth establishment. It states that "Both validators confirmed that the Fenestrated Stent Planning using Endovascular Stent Planning software was safe and effective and met the intended use." This suggests a consensus or affirmation, but not a structured adjudication process.

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 conducted. The document states, "The subject of special 510(k) notification, Endovascular Stent Planning software, did not require clinical studies to support safety and effectiveness of the software." The emphasis is on demonstrating substantial equivalence to the predicate device, not on improved human reader performance with AI assistance. The software is described as an "assist," but its impact on human reader performance is not quantified.

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

The document focuses on the software assisting medical professionals, with users reviewing and correcting results. While verification and validation tests were performed on the software, the "External Validation" section refers to "experienced medical professionals evaluated the application." This suggests a human-in-the-loop evaluation for the external validation. Therefore, a purely standalone performance evaluation is not explicitly described as the primary validation for this submission. The software performs automated segmentation and initializes measurements, but users retain control for review and correction.

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

For the "External Validation," the ground truth appears to be established by the "experienced medical professionals" confirming that the software "was safe and effective and met the intended use." This is closest to expert consensus/opinion regarding the software's functionality and utility for its intended purpose of assistance. It is not based on pathology or long-term outcomes data presented in this document.

8. The sample size for the training set

The document does not specify a sample size for any training set. This 510(k) is for a modification to an already cleared device, and the focus is on the added feature within the context of the existing system. Details about the original training set for the predicate device (K091498) are not provided in this specific document.

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

As no training set information is provided, the method for establishing its ground truth is also not specified.

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Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. In addition, Vitrea has the following additional indication:

The Endovascular Stent Planning Software application is intended for use with CT (computed tomography) images to assist medical professionals in the analysis, treatment and follow-up of aortic vascular disorders that may require a stent procedure. The software provides 3D segmentation of the aorta and initializes stent measurements based on a template provided by the stent manufacturers. The user can review the 2D and 3D images, verify and correct the results of the segmentation and initialization, and generate a report with the stent measurements.

The Endovascular Stent Planning Software, an application module for the Vitrea software, enables visualization and measurements of the aortic vessel for evaluation, treatment and follow up for aortic vascular disorders that may require a stent procedure. It has the following features:

• Automated segmentation of the aortic vessel, including thrombus .
• Custom and manufacturer-recommended stent-graft worksheets and report . templates for stent sizing
• Automatic initialization of endovascular measurements (diameters, lengths, . angles, volumes) based on the stent template selection, with easy centerline and contour editing tools
• Workflows for pre-treatment (stent, surgery) planning and post-treatment . follow up, including a side-by-side comparative review layout

The provided document does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or quantitative performance metrics typically found in clinical validation studies for medical devices. The document is a 510(k) summary for the "Endovascular Stent Planning Software," primarily focusing on its substantial equivalence to predicate devices.

However, based on the provided text, I can infer the general nature of the "acceptance criteria" and the "study" conducted.

Inferred Acceptance Criteria:

The acceptance criteria appear to be implicitly related to the software functioning as intended, providing accurate segmentation and measurements, and not introducing new safety or effectiveness concerns compared to predicate devices. Specific quantitative metrics are not provided.

Inferred Study:

The "study" described is primarily focused on software verification and validation testing, rather than a clinical performance study with human subjects.

Here's a breakdown of the requested information based on the provided text, with many fields being "Not Applicable" or "Not Provided" due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The "test set" likely refers to data used for internal software testing. There's no mention of a patient-specific dataset size.
• Data Provenance: Not specified.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. Given this was a software validation, ground truth might have been established by engineering specifications or clinical experts during development, but details are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not described or referenced. The submission focuses on substantial equivalence through technological comparison and software validation, not clinical efficacy with human readers.
• Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no such study was performed or reported. The device is an "assistance" tool, but its impact on human reader performance was not quantified in this submission.

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

• Standalone Performance: The document describes the device's capabilities, such as "Automated segmentation of the aortic vessel" and "Automatic initialization of endovascular measurements." The user "can review... verify and correct the results." This implies there is an automated component (standalone algorithm) whose output serves as a starting point for the human user. However, no specific standalone performance metrics (e.g., accuracy of automated segmentation or initial measurements without correction) are provided. The "study" was about software functionality.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. For software testing, ground truth would likely be defined by:
  • Engineering specifications/requirements: To verify that the software outputs match predefined specifications for segmentation, measurement initialization, and report generation.
  • Potentially, expert review: To confirm that the automated outputs (segmentation, initial measurements) are clinically reasonable and align with expert understanding, before user correction. However, this is inferred, not explicit.

8. The Sample Size for the Training Set

• Sample Size (Training Set): Not applicable or not specified. This document describes a software that performs image processing and measurement initialization. It's not explicitly stated as a machine learning or AI-driven system that requires a distinct "training set" in the modern sense. While it has "automated segmentation," the methodology (e.g., rule-based, traditional image processing, or early AI) and any associated training data are not detailed.

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

• Ground Truth Establishment (Training Set): Not applicable or not specified, as a distinct training set for an AI model is not mentioned. If the "automated segmentation" involves machine learning, the method for establishing ground truth for any potential training data is not described.

Summary of Device and Evidence:

The "Endovascular Stent Planning Software" provides tools for visualization and measurement of aortic vessels for stent planning. The primary evidence presented in this 510(k) summary for its "acceptance" is that it underwent software verification and validation testing to ensure it functions according to requirements, interacts without negatively impacting existing software functionality, and performs as intended without unacceptable risks. The submission relies heavily on demonstrating substantial equivalence to previously cleared predicate devices, suggesting that the technological characteristics and intended use are similar enough that no new clinical performance studies were deemed necessary to establish safety and effectiveness for a regulatory decision.

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