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ANKYRAS enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery.

ANKYRAS also allows for the ability to computationally model the placement of neurointerventional braided endovascular devices.

General functionalities are provided such as:

• Segmentation of neurovascular structures*
• Semi-automatic centerline generation from segmented blood vessels*
• Visualization of X-ray based images*
• Placing and sizing tools for braided endovascular devices
• Save user data
• Download** and share simulation***

Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider´s judgment and analysis of the patient´s condition.

ANKYRAS is available in different platforms: Standalone, WebGL and Mobile App.

*Available for Standalone and WebGL platforms
**Available for WebGL platform
***Available for WebGL and Mobile App platforms

ANKYRAS is a medical device software application that allows the simulation of neurointerventional endovascular braided devices, such as flow diverters (FDs), and is intended to be used by physicians trained in medical procedures involving percutaneous and intravascular interventions for preoperational planning and sizing for neurovascular interventions and surgery. The software includes a database with braided endovascular FD devices: P100018/S015 - Pipeline Flex Embolization Device and P100018/S026 - Pipeline Flex Embolization Device with Shield Technology, Medtronic, Inc.; P170024/S003 - Surpass Evolve Flow Diverter System, Stryker Neurovascular; P180027 - Flow Re-Direction Endoluminal Device (FRED®) System and P180027/S002 - Flow Re-Direction Endoluminal Device (FRED®) X System, MicroVention, Inc. This database can be customized (among FDA cleared braided endovascular devices previously mentioned) according to the user's institution or needs.

ANKYRAS is intended to be used with 3D Rotational Angiography (3DRA) images or with VTK surface models from the target artery. From the 3DRA images, the user can extract the target artery vessel model using ANKYRAS segmentation functionality for further anatomical analysis and computational modeling (simulation) of the listed above FDs:

• First, using the vessel model and proximal and distal points selected by the user, ANKYRAS calculates the vessel centerline and displays cross-sectional dimensional information in an interactive chart.
• Second, using the vessel model, centerline, and morphology measurements, ANKYRAS simulates the FD devices selected by the user. The user can compare the results between different simulated FD devices and/or different FD positions including simulated device length, expansion along the centerline, and local porosity.

The information provided by the software is not intended in any way to eliminate, replace, or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

ANKYRAS software is intended to be user with a user license and can be installed on a computer with Windows operating systems or installed on an iOS/Android mobile device.

The FDA 510(k) clearance letter for ANKYRAS (K250160) states that the device was deemed substantially equivalent to the predicate device (K230006) based on verification, validation, and performance testing. While the document outlines the types of tests conducted, it does not provide specific quantitative acceptance criteria or detailed results of those tests. It states that "All tests have passed and demonstrate that the software is designed to meet the software requirements" and that "The computational modeling and prediction accuracy/error deployed length, expansion, and porosity of the selected flow diverters was evaluated through the following two tests." However, it lacks the numerical data to populate a table of reported device performance against specific criteria.

Therefore, many of the requested details about the study that proves the device meets the acceptance criteria are not explicitly present in the provided FDA 510(k) clearance letter. I will extract and infer what information is available and highlight what is missing.

Acceptance Criteria and Device Performance

The document describes the criteria used in software validation testing conceptually, but not with specific numerical thresholds for acceptance. It states what the accuracy of ANKYRAS's estimations "has to be equal or better than" certain references, but it doesn't quantify "equal or better than" in terms of a percentage or specific numerical tolerance.

Table 1: Acceptance Criteria (Conceptual) and Reported Device Performance (Not Quantified)

Study Details:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: The document mentions "physical phantoms representative of anatomy of patients presenting with intracranial aneurysms" and "retrospective clinical images." However, it does not specify the number of phantoms or retrospective clinical images used in the test set.
   • Data Provenance:
     • Physical Phantoms: Implied to be generated for the study, often representing generic or synthesized anatomies. No specific country of origin mentioned.
     • Retrospective Clinical Images: Data provenance is "retrospective clinical images." No country of origin is specified.

2. Number of Experts and Qualifications for Ground Truth:

   • The document states: "Segmentation by user with clinician review and comment." This implies human input for ground truth, particularly for the anatomical models used.
   • However, the number of experts used to establish the ground truth for the test set and their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

3. Adjudication Method for the Test Set:

   • The document implies a "clinician review and comment" for segmentation.
   • The specific adjudication method (e.g., 2+1, 3+1, none) for resolving discrepancies in ground truth establishment for the test set is not detailed.

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

   • No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The validation tests focused on the accuracy of the computational model's predictions (length, expansion, porosity) against a ground truth, rather than measuring how human readers improve with AI assistance compared to without.

5. Standalone Performance:

   • Yes, a standalone (algorithm only) performance evaluation was done for the computational modeling functionality. The validation tests evaluated "the performance (error) of the ANKYRAS in calculating the deployed length, expansion, and porosity of the selected flow diverters." This refers to the accuracy of the algorithm's output itself, not its use by a human.

6. Type of Ground Truth Used:

   • Combined approach:
     • Physical Phantoms: Likely based on precisely measured physical properties or known configurations of flow diverters within phantoms.
     • Clinical Images: The "true length of FD after intervention," "true expansion of FD after intervention," and "true porosity of FD after intervention" were used as reference for the retrospective clinical images. This implies that actual post-intervention measurements, potentially from follow-up imaging, surgical reports, or device specifications applied to the observed post-implant state, served as ground truth. The segmentation itself from 3DRA images involved "clinician review and comment," suggesting expert consensus for the anatomical model from which measurements were derived.

7. Training Set Sample Size:

   • The document does not provide any information on the sample size used for the training set.

8. How Ground Truth for Training Set was Established:

   • The document does not provide any information on how the ground truth for the training set was established. This information is typically proprietary to the manufacturer and not usually detailed in a 510(k) summary.

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ANKYRAS enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery.

ANKYRAS also allows for the ability to computationally model the placement of neurointerventional braided endovascular devices.

General functionalities are provided such as:

• Segmentation of neurovascular structures
• Semi-automatic centerline generation from segmented blood vessels
• Visualization of X-ray based images
• Placing and sizing tools for braided endovascular devices
• Save user data

Information provided by the software is not intended in any way to eliminate, replace or substitute for in part, the healthcare provider's judgment and analysis of the patient's condition.

ANKYRAS is a software as a medical device that allows the simulation of neurointerventional braided endovascular devices, such as flow diverters (FDs), and is intended to be used by physicians trained in medical procedures involving percutaneous and intravascular interventions for preoperational planning and sizing for neurovascular interventions and surgery. The software includes a database with FDA-approved FDs: P100018/S015 - Pipeline Flex Embolization Device, Medtronic, Inc.; P170024/S003 - Surpass Evolve Flow Diverter System, Stryker Neurovascular; P180027 - Flow Re-Direction Endoluminal Device (FRED®) System, MicroVention, Inc.

ANKYRAS is intended to be used with 3D Rotational Angiography (3DRA) images. From the 3DRA images the user can extract the target artery vessel model using ANKYRAS segmentation functionality for further analysis and computational modeling (simulation) of the listed above FDs:

• . First, using the vessel model and proximal and distal points selected by the user, ANKYRAS calculates the vessel centerline and displays cross-sectional dimensional information in an interactive chart.
• . Second, using the vessel model, centerline, and dimensions, ANKYRAS simulates the FD devices selected by the user can compare the results between different simulated FD devices and/or different positions including simulated device length, expansion along the centerline, and local porosity.

The information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

ANKYRAS software is intended to be installed on a computer with Windows operating systems.

The provided document describes the ANKYRAS device, its intended use, and its comparison to a predicate device (Sim&Size). It also briefly mentions performance testing. However, it does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria, especially in the format requested (e.g., a table of performance metrics with thresholds).

The document states:

• "The computational modeling and prediction accuracy/error of deployed length, expansion, and porosity of the selected flow diverters by ANKYRAS was evaluated through the following two tests:"
  • "Using physical phantoms representative of anatomy of patients presenting with intracranial aneurysms to compare the in vitro placement and measurement of flow diverters to virtual flow diverter placement and outputs by ANKYRAS."
  • "Using retrospective clinical images to compare the placement and measurements of actual flow diverters to virtual flow diverter placement and outputs by ANKYRAS."
• "All tests have passed and demonstrate that the software is designed to meet the software requirements."

This indicates that performance testing was conducted, but the specific acceptance criteria (e.g., "accuracy of deployed length must be within X mm") and the quantitative results (e.g., "achieved accuracy of Y mm") are not included in this FDA K-Number summary.

Therefore, I cannot populate all the requested information. I can, however, extract what is available and note what is missing.

Based on the provided document, here's what can be extracted and what is missing regarding acceptance criteria and performance studies:

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

   • ACCEPTANCE CRITERIA: Not explicitly stated as quantitative thresholds in this document. The document vaguely states "All tests have passed and demonstrate that the software is designed to meet the software requirements," implying functional requirements were met, but specific accuracy, precision, sensitivity, or specificity thresholds for computational modeling of length, expansion, or porosity are not provided.
   • REPORTED DEVICE PERFORMANCE: No quantitative performance metrics (e.g., specific accuracy values for length, expansion, porosity) are reported in this document. It only states that tests "passed."

   Table (Incomplete due to lack of data in source document):

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

   • Test Set Sample Size: Not specified.
   • Data Provenance:
     • "Using physical phantoms representative of anatomy..."
     • "Using retrospective clinical images..." (Country of origin not specified, but the applicant is from Spain, and the context often implies data from similar Western healthcare systems when not explicitly stated).
     • The document implies the use of DICOM images from 3D Rotational Angiography (3DRA).

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. The document mentions "physicians trained in medical procedures involving percutaneous and intravascular interventions" in the context of the device's intended users, but not specifically for ground truth establishment.

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

   • Not specified. The document mentions "in vitro placement and measurement" and "placement and measurements of actual flow diverters," but does not detail how potential discrepancies in measurement or ground truth definition were adjudicated.

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

   • MRMC Study: Not reported or implied. The studies described are focused on the accuracy of the computational modeling of the device itself (standalone performance against ground truth from phantoms or retrospective images), not on human reader performance with or without the device. The device is for "preoperational planning and sizing," and is stated to "not intended in any way to eliminate, replace or substitute for... the healthcare provider's judgment."
   • Effect Size: Not applicable, as no MRMC study is detailed.

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

   • Yes, implicitly. The performance testing described, particularly "computational modeling and prediction accuracy/error of deployed length, expansion, and porosity," appears to be a standalone evaluation of the algorithm's output against ground truth from phantoms or real cases. The device performs a "simulation" of FD devices which implies an algorithmic output.

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

   • Physical Phantoms: In vitro measurements obtained from physical phantoms. This would typically involve highly accurate, direct measurements.
   • Retrospective Clinical Images: "Placement and measurements of actual flow diverters." This implies ground truth was established from clinical assessment or imaging analysis to determine the "actual" deployed characteristics of the flow diverters. The method of establishing this ground truth (e.g., expert reader, consensus, another gold-standard measurement) is not specified.

8. The sample size for the training set

   • Not specified. This document is a 510(k) summary focused on the submission for market clearance, not a detailed technical report on model development. It details performance testing but not training data specifics.

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

   • Not specified. (See point 8).

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