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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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