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.

Device Description

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.

AI/ML Overview

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:

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):

Metric / Feature Tested	Acceptance Criteria (Quantified)	Reported Device Performance (Quantified)
Computational Modeling	Not specified	Tests passed.
Accuracy of deployed length	Not specified	Tests passed.
Accuracy of expansion	Not specified	Tests passed.
Accuracy of porosity	Not specified	Tests passed.
DICOM Image Import	Functional (Implied)	Passed
Patient List Management	Functional (Implied)	Passed
Image Display/Processing	Functional (Implied)	Passed
Anatomic Reconstruction Visualization	Functional (Implied)	Passed
Save User Data & Visualization	Functional (Implied)	Passed
Cybersecurity	Functional (Implied)	Passed

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).
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.
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.
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.
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.
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.
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.
How the ground truth for the training set was established
- Not specified. (See point 8).

Summary

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December 28, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

MENTICE SPAIN S.L.

Héctor Fernández Responsible Technician and PRRC Rambla de Catalunya 53, 4-H Barcelona. 08007 Spain

Re: K230006

Trade/Device Name: ANKYRAS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: PZO Dated: November 27, 2023 Received: November 29, 2023

Dear Héctor Fernández:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Naira Muradyan -S

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K230006

Device Name ANKYRAS

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K230006

This 510(k) Summary is being submitted in accordance with the requirements detailed in 21 CFR 807.92.

SUBMITTER NAME:	MENTICE SPAIN S.L.
SUBMITTER ADDRESS:	Rambla de Catalunya 53, 4-H
	08007 BARCELONA
	SPAIN
Contact person:	Héctor Fernández
	Responsible technician and PRRC
Phone:	+34 658 17 38 80
e-mail:	hector.fernandez@mentice.com
Contact person:	Göran Malmberg
	Top Manager
Phone:	+34 933 28 39 64
e-mail:	Goran.Malmberg@mentice.com
Date Prepared:	December 26, 2023
DEVICE TRADE NAME:	ANKYRAS
COMMON NAME:	Software for Visualization of Vascular Anatomy and Intravascular
	Devices
DEVICE CLASS:	Class II
REGULATION NUMBER:	892.2050
REGULATION NAME:	Medical Image Management and Processing System
PRODUCT CODE:	PZO
PREDICATE DEVICE:	Sim&Size (Sim&Cure: K190049)

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DEVICE DESCRIPTION

. 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.

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

INTENDED USE/INDICATIONS FOR USE

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 whole or in part, the healthcare provider´s judgment and analysis of the patient´s condition.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

Characteristics and features of ANKYRAS software have been compared to the characteristics and features of the predicate device Sim&Size.

	Proposed DeviceANKYRAS(MENTICE SPAIN S.L.)	Predicate DeviceSim&Size(Sim&Cure)	Comments
Characteristic
Regulatory Information
Regulatory Class	Class II	Class II	Same
Classification name	Software forVisualization of VascularAnatomy andIntravascular Devices	Software forVisualization ofVascular Anatomy andIntravascular Devices	Same
Regulation Number	21 CFR 892.2050	21 CFR 892.2050	Same
Product Code	PZO	PZO	Same
510(k) Number	K230006	K190049	-
Indications for Use	ANKYRAS enablesvisualization of cerebralblood vessels forpreoperational planningand sizing forneurovascularinterventions andsurgery.ANKYRAS also allows forthe ability tocomputationally modelthe placement ofneurointerventionalbraided endovasculardevices.General functionalitiesare provided such as:• Segmentation ofneurovascularstructures• Semi-automaticcenterlinegeneration fromsegmentedblood vessels• Visualization ofX-ray basedimages• Placing andsizing tools for	Sim&Size enablesvisualization ofcerebral blood vesselsfor preoperationalplanning and sizing forneurovascularinterventions andsurgery.Sim&Size also allowsfor the ability tocomputationallymodel the placementand deployment ofneurointerventionaldevices.Generalfunctionalities areprovided such as:• Segmentation ofneurovascularstructures• Automaticcenterlinedetection• Visualization of X-Ray based imagesfor 2D review and3D reconstruction• Placing and sizingtools• Reporting tools	Similar
Characteristic	Proposed DeviceANKYRAS(MENTICE SPAIN S.L.)	Predicate DeviceSim&Size(Sim&Cure)	Comments
	braidedendovasculardevices• Save user dataInformation provided bythe software is notintended in any way toeliminate, replace orsubstitute for, in wholeor in part, the healthcareprovider's judgment andanalysis of the patient'scondition.	Information providedby the software is notintended in any wayto eliminate, replaceor substitute for, inwhole or in part, thehealthcare provider'sjudgment and analysisof the patient'scondition.
Technical Characteristics
Computer OS Compatibility	MS Windows	MS Windows and MacOS	ANKYRAS iscompatiblewith MSWindowsonly
Interface to Image Sources	DICOM Image Data	DICOM Image Data	Same
Import of Patient Data	Manual throughkeyboard/mouse,automatic import withimage file ormorphological mesh,study creation list.	Manual throughkeyboard/mouse,automatic import withimage file, studycreation list.	Similar
Image Processing	Segmentation and useby physician.	Segmentation and useby physician.	Same
3D Assessment	3D assessment based on3D model of thesimulated endovascularbraided device insidethe vessels.	3D assessment basedon 3D model of thesimulatedneurointerventionaldevice inside thevessels.	Same
Image and 3D Display	Orthogonal, colorvolume rendering, 2Dslide review, activepresets, 3D view ofassemblies ofendovascular braideddevices.	Orthogonal, colorvolume rendering, 2Dslide review, activepresets, 3D view ofassemblies ofdevices.	Same
DICOM Support	Read DICOM imagesfrom 3D rotationalangiography (3DRA).	DICOM compliance forCT andenhanced CT, readDICOM images from3D rotational	Similar
Characteristic	Proposed DeviceANKYRAS(MENTICE SPAIN S.L.)	Predicate DeviceSim&Size(Sim&Cure)	Comments
		angiography stations.
DataInterchange / TransferMethod	Transfer by physicalmedia; i.e. USBmemory stick.	Transfer by physicalmedia; i.e. USBmemory stick.	Same
Output File Format	Local openGL rendering	Local openGL rendering	Same
PreoperationalPlanning	Yes	Yes	Same
Patient Contact	No	No	Same
Human Interventionfor Interpretation of Images	Yes	Yes	Same

Table 1: Summary of comparison of characteristics and features – proposed and predicate devices.

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Performance Testing

The following verification and validation tests were performed on ANKYRAS in support of the substantial equivalence to the predicate.

Software verification and validation tests were conducted and documentation was provided as recommended by FDA, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

The following tests were conducted:

Tests of importation of DICOM images. ●
Patient list management tests.
Tests of image display and processing.
Functioning tests for visualization of anatomic reconstruction. ●
Save user data and visualization tests.
Cybersecurity tests.

All tests have passed and demonstrate that the software is designed to meet the software requirements.

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.

Conclusions

ANKYRAS (subject device) and Sim&Size (predicate device) have similar indications for use and similar technological characteristics. The differences between the technological characteristics do not raise different questions of safety and effectiveness. The verification, and performance testing of ANKYRAS demonstrate that the device performs as intended.

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MENTICE SPAIN S.L. concludes that the ANKYRAS (subject device) is substantially equivalent to the Sim&Size (predicate device).

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).