Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement and deployment of neurointerventional devices.

General functionalities are provided such as:

Segmentation of neurovascular structures
Automatic centerline detection
Visualization of X-ray based images for 2D review and 3D reconstruction
Placing and sizing tools
Reporting tools

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

Device Description

Sim&Size is software that allows for the preoperational planning of medical device sizes for the treatment of intracranial aneurysms. The computational modeling of neurointerventional devices, such as flow diverters and intrasaccular devices, are supported by the software to provide a patient-specific visualization of the deployment of the device from angiographic DICOM 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.

The Sim&Size software is intended to be loaded on any Windows- or Mac-OS personal computer. A user license(s) must be purchased from the company in order to use the software after installation. The software also has a training module that offers learning assessments that are relevant to the software.

The software interacts with a patient's DICOM images, the user, and the device. To do so, the graphical interface is organized into three graphical pages (or screens):

a. Patient selection page
b. Module selection page
Simulation page C.

Sim&Size was designed to enable the visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement, deployment and apposition of neurointerventional devices.

AI/ML Overview

The provided document is a 510(k) summary for the Sim&Size device. It states that "All bench testing has been performed and the software has met the required specifications for the completed tests." However, it does not provide detailed acceptance criteria or the specific results of the device performance against those criteria. It also lacks information on the sample size used for the test set, data provenance, number of experts for ground truth, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, type of ground truth used, or details regarding the training set.

Therefore, based solely on the provided text, I cannot complete the requested tables and information.

If I were to make an educated guess about the content of such a study based on the general FDA 510(k) format and the device's function (pre-operational planning and sizing in neurovascular interventions), the study would likely focus on the accuracy of measurements, segmentation, and the computational modeling of device placement against a gold standard. However, this is speculative and not found in the provided document.

Here's what can be extracted from the document regarding the performance testing, acknowledging the significant missing information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Importation of DICOM images	Met required specifications (implies successful import)
Patient manager functions	Met required specifications (implies proper functionality)
Image display and processing	Met required specifications (implies accurate display/processing)
Visualization of anatomic reconstruction	Met required specifications (implies accurate visualization)
Computational modeling of neurovascular devices	Met required specifications (implies accurate modeling)
Physical device deployment (verification of computational model)	Met required specifications (implies computational model accurately reflects physical deployment)
Report creation and visualization	Met required specifications (implies successful report generation/display)

Note: The document only states that the device "met the required specifications" for all performed tests without detailing what those specifications were (e.g., specific accuracy thresholds, error rates, etc.).

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

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "angiographic DICOM data" but doesn't detail its origin or nature for the test set.

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.

4. Adjudication method for the test set:

Adjudication Method: Not specified.

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 mentioned as being performed or presented. The comparison table focuses on technological characteristics between the subject device and its predicate.

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

Standalone Study: The performance tests conducted ("bench tests") are implied to be standalone evaluations of the software's functionality and computational modeling. However, no specific "standalone performance" metrics (e.g., recall, precision for segmentation, or specific measurement accuracy) are provided in isolation from human input or a clinical context. The "Human Intervention for Interpretation of Images" characteristic is listed as "Yes" for both subject and predicate devices, suggesting that the device is intended for human-in-the-loop use.

7. The type of ground truth used:

Type of Ground Truth: Implied to be against "required specifications" and potentially physical device deployment for verification of the computational model. For segmentation and measurements, it would typically be expert annotations or known physical measurements, but this is not explicitly stated.

8. The sample size for the training set:

Sample Size: Not specified.

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

Ground Truth Establishment: Not specified.

Summary

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September 17, 2019

Sim&Cure % Scott Blood Regulatory Consultant MEDIcept, LLC 22 Nichols Street #2 Salem, Massachusetts 01970

Re: K190049

Trade/Device Name: Sim&Size Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: PZO Dated: August 2, 2019 Received: August 6, 2019

Dear Scott Blood:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

Brian Pullin, M.S Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190049

Device Name Sim&Size

Indications for Use (Describe)

General functionalities are provided such as:

· Segmentation of neurovascular structures
· Automatic centerline detection
· Visualization of X-ray based images for 2D review and 3D reconstruction
· Placing and sizing tools
· Reporting tools

Information provided by the software is not intended in any way to eliminate, replace or 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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K190049

Image /page/3/Picture/1 description: The image shows the logo for Sim&Cure. The word "Sim" is in black, followed by a red ampersand and the word "Cure" in black. Below the logo is the text "SECURE YOUR TREATMENT" in a smaller, sans-serif font.

510(k) Summary

1. Sponsor Name

Submitter's Name: Sim&Cure Address: 1682 Rue de la Valsière 34790 Grabels FRANCE Phone: +33 769 51 37 98

Contact Person: Scott Blood Regulatory Consultant MEDIcept 978.729.5978 scottqara@gmail.com

Date of Preparation: September 17, 2019

2. Device Information

Trade Name:	Sim&Size
Common Name:	Radiological Image Processing Software
Regulation Number:	892.2050
Regulation Name:	Picture Archiving and Communications System
Class:	II
Product Code:	PZO

3. Predicate Device

K171534 - SurgicalPreview, EndoVantage LLC

4. Device Description

The Sim&Size software is intended to be loaded on any Windows- or Mac-OS personal computer. A user license(s) must be purchased from the company in order to use the software

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Image /page/4/Picture/0 description: The image is a logo for Sim&Cure. The word "Sim" is in black, followed by a red ampersand. The word "Cure" is in black. Below the logo is the text "SECURE YOUR TREATMENT" in a smaller font size.

after installation. The software also has a training module that offers learning assessments that are relevant to the software.

The software interacts with a patient's DICOM images, the user, and the device. To do so, the graphical interface is organized into three graphical pages (or screens):

a. Patient selection page
b. Module selection page
Simulation page C.

5. Intended Use

Segmentation of neurovascular structures ●
Automatic centerline detection
Visualization of X-ray based images for 2D review and 3D reconstruction
Placing and sizing tools
Reporting tools

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.

6. Comparison of Technological Characteristics

The predicate device for the Sim&Size software is SurgicalPreview™, cleared per premarket notification K171534. Both Sim&Size and SurgicalPreview have the same indications for use for preoperational planning of neurovascular procedures using existing image data. A summary comparison of technological characteristics in provided below:

Characteristic	Predicate deviceSurgicalPreviewK171534	Subject deviceSim&SizeThis submission
Indications for Use	SurgicalPreview enables visualizationand measurement of cerebral bloodvessels for preoperational planning and	Sim&Size enables visualization ofcerebral blood vessels forpreoperational planning and sizing for
Characteristic	Predicate deviceSurgicalPreviewK171534	Subject deviceSim&SizeThis submission
	sizing for neurovascular interventionsand surgery. SurgicalPreview alsoallows for the ability to computationallymodel the placement and deployment ofneurointerventional devices.General functionalities are providedsuch as:• Segmentation of neurovascularstructures• Automatic centerline detection• Visualization of CT scan images for2D review and 3D reconstruction• Measurement and annotation tools• Reporting toolsInformation provided by the software isnot intended in any way to eliminate,replace or substitute for, in whole or inpart, the healthcare provider's judgmentand analysis of the patient's condition	neurovascular interventions andsurgery. Sim&Size also allows for theability to computationally model theplacement and deployment ofneurointerventional devices.General functionalities are providedsuch as:• Segmentation of neurovascularstructures• Automatic centerline detection• Visualization of X-ray based imagesfor 2D review and 3Dreconstruction• Placing and sizing tools• Reporting toolsInformation provided by the softwareis not intended in any way toeliminate, replace or substitute for, inwhole or in part, the healthcareprovider's judgment and analysis ofthe patient's condition
Interface to ImageSources	DICOM Image Data	Same
Import of Patient Data	Manual through keyboard/mouse,automatic import with image file, studycreation list	Same
List ImageFunctionality	Deleting, anonymizing, search	Same
Image Processing	Segmentation by user with clinicianreview and comment	Same
3D Assessment	Linear (length and diameter)measurements, volume measurements	3D assessment based on 3D model ofthe simulated device inside the vessels
Image and 3D Display	Orthogonal, color volume rendering, 2Dslide review, active presets, 3D view ofassemblies of devices	Same
DICOM Support	Compatible with all scanner vendorDICOM datasets, storage SCP, importDICOM files, DICOM compliance forCT and enhanced CT, import fromDICOMDIR, storage SCU,query/retrieve SCU	DICOM compliance for CT andenhanced CT, Read DICOM imagesfrom 3D rotational angiographystations
Computer OSCompatibility	MS Windows and Mac OS	Same
DataInterchange/Transfer	Secure Internet File Server	Transfer by physical media; i.e. USBmemory stick
Characteristic	Predicate deviceSurgicalPreviewK171534	Subject deviceSim&SizeThis submission
Output File Format	Web browser via WebGL	Local openGL rendering
PreoperationalPlanning	Yes	Yes
Patient Contact	No	No
Human Interventionfor Interpretation ofImages	Yes	Yes

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Sim&Cure Secure Your Treatment

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7. Performance Testing

Performance tests on the bench were performed on the Sim&Size. The following were performed:

Tests of importation of DICOM images ●
Patient manager tests
Tests of image display and processing
Functioning tests for visualization of anatomic reconstruction
. Functioning tests for computational modeling of currently-approved neurovascular devices
Physical device deployment testing to verify the computational model .
. Report creation and visualization tests

All bench testing has been performed and the software has met the required specifications for the completed tests.

9. Summary

Sim&Cure has demonstrated that the Sim&Size is substantially equivalent to its listed 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).