ScanIP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options. Scan1P is not intended to be used for mammography imaging.

Device Description

ScanIP represents a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner to an output file. ScanIP provides a core image processing interface with several additional modules available to users – these include +CAD, +FE and +NURBS - which provide further options for working with image data. +CAD enables the integration of computer-aided design (CAD) drawings such as implants with patient-specific data; +FE allows segmented image data to be exported as computational models for physics-based simulations in other software; +NURBS is designed to allow users to export segmented data as NURBS IGES files to CAD software.

ScanIP is written in C++ and designed using the integrated development environment (IDE) Microsoft Visual Studio. Minimum hardware requirements for the operating system are Windows 7, Windows 8, Windows Vista, and Windows XP. 32 and 64 bit versions of the software are available. Minimum processor requirements are an Intel Core i3 or equivalent; minimum memory requirements for the software to run are 4096 MB (4GB), while an OpenGL compatible graphics card with 32 MB of RAM is required. The screen resolution of a workstation should be a minimum of 1024 x 768 high colour (16 bit), and 10 GB of disk space is recommended as a minimum.

The software is required to be able to visualise and process medical images using a range of filters and tools, and can export models as output files. ScanIP meets DICOM standards for the transfer of medical images. The software is also intended for use in the early stages of pre-surgical planning for visualising patient-specific data, taking measurements and obtaining statistics (such as bone density, distances and angles between arteries), and for integrating computer drawings of implants with patient data to evaluate fitness for use. This functionality has applications to implant evaluation and export of models for simulation in other software. Output files can be used in these other applications; ScanIP does not integrate with them directly.

Processed medical images can also be exported as output files to 3D printing processes for the creation of physical models that can be used in pre-surgical planning (inspection of implant fit), and as computational models to other software programs for running simulations (e.g. stress/strain limits in bone, fluid flow through vessels and airways).

ScanIP has FDA clearance to generate 3D models and export these models in a format suitable for 3D printing to be used as physical models for visualization or educational purposes only. This clearance does not cover medical devices manufactured from those output files.

AI/ML Overview

This document primarily describes the regulatory clearance of a software device, ScanIP; it does not contain a typical study performed to meet acceptance criteria with specific performance metrics such as sensitivity, specificity, or reader improvement. The "performance data" section states that "Software Verification and Validation Testing" was conducted, and the conclusions state that "Verification and validation testing of ScanIP, and inclusion of the subject device's Reference Guide and the predicate's Reference Guide supports substantial equivalence based on performance testing and detailed descriptive criteria." This generally refers to internal software testing, not a clinical performance study with human subjects or readers as one might typically expect for evaluating the efficacy of an AI-powered diagnostic tool.

The document focuses on establishing substantial equivalence to a predicate device (Mimics K073468) based on technological characteristics and software verification/validation activities.

Therefore, many of the requested items cannot be extracted directly from the provided text.

Here's an attempt to answer the questions based on the information available:

Acceptance Criteria and Study Details for ScanIP

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, the "acceptance criteria" appear to be related to demonstrating substantial equivalence through software verification and validation, aligning with the predicate device's functionality, and mitigating potential risks associated with software failure. Specific quantitative performance metrics (e.g., sensitivity, specificity, F-score) are not provided.

Acceptance Criteria Category	Description from Document	Reported Device Performance/Status
Technological Equivalence to Predicate	The device should have equivalent technological elements to the predicate device (Mimics K073468) including: - Visualization, segmentation, processing, and file export of medical images - Application of software algorithms, filters, and tools - Compatibility with scanner data (MRI, CT, micro-CT) - Ability to visualize data in 2D and 3D - Use of tools to take measurements and record statistics - Use of algorithms to create surface meshes (e.g., STL) - Use of filters for morphological image processing - Use of tools for 3D editing (e.g., paint) - Use of tools for segmenting images (e.g., thresholding) - Export files for FEA, CAD, and 3D printing.	ScanIP is stated to be "substantially equivalent" to Mimics (K073468) based on satisfying these technological characteristics. The document explicitly lists these points as "equivalent technological elements." The only difference noted is that the predicate has dedicated surgical planning modules, which the subject device does not. This difference was likely deemed not to impact substantial equivalence for the stated indications.
Software Verification and Validation (V&V)	As recommended by FDA's Guidance for the Industry and FDA Staff: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This includes system-level tests and validation testing.	"Software verification and validation testing were conducted and documentation was provided." The document concludes that "Verification and validation testing of ScanIP... supports substantial equivalence based on performance testing and detailed descriptive criteria." The software was considered "Moderate" level of concern, and appropriate steps were taken to ensure mitigation of potential risks (e.g., misinterpreting scanned data leading to minor injury for a surgical implant design).
Risk Mitigation	Mitigation of hazards, where a failure of the device could result in minor injury (e.g., misinterpreting scanned data causing incorrect surgical implant design).	Software documentation, including V&V activities and related performance data, was provided to demonstrate that "appropriate steps have been taken to ensure mitigation of potential risks."
DICOM Compliance	Voluntary compliance with the ACR/NEMA Digital Imaging and Communication in Medicine (DICOM) Standard (Version 3.0).	"ScanIP meets DICOM standards for the transfer of medical images." Both subject and predicate devices are "voluntarily compliant with the ACR/NEMA Digital Imaging and Communication in Medicine (DICOM) Standard (Version 3.0)."

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

The document does not describe a "test set" in the context of a clinical performance study with patient data. The "performance data" refers to software verification and validation testing. Therefore, details about sample size (e.g., number of cases/patients) and data provenance (country of origin, retrospective/prospective) are not applicable/provided for a clinical test set.

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

This information is not applicable/provided as the document does not describe a clinical evaluation with a test set requiring expert ground truth for specific diagnostic outcomes.

4. Adjudication method for the test set

This information is not applicable/provided as there is no described test set requiring expert adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not described in this document. The device is a software interface and image segmentation system, not an AI-assisted diagnostic tool designed to directly improve human reader performance in a diagnostic task. Its purpose is for image processing, segmentation, measurement, and export for pre-surgical planning or other downstream applications.

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

A standalone performance study in the sense of evaluating diagnostic accuracy of an algorithm without human intervention was not conducted or described. The document focuses on the software's functionality and its role as a tool for trained professionals. Its outputs (segmented images, measurements, models) are intended to be used by clinicians who "retain the ultimate responsibility for making a decision."

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

The concept of "ground truth" used in typical clinical performance studies (e.g., against pathology or clinical outcomes) is not applicable/provided for the software verification and validation described. The "ground truth" for software testing would typically involve expected outputs based on specified inputs and functional requirements, rather than clinical diagnostic ground truth.

8. The sample size for the training set

This document does not describe an AI model that undergoes "training." ScanIP is an image processing and segmentation software; it is not presented as a machine learning or AI-powered model that would require a "training set" in the conventional sense. Therefore, this information is not applicable/provided.

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

As there is no described "training set" for an AI model, this information is not applicable/provided.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 17, 2015

Simpleware LTD. % Dr. Gareth James Marketing and PR Officer Bradninch Hall Castle Street EXETER, GB EX43PL DEVON

Re: K142779

Trade/Device Name: ScanIP: ScanIP: Medical Edition: ScanIP: Med Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: LLZ Dated: March 19, 2015 Received: March 25, 2015

Dear Dr. James:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142779

Device Name ScanIP ; ScanIP: Medical Edition; ScanIP: Med

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

2.2 Updated 510(k) Summary

(as required by 21 CFR 807.92c)

I. SUBMITTER

Simpleware Ltd. Bradninch Hall, Castle Street, Exeter, EX4 3PL UK Phone: +44 (0)1392 428751 Fax: +44 (0)1392 428769 Contact Person: Dr. Gareth James Date Prepared: March 16th 2015

II. DEVICE

Name of Device: ScanIP; ScanIP: Medical Edition; ScanIP: Med

Common or Usual Name: Image processing system and preoperative software for simulating and evaluating surgical treatment options

Classification Name: Picture Archiving and Communications System (21 CFR 892.2050)

Regulatory Class: II

Product Code: LLZ

III. PREDICATE DEVICE

Manufacturer	Device	510(k) Number
Materialise N.V.	Mimics	K073468

No reference devices were used in this submission.

IV. Device Description

{4}------------------------------------------------

The intended environment for use is by a trained professional working on a standard workstation (see recommended hardware specifications above). The clinician receiving images and models from the software retains the ultimate responsibility for making a

{5}------------------------------------------------

decision based on their surgical applications and patient assessment, using their standard practices and visual comparison of the information with original scans.

ScanIP and its related modules has been commercially available since 2004, but has previously not required FDA clearance as it was marketed for research use only, rather than for potential clinical applications.

V. INDICATIONS FOR USE

ScanIP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner to an output file. It is also intended as preoperative software for simulating/evaluating surgical treatment options. ScanIP is not intended to be used for mammography imaging.

The Indications for Use statement for ScanIP is identical to that of the predicate device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

ScanIP is considered to be substantially equivalent to Mimics (K073468) from Materialise (Establishment Registration No: 3003998208). The two devices provide software capabilities for importing and processing medical images, and for exporting output files. Both devices are voluntarily compliant with the ACR/NEMA Digital Imaging and Communication in Medicine (DICOM) Standard (Version 3.0).

At a high level, the subject and predicate devices are based on the following equivalent technological elements:

The visualisation, segmentation, processing and file export of medical images ● through the application of software algorithms, filters and tools
Compatibility with scanner data (e.g. MRI, CT, micro-CT ... ) ●
The ability to visualise data in 2D and 3D views ●
Use of tools to take measurements and record statistics ●
Use of algorithms to create surface meshes (e.g. STL) ●
. Use of filters for morphological image processing
Use of tools for 3D editing (e.g. paint) ●
Use of tools for segmenting images (e,g. thresholding) ●
Export files can be used in Finite Element Analysis (FEA) software .
Export files can be used in CAD software ●
. Export files can be used in 3D printing processes (please see 3D printing statement for limitations on this use)

{6}------------------------------------------------

The following technological differences exist between the subject and predicate devices:

. Predicate device has dedicated surgical planning modules and subject device does not

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for the Industry and FDA Staff: · Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.' Testing include system level tests and validation testing.

The software for this device was considered as a "Moderate" level of concern, as, prior to mitigation of hazards, a failure of the device could result in minor injury. A failure or misuse of ScanIP, such as misinterpreting scanned data, could in exceptional circumstances cause a minor injury to a patient. This could take the form of a surgical implant design being incorrectly positioned, for example. Software documentation, including verification and validation activities and related performance data, has been provided to demonstrate that appropriate steps have been taken to ensure mitigation of potential risks.

VIII. CONCLUSIONS

Verification and validation testing of ScanIP, and inclusion of the subject device's Reference Guide and the predicate's Reference Guide supports substantial equivalence based on performance testing and detailed descriptive criteria. It is therefore believed that ScanIP is substantially equivalent with respect to safety and effectiveness as the predicate device that is currently marketed for the same intended use.

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).