Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc.

It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basic image filters, etc.

It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition through vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling.

The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions.

Device Description

The Visible Patient Suite is a software device that does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the software, but by radiologists, clinicians and referring physicians. A physician, provided with ample opportunity for competent human intervention, interprets images and information being displayed.

In sum, Visible Patient Suite is a software suite and includes three software components: Visible Patient Sender (VP Sender), Visible Patient Lab (VP Lab), and Visible Patient Planning (VP Planning). Visible Patient Lab is the main software component of Visible Patient Suite and includes all modules available in the software suite (except for the DICOM files anonymization module present in the Visible Patient Sender module).

Visible Patient Sender includes only modules dedicated to data management. The software is a simple tool to anonymize multidimensional digital images acquired from a variety of medical imaging modalities (DICOM images). There is no 3D data volume interpretation in this software.

Visible Patient Lab includes all Visible Patient Suite modules: data management (except for DICOM files anonymization module), data analysis and data processing. This software offers a flexible solution to help trained medical professionals with image processing knowledge (usually radiologists or radiologist technicians) in (1) the evaluation of patient's anatomy and pathology, and (2) in the creation of a 3D model of the patient's anatomy. This software proposes flexible workflow options: visualization of patient's anatomy and pathology from medical images; creation a 3D model of the patient's anatomical structures, organ segments and volumetric data; creation of an anatomical atlas (a colored image where each color represents a structure); and exports these medical data to be analyzed or reviewed later.

Visible Patient Planning includes modules dedicated to data management and data analysis, and simply contains a subset of the software modules present in Visible Patient Lab. This software offers a flexible visualization solution to help trained medical professionals (clinicians) in the evaluation of patient's anatomy and pathology to plan therapy or surgery.

AI/ML Overview

Based on the provided text, the "Visible Patient Suite" is a medical imaging software that offers various tools for reading, interpreting, and treatment planning, including advanced features like organ segmentation (liver, lungs, kidneys) and vascular/airway definition.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity, specificity values) for the device's performance. Instead, the performance validation is described qualitatively.

Acceptance Criteria (Implied)	Reported Device Performance
Software functions as intended	"In all instances, the Visible Patient Suite functioned as intended."
Device is safe and effective	"The Visible Patient Suite is as safe and effective as the Synapse 3D Base Tools (K120361), Synapse 3D Liver and Kidney Analysis (K142521) and Synapse 3D Lung and Abdomen Analysis (K130542)."
No new issues of safety or effectiveness from technological differences	"The minor technological differences between the Visible Patient Suite and its predicate devices raise no new issues of safety or effectiveness."
Performs similarly to predicate devices	"Performance data demonstrate that the Visible Patient Suite performs as intended and in a manner similar to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

The document states: "The company has verified and validated the Visible Patient Suite's moderate level of concern software." However, it does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications. It states the software is "designed to be used by trained professionals (including physicians, surgeons and technicians)" and that "Diagnosis is not performed by the software, but by radiologists, clinicians and referring physicians," but this refers to the users of the software, not the experts who established the ground truth for validation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size related to human readers improving with AI vs. without AI assistance. The regulatory submission emphasizes the device's substantial equivalence to predicate devices, focusing on the software tools themselves rather than human-AI collaboration.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document implies that the software's performance was validated, but it focuses on the software as a "tool" to assist trained medical professionals. The statement "Diagnosis is not performed by the software, but by radiologists, clinicians and referring physicians" suggests that the device's intended use is not as a standalone diagnostic tool without human oversight. The provided information does not detail specific standalone performance metrics for the algorithms within the software (e.g., for segmentation accuracy in isolation).

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for validation. It mentions the creation of a "3D model of the patient's anatomical structures, organ segments and volumetric data" and an "anatomical atlas," which might imply comparisons to known anatomical references or expert-derived segmentations, but it's not explicitly defined as pathology, outcomes data, or expert consensus.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set was established.

Summary of what is Lacking in the Provided Text:

The provided 510(k) summary focuses primarily on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and a broad qualitative statement of performance ("functioned as intended," "as safe and effective as predicate devices"). It lacks detailed information on the specific validation study methodology, including:

Quantitative acceptance criteria
Test set size and provenance
Details of ground truth establishment (number/qualifications of experts, adjudication)
Results from specific performance metrics (e.g., accuracy, sensitivity, specificity for segmentation tasks)
Information on training data and its ground truth.
Any MRMC study results.

Summary

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

Image /page/0/Picture/1 description: The image contains the seal of the U.S. Department of Health & Human Services. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.

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

October 15, 2015

Visible Patient, SAS % John Smith, M.D., Ph.D. Regulatory Counsel Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004

Re: K151988

Trade/Device Name: Visible Patient Suite Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 9, 2015 Received: September 9, 2015

Dear Dr. Smith:

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 Ocko

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

Enclosure

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

510(k) Number (if known)

K151988

Device Name

Visible Patient Suite

Indications for Use (Describe)

Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning. Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

It includes a basic image processing workflow and a custom Ul to segment anatomical structures, which are visible in the image data (bones, organs, vascular/ainway structures, etc.), including interactive segmentation tools, basic image filters, etc.

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}------------------------------------------------

510(k) SUMMARY Visible Patient, SAS's Visible Patient Suite

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Visible Patient, SAS RCS Strasbourg TI 794 458 125 1 place de l'hôpital 67000 Strasbourg, France Phone: 33 (0)3 90 22 42 00 Facsimile: 33 (0)3 88 11 90 99

Contact Person: Ms. Aude PETITJEAN Phone number: 33 (0)3 90 22 42 03

Date Prepared: July 17, 2015

Name of Device and Name/Address of Sponsor

Visible Patient Suite Visible Patient, SAS RCS Strasbourg TI 794 458 125 1 place de l'hôpital 67000 Strasbourg, France

Common or Usual Name

Medical Image Processing Software

Classification Name / Regulation Number / Product Code / Review Panel

Picture Archiving and Communications System / 21 C.F.R. § 892.2050 / Product Code: LLZ / Radiology Review Panel

Predicate Devices

FUJIFILM Medical Systems U.S.A., Inc.'s:

Synapse 3D Base Tools (K120361) ●
. Synapse 3D Liver and Kidney Analysis (K142521)
Synapse 3D Lung and Abdomen Analysis (K130542) .

Intended Use / Indications for Use

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

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

Technological Characteristics

Visible Patient Sender a)

b) Visible Patient Lab

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

c) Visible Patient Planning

Performance Data

The company has verified and validated the Visible Patient Suite's moderate level of concern software. In all instances, the Visible Patient Suite functioned as intended.

Substantial Equivalence

The Visible Patient Suite is as safe and effective as the Synapse 3D Base Tools (K120361), Synapse 3D Liver and Kidney Analysis (K142521) and Synapse 3D Lung and Abdomen Analysis (K130542). The Visible Patient Suite has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Visible Patient Suite and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Visible Patient Suite performs as intended and in a manner similar to the predicate devices. Thus, the Visible Patient Suite is substantially equivalent.

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).