PERFSCAPE V2.0 is a PACS system that allows the display, analysis and postprocessing of dynamically acquired Magnetic Resonance (MRI) and Computed Tomography (CT) datasets to evaluate image intensity variations over time.

PERFSCAPE V2.0 retrieves and accepts data from existing MRI and CT systems. Based on these data, PERFSCAPE V2.0 performs quality control checks, displays Diffusion Weighted Images (MRI only) and generates parametric maps such as Relative Blood Volume, Relative Blood Flow, Relative Mean Transit Time, Time to Peak, Impulse Response Time to Peak, permeability and leakage between intravascular and extracellular space (MRI only), and temporal Maximum Intensity Projection (CT only). PERFSCAPE V2.0 also generates Diffusion Weighted Images and/or Diffusion Tensor Images (MRI only).

These images, when interpreted by a trained physician, may yield clinically useful information.

PERFSCAPE V2.0 is compliant with the DICOM standard allowing the system to visualize medical images. The system is a multiplatform software running on Windows, Mac and Linux operating systems.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Device Description

PERFSCAPE V2.0 is a software application designed to analyze dynamically acquired datasets. The software provides a wide range of basic image processing and manipulation functions applied to MRI or CT datasets.

Using well-established algorithms, parametric maps can be generated such as Relative Blood Volume, Relative Blood Flow. Relative Mean Transit Time. Time to Peak, impulse response time to peak, permeability and leakage between intravascular and extracellular space (MRI only), temporal Maximum Intensity Projection (CT only). PERFSCAPE V2.0 also generates Diffusion Weighted Images and/or Diffusion Tensor Images (DWI and DTI, MRI only).

The PERFSCAPE V2.0 device includes critical features such as:

Enables the computation of DWI and DTI maps from co-registered . Bxxx images (eg B0 B500 B1000);
. Enables rapid creation of a complete array of critical parameter maps;
Automated organ mask generation; .
. View dynamic signal time course on a per-voxel basis;
Integrated motion correction ; .
Automatic and Interactive Arterial Input Function (AIF) selection; ●
Automatic and Interactive Venous Output Function (VOF) selection; .
Export computed perfusion map to PACS or to DICOM files in . filesystem.

PERFSCAPE V2.0 also allows the user to view the computed maps using the NEUROSCAPE software (K083491).

Based on these common functionalities, Perfscape is divided into three modules named:

MRI module, ●
. CT module, and
MRI-LC module. .

Each module is designed to address useful subsets of images.

AI/ML Overview

The provided 510(k) summary for PERFSCAPE V2.0 does not contain the acceptance criteria or a study demonstrating that the device meets explicit acceptance criteria in the manner typically found in a clinical performance study.

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving clinical performance or meeting specific acceptance criteria through a formal study with statistical endpoints. The information provided relates to the device's description, intended use, and comparative characteristics to a predicate device.

Therefore, many of the requested fields cannot be extracted or are not applicable based on the provided text.

Here's an breakdown of what can and cannot be answered:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria: Not explicitly stated in the document. 510(k) summaries for PACS systems typically focus on functional equivalence rather than clinical performance metrics with pre-defined acceptance thresholds.
Reported Device Performance: The document describes the device's capabilities (e.g., generates parametric maps, performs quality control checks, displays DWI/DTI), but it does not report quantitative performance metrics against specific acceptance criteria. It mentions "well-established algorithms" but provides no performance data on them.

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

Sample Size: Not mentioned. No test set is described for formal performance evaluation against acceptance criteria.
Data Provenance: Not mentioned.

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

Not mentioned. No test set or ground truth establishment process is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not mentioned. No test set is described.

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:

No MRMC study is mentioned. The device is a PACS system that provides analysis and post-processing, and its output is to be "interpreted by a trained physician," implying it's a tool, but not an AI-assisted diagnostic aid for which an MRMC study would typically be performed.

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

No standalone performance study is mentioned. The device's output is intended for interpretation by a physician.

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

Not mentioned. No ground truth is described for performance evaluation.

8. The sample size for the training set:

Not mentioned. This document describes a software application that uses "well-established algorithms" rather than a machine learning model that would typically require a training set.

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

Not applicable/Not mentioned, as no training set is described.

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Nordic Image Control and Evaluation (nICE) Software, K090546) based on indications for use, performance, and technological characteristics. For a PACS system that processes and displays medical images, the "performance" typically refers to its ability to correctly execute its defined functions (e.g., generate specific parametric maps, handle DICOM data, perform motion correction) rather than clinical diagnostic accuracy per se. There is no mention of a clinical study or performance evaluation with acceptance criteria to prove diagnostic efficacy or accuracy.

Summary

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K111161
NOV - 4 2011 P 1/5

510(k) Summary

(in accordance with 21 CFR 807.92)

510(k) Number K

I. Applicant Information

Applicant:
------------	--

OLEA MEDICAL

93 avenue des Sorbiers, Zone Athelia IV
La Ciotat 13600
France

Contact Person: Caroline Lene . Quality Manager Tel: (011) 33 4 42 71 24 20 Fax: (011) 33 4 42 71 24 27 e-mail: caroline.lene@olea-medical.com

Application Correspondent:

EMERGO GROUP INC. 611 West 5th Street, Third Floor Austin, TX 78701 U.S.A.

Contact Person: Kristi Gusman Project Manager Tel: (512) 327-9997 Fax: (512) 327-9998 e-mail: kristi@emergogroup.com

Date Prepared: April 15, 2011

II. Device Name and Classification

Proprietary Name:	PERFSCAPE V2.0
Common/Usual Name:	PACS
Classification Name:	Picture Archiving Communications System
Regulation Number:	892.2050
Product Codes:	LLZ
Classification:	Class II
Classification Panel:	Radiology Devices

510(k) - PERFSCAPE V2.0

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Image /page/1/Picture/0 description: The image shows the logo for Olea Medical. The logo consists of a cube with a human figure on one side and a pattern of dots on the other. To the right of the cube is the text "Olea" in a bold, sans-serif font, with the word "medical" in a smaller font below it.

K111161

P²/₄

III. Predicate Device

The PERFSCAPE V2.0 device is substantially equivalent to the following FDA cleared predicate device with regard to indications for use, performance and technological characteristics:

510(k) Number:	K090546
Trade Name:	Nordic Image Control and Evaluation (nICE)Software
Manufacturer:	NordicIceMedical AS
Classification Name:	Picture Archiving Communications System
Common/Usual Name:	PACS
Regulation Number:	892.2050
Product Codes:	LLZ
Classification:	Class II

IV. Device Description

The PERFSCAPE V2.0 device includes critical features such as:

Enables the computation of DWI and DTI maps from co-registered . Bxxx images (eg B0 B500 B1000);
. Enables rapid creation of a complete array of critical parameter maps;
Automated organ mask generation; .
. View dynamic signal time course on a per-voxel basis;
Integrated motion correction ; .
Automatic and Interactive Arterial Input Function (AIF) selection; ●
Automatic and Interactive Venous Output Function (VOF) selection; .

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Image /page/2/Picture/1 description: The image shows the logo for Olea Medical. The logo consists of a cube with a human figure on one side and a pattern of circles on another side. To the right of the cube is the text "Olea" in a larger font, with the word "MEDICAL" underneath in a smaller font.

Export computed perfusion map to PACS or to DICOM files in . filesystem.
PERFSCAPE V2.0 also allows the user to view the computed maps using the NEUROSCAPE software (K083491).

Based on these common functionalities, Perfscape is divided into three modules named:

MRI module, ●
. CT module, and
MRI-LC module. .

Each module is designed to address useful subsets of images.

V. Intended Use

PERFSCAPE V2.0 is a PACS system that allows the display, analysis and post-processing of dynamically acquired Magnetic Resonance (MRI) and Computed Tomography (CT) datasets to evaluate image intensity variations over time.

These images, when interpreted by a trained physician, may vield clinically useful information.

PERFSCAPE V2.0 is compliant with the DICOM standard allowing the system to visualize medical images. The system is a multiplatform software running on Windows, Mac and Linux operating systems.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

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Image /page/3/Picture/1 description: The image shows the logo for Olea Medical. The logo consists of a cube with a human figure on one side and a pattern of dots on the other. To the right of the cube is the text "olea" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it.

VI. Summary of the Technical Characteristics

PERFSCAPE V2.0 is a PACS software designed to access series of CT or MRI images in DICOM format. PERFSCAPE V2.0 analyzes dynamically acquired CT or MR datasets and generates parametric maps.

Used in combination with MRI datasets, PERFSCAPE V2.0 allows automatic or interactive and multiple selections of arterial input functions and displays map results of the selected slice in real time. The selected AIF can be manually filtered. It also allows generating, manually or automatically, an organ mask to remove non-organ voxels. PERFSCAPE V2.0 also allows computing DWI and DTI maps from Bxxx coregistered images.

Used in combination with CT datasets, PERFSCAPE V2.0 allows automatic or interactive and multiple selections of arterial input functions, venous output functions and displays map results of the selected slice in real time. The selected AIF can be manually filtered. It also allows generating, manually or automatically, an organ mask to remove non-organ voxels.

PERFSCAPE V2.0 allows creating a NEUROSCAPE (K083491) study with computed and/or imported maps. It also allows exporting the results as a DICOM study to the PACS or the file system.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in bold, uppercase letters. To the left of the text is a symbol that includes an eagle.

Public Health Service

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

Olea Medical % Ms. Kristi Gusman Project Manager Emergo Group, Inc. 611 West 5th Street, Third Floor AUSTIN TX 78701

NOV - 4 2011

Re: K11161

Trade/Device Name: PERFSCAPE V2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 6, 2011 Received: October 7, 2011

Dear Ms. Gusman:

We have reviewed vour 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5.10(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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4. Indication for Use Statement

510(k) Number (if known): __|<\1\1 \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \

Device Name:

PERFSCAPE V2.0

Indications for Use:

These images, when interpreted by a trained physician, may yield clinically useful information.

PERFSCAPE V2.0 is compliant with the DICOM standard allowing the system to visualize medical images. The system is a multiplatform software running on Windows, Mac and Linux operating systems.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Prescription Use X (Part 21 CFR 801 Subpart D)

510K

AND/OR '

Over-The-Counter Use (21 CFR 801 Subpart C)

Diagnostic

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (QDE).

Mury S. Patal
(Division Sign Off)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

Devices

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).