The NeuColonCARE is a soft-copy reading workstation intended for clinical review of CT abdominal (gastrointestinal) images which allows easy acquisition, transmission and review of the medical images and supports VC (Virtual Colonoscopy) function. Images may be interpreted by a trained physician to obtain information that may be useful in the determination of a diagnosis.

Device Description

NeuColonCARE software product is a soft-copy reading workstation used to clinically evaluate the CT abdominal (gastrointestinal) images. It is a self-contained software package, providing the functions of patient information management, image viewer (2D view, standard MPR views and 3D visualization view), and the analysis and processing of the gastrointestinal system, especially the colon. It allows the user to conduct air segmentation based on a customized threshold value, extract the centerline automatically and interactively, view the colon lumen structure in the manner of virtual colonoscopy or virtual dissection along the centerline, view the ROI, and finally acquire useful clinical information by marking and measuring the ROI (3D distance and CT value).

AI/ML Overview

The provided text is a 510(k) summary for the Neusoft NeuColonCARE device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the detailed information required to answer all parts of your request, specifically regarding acceptance criteria and a study proving those criteria are met.

Here's an analysis of what can and cannot be answered based on the provided text:

Acceptance Criteria and Study (Cannot be fully answered):

The document states:

"The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. A summary of the software design description, risk management, level of concern and verification&validation testing information can be found in the attached submission."
"It is further verified for system compatibility with the devices with which it communicates, including conformance to DICOM 3.0 standard."
"Neusoft Medical Systems considers the NeuColonCARE software product to be as safe, as effective, and performance is substantially equivalent to the predicate devices."

This broadly indicates that some form of "verification and validation testing" was performed to show conformance to design specifications and industry standards. However, the document does not provide specific acceptance criteria (e.g., a certain sensitivity/specificity threshold for polyp detection, or accuracy of measurements) nor does it describe any specific study that quantitatively measures the device's performance against such criteria. The basis for clearance is substantial equivalence to predicate devices, not a demonstration of specific performance metrics against pre-defined acceptance criteria.

Therefore, the table of acceptance criteria and reported device performance cannot be generated from the provided text. The subsequent questions (#2-9) regarding sample sizes, ground truth, experts, etc., are also not addressed because there is no description of a performance study in the provided text.

Summary of available information:

Table of acceptance criteria and the reported device performance:
- N/A. The document does not provide specific acceptance criteria or reported device performance metrics from a clinical study. It relies on a comparison to predicate devices for substantial equivalence.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- N/A. No such details are provided as no specific performance study is detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- N/A. No such details are provided as no specific performance study is detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. No such details are provided as no specific performance study is detailed.
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:
- N/A. The document does not mention any MRMC comparative effectiveness study or AI assistance. The device is described as a "soft-copy reading workstation" and focuses on visualization and analysis tools, not AI-driven improvement for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. The document describes the device as a "soft-copy reading workstation" intended for "clinical review of CT abdominal (gastrointestinal) images" where "Images may be interpreted by a trained physician." This implies a human-in-the-loop system. No standalone algorithm performance is described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. No such details are provided as no specific performance study is detailed.
The sample size for the training set:
- N/A. No such details are provided as no specific training of a machine learning algorithm is discussed.
How the ground truth for the training set was established:
- N/A. No such details are provided as no specific training of a machine learning algorithm is discussed.

Conclusion from the document:

The Neusoft NeuColonCARE device was cleared based on substantial equivalence to its predicate devices (Voxar 3D Entreprise with ColonMetrix K070831 and Philips ViewForum 2003 K032096). The text outlines that the device shares similar technological characteristics and functions (e.g., standard MPR, Virtual Endoscopy, Virtual Dissection, ROI bookmarking and measurement) with the predicate devices. It states that the device "employs the same or similar fundamental technology as its predicate devices and dose not introduce any new potential safety risks," leading to the conclusion that it is "as safe, as effective, and performance is substantially equivalent to the predicate devices."

The description of "non-clinical tests" refers to conformance to design specifications, industry standards (DICOM 3.0), software design description, risk management, and verification & validation—these are general software development and regulatory compliance activities, not a detailed clinical performance study with specific acceptance criteria and outcome metrics.

Summary

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Neusoft

で

Summary of Safety and Effectiveness

JAN 2 8 2011

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)

General Information:

Trade Name:	NeuColonCARE
Version Number:	1.0
Common Name:	Soft-Copy Medical Image Reading Workstation
CFR Section:	21 CFR Part 892.2050
Classification Name:	Picture Archiving and Communication System (PACS).
Product Code:	LLZ
Device Class:	Class II
Applicable Standard:	DICOM 3.0
Manufacturer andDistributor:	Neusoft Medical Systems Co., Ltd.No. 16, Shiji Road, Hunnan Industial Area,Shenyang,Liaoning, ChinaPost Code : 110179
Submitter:	Contact': Tian Yuehui

Title : Manager of Quality Management Department Tel : 86-24-83660646 Fax : 86-24-83780480 E-Mail :tianyh@neusoft.com

Summary prepared : Nov.24,2010

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Safety and Effectiveness Information

Intended Uses:

Device Description:

Technological characteristics:

The NeuColonCARE software product is executed on a general PC and employs the same or similar fundamental technology as its predicate devices.

Summary of Non-Clinical Tests:

The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. A summary of the software design description, risk management, level of concern and verification&validation testing information can be found in the attached submission. It is further verified for system compatibility with the devices with which it communicates, including conformance to DICOM 3.0 standard.

Predicate Device:

K070831 : Voxar 3D Entreprise with ColonMetrix K032096 : Philips ViewForum 2003

Statement of Substantial Equivalence:

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The Neusoft NeuColonCARE is comparable and substantially equivalent to the Voxar 3D Entreprise with ColonMetrix (K070831) and the Philips ViewForum 2003 (K032096).

The NeuColonCARE and the Philips ViewForum 2003 share similar technological specifications. Both of them support DICOM protocol for communication of images with other medical imaging devices. Furthermore, they both provide various tools for physicians to view images.

The NeuColonCARE has the similar technological characteristics with the Voxar 3D Entreprise with ColonMetrix. Both of them provide functions such as standard MPR, Virtual Endoscopy, Virtual Dissection and they both provide the function of ROI bookmark and measurement, as well as quantitative analysis of the ROI.

According to the comparison based on the requirements of 21.CFR 807.87, we state that these devices are substantially equivalent.

Conclusion:

The NeuColonCARE software product employs the same or similar fundamental technology as its predicate devices and dose not introduce any new potential safety risks. So, Neusoft Medical Systems considers the NeuColonCARE software product to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Neusoft Medical Systems Co., Ltd. % Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542

JAN 2 8 2011

Re: K110077

Trade/Device Name: NeuColonCARE Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 21, 2010 Received: January 11, 2011

Dear Mr. Mouser:

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.

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 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 510(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 Postel.

Mary Pastel, ScD. 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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Neusoft

510(k)

Indications for Use Form

510(k) Number (if known) :

Device Name: NeuColonCARE

Indications for use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Deices (OIVD)

ely D'Ahm

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110077

Page 1 of 1

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).