MED-SEG is a software device that receives medical images and data from various imaging sources (including but not limited to CT, MR, US, RF units), computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources). Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

In addition to general PACS use, this system can be used by trained professionals (e.g. physicians, radiologists, nurses, medical technicians, and assistants) to separate 2D images into "digitally related" sections or regions that, after colorization, can be individually labeled by the user. These images can be used to find appropriate window/level settings, to facilitate report generation and communication, or for other uses. These processed images should not be used for primary image diagnosis.

Only DICOM "for presentation" uncompressed or non-lossy compressed images can be used on an FDA cleared or approved monitor for primary image diagnosis in mammography.

Device Description

MED-SEG™ software is a Picture Archiving and Communications System (PACS) for radiological image processing, storage, display and communication. The system can receive digital images via a secure internet communication link. The system incorporates parallel-computing algorithms that perform high-speed segmentation and regionalization. The system does not contact the patient nor does it control any life sustaining devices. A clinician interprets the images and information displayed by the system. providing ample opportunity for human intervention in the clinical decision process.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or detailed performance data in the format requested. The submission is a 510(k) summary for the Bartron Medical Imaging MED-SEG™ System, focusing on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study against defined acceptance criteria.

The key points from the provided document regarding performance are:

Performance Data: "Laboratory testing documented that MED-SEG™ complies with the recognized consensus standards for radiological image processing systems." This is a general statement and does not include specific metrics, sample sizes, or methodologies.
Substantial Equivalence: The primary argument for clearance is that MED-SEG™ is "substantially equivalent" to its predicate device (DEMASQ Imaging Software) because it "uses the same software technology, and complies with the same recognized consensus standards as its predicate device. It has the same intended use and indications for use as the predicate system." This implies that by meeting the same standards as the predicate, its performance is considered acceptable.

Therefore, I cannot populate the table or answer most of the questions because the document explicitly states that the device's substantial equivalence is based on using the "same software technology" and complying with "recognized consensus standards" as its predicate device, rather than providing a detailed performance study with acceptance criteria and results.

Here's how I would address your request based only on the provided text, indicating where information is absent:

Acceptance Criteria and Device Performance Study (Based on Provided Document)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Comments
Compliance with recognized consensus standards for radiological image processing systems	Documented via laboratory testing	Specific standards, metrics, and results are not detailed in this 510(k) summary.
Substantial Equivalence to predicate device (DEMASQ Imaging Software, K090481)	Uses the same software technology and complies with the same recognized consensus standards as the predicate. Has the same intended use and indications for use.	This is the primary "performance" discussed for regulatory clearance. Actual quantitative performance metrics are not provided.

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

Sample Size (Test Set): Not specified in the provided document.
Data Provenance: Not specified in the provided document. (e.g., country of origin, retrospective or prospective data)

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

Not specified. The document indicates "laboratory testing" and compliance with consensus standards, but does not detail a study involving expert-established ground truth for a test set.

4. Adjudication method for the test set

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

No MRMC comparative effectiveness study is mentioned. The device's purpose is to "separate 2D images into 'digitally related' sections or regions," facilitate "appropriate window/level settings," "report generation and communication," and for "other uses." It explicitly states: "These processed images should not be used for primary image diagnosis." The description suggests it's a tool for image manipulation and organization, not a diagnostic aid intended to improve human reader performance in primary diagnosis.

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

Not explicitly mentioned. The "laboratory testing" for compliance to consensus standards might involve standalone evaluation, but details are not provided. The device is a "software device" with "parallel-computing algorithms that perform high-speed segmentation and regionalization," implying standalone algorithmic function. However, the regulatory submission focuses on its equivalence as a PACS and image processing system.

7. The type of ground truth used

Not specified. Given the focus on "compliance with recognized consensus standards for radiological image processing systems" and substantial equivalence, the "ground truth" likely refers to the software's ability to accurately perform its functions (segmentation, regionalization, image processing, storage, display) as per those standards, rather than diagnostic ground truth (e.g., pathology, outcomes data).

8. The sample size for the training set

Not applicable/Not specified. This document is a 510(k) summary for a PACS and image processing system, which, at least as described here, is not presented as an AI/ML device in the modern sense requiring a 'training set' for machine learning. Its functionality seems to be based on programmed algorithms for segmentation and regionalization, validated against established standards.

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

Not applicable/Not specified, as no training set for an AI/ML model is mentioned.

Summary

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

MEDICAL IMAGING INC RTH A THOUSAND WORDS

510 (k) SUMMARY

Bartron Medical Imaging MED-SEG™ System

JUL 26 2010

KO92328 P. 1082

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

Prepared:
Manufacturer:	Bartron Medical Imaging, Inc.1100 Mercantile Lane, Ste 115ALargo, MD 20774Telephone: (301) 583-4642 /x243Facsimile: (301) 772-8540
Contact Person:	Zvi Ladin, PhD.PrincipalBoston MedTech Advisors, Inc.990 Washington StreetSuite #204Dedham, MA 02026Telephone: (781) 407 0900 x104Facsimile: (781) 407 0901Email: zladin@bmtadvisors.com
Date Prepared:	July 12, 2010
Name of Device and Name/Address of Sponsor
Trade/Proprietary Name:	MED-SEG™
Common Name:	Picture Archiving and Communication System
Classification Name:	System, Image Processing, Radiological
Regulatory Class:	II
Product Code:	LLZ
Federal Regulation:	21 CFR §892.2050
Manufacturing Facility:	Bartron Medical Imaging, Inc.91 Shelton StreetNew Haven, CT 06511Telephone: (203) 498-2184Facsimile: (203) 498-2189
Establishment Registration Number:	N/A
Owner/operator number:	N/A

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

AEDICAL IMAGING INC H A THOUSAND WORDS

Predicate Device

DEMASQ Imaging Software, manufactured by DEMASQ Ltd of Wales, United Kingdom and cleared under 510(k) #K090481 on March 19, 2009.

Intended Use / Indications for Use

Only DICOM "for presentation" uncompressed or non-lossy compressed images can be used on an FDA cleared or approved monitor for primary image diagnosis in mammography.

Technological Characteristics

Performance Data

Laboratory testing documented that MED-SEG™ complies with the recognized consensus standards for radiological image processing systems.

Substantial Equivalence

MED-SEG™ is a PAC system that uses the same software technology, and complies with the same recognized consensus standards as its predicate device. It has the same intended use and indications for use as the predicate system and therefore is substantially equivalent.

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

Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an eagle-like symbol in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the perimeter of the circle.

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

Bartron Medical Imaging, Inc. % Zvi Ladin, Ph.D. Principal Boston Medtech Advisors, Inc. 990 Washington Street, Suite 204 DEDHAM MA 02026

JUL 2 6 2010

Re: K092328

Trade/Device Name: MED-SEGTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 5, 2010 Received: February 16, 2010

Dear Dr. Ladin:

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. Isting 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

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

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,

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Indications for Use

JUL 2 6 2010

510(k) Number (if known): K092328

Device Name:	MED-SEG™
--------------	----------

Indications For Use:

Only DICOM "for presentation" uncompressed or non-lossy compressed images can be used on an FDA cleared or approved monitor for primary image diagnosis in mammography.

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 IF NEEDED)

Concurrence of CDRH, @ffice of Beview Evaluation (ODE) OTV(

signature

(Division Sign-Of Division of Raulological Devices Office of In Vitro Diagnostic Devices Exaluation and Safety

510K K692328

Page 1 of

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).