The PacsSCAN Medical Imaging Software with QC Module is intended to be used by authorized staff to perform various quality control operations on PACSGEAR imaging studies before they are made available to other locations in the network. These operations include scanning film images, capturing video images, confirming or editing patient demographics, reviewing the history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.

Device Description

The PacsSCAN Medical Imaging Software with OC Module is intended to be used by authorized staff to perform various quality control operations on PacsSCAN imaging studies before they are made available to other locations in the network. These operations include digitizing film images, capturing video images, confirming or editing patient demographics, reviewing the history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the PacsSCAN Medical Imaging Software with QC Module, based on the provided 510(k) summary:

Summary of Device Performance and Acceptance Criteria

A primary function of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device. For the PacsSCAN Medical Imaging Software with QC Module, the acceptance criteria are implicitly defined by directly comparing its functionalities to those of the predicate device, RadWorks Medical Imaging Software with Quality Control Module (K982862). The study described for this submission is a software validation that verifies the device meets its intended use and established specifications, which are intrinsically linked to the predicate's capabilities.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Functionality	Acceptance Criteria (Predicate: RadWorks)	Reported Device Performance (PacsSCAN)
Digitize film	Yes	Yes
Capture video	Yes	Yes
Edit patient demographics	Yes	Yes
Review reports/study history	Yes	Yes
Add/remove images	Yes	Yes
Combine studies	Yes	Yes
Renumber Images	Yes	Yes
Edit patient orientation information	Yes	Yes
Set/edit routing information	Yes	Yes
Image review (Flip/Rotate/Pan/Zoom)	Flip/Rotate/Pan/Zoom	Flip/Rotate/Pan/Zoom
JPEG lossy/lossless compression	Yes	Yes and JPEG2000 lossy/lossless compression
LUT compensation	Yes (manual)	Yes (automatic)
Image processing (segmentation, smoothing)	Yes	Yes
DICOM Print	Yes	Yes

Interpretation of Acceptance: The device is considered to meet the acceptance criteria if it functions similarly or equivalently to the predicate device for all listed capabilities. In some cases, like JPEG2000 compression and automatic LUT compensation, the PacsSCAN device demonstrates enhanced functionality compared to the predicate, which is acceptable in a 510(k) as long as it doesn't introduce new safety or effectiveness concerns.

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

The provided 510(k) summary does not explicitly state a specific sample size for a "test set" in terms of patient data or images. The study described is a "Software validation" which typically involves testing the software's functionalities against established requirements and specifications. This would usually be a functional and performance testing approach rather than a clinical study with a patient data test set.

Sample Size (Test Set): Not specified in terms of patient data/images. The "test set" would be the software itself and its various functions.
Data Provenance: Not applicable in the context of a clinical test set from patient data. The validation would involve internal testing scenarios and simulated data to verify software functionality.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the 510(k) summary. Given the nature of the device (medical imaging software for QC operations), the "ground truth" for software validation would be the functional requirements and specifications derived from the predicate device and the intended use. These are typically established by software engineers, quality assurance personnel, and potentially input from clinical users (e.g., radiologists, PACS administrators) to define how the software should perform.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple readers interpret images to establish a consensus ground truth. For software validation of a QC module, the 'adjudication' would be against the defined software requirements and expected outputs.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done or at least not reported in this 510(k) summary. This type of study is usually conducted for diagnostic AI/CAD devices to demonstrate improved reader performance with AI assistance. The PacsSCAN device is a QC module, whose primary function is to manage and process images, not to provide diagnostic interpretations.

Effect Size of Human Readers Improvement with AI: Not applicable, as an MRMC study was not performed.

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

Yes, in essence. The "Software validation" described would inherently evaluate the algorithm's performance in a standalone manner. The device's functions (digitizing, capturing, editing, combining, etc.) are performed by the software itself, and the validation would confirm that these operations execute as intended and meet their specifications, independent of real-time human diagnostic input.

7. Type of Ground Truth Used

The ground truth used for the software validation would be:

Functional Requirements and Specifications: Each feature (e.g., "Digitize film," "Edit patient demographics") has a defined expected behavior and output. The software validation tests against these pre-defined behaviors.
Comparison to Predicate Behavior: The predicate device's known functionalities serve as the benchmark for many of the "acceptance criteria."

The ground truth is therefore based on engineering specifications and comparative functional parity with the predicate, rather than medical outcomes, pathology, or expert consensus on clinical findings.

8. Sample Size for the Training Set

This information is not applicable and not provided. The PacsSCAN Medical Imaging Software with QC Module is not described as an AI/ML-based device that requires a training set in the conventional sense (i.e., for learning from data to make predictions or classifications). It is a software application designed to perform specific quality control operations. Its development would involve traditional software engineering and testing, not training on a dataset.

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

This information is not applicable and not provided for the same reasons as #8. The device is not an AI/ML model that would have a "training set" with associated ground truth for learning.

Summary

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K083618

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

Submitter Information:

PACSGEAR, Inc. 7020 Koll Center Pkwy. Suite 100 Pleasanton, CA 94566

JAN 2 8 2009

Date Summary Prepared:

July 2, 2008

Contact Person:

Ian P. Gordon Emergo Group, Inc. Telephone: 512-327-9997 Fax: 512-327-9998

Device Name:

Trade Name(s): PacsSCAN Medical Imaging Software with QC Module Classification Name: Image Processing System Classification Regulation: 892.2050 Panel: Radiology Product Code: LLZ

Predicate Device Information:

Device Name: RadWorks Medical Imaging Software with Quality Control Module Manufacturer: Applicare Medical Imaging, B.V. Reference: K982862

Device Description:

Intended Use:

The PacsSCAN Medical Imaging Software with QC Module is intended to be used by authorized staff to perform various quality control operations on PACSGEAR imaging studies before they are made available to other locations in the network. These operations include scanning film images, capturing video images, confirming or editing patient demographics, reviewing the history of the study, adding or removing images. combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.

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Specification	PACSGEAR MedicalImaging Software	RadWorks MedicalImaging Software
Digitize film	Yes	Yes
Capture video	Yes	Yes
Edit patient demographics	Yes	Yes
Review reports/studyhistory	Yes	Yes
Add/remove images	Yes	Yes
Combine studies	Yes	Yes
Renumber Images	Yes	Yes
Edit patient orientationinformation	Yes	Yes
Set/edit routing information	Yes	Yes
Image review	Flip/Rotate/Pan/Zoom	Flip/Rotate/Pan/Zoom
JPEG lossy/losslesscompression	Yes and JPEG2000lossy/lossless compression	Yes
LUT compensation	Yes (automatic)	Yes (manual)
Image processing (imagesegmentation, imagesmoothing)	Yes	Yes
DICOM Print	Yes	Yes

Comparison to Predicate Device:

Testing and Conclusions:

Software validation has established the device's ability to meet its intended use and established specifications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PACSGEAR, Inc. JAN 2 8 2009 c/o Mr. Ian Gordon Senior Vice President Emergo Group, Inc. 1705 S. Capitol of Texas Highway, Suite 500 AUSTIN TX 78746

Re: K083618

Trade/Device Name: PacsSCAN Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 20, 2008 Received: December 9, 2008

Dear Mr. Gordon:

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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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; 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-011
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-011
21 CFR 892.xxx	(Radiology)	(240) 276-012
Other		(240) 276-010

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.support/ind/subml/

Sincerely yours.

Janine M. Morris

Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 1083618

Device Name: PacsSCAN Medical Imaging Software with QC Module

Indications for Use: The PacsSCAN Medical Imaging Software with QC Module is intended to be used by authorized staff to perform various quality control operations on PACSGEAR imaging studies before they are made available to other locations in the network. These operations include scanning film images, capturing video images, confirming or editing patient demographics, reviewing the history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.

Prescription Use XX (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, Office of Device Evaluation (ODE)

(Division Sign-off)

Division of Reproductive, Abdominal a Radiological Devices 510(k) Number

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).