The AlphaPoint software is a device that allows review, analysis, and interchange of CT chest images. It is intended for use with CT Chest images to assist medical professionals in image analysis. It is not intended to be the primary interpretation. The software provides segmentation and Hounsfield numerical analysis values which are indicative of various substances (i.e., air, lung, soft tissue, fat, water, transudate, exudate, blood, muscle and bone). The user can review, verify and correct the results of the system and generate a report of the findings.

Device Description

The AlphaPoint system provides a full application framework with integration to PACS using DICOM. The system has the following functions:

Communicates with PACS to get imaging studies for processing; .
Activates one or more applications that process the imaging data . and use segmentation and Hounsfield measurements algorithms to find and measure various attributes in the images, and also identify particular slices as references images for the findings ;
Formats the processing results for each study into a Preliminary . Findings Report
Sends the results to PACS. .
The software is written in C++, C# and Matlab. .

AI/ML Overview

The provided text does not contain the detailed performance study results, acceptance criteria, or specific information about the test set (sample size, data provenance, ground truth establishment, or expert qualifications) that would allow for a comprehensive answer to your request.

The document is a 510(k) summary and FDA clearance letter for the AlphaPoint Imaging Software. It primarily focuses on:

Device Description and Intended Use: What the device does and what it's for.
Substantial Equivalence: How it compares to a predicate device.
Verification and Validation Statement: A general statement that the software underwent V&V processes according to company procedures and FDA guidance, including DICOM compliance testing and internal software testing (unit tests, system testing). It mentions a Software Test Description (STD) specifying acceptance criteria and a Software Test Report (STR) documenting results, but these documents themselves are not included or summarized in detail in the provided text.

Therefore, I cannot populate the table or answer most of your specific questions about the performance study.

Here's what can be extracted and what information is missing:

Missing Information:

Specific Acceptance Criteria: The document states that the STD "describes the test cases for the device, along with its acceptance criteria," but it does not list these criteria or the associated reported device performance.
Detailed Device Performance: Beyond DICOM compliance, there are no specific metrics (e.g., accuracy, precision, sensitivity, specificity for segmentation or Hounsfield analysis) reported.
Sample Size for Test Set: Not mentioned.
Data Provenance (country, retrospective/prospective): Not mentioned.
Number of Experts/Qualifications for Ground Truth: Not mentioned.
Adjudication Method: Not mentioned.
MRMC Comparative Effectiveness Study: No mention of such a study.
Standalone Performance: While the device acts as an algorithm (software), specific standalone performance metrics (e.g., accuracy of its segmentation compared to ground truth) are not provided.
Type of Ground Truth: Not mentioned how ground truth was established for "segmentation and Hounsfield numerical analysis" beyond general V&V.
Sample Size for Training Set: Not mentioned.
How Ground Truth for Training Set was Established: Not mentioned.

Available Information (or lack thereof, based on your questions):

Information Point	Details from Provided Text
1. Table of Acceptance Criteria and Reported Device Performance	Cannot be provided. The text states that the "Software Test Description (STD) for the Alphapoint System describes the test cases for the device, along with its acceptance criteria, and the detailed test procedure." It also mentions DICOM compliance testing, which "passed the six DICOM specific test cases." However, no specific performance metrics (e.g., accuracy for segmentation) or detailed acceptance criteria for the core functions (segmentation, Hounsfield analysis) are present in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)	Not specified. The document mentions "test cases for the device" and "validation test runs" but does not detail the size or nature of the dataset used for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts	Not specified. There is no information regarding the establishment of ground truth by experts for any dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) 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 indication that an MRMC comparative effectiveness study was done. The device's intended use states it "is not intended to be the primary interpretation" and "assist medical professionals," suggesting an assistive role, but no study comparing human performance with and without the device is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done	Implicitly, yes, for certain functional aspects, but no performance metrics are given. The document states the system "Activates one or more applications that process the imaging data and use segmentation and Hounsfield measurements algorithms to find and measure various attributes in the images." Testing for DICOM compliance and internal "unit tests and system testing" would evaluate the algorithm's functionality in a standalone manner. However, specific standalone performance (e.g., accuracy of algorithm segmentation vs. expert ground truth) is not reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)	Not specified. While the software performs "segmentation and Hounsfield numerical analysis," the method for establishing the "correct" segmentation or Hounsfield values for validation is not described.
8. The sample size for the training set	Not applicable/Not specified. The document does not describe the device as a machine learning/AI model that undergoes a "training" phase with a separate training set. It describes algorithms for segmentation and Hounsfield measurements. If these algorithms are more traditional image processing rather than learned AI models, a training set might not exist in the conventional sense. Even if it were an AI model, the training set size is not mentioned.
9. How the ground truth for the training set was established	Not applicable/Not specified. As above, a "training set" is not mentioned in the context of this device's development as described.

Summary

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510(k) Summary Prepared January 7, 2011

APR 1 3 2012

Sponsor:	RadLogics, Inc.
Contact Person:	Moshe Becker
Telephone:	408 966 4874
Fax:	408 966 4874
Submission Date:	December 6, 2011
Device Name:	AlphaPoint Imaging Software
Common Name:	Imaging Software
Classification:Regulatory Class:Review Category:Classification Panel:	IIClass IIRadiologySystem, Imaging Processing ; 21 CFR 892.2050; LLZ

A. Legally Marketed Predicate Devices

The modified software is substantially equivalent to the Vitrea 2 software manufactured by Vital Images, Inc. and cleared pursuant to K060378.

B. Device Description:

The AlphaPoint system provides a full application framework with integration to PACS using DICOM. The system has the following functions:

Communicates with PACS to get imaging studies for processing; .
Activates one or more applications that process the imaging data . and use segmentation and Hounsfield measurements algorithms to find and measure various attributes in the images, and also identify particular slices as references images for the findings ;
Formats the processing results for each study into a Preliminary . Findings Report
Sends the results to PACS. .
The software is written in C++, C# and Matlab. .

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C. Intended Use

ﻨﺎ

The AlphaPoint software is a device that allows review, analysis, and interchange of CT chest images. It is intended for use with CT Chest images to assist medical professionals in image analysis. It is not intended to be the primary interpretation. The software provides segmentation, Hounsfield numerical analysis, and substance indication. The user can review, verify and correct the results of the system and generate a report of the findings.

D. Substantial Equivalence

The submission device is substantially equivalent to the predicate software device with regard to both intended use and technological characteristics. Both devices retrieve and process chest images from Computed Tomography (CT), Both systems are DICOM compliant.

E. Performance Data

The AlphaPoint software has been verified and validated according to the company's design control process. It was tested for compliance with the DICOM Standard and passed the six DICOM specific test cases provided in Section 4.4.2 of the Validation Test Report. The software development process complies with FDA Guidance documents related to software in Medical Devices and all of the documents specified have been submitted in the 510(k) Notification and can be summarized as follows

The software development life cycle includes various verification activities and the formal software validation. The software verification activities include design reviews, code reviews, unit tests and system testing.

The Software Test Description (STD) for the Alphapoint System describes the test cases for the device, along with its acceptance criteria, and the detailed test procedure. The test cases in the STD are traced to the requirements found in the SRS. The STD was developed using the template found in the IEEE Std 829-2008, IEEE Standard for Software Test Documentation and J-STD 016 (IEEE STD 1498), Software Development and Documentation.

The validation test runs were documented in the Software Test Report (STR) for the Alphapoint System. The STR contains the date, tester name, software versions, specific configurations used in the testing and the Pass/Fail grade for each test procedure step. The STR summarizes the validation assessment, which states that the software is ready for release. The STR was developed using the template found in the IEEE Std 829-2008, IEEE Standard for Software Test Documentation and J-STD 016 (IEEE STD 1498), Software Development and Documentation.

The validation was performed by a qualified independent software validation engineers who were not directly involved in the software design and implementation efforts. All anomalies have been resolved.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" 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

RadLogics, Inc. Mr. Mark Job Accredited Third Party Reviewer % Regulatory Technology Services Incorporated 1394 25th Street, NW BUFFALO MN 55313

APR 1 3 2012

Re: K120161

Trade/Device Name: AlphaPoint Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 20, 2012 Received: February 21, 2012

Dear Mr. Job:

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 (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,

Janine M. Morris

Acting 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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510(k) Number (if known):

Device Name:

AlphaPoint Imaging Software

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 Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices
Office of in Vitro Diagnostic Device Evaluation and Safety
510K
K120161

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).