Advanced Lung Analysis II is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lesions, etc.) from a set of Computed Tomography (CT) images.

The software is designed to support the physician in confirming the presence or absence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. ALA II software allows analysis and displays statistics for nodule characterization all the different nodule types.

ALA II optional Digital Contrast Agent (DCA) module is an automated highlight feature for the visual identification of possible lesions. Digital Contrast Agent (DCA) is a 3D filter that produces images that highlight spherical (S) and cylindrical (C) anatomical regions, such as nodules, cysts, scars, and vessels. Images are made available to the physician to aid in characterization of suspicious nodules and thus, the patient management care decision process.

ALA II provides to physician with additional information, meant to complement diagnosis based on classical techniques.

Device Description

CT Advanced Lung Analysis (ALA 2 / ALA II) is a post processing analysis software package designed to assist radiologists and other clinicians in the evaluation and assessment of nodules and other lesions in the lung.

Advanced Lung Analysis II provides an effective solution for providing quick analysis and measurements to help differentiate the radiologist's findings during the primary read. The software assesses and measures all lung nodule types, including measuring volume and their changes over time. Following a C1 scan, the user clicks on a specific nodule and the software automatically calculates and displays a 3-dimensional volume and rendering of the nodule as well as the associated measurements. Advanced Lung Analysis II also offers functionality for quick comparisons between the current and previous patient procedures.

The Digital Contrast Agent (DCA) option will further compliment the Radiologist's diagnostic capability by highlighting spherical (S) and cylindrical (C) anatomical regions, such as nodules, cysts, scars. and vessels.

ALA II and DCA are software options that operate on the GE family of LightSpeed multi-slice CT scanners. Advantage Workstation 4.2 (or higher), and GE PACS systems.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study details for the Advanced Lung Analysis II device:

Important Note: The provided 510(k) summary (K042694) for "Advanced Lung Analysis II" does not contain specific details about acceptance criteria, a dedicated study proving device performance against those criteria, or quantitative performance metrics. This 510(k) relies heavily on demonstrating substantial equivalence to predicate devices (Advanced Lung Analysis I and LungCare CT) by stating that "The Advanced Lung Analysis II docs not result in any new potential safety risks and performs as well as devices currently on the market."

Therefore, much of the requested information (like specific acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment methods for training and test sets) is not present within this document. The summary focuses on product description, indications for use, and a general statement of equivalence.

Acceptance Criteria and Device Performance

Since explicit acceptance criteria and corresponding reported performance are not detailed in the provided 510(k) summary, this section is largely based on the general statements made about the device's function and equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Indications of Use and Equivalence Statement)	Reported Device Performance (Inferred from Equivalence Statement)
Accuracy in measuring lung abnormalities (nodules, lesions): Specifically, measuring volume and changes over time using a consistent standardized measurement protocol, and estimating volume doubling time.	"performs as well as devices currently on the market" (Predicate devices: Advanced Lung Analysis I and LungCare CT, which are presumed to fulfill this criterion).
Ability to support physicians in confirming presence/absence of identified lung lesions.	"performs as well as devices currently on the market" (Predicate devices).
Ability to analyze and display statistics for different nodule types.	"performs as well as devices currently on the market" (Predicate devices).
Effectiveness of Digital Contrast Agent (DCA) module in highlighting spherical and cylindrical anatomical regions (e.g., nodules, cysts, scars, vessels).	"performs as well as devices currently on the market" (Predicate devices).
No new potential safety risks compared to predicate devices.	Controlled by "Software Development, Validation and Verification Process" and "Adherence to industry and international standards." Implied to have no new risks given clearance.

Study Details (Based on available information in the 510(k) summary)

The 510(k) summary does not describe a specific clinical or performance study with quantitative results to prove the device meets acceptance criteria. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices (Advanced Lung Analysis I and LungCare CT) and mentions general "Software Development, Validation and Verification Process" and adherence to standards.

2. Sample size used for the test set and the data provenance:
* Sample size for test set: Not specified in the document.
* Data provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not specified in the document. The general statement refers to the device assisting "radiologists and other clinicians," but details about expert involvement in a test set are absent.

4. Adjudication method for the test set:
* Not specified in the document.

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 or detailed in the provided 510(k) summary. The document does not provide any data or discussion on human reader improvement with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* No standalone performance study is mentioned or detailed in the provided 510(k) summary. The device is described as "designed to assist radiologists and other clinicians," implying a human-in-the-loop context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not specified in the document. The document refers to "physician identified lung lesions" in its indications, suggesting that clinical interpretation is central, but how ground truth was formally established for any testing is not described.

8. The sample size for the training set:
* Not specified in the document.

9. How the ground truth for the training set was established:
* Not specified in the document.

Summary of Missing Information:

It is crucial to re-emphasize that this 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone performance study with detailed acceptance criteria and empirical evidence. Therefore, most of the quantitative and methodological details typically found in such a study are absent from this document. The "study" mentioned is the overall "Software Development, Validation and Verification Process" and "Adherence to industry and international standards," which are general quality control measures rather than a specific performance evaluation study with the requested metrics.

Summary

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Ko42694 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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

Submitter Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager Tel: (262) 544-3894 Fax: (262) 544-4768 GE Medical Systems W-400 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: July 15, 2004

PRODUCT IDENTIFICATION

Name:	Advanced Lung Analysis II
Classification Name:	Accessory to Computed Tomography System
Manufacturer:	General Electric Medical Systems283, rue de la Minière78533 Buc Cedex, FRANCE
Distributor:	General Electric Medical Systems, Buc, France.

Marketed Devices The Advanced Lung Analysis II is substantially equivalent to the devices listed below:

• Model:	Advanced Lung Analysis I
• Manufacturer:	General Electric Medical Systems, Buc - France
• 510(k) #:	K013381

Model: . LungCarc CT
. Manufacturer: Siemens, Malvern - PA19355 510(k) #: K033374

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Device Description:

K04269y

ALA II and DCA are software options that operate on the GE family of LightSpeed multi-slice CT scanners. Advantage Workstation 4.2 (or higher), and GE PACS systems.

Indications for Use:

The software is dcsigned to support the physician in confirming the presence or absence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. ALA II software allows analysis and displays statistics for nodule characterization all the different nodule types.

ALA II provides to physician with additional information, meant to complement diagnosis based on classical techniques.

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Comparison with Predicate:

K042694

The functional features of Advanced Lung Analysis II software package are substantially equivalent to that of the following device:

Device Name	FDA Clearance Number
Advanced Lung Analysis I	K013381
LungCare CT	K033374

Adverse Effects on Health:

The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:

· Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
· Adherence to industry and international standards.

Conclusions:

The Advanced Lung Analysis II docs not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the Advanced Lung analysis II to be equivalent to those of Advanced Lung Analysis I (K013381) and LungCare CT (K033374).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

MAR 1 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems % Mr. Daniel W. Lehtonen Staff Engineer Intertek Testing Services 70 Codman Hill Road BOXBOROUGH MA 01719

K042694 Re: Trade/Device Name: Advanced Lung Analysis II Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: OEB Dated: November 8, 2004 Received: November 9, 2004

Dear Mr. Lehtonen:

This letter corrects our substantially equivalent letter of November 18, 2004.

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 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 (OS) 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) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

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 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.suppot/index.html.

Sincerely yours,

Image /page/4/Picture/7 description: The image shows a black and white close-up of a handwritten symbol or character. The symbol consists of a curved line that starts thick and tapers to a point, resembling a stylized letter or abstract design. The stroke appears fluid and calligraphic, suggesting it was created with a brush or pen.

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 042694

510(k) Number (if known):

Device Name:

ADVANCED LUNG ANALYSIS II

Indications for Use:

ALA II provides to physician with additional information, meant to complement diagnosis based on classical techniques.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Hanson

Division of Reproductive, Abdom and Radiological Device

Page

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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).