Comprehensive software package for visualization and analysis of thoracic CT datasets, which is intended to help the reading physician to analyze regions of the lung, such as nodules and other lung parameters, and to generate an automatic report.

Device Description

The Acculmage PrimeLung software module is an additional software option to K990241, AccuView Diagnostics Imaging Workstation with AccuScore, AccuAnalyze, AccuShade, AccuVRT and AccuMIP plug-ins. The AccuShade plug-in is not currently marketed, the AccuMIP plug-in is currently marketed with the name ProjectorPro. The Acculmage PrimeLung plug-in provides visualization and analysis tools for viewing regions of the lung, and generating reports with patient information, images, results and recommendations.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:

Evaluation of Acceptance Criteria and Device Performance for PrimeLung (K024149)

Based on the provided 510(k) summary for PrimeLung (K024149), the information regarding acceptance criteria and performance studies is limited and primarily focuses on functional verification rather than clinical accuracy for diagnostic tasks.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for nodule detection or characterization). Instead, the "test results" section describes functional verification.

Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Graphic User Interface (GUI) conforms to functional specification	GUI, menus, and buttons conform as per PrimeLung functional specification.
All functionality works as described in functional specification	All functionality works as described in the PrimeLung Functional Specification.
Auto-matching comparison tool provides reliable results	100% matching accuracy on the specified data sets.
Report generator can be created and results printed	Report generator can be created and results can be printed.
Segmentation of lung nodule functionality	Yes (as per comparison table, but no performance metrics provided)
Volume measurements, comparator tool for nodule matching functionality	Yes (as per comparison table, but no performance metrics provided)
Visualization tools (MIP, MPR, 3D Volume Rendering) functionality	Yes (as per comparison table, but no performance metrics provided)

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

The document states: "The testing performed showed that auto-matching comparison tool provides very reliable results with 100% of matching accuracy on the specified data sets."

Sample Size: The exact sample size used for the "specified data sets" is not provided.
Data Provenance: The country of origin and whether the data was retrospective or prospective is not specified.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for any of the testing. The "100% matching accuracy" for the comparison tool implies that there was a reference standard, but how that standard was derived is not detailed.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

No, an MRMC comparative effectiveness study that assesses human reader improvement with AI assistance versus without AI assistance was not mentioned or reported in this 510(k) summary. The summary focuses on the device's functional equivalence to predicate devices and its own functional performance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The reported performance for the "auto-matching comparison tool" achieving "100% matching accuracy on the specified data sets" seems to be a standalone algorithm performance metric. However, this is a very specific function and not a comprehensive diagnostic standalone claim (e.g., for nodule detection or characterization).
The overall context of the device as "intended to help the user to analyze lung nodules" suggests it's an assistive tool, not a standalone diagnostic. Therefore, a comprehensive standalone performance study for diagnostic tasks was not explicitly stated or reported.

7. The Type of Ground Truth Used

For the "auto-matching comparison tool," the ground truth was likely established by manual matching performed by a human expert or a pre-defined reference, against which the automated matching was compared. The exact nature of this ground truth (e.g., consensus, pathology, follow-up) for general nodule analysis is not specified.
For other functionalities like GUI conformity and report generation, the "ground truth" is simply adherence to the functional specification.

8. The Sample Size for the Training Set

The document does not mention any training set or its sample size. This is consistent with the era of the submission (2002-2003) where deep learning and large-scale training datasets were not standard practice for medical device submissions of this type. The device's functionality appears to be based on more traditional image processing algorithms rather than machine learning requiring a distinct training phase.

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

As no training set is mentioned (see point 8), the method for establishing its ground truth is also not applicable/provided.

Summary of Study Limitations and Nature:

The "study" described in the 510(k) summary is primarily a functional verification test (also known as verification and validation testing) rather than a clinical performance study. It confirms that the software's user interface works as designed, its features perform their intended actions, and a specific "auto-matching comparison tool" achieves high accuracy for matching tasks on limited, unspecified data. It does not provide clinical performance metrics like sensitivity, specificity, or reader agreement for diagnostic tasks such as nodule detection or characterization, which are common in more recent AI/CADe submissions. The submission relies on substantial equivalence to predicate devices that also provided visualization and analysis tools.

Summary

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Section 1

Ko24149

510(K) Summary

(as required by 21 CFR § 807.92)

Date:

A. Submitter's Information:

Name:	Acculmage Diagnostics Corporation
Address:	400 Grandview DriveSouth San Francisco, CA 94080
Telephone Number:	(650) 875-0192
Fax Number:	(650) 875-0194
Contact Name:	Oscar Gils Carbó
Contact Email address:	oscar@accuimage.com
B. Device Information:
Proprietary Name:	PrimeLung
Common or Usual Name:	Lung nodule visualization and analysis softwarepackage.
Classification:	Class II 21 CFR 892.2050 LLZ
Substantial Equivalence:	The Acculmage PrimeLung option is SubstantiallyEquivalent to the Siemens Medical SolutionsLungcare CT Software Package, to the GE MedicalSystems Advanced Lung Analysis, and to theAcculmage AccuView Workstation with AccuScoresoftware module.
Device Description:	The Acculmage PrimeLung software module is anadditional software option to K990241, AccuViewDiagnostics Imaging Workstation with AccuScore,AccuAnalyze, AccuShade, AccuVRT and AccuMIPplug-ins. The AccuShade plug-in is not currentlymarketed, the AccuMIP plug-in is currentlymarketed with the name ProjectorPro. TheAcculmage PrimeLung plug-in providesvisualization and analysis tools for viewing regionsof the lung, and generating reports with patientinformation, images, results and recommendations.

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K02-4149

Intended Use:

PrimeLunq is a comprehensive software package for visualization and analysis of thoracic CT datasets, which is intended to help the user to analyze lunq nodules and other lung parameters, and to generate an automatic report.

C. Technological Characteristics of the Device as compared to Predicate Devices:

Manufacturer	Siemens MedicalSolutions	GE MedicalSystems	Acculmage DiagnosticsCorp.	AcculmageDiagnostics Corp.
Product Name	LungCare CT Software	Advanced LungAnalysis	AccuView Workstation withAccuScore, etc.	PrimeLung
510(k) Number	K022013	K013381	K990241/ K012106
Computer Platform	PC Workstation withWindows OperatingSystem	Sun Workstation	PC Workstation withWindows Operating System	PC Workstation withWindows OperatingSystem
Type of CT Scannerfor which it isapplicable	Standard or low-dosespiral CT scanners	At least helical CTscanners	Helical, Multidetector andElectron Beam CT scanners	Helical, Multidetectorand Electron Beam CTscanners
Draw, Edit, DeleteROI (possiblenodules	Yes	Yes	Yes	Yes
Image ProcessingTools	MIP, MPR, 3D VolumeRendering	Yes	MIP, MPR, 3D VolumeRendering	MIP, MPR, 3D VolumeRendering
Segmentation of lungnodule	Yes	Yes	n/a	Yes
Volumemeasurements,Comparator tool fornodule matching	Yes	Yes	n/a	Yes
Report Generator	Yes	Unknown	Yes	Yes

Substantial Equivalence Comparison Chart

D. Brief Discussion of Test Results Submitted:

The test plan covers all aspects of the functionality, exercising every user interface button, all menus and submenus, as well as all configurable items, including the measurement tool, segmentation tool and report generator tool.

E. Conclusions from Test Results:

From the Graphic User Interface test results: The Graphic User Interface, its menus and buttons conform as per the PrimeLung functional specification.

From a functionality point of view, all functionality works as described in the PrimeLung Functional Specification.

From Comparison Tool test results:

The testing performed showed that auto-matching comparison tool provides very reliable results with 100% of matching accuracy on the specified data sets.

From Report Generator Test results:

ests results show that the report generator can be created and results can be printed.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2003

Mr. Oscar Gils Carbó Vice President Acculmage Diagnostics Corporation 400 Grandview Drive SOUTH SAN FRANCISCO CA 94080 Re: K024149

Trade/Device Name: PrimeLung Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: December 6, 2002 Received: December 16, 2002

Dear Mr. Carbó:

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 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.

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.

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

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This letter will allow you to begin marketing your device as des

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

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Section 1.1

Ko2449

INDICATIONS FOR USE

Applicant:

Acculmage Diagnostics Corporation

510(k) Number: K024149

PrimeLung Device Name:

Indications for Use:

Prescription Use
(Per 21 CFR 801.109)

Nancy Hodsdon

(Division Sig Division of Re and Radiolog 510(k) Num

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.