The Imbio CT Lung Density Analysis Software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. The Imbio CT Lung Density Analysis Software can be used to support the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation of sub-compartments, volumetric analysis, density evaluations and reporting tools are provided.

Device Description

The Imbio CT Lung Density Analysis Software (Imbio LDA) is a set of image post-processing algorithms that perform image segmentation, registration, thresholding, and classification on CT images of human lungs. The algorithms within the Imbio CT Lung Density Analysis Software are combined into a single command-line executable program that may be run directly from the command-line or through scripting. The Imbio CT Lung Density Analysis Software program performs segmentation, then registration, then thresholding and classification. The program reads in DICOM datasets, processes the data, then writes output DICOM files to a specified directory. The Imbio CT Lung Density Analysis Software is a command-line software application that analyzes DICOM CT lung image datasets and generates reports and DICOM output that show the lungs segmented and overlaid with color-codings representing the results of its thresholding and classification rules. It has simple file management functions for input and output, and separate modules that implement the CT image-processing algorithms. Imbio CT Lung Density Analysis Software does not interface directly with any CT or data collection equipment; instead the software imports data files previously generated by such equipment.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Imbio CT Lung Density Analysis Software, based on the provided FDA 510(k) summary:

This device is cleared under a 510(k), which means it demonstrates substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" here refers more to the demonstration that the device's performance aligns with its specifications and is comparable to the predicate, rather than meeting specific clinical efficacy thresholds.

Study that proves the device meets the acceptance criteria:

The study primarily focused on non-clinical testing to demonstrate substantial equivalence to the predicate device (VIDA Pulmonary Workstation 2 (PW2), K083227).

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) summary focused on substantial equivalence through non-clinical testing, specific quantitative "acceptance criteria" and "reported performance" in a typical clinical trial sense are not explicitly provided with numerical thresholds. Instead, the acceptance criteria were implicitly "functional equivalence," "accurate segmentation," and "accurate thresholding" compared to the predicate device and the ground truth derived from the datasets.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicate: Performs similar image post-processing (segmentation, registration, thresholding, classification) for CT lung images.	The Imbio CT Lung Density Analysis Software imports CT DICOM data, analyzes it, and produces reports with quantitative and graphical results, similar to the predicate. "Direct quantitative comparisons using the same CT lung scans yielded similar results." Differences (command-line interface vs. GUI, automated vs. manual inspiration/expiration registration, lack of interactive visualization, low-density cluster analysis, and airway report compared to predicate) were deemed not to affect efficacy and safety.
Accurate Scan Processing Completion: Software successfully processes all scans as expected.	"Direct predicate comparison for scan processing completion" was performed, indicating successful processing.
Accurate Segmentation: Correctly identifies and separates anatomical structures (e.g., lungs).	"Direct predicate comparison for... segmentation" was performed, indicating accurate segmentation.
Accurate Thresholding: Applies density thresholds correctly for classification.	"Direct predicate comparison for... thresholding" was performed, indicating accurate thresholding.
Specification Compliance: Software functions according to its stated specifications.	"Software verification and validation testing for each requirement specification" was conducted.
Algorithmic Functionality: Each algorithmic function performs as intended.	"Software verification and validation testing for each algorithmic function" was conducted.
System Reliability: Software operates reliably at unit, integration, and system levels.	"Software verification and validation testing at the unit, integration, and system level" was conducted.
Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to the predicate device.	The conclusion states: "It has been shown in this 510(k) submission that the differences between the Imbio CT Lung Density Analysis Software and the VIDA PW2 (K0832277) do not raise any questions regarding safety and effectiveness."

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

Sample Size: Not explicitly stated as a number of patients or cases. The document mentions "CT datasets available upon request from the COPDGene study (www.copdgene.org) and the DIR-Lab (www.dir-lab.com)." These are large, publicly available research datasets, implying a potentially substantial number of cases were available for testing.
Data Provenance:
- Country of Origin: Not specified for individual cases, but COPDGene is a multi-center study in the United States. DIR-Lab also sources data, often from US institutions. So, likely predominantly USA.
- Retrospective or Prospective: The use of "available upon request" datasets like COPDGene and DIR-Lab strongly suggests a retrospective analysis of existing data.

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

This information is not provided in the summary. Since the testing was primarily non-clinical and involved comparing software output to established datasets and a predicate device, explicit expert ground truth labeling for a test set (e.g., by radiologists) is not detailed. The "ground truth" for segmentation and density measurements would be derived from the inherent data characteristics and comparison to the predicate's outputs, which are themselves based on accepted medical imaging principles.

4. Adjudication Method for the Test Set:

Not applicable/Not specified. Given the nature of the non-clinical testing focused on software functionality and comparison to a predicate, an expert adjudication process (like 2+1 reading) is not described. The "direct predicate comparison" served as a primary reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement:

No, an MRMC comparative effectiveness study was not done. The summary explicitly states: "This technology is not new, therefore a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone performance assessment was effectively done. The non-clinical testing detailed ("Direct predicate comparison for scan processing completion, segmentation, and thresholding," and "Software verification and validation testing for each requirement specification," "each algorithmic function," and "at the unit, integration, and system level") assesses the algorithm's performance directly, without human intervention during the processing steps.

7. The Type of Ground Truth Used:

The primary "ground truth" for the non-clinical testing was:
- Reference standard from public datasets: The inherent, accepted characteristics of the COPDGene and DIR-Lab CT datasets regarding lung anatomy and density.
- Comparison to Predicate Device Output: The outputs of the legally marketed predicate device (VIDA PW2) on the same CT lung scans were used as a primary comparative reference, implying that the predicate's performance served as a de facto "ground truth" for equivalence.
- Software Specifications: The internal design specifications and expected behaviors of the Imbio software itself were also used as a basis for verification and validation.

8. The Sample Size for the Training Set:

Not specified. The document mentions the use of COPDGene and DIR-Lab datasets for "non-clinical testing" and verifying function. It does not provide details on how the training of the algorithms (if applicable, for example, for segmentation models) was performed or the specific datasets and sample sizes used for that purpose. This summary is focused on the verification and validation of the final product for regulatory submission.

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

Not specified. As the training set details are not provided, neither is the method for establishing its ground truth. However, for algorithms like segmentation and density analysis, ground truth for training would typically involve manual annotation by expert radiologists or technologists, or derived from other well-established imaging techniques or pathological correlation, depending on the algorithm's specifics.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 17, 2014

Imbio LLC % Mr. Jason Sheard Director of Operations 227 Colfax Avenue N., Suite 144 MINNEAPOLIS MN 55405

Re: K141069

Trade/Device Name: Imbio CT Lung Density Analysis Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 14, 2014 Received: August 19, 2014

Dear Mr. Sheard:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041

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or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh.f)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141069

Device Name Imbio CT Lung Density Analysis Software

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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5 510(k) Summary

510(k) Summary (As required by Section 21 CFR 807.92(c))
Submitter:	Imbio LLC227 Colfax Ave N, Suite 144Minneapolis MN 55405 USA
Contact Person:	Jason SheardDirector of OperationsTelephone: 612-520-7360Email: jasonsheard@imbio.comImbio LLC227 Colfax Ave N, Suite 144Minneapolis MN 55405 USA
Date Prepared:	August 14, 2014
Trade Name:	Imbio CT Lung Density Analysis Software
Common/Usual Name:	Software Accessory to a Computed Tomography Device
Classification:	21 CFR 892.1750Product Code 90 JAK, Class IIComputed tomography x-ray system
Product Code:	90 JAK, Class II
Manufacturer:	Imbio LLC227 Colfax Ave N, Suite 144Minneapolis MN 55405 USA
Establishment Registration:	N/A
Predicate Device:	Manufacturer:	VIDA Diagnostics
	Trade name:	VIDA Pulmonary Workstation 2 (PW2)
	510(k) Number:	K083227
	Date Cleared:	November 18, 2008
510(k) Summary (As required by Section 21 CFR 807.92(c))
Device Description	The Imbio CT Lung Density Analysis Software (Imbio LDA) is a set of imagepost-processing algorithms that perform image segmentation, registration,thresholding, and classification on CT images of human lungs.The algorithms within the Imbio CT Lung Density Analysis Software arecombined into a single command-line executable program that may be rundirectly from the command-line or through scripting. The Imbio CT LungDensity Analysis Software program performs segmentation, thenregistration, then thresholding and classification. The program reads inDICOM datasets, processes the data, then writes output DICOM files to aspecified directory.The Imbio CT Lung Density Analysis Software is a command-line softwareapplication that analyzes DICOM CT lung image datasets and generatesreports and DICOM output that show the lungs segmented and overlaidwith color-codings representing the results of its thresholding andclassification rules. It has simple file management functions for input andoutput, and separate modules that implement the CT image-processingalgorithms. Imbio CT Lung Density Analysis Software does not interfacedirectly with any CT or data collection equipment; instead the softwareimports data files previously generated by such equipment.
Intended Use	The Imbio CT Lung Density Analysis Software provides reproducible CTvalues for pulmonary tissue, which is essential for providing quantitativesupport for diagnosis and follow up examinations. The Imbio CT LungDensity Analysis Software can be used to support the physician in thediagnosis and documentation of pulmonary tissue images (e.g.,abnormalities) from CT thoracic datasets. Three-D segmentation andisolation of sub-compartments, volumetric analysis, density evaluations,and reporting tools are provided.
510(k) Summary (As required by Section 21 CFR 807.92(c))
Summary of Technical Comparisons	Similarities:Both the predicate device and the Imbio CT Lung Density Analysis Software are software applications that import CT DICOM data files, analyze them, and produce reports with quantitative and graphical results. The functionality of Imbio CT Lung Density Analysis Software is substantially equivalent to the predicate device. Direct quantitative comparisons using the same CT lung scans yielded similar results.Differences:The Imbio Lung Density Analysis Software provides a command-line interface, while the predicate device provides a graphic user interface. The Imbio Lung Density Analysis Software provides automated registration of the Inspiration / Expiration image pairs, while this registration is manual (i.e., visually performed by the radiologist) with the predicate device. The predicate device provides an interactive visualization of the reconstructed three-dimensional volume, low-density cluster analysis, and an airway report. These features are not part of the Imbio CT Lung Density Analysis Software. These differences do not affect the efficacy and safety of the Imbio CT Lung Density Analysis Software.
Non-Clinical Testing	The following testing was conducted on Imbio CT Lung Density Analysis Software by analyzing CT datasets available upon request from the COPDGene study (www.copdgene.org) and the DIR-Lab (www.dir- lab.com): Direct predicate comparison for scan processing completion, segmentation, and thresholding. This was done to verify that the software functions according to its specifications and to support substantial equivalence. Software verification and validation testing for each requirement specification. Software verification and validation testing for each algorithmic function. Software verification and validation testing at the unit, integration, and system level The following quality assurance measures were applied during software development: Software Development Life Cycle Software Risk Assessment. Risk Assessment of Off-the-Shelf (OTS) Software. Software Configuration Management and Version Control. Software issue tracking and resolution
510(k) Summary (As required by Section 21 CFR 807.92(c))
Design Validation	Design validation was performed using the Imbio CT Lung Density AnalysisSoftware in actual and simulated use settings. The results supportsubstantial equivalence to the predicate device and demonstrate that theImbio CT Lung Density Analysis Software is safe for its intended use.
Clinical Testing	This technology is not new, therefore a clinical study was not considerednecessary prior to release. Additionally, there was no clinical testingrequired to support the medical device as the indications for use isequivalent to the predicate device. The substantial equivalence of thedevice is supported by the non-clinical testing.
Conclusion:	We conclude that the results of testing show the Imbio CT Lung DensityAnalysis Software to be substantially equivalent to the predicate device.The Imbio CT Lung Density Analysis Software has the same technologicalcharacteristics as the predicate device in that it has a similar intended use,same general operating principle, and same technology. The specificdetails of the predicate device may vary from those of Imbio CT LungDensity Analysis Software, but testing shows that similar results areproduced.It has been shown in this 510(k) submission that the differences betweenthe Imbio CT Lung Density Analysis Software and the VIDA PW2(K0832277) do not raise any questions regarding safety and effectiveness.The Imbio CT Lung Density Analysis Software, as designed andmanufactured, is substantially equivalent to, and as safe and effective as,the referenced predicate device.

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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.