The Thirona LungQ software provides CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The Lung Q software can be used to support physician in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluation, fissure evaluation, and reporting tools are provided.

Device Description

The LungQ software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. LungQ is standalone command-line software which must be run from a command-line interpreter and does not have a graphical user interface.

AI/ML Overview

The provided text describes two non-clinical performance studies conducted for the LungQ software: an "Equivalence study" and "Additional performance testing of Thirona LungQ fissure analysis."

Here's a breakdown of the acceptance criteria and study details for the Equivalence Study, as it is the primary study proving the device meets general acceptance criteria by demonstrating equivalence to a predicate device:

1. A table of acceptance criteria and the reported device performance

Measurement type	Acceptance Criteria	Reported Device Performance
Lung and lobar volume	Difference ≤ 10%	Results showed equivalence to predicate device (VIDA PW2)
Lung and lobar density (LAA-950HU)	Agreement limits -1% to 1%	Results showed equivalence to predicate device (VIDA PW2)
Lung and lobar density (LAA-910HU)	Agreement limits -10% to 10%	Results showed equivalence to predicate device (VIDA PW2)
Lung and lobar density (15th percentile)	Agreement limits -10 HU to 10 HU	Results showed equivalence to predicate device (VIDA PW2)

Note: The document states "The results showed that outputs from Thirona LungQ 1.1.0 are equivalent to the predicate device, VIDA PW2," implying that all defined acceptance criteria were met. Specific numerical results for each metric proving equivalence are not provided beyond this general statement within the text.

2. Sample size used for the test set and the data provenance

Sample Size: 250 CT scans.
Data Provenance:
- Country of Origin: Not explicitly stated, but the data is from the COPDGene study (http://www.copdgene.org), which is a U.S. based study.
- Retrospective or Prospective: Retrospective, as scans were "randomly selected from the entire COPDGene cohort."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The "ground truth" for this equivalence study was established by the predicate device, VIDA PW2. Human experts were not used to establish a separate ground truth for comparison in this study. The study aims to show that LungQ's outputs are equivalent to those of an already FDA-cleared device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as ground truth was established by the predicate device, not through human consensus or adjudication. The comparison was direct between the two software outputs.

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, a MRMC comparative effectiveness study involving human readers and AI assistance was not conducted for this equivalence study. This study focused on software-to-software equivalence.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, an algorithm-only standalone performance study was done for both the LungQ software and the predicate device (VIDA PW2). The outputs of LungQ were directly compared to the outputs of VIDA PW2 to determine equivalence.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this equivalence study was the output of a legally marketed predicate device (VIDA PW2).

8. The sample size for the training set

The document does not explicitly state the sample size used for the training set of the LungQ software. The "Equivalence Study" describes the test set used for validation.

9. How the ground truth for the training set was established

The document does not provide details on how the ground truth for the training set was established. The focus of this submission is on the non-clinical validation of the device against a predicate, not on the specifics of its development or training data.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 5th , 2018

Thirona Corporation % Jean-Paul Charbonnier Managing Director Toernooiveld 300 6525 EC Nijmegen THE NETHERLANDS

Re: K173821

Trade/Device Name: LungQ Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 31, 2018 Received: June 1, 2018

Dear Jean-Paul Charbonnier:

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 of medical device-related adverse events) (21 CFR 803); 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.

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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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeff Bargar

for Robert Ochs, Ph.D. 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)

K173821

Device Name LungQ

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)

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Submitter	Thirona Corporation
Contact Person	Eva van Rikxoort
	Managing Director
	Thirona BV
	Toernooiveld 300
	6525 EC Nijmegen
	the Netherlands
	Phone: +31 (0)647142838
	E-mail: evavanrikxoort@thirona.eu
Date Prepared	June X, 2018
Trade Name	LungQ
Common Use/UsualName	Computer Tomography X-ray system
Product Code	JAK
Classification	Class II, 21 CFR 892.1750
Device Panel	Radiology
Predicate Device	VIDA PW2
Predicate Classification	Class II, 21 CFR 892.1750
Reference Device	Imbio CT Lung Density Analysis Software
Reference Classification	Class II, 21 CFR 892.1750

Section 2.0 510(k) Summary

Device Description

Indications for Use

The Thirona LungQ software provides CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The LungQ software can be used to support physician in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, fissure evaluation, and reporting tools are provided.

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Summary of Technical Comparisons

The table below compares the Thirona LungQ software to both the predicate and reference devices.

Item	LungQThirona(Subject Device)	VIDA PW2VIDADiagnosticsK083227(Predicate Device)	Imbio CTLung DensityAnalysisSoftwareImbio LLCK141069(Reference Device)
Product Code	JAK	Identical	Identical
RegulationNumber	21 CFR 892.1750	Identical	Identical
DeviceClassification	Class II	Identical	Identical
Common Name	Software Accessory to aComputed tomographyx-ray system	Identical	Identical
Item	LungQThirona(Subject Device)	VIDA PW2VIDADiagnosticsK083227(PredicateDevice)	Imbio CTLung DensityAnalysisSoftwareImbio LLCK141069(ReferenceDevice)
Intended Use	The Thirona LungQsoftware provides CTvalues for pulmonarytissue which is essentialfor providingquantitative support fordiagnosis and follow upexamination. TheLungQ software can beused to supportphysician in thediagnosis anddocumentation ofpulmonary tissuesimages (e.g.,abnormalities) from CTthoracic datasets. Three-D segmentation andisolation of sub-compartments,volumetric analysis,density evaluations,fissure evaluation, andreporting tools areprovided.	Nearly Identical	Nearly Identical
Modality	CT	Identical	Identical
Data Loading	DICOM	Identical	Identical
Application	Command-line interface	Includes aworkstation	Identical
Segmentation	Provides 3Dsegmentation	Identical	Identical
Item	LungQThirona(Subject Device)	VIDA PW2VIDADiagnosticsK083227(PredicateDevice)	Imbio CTLung DensityAnalysisSoftwareImbio LLCK141069(ReferenceDevice)
	Provides Segmentationof the:• Left Lung• Right Lung• Left Upper Lobe• Left Lower Lobe• Right UpperLobe• Right MiddleLobe• Right LowerLobe	Identical	Similar
	Provides AirwaysSegmentation	Identical	Different
	User cannot manuallyedit segmentation	User can manuallyedit segmentation	Identical
Lung VolumeAnalysisSupport	Ability to measurevolume for:• Both Lungs• Left Lung• Right Lung• Left Upper Lobe• Left Lower Lobe• Right Upper Lobe• Right Middle Lob• Right Lower Lobe	Identical	Similar
Item	LungQThirona(Subject Device)	VIDA PW2VIDADiagnosticsK083227(PredicateDevice)	Imbio CTLung DensityAnalysisSoftwareImbio LLCK141069(ReferenceDevice)
VolumeDensityAnalysis	Ability to measurevolume at multipledensity ranges for:• Both Lungs• Left Lung• Right Lung• Left Upper Lobe• Left Lower Lobe• Right Upper Lobe• Right Middle Lob• Right Lower Lobe	Identical	Similar
	Ability to measure the15th percentile densityanalysis	Identical	Different
	Does not perform lowdensity cluster analysis	Does perform lowdensity clusteranalysis	Identical
FissureAnalysis	Ability to performfissure evaluations	Identical	Does notperform fissureevaluations
Analyzed DataOutput	Provides a report	Identical	Identical

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Non-Clinical Testing

Software Verification testing was conducted to ensure that the Lung Q software met its requirements. The verification testing included white box testing to verify implantation and system integration testing. The LungQ software successful passed the verification testing.

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Software Validation was conducted to ensure the software met the user needs (i.e. input requirements). This validation was based on user scenarios. The LungO software successfully passed the software validation.

An equivalence study comparing 250 CT scans from the COPDGene study (http://www.copdgene.org) analyzed by the predicate device, VIDA PW2, and the same 250 CT scans analyzed by Thirona LungQ. LungQ 1.1.0 was run allowing for interaction with the LungQ results in the Image Analysis Service as described in the Service Manual. The scans were randomly selected from the entire COPDGene cohort, leading to a population of subjects with and without COPD and with different stages of COPD. The distribution of subjects with respect to their disease state is provided below.

Category	Disease state	# of subjects	% of data set
Control subjects: current or formersmokers without airflow limitation	GOLD stage 0	112	44.80%
Subjects with COPD but with minimalairflow limitations	GOLD stage 1	26	10.40%
Subjects with COPD and with moderate tosevere airflow limitations	GOLD stage 2-4	76	30.40%
Subjects with preserved ratio but impairedspirometry	GOLD stage PRISm	33	13.20%
Control subjects: non-smokers	None	3	1.20%

The 250 scans were taken with a wide variety of scanners. The imaging parameters of the 250 scans are provided below.

The outputs between VIDA PW2 and Thirona LungQ 1.1.0 were compared. The following measurements were analyzed for equivalence:

Lung and lobar volumes ●
Lung and lobar density scores: .
- o Low attenuation areas below -950 HU (LAA-950HU)
- o Low attenuation areas below -910 HU (LAA-910HU)
- o 15th percentile of density histogram (perc15)

Equivalence was determined using the following criteria:

Lung and lobar volume: Difference ≤ 10% ●
. Lung and lobar density measurements:
- o LAA-950HU: Agreements limits -1% to 1%
- o LAA-910HU: Agreement limits -10% and 10%
- o 15th Percentile: Agreement limits -10 HU to 10 HU

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The results showed that outputs from Thirona LungQ 1.1.0 are equivalent to the predicate device, VIDA PW2.

Additional performance testing of Thirona LungQ fissure analysis was conducted to compare a previously published version to LungQ 1.1.0. This study was performed on a set of 55 scans taken from a multicentre study conducted at five clinical study sites located in Germany, the Netherlands and Sweden (NCT01101958). The 55 scans were taken with a wide variety of scanners. The imaging parameters of the 55 scans are provided below.

Voxel-wise fissure completeness was compared to a manual reference standard in order to evaluate the performance of the two algorithms. The area under the receiver operating characteristic curve (Az) was used as a performance measure. A statistically higher Az value was set as the criteria to prove that LungQ 1.1.0 outperforms the previously published version.

For each individual scan. the Az value for LungO 1.1.0 was higher compared to the previously published version. The average Az of LungQ 1.1.0 was 0.95, compared to a statistically significantly lower average Az value of 0.76 for the previously published version (tested with a paired-sample t-test, p<0.001). This study showed that the fissure analysis of LungQ 1.1.0 significantly outperforms the previously published version.

Imaging parameters	Equivalence study	Fissure analysis
# of scans	250	55
Voxel spacing	0.50 - 0.97 mm	0.44 - 0.81 mm
Slice thickness	0.625 - 0.9 mm	0.6 - 1.5 mm
Slice spacing	0.45 - 0.625 mm	0.45 - 1.2 mm
Peak Kilovoltage	120 pKv	120 - 130 pKv
Scanner manufacture	GE MEDICAL SYSTEMS; SIEMENS;Philips	SIEMENS; Philips
Scanner types	LightSpeed16; LightSpeed VCT;Sensation 64; Definition; Sensation 16;Definition AS+; SOMATOM DefinitionFlash; Brilliance 64; LightSpeed Pro 16;Discovery CT750 HD; SOMATOMDefinition	Mx8000 IDT 16; iCT128; Volume Zoom;Emotion 16; Sensation64; Definition;SOMATOM Definition;
Reconstruction algorithms	Filtered back projection	Filtered back projection
Reconstruction kernels	STANDARD; B35f; B	B40f; B50s; B60f; B60s;B80f
milliampere second	200 mAs	NA

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Conclusions

Based on the comparison of intended use and key technological characteristics, Thirona believes that the Subject Device (LungQ) is substantially equivalent to the Predicate Device.

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.