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

Device Description

The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional. The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format.

AI/ML Overview

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" in a dedicated table format with specific numerical thresholds (e.g., "accuracy > 90%"). Instead, it describes an equivalence study where the acceptance criteria were met if the results from the subject device (LIA) were "similar" to the predicate device (Thirona LungQ). The study compared specific measurements, implying that the LIA's ability to produce comparable values for these measurements constituted meeting the acceptance criteria.

Table of Acceptance Criteria (Inferred) and Reported Device Performance

Feature/Metric Compared	Acceptance Criteria (Inferred from Study Design)	Reported Device Performance
Fissure Calculations (n=120)	Results "similar" to the predicate device (Thirona LungQ).	LIA computed 120 fissure calculations from 30 scans. Results from the two devices were similar, meeting the acceptance criteria.
Lobar Volumes (n=180)	Results "similar" to the predicate device (Thirona LungQ).	LIA computed 180 lobar volumes from 30 scans. Results from the two devices were similar, meeting the acceptance criteria.
Voxel Density Scores (n=360)	Results "similar" to the predicate device (Thirona LungQ).	LIA computed 360 voxel density scores from 30 scans. Results from the two devices were similar, meeting the acceptance criteria.
Overall Performance Equivalence	Demonstrated to be equivalent in performance to the predicate device.	"Results from the two devices were similar, meeting the acceptance criteria. This shows that the Lung Image Analysis software is equivalent in performance to the predicate device."

Note: The term "similar" is subjective without defined statistical thresholds (e.g., p-value, correlation coefficient, absolute difference thresholds). However, the FDA’s clearance implies they deemed the similarity sufficient for substantial equivalence.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 30 scans.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- The document does not mention using experts to establish ground truth for the test set in the context of the equivalence study. The study appears to directly compare the LIA device's output to the predicate device's output, with the predicate device's output implicitly serving as a reference.
Adjudication Method for the Test Set:
- Not applicable as the study compares the LIA's output directly to the predicate device's output, rather than to an expert-adjudicated ground truth.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focused on comparing the algorithmic measurements of the LIA to a predicate device's algorithmic measurements.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance study described is a standalone (algorithm-only) study. It compares the computational output of the LIA software directly with the computational output of the predicate device (Thirona LungQ) for specific measurements (fissure calculations, lobar volumes, voxel density scores). There is no human-in-the-loop component described for this comparison study.
The type of ground truth used:
- The "ground truth" for the equivalence study was effectively the measurements provided by the legally marketed predicate device (Thirona LungQ). The study's goal was to show that LIA's measurements were "similar" to those of the predicate.
The sample size for the training set:
- The document does not specify the sample size used for the training set for the LIA software. The provided text only describes the validation/test set for the equivalence study.
How the ground truth for the training set was established:
- The document does not specify how the ground truth for any potential training set was established. This information is typically proprietary to the manufacturer and not always included in a 510(k) summary focused on validation.

Summary

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September 2, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

Pulmonx Corporation % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K212494

Trade/Device Name: Lung Image Analysis (LIA) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 6, 2021 Received: August 9, 2021

Dear Prithul Bom:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

, for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K212494

Device Name

Lung Image Analysis (LIA)

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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K212494

510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

Applicant Information:

Pulmonx Corporation 700 Chesapeake Drive Redwood City, California 94063

Contact Person:

Terry Solomon Email: tsolomon@pulmonx.com Phone: (650) 216-0195

Device Information:

Trade Name: Regulation Name: Regulation Medical Specialty: Device Class: Product Code:

Lung Image Analysis (LIA) Computed tomography x-ray system Radiology ll JAK

Predicate Device:

LungQ, K173821 The predicate device has not been subject to a design-related recall.

No reference device is being used in this submission.

Date Prepared:

June 30, 2021

Device Description:

The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format.

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Indications for Use:

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

Summary of Technical Comparison:

The LIA software is comparative to the predicate device, the Thirona LungQ Software (see Table 1). The software has the same intended use and similar technological characteristics, which do not raise any new questions of safety or effectiveness.

Item	LIAPulmonx(Subject Device)	LungQThironaK173821(Predicate Device)	Equivalence
Product Code	JAK	JAK	Yes, identical.
RegulationNumber	21 CFR 892.1750	21 CFR 892.1750	Yes, identical.
DeviceClassification	Class II	Class II	Yes, identical.
Common Name	Software Accessory to aComputed tomography x-raysystem	Software Accessory to aComputed tomography x-raysystem	Yes, identical.
Intended Use	The LIA software provides CTvalues for pulmonary tissuewhich is essential for providingquantitative support fordiagnosis and follow upexamination. The LIA softwarecan be used to supportphysician in the diagnosis anddocumentation of pulmonarytissue images (e.g.abnormalities) from CTthoracic datasets. Three-Dsegmentation and isolation ofsub-compartments (includinglung structures), volumetricanalysis, density evaluations,fissure evaluation, andreporting tools are provided.	The Thirona LungQ softwareprovides CT values forpulmonary tissue which isessential for providingquantitative support fordiagnosis and follow upexamination. The LungQsoftware can be used tosupport physician in thediagnosis and documentationof pulmonary tissue images(e.g. abnormalities) from CTthoracic datasets. Three-Dsegmentation and isolation ofsub-compartments, volumetricanalysis, density evaluations,fissure evaluation, andreporting tools are provided.	Yes, identical.
Modality	CT	CT	Yes, identical.
Data Loading	DICOM	DICOM	Yes, identical.
Application	Graphical User Interface and	Command-line interface	Yes, both devices provide
Item	LIAPulmonx(Subject Device)	LungQThironaK173821(Predicate Device)	Equivalence
	Command-line interface		a command-line interfacewhile the subject devicealso provides a GUI. Theaddition of the GUIprovides a more user-friendly interface.
	Provides 3D segmentation	Provides 3D segmentation	Yes, identical.
Segmentation	Provides segmentation of the:Left LungRight LungLeft Upper LobeLeft Lower LobeRight Upper LobeRight Middle LobeRight Lower Lobe	Provides segmentation of the:Left LungRight LungLeft Upper LobeLeft Lower LobeRight Upper LobeRight Middle LobeRight Lower Lobe	Yes, identical.
	Provides AirwaysSegmentation	Provides AirwaysSegmentation	Yes, identical.
	Software automaticallycalculates segmentation (i.e.lobe boundaries) and user canmanually edit lobe boundaries	Software automaticallycalculates segmentation.	Yes, both devicesautomatically calculatesegmentation.The subject device alsoallows the user tomanually editsegmentation. Manuallyediting segmentation wasincluded as a feature forcases where the lobeboundaries may be difficultto automatically segment.
Lung VolumeAnalysis Support	Ability to measure volume for:Both LungsLeft LungRight LungLeft Upper LobeLeft Lower LobeRight Upper LobeRight Middle LobeRight Lower Lobe	Ability to measure volume for:Both LungsLeft LungRight LungLeft Upper LobeLeft Lower LobeRight Upper LobeRight Middle LobeRight Lower Lobe	Yes, identical.
Volume DensityAnalysis	Ability to measure volume atmultiple density ranges for:Both LungsLeft LungRight LungLeft Upper LobeLeft Lower LobeRight Upper LobeRight Middle Lobe	Ability to measure volume atmultiple density ranges for:Both LungsLeft LungRight LungLeft Upper LobeLeft Lower LobeRight Upper LobeRight Middle Lobe	Yes, identical.
Item	LIAPulmonx(Subject Device)	LungQThironaK173821(Predicate Device)	Equivalence
	Right Lower Lobe	Right Lower Lobe
	Allows the user to perform the15th percentile densityanalysis	Software provides the 15thpercentile density analysis	Yes, the output provideshistogram data that thiscan be calculated from.
Fissure Analysis	Ability to perform fissureevaluations	Ability to perform fissureevaluations	Yes, identical.
Analyzed DataOutput	Provides data in .csv or .jsonfile	Provides a report	Yes, both devices provideoutput to be used byphysicians.

Table 1: Substantial Equivalence between LIA and LungQ, the predicate device.

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Performance Data:

Software verification and validation (V&V) were conducted to ensure that the LIA software met its intended use and software requirements. The V&V testing included subsystem integration testing, unit testing, module testing, and code reviews. The Lung Image Analysis software successfully passed the verification and validation.

An equivalence study was conducted to compare data from 30 scans that were analyzed by both the predicate device, Thirona LungQ, and the subject device, Lung Image Analysis. Each device computed 120 fissure calculations, 180 lobar volumes, and 360 voxel density scores from 30 scans. Results from the two devices were similar, meeting the acceptance criteria. This shows that the Lung Image Analysis software is equivalent in performance to the predicate device.

Summary:

The LIA software has the same intended use as the predicate device. In addition, it has similar technological characteristics; performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness.

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.