The Lung Nodule Assessment and Comparison Option is intended for use as a diagnostic patient-imaging tool. It is intended for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.

Device Description

The Lung Nodule Assessment and Comparison Option application is intended for use as a diagnostic patient-imaging tool. It is intended for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed. The user interface and automated tools help to determine growth patterns and compose comparative reviews. The Lung Nodule Assessment and Comparison Option application requires the user to identify a nodule and to determine the type of nodule in order to use the appropriate characterization tool. Lung Nodule Assessment and Comparison Option may be utilized in both diagnostic and screening evaluations supporting Low Dose CT Lung Cancer Screening*.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device Name: Lung Nodule Assessment and Comparison Option (LNA)

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantified acceptance criteria with numerical targets. Instead, it indicates that the device was tested against its defined functional requirements and performance claims, and that it "meets the acceptance criteria and is adequate for its intended use and specifications." The "acceptance criteria" are implied by the verification and validation tests performed to ensure the device's design meets user needs and intended use, and that its technological characteristics claims are met.

However, based on the description of the device's capabilities, we can infer some key performance areas that would have been subject to acceptance criteria:

Acceptance Criteria (Inferred from features and V&V activities)	Reported Device Performance
Accuracy of Lung and Lobe Segmentation	Validation activities assure that the lung and lobe segmentation are adequate from an overall product perspective.
Accuracy of Nodule Segmentation (Single-click and Manual Editing)	Verified and validated as part of the overall design and functionality.
Accuracy of Nodule Measurements (Diameter, Volume, Mean HU)	Automatic software calculation of these measurements is a key feature, and the device was tested to meet its defined functionality requirements and performance claims. Manual editing with automatic recalculation is also validated.
Functionality and Accuracy of Comparison and Matching for Temporal Studies	Validation activities assure that the comparison, as well as the nodule matching and propagation functionality, are adequate from an overall product perspective. Automatic calculations of doubling time and percent/absolute changes in measurements were tested.
Functionality of Lung-RADS™ Reporting	Validation activities assure the Prefill functionality for the Lung RADS score is adequate.
Accuracy and Functionality of Risk Calculator Tool	The risk prediction functionality was validated. Based on McWilliams et al. (2013) study, which showed excellent discrimination and calibration (AUC > 0.90). The LNA's risk calculator is based on this model and its performance was validated.
Usability of the Software	A usability study was conducted according to standards.
Compliance with Relevant Standards and Guidance Documents	Complies with ISO 14971, IEC 62304, IEC 62366-1, and FDA guidance for software in medical devices.
Overall functionality and performance of the clinical workflow	Each test case was evaluated for the complete clinical workflow in a validation study using real recorded clinical data.

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

Test Set Sample Size: The document does not specify a numerical sample size for the internal validation studies conducted by Philips for the LNA application. It states that the LNA application was validated "using real recorded clinical data cases in order to simulate the actual use of the software."
Data Provenance for Philips' Internal Tests: The text implicitly suggests the data was retrospective, as it refers to "real recorded clinical data cases." The country of origin for these internal test cases is not specified.
Data Provenance for the Risk Calculator (McWilliams et al. study):
- Development Data Set: Participants from the Pan-Canadian Early Detection of Lung Cancer Study (PanCan).
- Validation Data Set: Participants from chemoprevention trials at the British Columbia Cancer Agency (BCCA), sponsored by the U.S. National Cancer Institute.
- This indicates the data was from Canada (PanCan, BCCA in British Columbia) and supported by the U.S. National Cancer Institute. Both were prospective population-based studies.

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

The document does not specify the number of experts or their qualifications for establishing ground truth specifically for Philips' internal V&V test set. It mentions the LNA application was validated to address "user needs" and simulate "actual use of the software," which implies expert input, but no details are provided.

For the Risk Calculator, the ground truth for malignancy in the McWilliams et al. study was established through tracking the final outcomes of all detected nodules. This likely involved pathology reports and clinical follow-up, adjudicated by clinical experts, but the exact number and qualifications of these experts are not detailed in this summary.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for Philips' internal V&V test set. The validation process involved evaluating each test case for the complete clinical workflow and ensuring the design meets user needs, which might involve expert review, but the formal adjudication protocol is not elaborated upon in this summary.

For the Risk Calculator's underlying study (McWilliams et al.), the "final outcomes of all nodules" suggests a definitive ground truth based on pathology or long-term clinical stability/progression, but the adjudication method for these biological outcomes is not specified within this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

The document does not report an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The studies described focus on the standalone performance and validation of the LNA application's features and the underlying model for the risk calculator.

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

Yes, standalone performance was evaluated for various features of the LNA application:

The automatic segmentation capabilities (lungs, lobes, nodules) were validated to be "adequate."
The automatic measurement calculations (diameters, volume, mean HU) were tested to comply with "defined functionality requirements and performance claims."
The comparison and matching functionality and "Prefill functionality for the Lung RADS score and the risk prediction" were assured to be "adequate."
The Risk Calculator tool itself (based on McWilliams et al.) demonstrated standalone predictive performance with "excellent discrimination and calibration, with areas under the receiver-operating-characteristic curve of more than 0.90." This indicates strong standalone performance of the algorithm in predicting malignancy.

7. The Type of Ground Truth Used

For Philips' Internal V&V: The ground truth appears to be based on "real recorded clinical data cases," implying clinical diagnoses, measurements, and potentially pathology results where applicable, as evaluated against the software's specified functionality and user needs. The specific hierarchy or gold standard used for each feature's ground truth (e.g., expert consensus for segmentation, pathology for nodule type) is not explicitly detailed.
For the Risk Calculator (McWilliams et al. study): The ground truth for malignancy was established by tracking "the final outcomes of all nodules," which would primarily be pathology results for cancerous nodules and long-term clinical outcome data (stability or benign diagnosis) for non-cancerous ones.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set used for the LNA application's algorithms, including the segmentation, measurement, and comparison features.

For the Risk Calculator's underlying model (McWilliams et al.):

The "development data set" (training set) included participants from the Pan-Canadian Early Detection of Lung Cancer Study (PanCan). The exact number of participants or nodules is not provided in this summary but the PanCan study is a large, population-based study.

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

For the Risk Calculator's underlying model (McWilliams et al.):

The ground truth for the development data set (PanCan study) was established by tracking "the final outcomes of all nodules of any size that were detected on baseline low-dose CT scans." This indicates that the ground truth for malignancy was based on definitive pathological diagnosis or long-term clinical follow-up confirming benignity or stability.

Summary

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

February 23, 2017

Philips Medical Systems Nederland B.V. % Yoram Levy General Manager Osite 31 Haavoda Street Binyamina, 30500 ISRAEL

Re: K162484

Trade/Device Name: Lung Nodule Assessment and Comparison Option (LNA) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, JAK Dated: January 15, 2017 Received: January 23, 2017

Dear Yoram Levy:

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.

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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 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.

Michael O'Hara

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) K162484

Device Name

Lung Nodule Assessment and Comparison Option (LNA)

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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510(k) Summary

K162484

Lung Nodule Assessment and Comparison Option

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

Date prepared: February 16, 2017

I. Submitter's name and address

I. Submitter's name and address
Establishment name:	Philips Medical Systems Nederland B.V.
Establishment address:	Veenpluis 4-65684 PC BestThe Netherlands
Establishment registration:	3003768277
Primary Contact person:	Yoram Levy, QsiteQA/RA Consultant31 Haavoda StreetBinyamina, Israel 30500Tel +(972)4-638-8837;Fax (972)4-638-0510Yoram@qsitemed.com
Alternative contact person	Mr. Yonel BraunsteinHead of Regulatory and Clinical AffairsPhilips Medical Systems Nederland B.VE-mail: Yonel.Braunstein@philips.com
II. Device information
Trade name:	Lung Nodule Assessment and Comparison Option (LNA)
Device Classification Name	System, Image processing, Radiological
Device Class	Class II
Classification Panel	LLZ, JAK
Product Code	Radiological Image Processing Software
Regulation Description	21 CFR 892.2050, 21CFR 892.1750

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III. Predicate device information

Predicate devices:

Device trade name	510(k) number	Date of clearance	Classification name	Product code	Regulation	Class	Classification panel
LungAnalysisSoftware	K151283	October30, 2015	System, Imageprocessing,Radiological	JAK,LLZ	21CFR892.1750	ClassII	Radiology
Lung NoduleAssessmentand	K023785	Feb 102003	System, Imageprocessing,Radiological	90JAK	21CFR892.1750	ClassII	Radiology

Reference devices:

Device tradename	510(k)number	Date ofClearance	Classificationname	Product code	Regulation	Class	Classificationpanel
PhilipsMulti-sliceCT systemwith LowDose CTlung cancerscreening	K153444	April 8,2016	ComputedTomographyX- ray system	JAK	21 CFR892.1750	II	Radiology
BrillianceiCT(BrillianceVolume)	K060937	June 5,2006	System, X-Ray,Tomography,Computed	JAK	21 CFR892.1750	II	Radiology

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I4 (IntegratedIntelligentImagingInformatics)system	K160315	February19, 2016	Picturearchiving andcommunicationsystem	LLZ,JAK	21 CFR892.2050	II	Radiology
EBW NM2.0	K111336	February3, 2011	Picturearchiving andcommunicationsystem	LLZ	21 CFR892.2050	II	Radiology

IV. Device description

*The screening must be performed within the established inclusion criteria of programs/ protocols that have been approved and published by either a governmental body or professional medical society. -Please refer to clinical literature that includes the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Key Features

1. Automatic Lungs and Lobes segmentation

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1. Single-click lung nodule segmentation
1. Manual nodule segmentation editing tools
1. Load up to 8 concurrent studies for temporal measurements
1. Restore previously segmented nodules from prior studies for comparison
1. Enhanced comparison feature that allows matching and establishing correspondence between pre identified nodules in two studies
1. Synchronization between studies from different time-points
1. 3D or MIP visualization of segmented nodules
1. Reporting based on Lung-RADS™ guidelines and option to export to Clipboard
1. Risk Calculator tool based on patient and nodule characteristics for estimation of the probability that lung nodules detected on baseline screening low-dose CT scans are malignant, based on McWilliams, Annette, et al. "Probability of cancer in pulmonary nodules detected on first screening CT." New England Journal of Medicine 369.10 (2013): 910-919.
1. Automatic software calculation of the following measurements for each segmented nodule:
Quantification of nodule parameters: A
- Long Axis- Longest diameter on an axial slice (mm)
- · Short axis- Longest diameter perpendicular to the long axis on the same
- slice (mm) .
  - Average \ Max 3D \ Effective diameter (mm)
  - Volume (mm3)
  - Mean HU (HU)
Manual edit of the nodule segmentation contour lines with automatic recalculation of . geometric measurements post-editing
Specification of the following characteristics for each nodule in configurable pre-sets
- Nodule type (solid, part-solid, ground-glass, calcified)
- Lobe Location
- Nodule shape (Circular/Oval/Triangular)
- Nodule Spiculation
Comparison and matching feature automatic calculations of the following measurements between each follow-up scan and the previous scan:

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I Doubling time in days
I Percent (%) and absolute change of all numerical parameters (growth in nodule long axis, short axis, average diameter, max 3D diameter, effective diameter, volume, mean HU).

Additional Information for Risk Calculator

The Risk Calculator feature in LNA is based on the full model with spiculation developed by Brock University as described in McWilliams, et al (2013). This model allows estimating the probability that lung nodules detected on baseline screening low-dose CT scans are malignant. The model's performance was validated using two large population-based prospective studies: the Pan-Canadian Early Detection of Lung Cancer Study (PanCan) and the chemoprevention trials at the British Columbia Cancer Agency (BCCA), sponsored by the U.S. National Cancer Institute.

Further details can be found in McWilliams, A., Tammemagi, M.C., Mayo, J.R., Roberts, H., Liu, G., Soghrati, K., Yasufuku, K., Martel, S., Laberge, F., Gingras, M. and Atkar-Khattra, S., (2013). Probability of cancer in pulmonary nodules detected on first screening CT. New England Journal of Medicine, 369(10), pp.910-919

V. Intended use

The Philips Medical Systems Lung Nodule Assessment and Comparison Option is intended for use as a diagnostic patient-imaging tool.

It is intended for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.

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VI. Substantial Equivalence Comparison

Philips believes that Lung Nodule Assessment and Comparison Option product is substantially equivalent to the identified predicate devices , primary- Toshiba's Lung Analysis Software (K151283) and predicate- Philips' Lung Nodule Assessment and Comparison option (K023785), with additional/enhanced functionality deriving from the reference devices: Philips Multi-slice CT system with Low Dose CT lung cancer screening (K153444), Brilliance iCT (Brilliance Volume) (K060937), 14 (Integrated Intelligent Imaging Informatics) system (K160315) and EBW NM2.0 (K111336)

Below is the comparison table to summarize the similarities and differences of the subject, predicates, and reference devices:

Feature	The proposeddevice:Lung NoduleAssessment andComparisonOption (LNAapplication)	Primary Predicate:Toshiba's LungAnalysis Software(K151283)	Predicate:Philips' LungNoduleAssessmentandComparisonoption(K023785)	Referencedevice
Device ClassificationName	System, Imageprocessing,Radiological	System, Imageprocessing,Radiological	System,Imageprocessing,Radiological	Not relevantfor thissubject
Device Class	Class II	Class II	Class II	Not relevant forthis subject
ClassificationPanel	Radiology	Radiology	Radiology	Not relevant forthis subject
Product Code	LLZ, JAK	JAK, LLZ	90 JAK	Not relevant forthis subject
RegulationDescription	RadiologicalImage ProcessingSoftware	Radiological ImageProcessing Software	RadiologicalImageProcessingSoftware	Not relevant forthis subject
RegulationNumber	21 CFR 892.205021CFR 892.1750	21CFR 892.1750	21CFR892.1750	Not relevant forthis subject
Indication ForUse	The Lung NoduleAssessment andComparisonOption is intendedfor use as adiagnostic patient-imaging tool.It is intended forthe review andanalysis ofthoracic CTimages, providingquantitative andcharacterizinginformation aboutnodules in thelung in a singlestudy, or over thetime course ofseveral thoracicstudies.Characterizationsinclude diameter,volume andvolume over time.The systemautomaticallyperforms themeasurements,allowing lungnodules andmeasurements tobe displayed.	The separately licensedLung Analysis option isintended for the reviewand analysis of thoracicCT images for thepurposes ofcharacterizing nodulesin the lung in a singlestudy, or over the timecourse of severalthoracic studies.Characterizationsinclude diameter,volume and volumeover time. The systemautomaticallyperforms themeasurements, allowinglung nodules andmeasurements to bedisplayed.	The LungNoduleAssessmentandComparisonOption isintended foruse as adiagnosticpatient-imaging tool.It is intendedto providequantitativeinformationaboutphysician-indicated lungnodules thatare identifiedon high-resolutioncomputedtomographyimages of thelung.	Not relevantfor this subject
Intended users	Radiologists andTechnologist	Radiologists,Technologist andOncologists	RadiologistsandTechnologist	Not relevantfor thissubject
Intended bodypart	Chest	Chest	Chest	Not relevant forthis subject
Type of scans	Thoracic CTimages	Thoracic CT images	Thoracic CTimages	Not relevant forthis subject
2D image review	Yes	Yes	Yes	Not relevant forthis subject
3D image review	Yes	Yes	Yes	Not relevant forthis subject
2D and 3Dcomparativereview	Yes	Yes	No	Not relevant forthis subject

2Dmeasurements	Yes	Yes	Yes	Not relevant forthis subject
Segmentation oflung airway,lungs and lunglobes	Yes	Yes	No	Brilliance iCT(BrillianceVolume),(K060937)
Single click lungnodulesegmentation	Yes	Yes	Yes	Not relevant forthis subject
NoduleCharacteristics	Yes	Yes	No	Not relevant forthis subject
Automaticcalculation ofmeasurementsfor eachsegmentednodule	Yes■ Shortaxis- Longestdiameterperpendicular tothe long axis onthe slice(mm)■ LongAxis- Longestdiameter on anaxial slice (mm)■ Average\ Max 3D <br>Effective diameter(mm)■ Volume(mm3)■ Mean densities(HU)	Yes■ Volume (mm³)■ Mean diameter(mm)■ Maximumdiameter (mm)■ Short axisdiameter (mm)■ Average/minimum/maximumdensities (HU)	No	Not relevant forthis subject
Comparison andMatching	Yes	Yes	Yes	EBW NM2.0(K111336)■ I4(IntegratedIntelligentImagingInformatics)system■ (K160315)
Comparison andmatchingautomaticcalculationsbetween eachfollow-up scanand the previousscan	Yes■ Doublingtime in days■ Percent(%) and absolutechange of allnumericalparameters	Yes■ Elapsed timein days■ Doubling timein daysPercent (%) growth innodule volume	Yes	Not relevant forthis subject
	long axis, shortaxis, averagediameter, max 3Ddiameter,effectivediameter, volume,mean HU).			Not relevant for
Workflow	■ Detect andSegment■ Comparison andMatching■ Results	■ Point-and-clickdetection■ Automated contouring■ Automatedmeasurements■ Manual correction	■ Detect andSegment■ Comparisonand Matching■ Results	this subject
Loading multiplestudies	YesUp to 8 studies	YesUp to 3 studies	YesUp to 3 studies	Not relevant forthis subject
Supporting Low-dose CT	Yes	Yes	No	Not relevant forthis subject
Reporting results	YesThe resultsincludes thefollowing:• Patientrelatedinformation• Dictation• Table withNodule resulttable andadditionalfindings• Lung-RADS• RiskCalculator	YesThe results includes thefollowing:• Dictation• Table with Noduleresult table• Lung-RADS• Fleischer• Criteria	YesThe resultsincludes thefollowing:• Dictation Tablewith Noduleresult table	Not relevant forthis subject
Printing Option	Yes	Yes	Yes	Not relevant forthis subject

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Philips Medical Systems Lung Nodule Assessment and Comparison Option (LNA application) and the identified predicate devices, primary- Toshiba's Lung Analysis Software (K151283) and predicate- Philips' Lung Nodule Assessment and Comparison option (K023785) are substantial equivalent in terms of indication for use and intended

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users, design features, principle of operation and fundamental scientific technology, and safety and/or effectiveness.

The above listed technological differences are considered low risk, providing further support to clinicians in accessing current technologies or features. These functionalities are derived from reference predicate devices and were verified and validated, and do not raise new questions on safety and/or effectiveness.

These features have not changed the intended use and operational principles of the device. Therefore, the Lung Nodule Assessment and Comparison Option is substantially equivalent to the identified predicate devices , primary- Toshiba's Lung Analysis Software (K151283) and predicate- Philips' Lung Nodule Assessment and Comparison option (K023785)and the reference devices in terms of technological characteristics.

VII. Brief discussion of the nonclinical tests submitted, referenced or relied on

No performance standards for PACS systems or components have been issued under the authority of Section 514. Non-clinical performance testing has been performed on ISPP and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

. ISO 14971 Medical devices – Application of risk management to medical devices
IEC 62304 Medical device software Software life cycle processes
IEC 62366-1 Medical devices Part 1:Application of usability engineering to medical ■ devices
. Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Lung Nodule Assessment and Comparison Option was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.

For the Lung Nodule Assessment and Comparison Option (LNA), validation and verification

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activities were conducted to provide objective evidence that the design meets user needs and intended use and application specification.

These validation activities assure that the lung and lobe segmentation, the comparison, as well as the nodule matching and propagation functionality, and the Prefill functionality for the Lung RADS score and the risk prediction are adequate from an overall product perspective. The LNA application was validated using real recorded clinical data cases in order to simulate the actual use of the software .Each test case was evaluated for the complete clinical workflow.

In addition, a usability study was conducted according to the standards

The test results in this 510(k) premarket notification demonstrate that Lung Nodule Assessment and Comparison Option:

. Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
. Meets the acceptance criteria and is adequate for its intended use and specifications.

VIII. Brief discussion of clinical tests submitted, referenced or relied on

McWilliams, A et al ' conducted a population-based prospective clinical study to determine factors predicting the probability that lung nodules detected on the first screening low-dose CT scans are malignant or will be found to be malignant on follow-up.

The authors indicated that the final parsimonious and full models showed excellent discrimination and calibration, with areas under the receiver-operating-characteristic curve of more than 0.90, even for nodules that were 10 mm or smaller in the validation set.

McWilliams A et al concluded that Predictive tools based on patient and nodule characteristics can be used to accurately estimate the probability that lung nodules detected on baseline screening low-dose CT scans are malignant.

The investigators analyzed data from two cohorts of participants undergoing low-dose CT screening. The development data set included participants in the Pan-Canadian Early Detection of

1 McWilliams, A., Tammemagi, M.C., Mayo, J.R., Roberts, H., Liu, G., Soghrati, K., Yasufuku, K., Martel, S., Laberge, F., Gingras, M. and Atkar-Khattra, S.,. Probability of cancer in pulmonary nodules detected on first screening CT. New England Journal of Medicine, 2013: 369(10), 910-919.

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Lung Cancer Study (PanCan). The validation data set included participants involved in chemoprevention trials at the British Columbia Cancer Agency (BCCA), sponsored by the U.S. National Cancer Institute. The final outcomes of all nodules of any size that were detected on baseline low-dose CT scans were tracked. Parsimonious and fuller multivariable logisticregression models were prepared to estimate the probability of lung cancer.

IX. The conclusions drawn from the nonclinical and clinical tests

Verification and Validation (V&V) activities required to establish performance and functionality of Lung Nodule Assessment and Comparison Option were performed. Testing performed demonstrated the Lung Nodule Assessment and Comparison Option meets all defined functionality requirements and performance claims.

Overall The Lung Nodule Assessment and Comparison Option is X. substantially equivalent to the identified predicate devices , conclusion: primary- Toshiba's Lung Analysis Software (K151283) and predicate- Philips'Lung Nodule Assessment and Comparison option (K023785), in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, verification and validation testing demonstrate the safety and efficacy of the device to meet its intended use and specification.
Philips Medical believes that the proposed device, Lung Nodule Assessment and Comparison Option, is substantially equivalence to its identified predicate device and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.

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).