(169 days)
The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.
Lung Analysis aids in measuring and characterizing lung nodules. The interface and automated tools help to efficiently determine growth patterns and compose comparative reviews. Lung Analysis is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed. The Lung Analysis Software requires the user to identify a nodule and to determine whether it is a GGO or solid nodule in order to use the appropriate characterization tool.
The Lung Analysis software from Vital Images, Inc. (K151283) had its performance evaluated through non-clinical tests including phantom testing and external validation.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provided details on phantom testing results for GGO volume, diameter, and mean CT attenuation measurements. Specific acceptance criteria values were not explicitly stated for all tests. However, for GGO volume measurements, the results were reported as "within acceptable" ranges.
| Test Case Name | Parameters (Reported) | Type | Status |
|---|---|---|---|
| GGO volume accuracy & precision: Siemens 64-CT scanner | GGO volume: Bias (Absolute error, APNE), Precision (PRC) | Phantom dataset (Passed) | Passed |
| GGO volume accuracy & precision: Philips 16-CT scanner | GGO volume: Bias (Absolute error, APNE), Precision (PRC) | Phantom dataset (Passed) | Passed |
| GGO volume accuracy & precision: Toshiba AQ1 320-CT scanner | GGO volume: Bias (Absolute error, APNE), Precision (PRC) | Phantom dataset (Passed) | Passed |
| Intra-reader & inter-reader variability of GGO volume measurements (patient-based) | Intra-reader agreement & Inter-reader agreement: CCCinter, TDI, Coverage Probability | Patient-based dataset (Passed) | Passed |
| GGO longest diameter measurement accuracy & precision: Toshiba AQ1 320-CT scanner | Longest diameter: Bias (Absolute error), Absolute percentage normalized error (APNE), Precision (within-nodule standard deviation, wSD) | Phantom dataset (Passed) | Passed |
| GGO mean attenuation measurement accuracy & precision: Toshiba AQ-One CT scanner | Mean attenuation: Bias (Absolute error), Absolute percentage normalized error (APNE), Precision (within-nodule standard deviation, wSD) | Phantom dataset (Passed) | Passed |
Summary of Measurement Accuracy for GGO Volume on Toshiba CT scanner (100mAs):
| GGO Ref. diameter | Bias APE% | Precision PRC% |
|---|---|---|
| 5mm | 15.04% | 24.74% |
| 8mm | 16.15% | 11.85% |
| 10mm | 5.49% | 3.24% |
| 12mm | 2.98% | 3.38% |
Note: The document states these results "may vary for other CT scanner types or CT manufacturers and for other acquisition conditions."
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "phantom datasets" and "patient-based datasets" for testing. However, it does not specify the exact sample sizes (number of phantoms or patients/cases) for these test sets. The provenance of the data (country of origin, retrospective or prospective) is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document mentions "experienced medical professionals" for external validation but does not specify the exact number of experts or their detailed qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1). It only mentions that "intra-reader and inter-reader agreement" was evaluated for GGO volume measurements on patient-based datasets.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
A MRMC comparative effectiveness study was not performed to evaluate how much human readers improve with AI vs. without AI assistance. The document focuses on the performance of the software itself and its validation against existing datasets and phantom models.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance evaluation of the algorithm appears to have been conducted through the phantom testing. The "accuracy and precision of the GGO volume measurements after semi-automatic segmentation and before manual editing" indicates an algorithm-only measurement phase.
7. The Type of Ground Truth Used:
The ground truth used for phantom testing was based on "anthropomorphic lung phantoms with synthetic nodules," which provides a controlled and known ground truth for volume and dimensional measurements. For patient-based datasets, the ground truth for reproducibility (intra-reader and inter-reader agreement) appears to have been established by human experts, as indicated by "User-edited GGOs" in the table. However, the ultimate ground truth for lesion characterization (e.g., pathology, outcomes data) is not specified.
8. The Sample Size for the Training Set:
The document does not provide information on the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide information on how the ground truth for the training set was established.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2015
Vital Images, Inc. % Mr. Parthiv Shah Sr. Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343
Re: K151283
Trade/Device Name: Lung Analysis Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK, LLZ Dated: October 9, 2015 Received: October 13, 2015
Dear Mr. Shah:
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) K151283
Device Name Lung Analysis
Indications for Use (Describe)
The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
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510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c)
| Purpose of Submission: | Vital Images, Inc. hereby submits this traditional 510(k) for changes that do not qualify for a Special 510(k) notification. |
|---|---|
| Submitter: | Vital Images, Inc.5850 Opus ParkwaySuite 300Minnetonka, MN, 55343-4414 |
| Establishment Registration: | 2134213 |
| 510(k) Submitter: | Parthiv ShahSr. Regulatory Affairs SpecialistPhone : 952-487-9574Fax: 952-487-9510E-mail: pshah@vitalimages.com |
| FDA Contact: | Vince SwensonSr. Director Quality and Regulatory AffairsPhone : 952-487-9548Fax: 952-487-9510E-mail: vswenson@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | October 9, 2015 |
| Device Trade Name: | Lung Analysis Software |
| Device Common Name: | Radiological Image Processing Software |
| Device Classification Name: | System, Image Processing, Radiological |
| Regulatory Description: | Picture Archiving and Communications System |
| Regulation Number: | 21 CFR 892.1750 |
| Product Code: | JAK |
| Regulatory Classification: | Class II |
043_Updated_007_510k_Summary (21 CFR 807.92)
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Predicate Device:
| Predicate Device | Manufacturer | FDA 510(k) number |
|---|---|---|
| Lung Analysis(Legally Marketed Device) | Vital Images, Inc. | K043333 |
Reference Device:
| Reference Device | Manufacturer | FDA 510(k) number |
|---|---|---|
| LungCARE CT(Legally Marketed Device) | Siemens Medical Solutions,Inc. | K033374 |
Device Description:
Lung Analysis aids in measuring and characterizing lung nodules. The interface and automated tools help to efficiently determine growth patterns and compose comparative reviews. Lung Analysis is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed. The Lung Analysis Software requires the user to identify a nodule and to determine whether it is a GGO or solid nodule in order to use the appropriate characterization tool.
Key features:
General Viewing:
- . Automated segmentation of lung and airways
- Single click lung nodule segmentation tools to include solid nodules and ground glass opacity (GGO) nodules
- Restore previously segmented nodules from prior studies for comparison ●
- Evaluation of nodules with quantitative measurements .
- Dictation Table with Lung-RADS, Fleischner Criteria and option to export to Clipboard
- Structured reporting available for export in the Viewer tab as well as the Reporting tab .
- Load three studies concurrently for temporal measurements .
- . Select a nodule in a single time point and the tool will automatically find the nodule in the other studies loaded
- Automatic nodule tracking of all measurements
- Improved nodule management and numbering ●
- Ability to export snapshots, CSV and copy to Clipboard features
- Available in Viewer and Report page o
General Image Display, Manipulation, and Analysis Tools:
- . Automatic software calculation of the following measurements for each segmented nodule:
- Volume (mm³) o
- Mean diameter (mm) O
043_Updated_007_510k_Summary (21 CFR 807.92)
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- Maximum diameter (mm) (RECIST) o
- O Short axis diameter (mm) (WHO)
- Average/minimum/maximum densities (HU) o
- Manual edit of the nodule segmentation contour lines with automatic recalculation of all measurements post-editing
- . Manual specification of the following characteristics for each nodule:
- o Lobe Location
- Shape o
- O Border
- . Comparison feature that allows establishing correspondence between nodules in two or three studies, and automatic calculation of the following temporal measurements between each follow-up scan and the previous scan:
- o Elapsed time in days
- Doubling time in days o
- Percent (%) growth in nodule volume O
Intended Use / Indications for Use:
The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing 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.
Changes from the last 510(k) clearance K043333:
| No. | Change(s) | Rationale for Changes |
|---|---|---|
| 1 | Change-1: Support of Ground Glass Opacity(GGO) NoduleProvides the ability to probe and segment aGGO type lung nodule. In addition, this featureincludes the ability to use 2nd MaximumDiameter to measure the solid portion of a GGOnodule and enabling solid nodules to besegmented prior to GGO nodules. | Extend the capabilities andfunctionality of the previously clearedLung Analysis software to providephysicians the ability to examine andreport on GGO nodules which canbe cancerous. |
| 2 | Change-2: Lung Analysis PerformanceEnhancementsImprovements to enhance the overallperformance of Lung Analysis. | Enhance performance to includeimproved execution and workflow forbetter user experience and function. |
| 3 | Change-3: Nodule Numbering EnhancementUpdated nodule numbering to automaticallyupdate numbering to the next sequentialnumber, specifically after deletion of a previouslynumbered nodule. | Provide continuous numberingduring probing and matching ofnodules for better user experience. |
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| No. | Change(s) | Rationale for Changes |
|---|---|---|
| 4 | Change-4: Dictation Table AdditionAdded a dictation table with the ability to enableL-Rad and Fleischner criteria. | Add the functionality of dictationtable with L-RAD and Fleischnercriteria as these are standard criteriafor reporting on lung cancerscreenings and diagnosis. |
| 5 | Change-5: Replaced Current Editing FeatureThe previous editing configuration was replacedwith a Lung Region editing functionality. | Replaced with Region editing toincrease the lung field which is to beexamined for more precise nodulesegmentation. |
| 6 | Change-6: Replaced Effective DiameterMeasurement FunctionThe previous measurement function “effectivediameter” was replaced with “mean diameter.” | Replaced for enhanced performanceand usability as mean diameterprovides a more accuratemeasurement. |
Intended for Disease / Condition / Patient Population:
The software provides Radiologists, Technologist, with a robust application to locate, identify, segment, measure and create reports on solid and GGO nodules. This application allows for the preparation of nodule comparison studies.
Substantial Equivalence Comparison:
● Regulatory Comparison with the Predicate Device
| Criteria | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Lung Analysis (K043333) | Lung Analysis(Modified LungAnalysis Software) | ||
| Device Type /Classification Name | System, Image Processing,Radiological | System, ImageProcessing,Radiological | Same |
| Common Name | Radiological Image ProcessingSoftware | Radiological ImageProcessing Software | Same |
| Regulation /Classification Number | 21 CFR 892.2050 | 21 CFR 892.1750 | Similar |
| Product Code | LLZ | JAK | Similar |
| Classification | Class II | Class II | Same |
| Review Panel | Radiology | Radiology | Same |
043_Updated_007_510k_Summary (21 CFR 807.92)
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| Criteria | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Lung Analysis(K043333) | Lung Analysis(Modified LungAnalysis Software) | ||
| Indications for Use | The separately-licensed LungAnalysis option isintended for thereview and analysisof thoracic CTimages for thepurposes ofcharacterizingnodules in the lung ina single study, orover the time courseof several thoracicstudies.Characterizationsinclude diameter,volume and volumeover time. Thesystem automaticallyperforms themeasurements,allowing lung nodulesand measurements tobe displayed. | The separately-licensed LungAnalysis option isintended for thereview and analysisof thoracic CTimages for thepurposes ofcharacterizingnodules in the lung ina single study, orover the time courseof several thoracicstudies.Characterizationsinclude diameter,volume and volumeover time. Thesystem automaticallyperforms themeasurements,allowing lung nodulesand measurements tobe displayed. | Same |
Intended Use Comparison with the Predicate Device ●
Technology Comparison with the Predicate Device ●
| Criteria | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Lung Analysis(K043333) | Lung Analysis(Modified LungAnalysis Software) | ||
| ImageCommunicationStandard: DICOM | Yes | Yes | Same |
| 2D Image Review | Yes | Yes | Same |
| 3D Image Review | Yes | Yes | Same |
| Criteria | Predicate Device | Subject Device | Comparison |
| Lung Analysis(K043333) | Lung Analysis(Modified LungAnalysis Software) | ||
| 2D and 3DComparative Review | Yes | Yes | Same |
| 3D Lung map | Yes | Yes | Same |
| 2D Measurements | Line and ROI toolswith statisticsArea | Line and ROI toolswith statisticsArea | Same |
| DensityMeasurements | Minimum, Maximumand Average HU | Minimum, Maximumand Average HU | Same |
| TemporalMeasurements | Elapsed Time% Growth in VolumeDoubling Time | Elapsed Time% Growth in VolumeDoubling Time | Same |
| Workflow | Point-and-clickdetectionAutomated contouringAutomatedmeasurementsManual correction | Point-and-clickdetectionAutomatedcontouringAutomatedmeasurementsManual correction | Same |
| Multi-planarreformatting | MPR in any user-defined linear plane,MIP and average | MPR in any user-defined linear plane,MIP and average | Same |
| Auto-cine | Yes | Yes | Same |
| Save workflow | Restorable state fromuser snapshots | Restorable state fromuser snapshots | Same |
| Reporting | Detailed tabular reportwith auto-population ofuser-defined keyimages | Detailed tabularreport with auto-population of user-defined key images | Same |
| Printing | Printing to standardwindows printers | Printing to standardwindows printers | Same |
| Criteria | Predicate Device | Subject Device | Comparison |
| Lung Analysis(K043333) | Lung Analysis(Modified LungAnalysis Software) | ||
| Ease of Use | Visualization presetsand semi-automatedsteps for typical imagereview procedures | Visualization presetsand semi-automatedsteps for typicalimage reviewprocedures | Same |
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. Technology Comparison with the Reference Device
| Criteria | Reference Device | Subject Device | Comparison |
|---|---|---|---|
| LungCARE CT(K033374) | Lung Analysis(Modified LungAnalysis Software) | ||
| Feature: Support ofGGO lung noduleThe GGO lungnodule featureallows for detection,segmentation andtracking over time ofGGO nodules. | Yes | Yes | SameNote: The addedGGO lung nodulefeature is similar tothe feature on thealready clearedSiemens MedicalSolutions, Inc.,LungCARE CT("Reference Device")software package byK033374. Therefore,the added featuredoes not raise newquestions of safetyand effectiveness. |
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Image /page/10/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.
| Criteria | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Lung Analysis(K043333) | Lung Analysis(Modified Lung Analysis Software) | ||
| Feature: Supportof Ground GlassOpacity (GGO)Nodule and 2ndMaximumDiameter RulersProvides the abilityto probe andsegment a GGOtype lung nodule. Inaddition, thisfeature includes theability to use 2ndMaximum Diameterto measure thesolid portion of aGGO nodule andenabling solidnodules to besegmented prior toGGO nodules. | No | Yes | The added featuresdo not affect theintended use orfundamental scientifictechnology of thealready cleared LungAnalysis software(K043333).Note: The addedGGO lung nodulefeature is similar tothe feature on thealready clearedSiemens MedicalSolutions, Inc.,LungCARE CT("Reference Device")software package byK033374. Therefore,the added featuredoes not raise newquestions of safetyand effectiveness. |
| Enhancement:Lung AnalysisPerformanceImprovements toenhance the overallperformance ofLung Analysis. | No | Yes | The addedperformanceenhancements do notaffect the intendeduse or fundamentalscientific technologyof the already clearedLung Analysissoftware (K043333). |
| Criteria | Predicate Device | Subject Device | Comparison |
| Lung Analysis(K043333) | Lung Analysis(Modified LungAnalysis Software) | ||
| Enhancement:NoduleNumberingUpdated nodulenumbering toautomaticallyupdate numberingto the nextsequential number,specifically afterdeletion of apreviouslynumbered nodule. | No | Yes | This enhancementdoes not affect theintended use orfundamental scientifictechnology of thealready cleared LungAnalysis software(K043333). |
| Enhancement:Dictation TableAdded a dictationtable with the abilityto enable L-Radand Fleischnercriteria. | No | Yes | This enhancementdoes not affect theintended use orfundamental scientifictechnology of thealready cleared LungAnalysis software(K043333). |
| Change: ReplacedCurrent EditingFeatureThe previouseditingconfiguration wasreplaced with aLung Regionediting functionality. | No | Yes | This change does notaffect the intendeduse or fundamentalscientific technologyof the already clearedLung Analysissoftware (K043333). |
| Change: ReplacedEffective DiameterMeasurementFunctionThe previousmeasurementfunction "effectivediameter" wasreplaced with"mean diameter." | No | Yes | This change does notaffect the intendeduse or fundamentalscientific technologyof the already clearedLung Analysissoftware (K043333). |
● Differences in Technology with the Predicate Device
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. Substantial Equivalence Analysis
The enhancements in the software do not affect the intended use or alter the fundamental scientific technology of the legally marketed Lung Analysis software (K043333). The modified Lung Analysis software has the same indications for use, principle of operation, and performs the same technological functions as the already cleared Lung Analysis software - K043333 (Predicate Device). The added GGO lung nodule feature is similar to the already cleared Siemens Medical Solutions, Inc., LungCARE CT (K033374) (Reference Device). The modifications are not consequential from the standpoint of device operation, safety, effectiveness or intended use. Any minor differences noted have been explained and do not raise any new questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, and the performed verification and validation tests demonstrate the safety and efficacy of the device is equivalent to the predicate device. Based on the comparison data and test data, Vital Images believes the subject device should be found substantially equivalent to the predicate device.
Summary of Non-Clinical Tests:
The changes to the software were designed, developed and tested according to written procedures that included applying risk management. Software testing was completed to ensure the new features operate according to their requirements.
Testing included verification, validation, and evaluation on previously acquired medical images. The following quality assurance measures were applied to the development:
- Risk Management ●
- . Requirements reviews
- Code designs .
- Code reviews
- . Design reviews
- . Verification of the software - that included performance and safety testing
- . Validation of the software – that included simulated usability testing by independent experienced medical professionals.
Risk Management:
Each risk pertaining to this feature has been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of at least "Remote". All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Based on the post market information contained in our Clinical Evaluation Report, injury or death is very rare for our product and products similar to ours. Because of this history and because of the risk control measures included in this feature, it is believed that the risk for the feature as a whole is extremely low. Taking into account all risks against the benefits of this feature, it has been assessed that the benefits do outweigh the risks for this feature.
During the design review, the following conclusions were reached:
- All risks were reduced as low as possible ●
- The medical benefits of the device outweigh the residual risk for each individual risk . and all risks together
- . The overall residual risk for the project is deemed acceptable
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Verification:
The software verification team's primary goal was to assure that the software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As a part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM.
Validation:
The software validation team's primary goal was assuring the software conforms to user needs and intended use. The validation team conducted workflow testing that provided evidence that the system requirements and features were implemented, reviewed and met.
Phantom Testing:
The phantom tests were performed is to verify that the Lung Analysis application generates reliable volumes and related linear and CT attenuation measurements of pulmonary ground glass opacifications (GGOs). The validation of the GGO measurements is based on anthropomorphic lung phantoms with synthetic nodules. Moreover, accuracy, intra-reader variability and interreader variability are assessed using patient-based datasets. In summary the following tests were performed:
-
- GGO volume accuracy and precision: the accuracy and the precision of the GGO volume measurements after semi-automatic segmentation and before manual editing are within acceptable.
-
- GGO volume reproducibility: the intra-reader and inter-reader agreement for the GGO volume measurements (patient-based dataset - after manual editing) are within acceptable ranges.
- GGO diameters accuracy and precision: the accuracy and the precision of the GGO 3. longest nodule diameter measurements after semi-automatic segmentation and before manual editing are within acceptable ranges.
- GGO mean CT attenuation accuracy and precision: the accuracy and the precision of 4. the GGO mean CT attenuation (HU) measurements after semi-automatic segmentation and before manual editing are within acceptable ranges.
| ID | Test Case Name | Parameters | Type | Status |
|---|---|---|---|---|
| Test 1.a | Evaluate the accuracy andprecision of the GGO volumemeasurement for Siemens 64-CTscanner. | GGO volumeBias: Absolute error (mm3)Absolute percentage normalizederror %(APNE)Precision: Percent RepeatabilityCoefficient (PRC) | Phantomdataset | Passed |
| ID | Test Case Name | Parameters | Type | Status |
| Test 1.b | Evaluate the accuracy andprecision of the GGO volumemeasurement for Philips 16-CTscanner. | GGO volumeBias: Absolute error (mm3)Absolute percentage normalizederror %(APNE)Precision: Percent RepeatabilityCoefficient (PRC) | Phantomdataset | Passed |
| Test 1.c | Evaluate the accuracy andprecision of the GGO volumemeasurement for Toshiba AQ1320-CT scanner | GGO volumeBias: Absolute error (mm3)Absolute percentage normalizederror %(APNE)Precision: Percent RepeatabilityCoefficient (PRC) | Phantomdataset | Passed |
| Test 2 | Evaluate the intra-reader andinter-reader variability of GGOvolume measurements onpatient-based datasets. | Intra-reader agreement andInter-reader agreement:Concordance CorrelationCoefficient (CCCinter, TotalDeviation Index (TDI), CoverageProbability (CV) | Patient-baseddatasetUser-editedGGOs | Passed |
| Test 3 | Evaluate the accuracy andprecision of the GGO longestdiameter measurement forToshiba AQ1 320-CT scanner. | Longest diameter (mm)Bias: Absolute error (mm)Absolute percentage normalizederror %(APNE)Precision: within-nodule standarddeviation (wSD). | Phantomdataset | Passed |
| Test 4 | Evaluate the accuracy andprecision of the GGO meanattenuation measurement forToshiba AQ-One CT scanner. | Mean attenuation (HU)Bias: Absolute error (HU) Absolutepercentage normalized error%(APNE)Precision: within-nodule standarddeviation (wSD). | Phantomdataset | Passed |
The following table summarize the performed phantom tests:
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Measurement Accuracy:
The following table summarize accuracy i.e. average bias (APE %) and precision (PRC %) for lung GGO volume measurement performed on Toshiba scanner with 100mAs exposure.
| GGO Ref. diameter | Bias APE% | Precision PRC% |
|---|---|---|
| 5mm | 15.04% | 24.74% |
| 8mm | 16.15% | 11.85% |
| 10mm | 5.49% | 3.24% |
| 12mm | 2.98% | 3.38% |
The accuracy and precision results of the GGO volume measurements may vary for other CT scanner types or CT manufacturers and for other acquisition conditions involving tube current, slice thickness, reconstruction filters, etc.
External Validation:
During external validation of Lung Analysis software, experienced medical professionals evaluated the application. All validators confirmed that the Lung Analysis software fulfills its intended uses.
Summary of Clinical Tests:
The subject of this traditional 510(k) notification, Lung Analysis software, did not require clinical studies to support safety and effectiveness of the software.
Cyber and Information Security:
- Confidentiality ●
The Vitrea platform (K150258) relies on built in Windows Login security to limit access to the system. The Vitrea platform can only be installed and configured by an administrator of the Windows machine.
● Intearity
The Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances.
● Availability
The Vitrea platform is always available to the logged on user as long as the Windows machine itself is properly maintained.
. Accountability
The Vitrea platform includes an audit capability that tracks authenticated and authorized user operations along with information on what data was accessed. Vitrea audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user.
Performance Standards:
The FDA has not established mandatory performance standards and no special controls exist for this device. General software verification and validation tests were conducted to confirm proper function of the device's features.
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Image /page/16/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.
The Lung Analysis software complies with the following voluntary recognized consensus standards:
| Standard No. | StandardsOrganization | Standard Title | Version | Date |
|---|---|---|---|---|
| PS 3.1-3.20(2011)(RecognitionNumber 12-238) | NEMA | Digital Imaging andCommunications inMedicine (DICOM) Set(Radiology) | 3 | 03/16/2012 |
| ISO 14971:2007(RecognitionNumber 5-70) | AAMI / ANSI/ ISO | Medical Devices -Applications of RiskManagement to MedicalDevices | 2007 | 03/16/2012 |
| IEC 62304:2006(RecognitionNumber 13-32) | AAMI / ANSI/ IEC | Medical Device Software -Software Life CycleProcesses (Software /Informatics) | 2006 | 08/20/2012 |
Conclusion:
Vital Images believes that the Lung Analysis software application has the same intended use and indications and similar principle of operation, and technological characteristics as the predicate and reference devices. Any minor differences noted have been explained and do not raise any new questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, labeling, and performed tests demonstrate the safety and efficacy of the device in comparison to the predicate device. Based on the comparison data and test data, Vital Images believes the subject device should be found substantially equivalent to the predicate device. The Lung Analysis software device is as safe and effective as the predicate device.
§ 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.