(266 days)
Not Found
No
The summary describes image processing steps and quantitative analysis based on CT values and geometric features, but it does not mention the use of AI, ML, or deep learning. The performance testing compares the device to a predicate and physician segmentations, not against a ground truth derived from an AI/ML model.
No
The device provides quantitative support for diagnosis and follow-up examination, and can be used to assess the effectiveness of therapy based on CT scan data, but it does not directly administer or apply a therapeutic treatment.
Yes
The device "Broncholab" is intended to "support physicians in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets," which aligns with the definition of a diagnostic device.
Yes
The device is explicitly described as "SaMD (Software as Medical Device)" and its function is to process CT images and provide quantitative values and reports. While it interacts with a web portal and a reporting accessory, these are described as enabling the software's function and do not appear to be hardware components that are part of the regulated device itself. The core functionality is image processing and data analysis performed by the software.
Based on the provided information, Broncholab is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Broncholab's Function: Broncholab analyzes medical images (CT scans) of the lungs. It does not analyze biological specimens taken from the patient's body. It processes existing image data.
- Intended Use: The intended use clearly states that Broncholab provides quantitative support for diagnosis and follow-up examination based on CT thoracic datasets. This is image analysis, not in vitro testing.
- Device Description: The device description reinforces that it transforms CT scan images into 3D models and provides quantitative CT values derived from these images.
Therefore, Broncholab falls under the category of medical image analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Broncholab provides physicians with reproducible CT values for providing quantitative support for diagnosis and follow-up examination. Broncholab can be used to support physicians in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of subcompartments, volumetric analysis, density evaluations, low density cluster analysis, fissure evaluation and reporting tools are combined with a dedicated workflow.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Broncholab is a SaMD (Software as Medical Device) which provides quantitative CT values that are intended to support the physician in the diagnosis and documentation of pulmonary tissues images (abnormalities) from CT scans. The CT scan images are transformed into 3D models of the patient-specific lungs using several image processing steps. Broncholab can be used to assess the effectiveness of therapy based on CT scan data. It is used along with the following accessories:
- Web Portal: Enables the uploading of CT scans and patient data
- Client Report: Enables the conversion of the output of Broncholab (CT values) into a desired digital format (PDF Report) and transfers this Report to the physician via email.
Inspiratory CT scan images uploaded by the users are converted into quantitative CT values using a combination of software tools. Quality checks (both manual and automated) are implemented to assure the quality of the final data. The outputs are provided as absolute values and as a percentage of the total airway volume/ lobar volume depending on the parameter. The device can be used on a computer with a web browser installed and consists of two accessories:
- An online portal to upload the CT scans
- · An accessory that enables the creation of the Report
The CT values include:
-
- Lung and Lobar Volume is the volume of the 3D model of each lung lobe.
-
- Airway Volume is defined as the region from the trachea until the segmental bronchi.
-
- Lung Density Scores/ Volumes is defined as all the intrapulmonary voxels with Hounsfield Units between -1024 and -950 using the inspiratory scans:
- · Low attenuation areas below -950 HU (LAA-950HU)
- · 15th percentile of density histogram : Percentile density (PD) can also be used to express Emphysema.
- · Blood vessel density : Blood vessel density can be determined through segmentation and 3-D reconstruction of the blood vessels. The segmentation is based on local geometry features and HU thresholds and is performed on the inspiratory CT scan.
-
- Fissure Analysis (fissure integrity) is the percentage of the fissure. Lung fissures are a doublefold of visceral pleura that either completely or incompletely separates the lungs into lung lobes.
CT scan images must be DICOM 3.0 compliant.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Pulmonary tissues (lungs), thoracic datasets
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The aim of this study was to assess and compare the measurement of lung structure parameters at inspiration, such as lobe volume, emphysema, blood vessel density, 15th percentile lung density (PD15) and fissure integrity, between the Broncholab device and the VIDA device, i.e. primary predicate (K083227). Firstly, both devices analyzed the lobe volume, emphysema, blood vessel density, PD15 and fissure integrity, Bland-Altman plots were used for the pairwise comparison of the lobe volume, emphysema, blood vessel density and PD15 measurements between the two devices. Moreover, for the comparison of the fissure integrity measurements between both devices, the Intraclass Correlation Coefficient (ICC) with 95% confidence interval (CI) was calculated. The airway volumes are not compared with the primary predicate but with segmentations which were corrected by three physicians. The pairwise comparison between Broncholab and the physicians was performed using Bland-Altman plots of airway volume. Ground truth for airway volume was established by taking the mean airway volume obtained from three physicians' segmentation.
The scans were take with a wide variety of scanner brands and models used to obtain scans in the datasets used for the performance testing are: GE Healthcare; Philips; Siemens scanner types: LightSpeed VCT; LightSpeed Pro 16; LightSpeed 16; Revolution CT;Revolution EVO; iCT 256; Emotion 16; SOMATOM Definition AS; SOMATOM Force; SOMATOM Definition Flash; Brilliance 64; Definition; Definition AS+;Discovery CT750 HD; Sensation 64.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing: Verification testing was conducted against predetermined acceptance criteria. Design validation was performed in simulated use settings.
A head-to-head performance testing was conducted between the subject and the predicate device.
Key Results: For lobe volume, emphysema and blood vessel density measurements expressed in relative values, the mean differences (range) between Broncholab and the primary predicate were all less than 5%. When expressed in absolute values, the mean differences (range) between Broncholab and the primary predicate were less than the threshold absolute value. The mean difference (range) between Broncholab and the primary predicate for the PD15 measurements was less than 1 HU. The ICC estimate (95% Cl) for comparison of the fissure integrity measurements between Broncholab and the primary predicate was found to be 0.75 (0.54, 0.87). The mean difference (range) between Broncholab and the physicians for the airway volume measurements expressed in relative values was less than 5%. Expressed in absolute values the mean difference (range) was less than the absolute threshold value.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean differences (range), Intraclass Correlation Coefficient (ICC) with 95% confidence interval (CI).
Tolerable variability for absolute and relative values are 150mL and 5%, respectively.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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March 4, 2020
Fluidda Inc. c/o Anjali Nair Regulatory Affairs Specialist 750 N. San Vicente Blvd. Suite 800 West WEST HOLLYWOOD CA 90069
Re: K191550
Trade/Device Name: Broncholab Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: January 28, 2020 Received: January 29, 2020
Dear Anjali Nair:
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
1
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 medical devices and radiation-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,
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
2
Indications for Use
510(k) Number (if known) K191550
Device Name Broncholab
Indications for Use (Describe)
Broncholab provides physicians with reproducible CT values for providing quantitative support for diagnosis and follow-up examination. Broncholab can be used to support physicians in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of subcompartments, volumetric analysis, density evaluations, low density cluster analysis, fissure evaluation and reporting tools are combined with a dedicated workflow.
| 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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3
Section 5 - 510(k) Summary
| Submitter | Fluidda Inc. |
|---|---|
| Submission Number | K191550 |
| Address | 750 N San Vicente Blvd Ste. 800 West, West Hollywood, CA |
| 90069, USA | |
| Contact Person | Anjali Nair |
| Regulatory Affairs Specialist at Fluidda Inc. | |
| Tel: +91 9324857705 | |
| Email: anjali.nair@fluidda.com | |
| Date Prepared | January 28, 2020 |
| Trade Name | Broncholab |
| Common Name | Quantitative CT analysis system |
| Classification Name | Computed Tomography X-Ray System |
| Regulation Number | 21 CFR 892.1750 |
| Classification | Class II |
| Product Code | JAK |
| Panel | Radiology |
| Legally marketed Primary Predicate Device | Vida Pulmonary Workstation 2 (PW2), Vida Diagnostics |
| (K083227) | |
| Predicate Regulation Number | 21 CFR 892.1750 |
| Predicate Classification & Product Code | Class II; Product Code- JAK |
| The predicate device has not been subject to a design-related | |
| recall. |
4
Device Description
Broncholab is a SaMD (Software as Medical Device) which provides quantitative CT values that are intended to support the physician in the diagnosis and documentation of pulmonary tissues images (abnormalities) from CT scans. The CT scan images are transformed into 3D models of the patient-specific lungs using several image processing steps. Broncholab can be used to assess the effectiveness of therapy based on CT scan data. It is used along with the following accessories:
- Web Portal: Enables the uploading of CT scans and patient data
- Client Report: Enables the conversion of the output of Broncholab (CT values) into a desired digital format (PDF Report) and transfers this Report to the physician via email.
Inspiratory CT scan images uploaded by the users are converted into quantitative CT values using a combination of software tools. Quality checks (both manual and automated) are implemented to assure the quality of the final data. The outputs are provided as absolute values and as a percentage of the total airway volume/ lobar volume depending on the parameter. The device can be used on a computer with a web browser installed and consists of two accessories:
- An online portal to upload the CT scans
- · An accessory that enables the creation of the Report
The CT values include:
-
- Lung and Lobar Volume is the volume of the 3D model of each lung lobe.
-
- Airway Volume is defined as the region from the trachea until the segmental bronchi.
-
- Lung Density Scores/ Volumes is defined as all the intrapulmonary voxels with Hounsfield Units between -1024 and -950 using the inspiratory scans:
- · Low attenuation areas below -950 HU (LAA-950HU)
- · 15th percentile of density histogram : Percentile density (PD) can also be used to express Emphysema.
- · Blood vessel density : Blood vessel density can be determined through segmentation and 3-D reconstruction of the blood vessels. The segmentation is based on local geometry features and HU thresholds and is performed on the inspiratory CT scan.
-
- Fissure Analysis (fissure integrity) is the percentage of the fissure. Lung fissures are a doublefold of visceral pleura that either completely or incompletely separates the lungs into lung lobes.
CT scan images must be DICOM 3.0 compliant.
Indications for Use Statement
Broncholab provides physicians with reproducible CT values for providing quantitative support for diagnosis and follow-up examination. Broncholab can be used to support physicians in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of subcompartments, volumetric analysis, density cluster analysis, fissure evaluation and reporting tools are combined with a dedicated workflow.
5
Summary of Technological Comparisons
| Subject Device | Predicate Device | |||
|---|---|---|---|---|
| Device Proprietary Name | Broncholab | Vida Pulmonary Workstation 2 (PW2) | SUBSTANTIAL | |
| EQUIVALENCE (SE) | ||||
| COMPARISON | ||||
| Manufacturer | Fluidda, Inc. | Vida Diagnostics | ||
| 510(k) | K191550 | K083227 | ||
| Labeling | ||||
| Regulation | 21 CFR 892.1750 | 21 CFR 892.1750 | Same | |
| Product code | JAK | JAK | Same | |
| Classification | Class. Name | Computed Tomography X- Ray | ||
| System | Computed Tomography X- Ray System | Same | ||
| Indications for Use Statement | Broncholab provides physicians | |||
| with reproducible CT values for | ||||
| pulmonary tissue for providing | ||||
| quantitative support for diagnosis | ||||
| and follow-up examination. | The Vida Pulmonary Workstation 2 (PW2) | |||
| software provides reproducible CT values for | ||||
| pulmonary tissue which is essential for | ||||
| providing quantitative support for diagnosis | ||||
| and follow up examinations. | Same | |||
| Broncholab can be used to support | ||||
| physicians in the diagnosis and | ||||
| documentation of pulmonary | ||||
| tissues images (e.g., | ||||
| abnormalities) from CT thoracic | ||||
| datasets. | The PW2 can be used to support the | |||
| physician in the diagnosis and documentation | ||||
| of pulmonary tissue images (e.g., | ||||
| abnormalities) from CT thoracic datasets. | Same | |||
| Three-D segmentation and | ||||
| isolation of subcompartments, | ||||
| volumetric analysis, density | ||||
| evaluations, low density cluster | ||||
| analysis, fissure evaluation and | ||||
| reporting tools are combined with | ||||
| a dedicated workflow. | Three-D segmentation and isolation of sub- | |||
| compartments, volumetric analysis, density | ||||
| evaluations, low density cluster analysis and | ||||
| reporting tools are combined with a | ||||
| dedicated workflow. | Same | |||
| Intended User Population | Physician | Physician | Same | |
| Patients population | Broncholab can be used to support | |||
| physicians in the diagnosis and | ||||
| documentation of pulmonary | ||||
| tissues images (e.g., | ||||
| abnormalities) from CT thoracic | ||||
| datasets. | The PW2 can be used to support the | |||
| physician in the diagnosis and documentation | ||||
| of pulmonary tissue images (e.g., | ||||
| abnormalities) from CT thoracic datasets. | Same | |||
| Subject Device | Predicate Device | |||
| Device Proprietary Name | Broncholab | Vida Pulmonary Workstation 2 (PW2) | SUBSTANTIAL | |
| EQUIVALENCE (SE) | ||||
| COMPARISON | ||||
| Manufacturer | Fluidda, Inc. | Vida Diagnostics | ||
| 510(k) | K191550 | K083227 | ||
| Technical (IT) Considerations | ||||
| Modality | CT | CT | Same | |
| Data Loading | DICOM | DICOM | Same | |
| Application | Graphical User Interface (GUI) | Workstation | Equivalent | |
| Using the GUI does not | ||||
| affect the processing of | ||||
| scans. It only provides a | ||||
| means to transfer the | ||||
| input and receive the | ||||
| output (Report). These | ||||
| differences do not raise | ||||
| different questions | ||||
| regarding the safety and | ||||
| effectiveness of the | ||||
| subject device. | ||||
| Automation of process | Automation of tasks within the | |||
| workflow of the FRI | ||||
| Quantification Software | Fully automated analysis of an | |||
| inspiratory chest CT scan | Equivalent | |||
| Software device that | ||||
| operates on industry | ||||
| standard hardware | Yes | Yes | Same | |
| CT Scan | ||||
| Protocol | ||||
| Requirements | Equivalent | Equivalent | Equivalent | |
| Input | Chest CT Scans | Chest CT Scans | Same | |
| Output | 1. | |||
| Lung and lobar volume |
Airway volume
3.
Lung and lobar density scores
4.
Fissure analysis | 1. Lung and lobar volume
2. Lung and lobar density scores
3. Fissure analysis | Like the predicate, the subject
device provides:
- Lung and lobar
volume - Lung and lobar
density scores - Fissure analysis
Performance testing to
demonstrate accuracy and
effectiveness of the airway
volume and blood vessel
density parameter, along with
all other outputs has been
performed and the results are
placed in Section 18 -
Performance Testing - Bench |
| | Analyzed Data Output | Provides a Report | Provides a report | Same |
| | Subject Device | Predicate Device | | |
| Device Proprietary Name | Broncholab | Vida Pulmonary Workstation 2 (PW2) | SUBSTANTIAL | |
| Manufacturer | Fluidda, Inc. | Vida Diagnostics | EQUIVALENCE (SE)
COMPARISON | |
| 510(k) | K191550 | K083227 | | |
| | | Tasks performed by Device | | |
| Segmentation | Provides Three-D Segmentation | Provides Three-D Segmentation | Same | |
| | Provides Segmentation of: | Provides Segmentation of: | Same | |
| | · Left Lung | · Left Lung | | |
| | · Right Lung | · Right Lung | | |
| | · Left Upper Lobe (LUL) | · Left Upper Lobe (LUL) | | |
| | · Left Lower Lobe (LLL) | · Left Lower Lobe (LLL) | | |
| | · Right Upper Lobe (RUL) | · Right Upper Lobe (RUL) | | |
| | · Right Middle Lobe (RML) | · Right Middle Lobe (RML) | | |
| | · Right Lower Lobe (RLL) | · Right Lower Lobe (RLL) | | |
| | Provides Airway Segmentation | Provides Airway Segmentation | Same | |
| | Intended user cannot manually
edit segmentation. | Intended user can manually edit
segmentation | These differences do not
raise different questions
regarding the safety and
effectiveness of the
subject device. | |
| Volumetric Analysis | Ability to measure volume for: | Ability to measure volume for: | Same | |
| | · Both Lungs
· Left Lung
· Right Lung
· Left Upper Lobe (LUL)
· Left Lower Lobe (LLL)
· Right Upper Lobe (RUL)
· Right Middle Lobe (RML)
· Right Lower Lobe (RLL) | · Both Lungs
· Left Lung
· Right Lung
· Left Upper Lobe (LUL)
· Left Lower Lobe (LLL)
· Right Upper Lobe (RUL)
· Right Middle Lobe (RML)
· Right Lower Lobe (RLL) | | |
| Density analysis | Ability to measure
volume at multiple
density ranges for:
· Both Lungs
· Left Lung
· Right Lung
· Left Upper Lobe (LUL)
· Left Lower Lobe (LLL)
· Right Upper Lobe (RUL)
· Right Middle Lobe (RML)
· Right Lower Lobe (RLL) | Ability to measure
volume at multiple
density ranges for:
· Both Lungs
· Left Lung
· Right Lung
· Left Upper Lobe (LUL)
· Left Lower Lobe (LLL)
· Right Upper Lobe (RUL)
· Right Middle Lobe (RML)
· Right Lower Lobe (RLL) | Same | |
| | Ability to measure 15th percentile
density. blood vessel density and | Ability to measure 15th percentile density,
blood vessel density and perform fissure | Same | |
| | perform fissure evaluations | evaluations | | |
| Detects Airway
Morphology | Yes | Yes | Same | |
| Steps in the use of the device | | | | |
| Quality check of CT
Scans | Quality Checks on CT Scans | Integrated scan quality check | Equivalent
Both the subject and
predicate devices conduct
quality checks on incoming
data although exact
wording is different. | |
| Analysis | Automation of tasks in the
workflow of the FRI Quantification
Software. | Fully automated quantification | Equivalent
In the case of both the
devices, image processing
steps that can be done
manually are done
automatically in order to
save time. Any differences
do not raise different
questions regarding the
safety and effectiveness of
the subject device. | |
| Review of output | The Report is QC verified before
it is emailed to the physician. | Automated quality check of the Report | Equivalent
In the case of both the
subject and the predicate
devices, the final output is
reviewed before it is made
available to the intended
user. | |
| Delivery of results:
the results are
delivered back to the
intended user | Yes | Yes | Same | |
| Other Areas of Comparison | | | | |
| Energy used and/or
delivered to patient | No | No | Same | |
| Materials | N/A | N/A | Same | |
6
7
8
9
Non-Clinical Performance Testing
Verification testing was conducted against predetermined acceptance criteria to show that the subject device performs the functions that are equivalent to the predicate device. Broncholab successfully passed verification testing. Design validation was performed in simulated use settings. The results support substantial equivalence of the subject device to the predicate device and demonstrate that it is safe and effective for its intended use.
The following quality assurance measures were applied during software development:
- Software Development Life Cycle
- · Software Risk Assessment
- Software Configuration Management and Version Control
- · Software issue tracking and resolution
A head-to-head performance testing was conducted between the subject and the predicate device.
The aim of this study was to assess and compare the measurement of lung structure parameters at inspiration, such as lobe volume, emphysema, blood vessel density, 15th percentile lung density (PD15) and fissure integrity, between the Broncholab device and the VIDA device, i.e. primary predicate (K083227). Firstly, both devices analyzed the lobe volume, emphysema, blood vessel density, PD15 and fissure integrity, Bland-Altman plots were used for the pairwise comparison of the lobe volume, emphysema, blood vessel density and PD15 measurements between the two devices. Moreover, for the comparison of the fissure integrity measurements between both devices, the Intraclass Correlation Coefficient (ICC) with 95% confidence interval (CI) was calculated. The airway volumes are not compared with the primary predicate but with segmentations which were corrected by three physicians. The pairwise comparison between Broncholab and the physicians was performed using Bland-Altman plots of airway volume.
The tolerable variability for absolute and relative values are 150mL and 5%, respectively.
The results showed that for the lobe volume, emphysema and blood vessel density measurements expressed in relative values, the mean differences (range) between Broncholab and the primary predicate were all less than 5%. When expressed in absolute values, the mean differences (range) between Broncholab and the primary predicate were less than the threshold absolute value. The mean difference (range) between Broncholab and the primary predicate for the PD15 measurements was less than 1 HU. The ICC estimate (95% Cl) for comparison of the fissure integrity measurements between Broncholab and the primary predicate was found to be 0.75 (0.54, 0.87). The mean difference (range) between Broncholab and the physicians for the airway volume measurements expressed in relative values was less than 5%. Expressed in absolute values the mean difference (range) was less than the absolute threshold value. Ground truth was established by taking the mean airway volume obtained from three physicians' segmentation.
The scans were take with a wide variety of scanner brands and models used to obtain scans in the datasets used for the performance testing are:
| Imaging parameters | Equivalence study |
|---|---|
| Scanner manufacture | GE Healthcare; Philips; Siemens |
| Scanner types | LightSpeed VCT; LightSpeed Pro 16; LightSpeed 16; Revolution CT;Revolution EVO; iCT 256; Emotion 16; SOMATOM Definition AS; SOMATOM Force; SOMATOM Definition Flash; Brilliance 64; Definition; Definition AS+;Discovery CT750 HD; Sensation 64 |
10
Clinical Performance Data
No clinical performance testing data is provided with this submission.
Conclusion
Based on the intended use and technological characteristics comparison, non-clinical tests described, it can be concluded that taken individually as well as in sum, the subject device (Broncholab) is as safe, as effective, and performs as well as the predicate device (Vida PW2) and is thus substantially equivalent to it.