(158 days)
The e-Lung software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support in the examination of radiological findings. These radiological findings can then be evaluated by the physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses. The e-Lung software package is intended to be a workflow enhancement and for the assessment of CT thoracic datasets. e-Lung can be used to support the physician when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. 3D segmentation, volumetric measurements, density evaluations, and reporting tools are combined with a dedicated workflow.
Brainomix 360 e-Lung is a software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. e-Lung is a CT processing module which operates within the integrated Brainomix 360 platform.
Brainomix 360 e-Lung is a stand-alone software device which uses a set of image processing algorithms to perform evaluation (3D segmentation and isolation of sub-compartments, volumetric measurements, and density evaluations), editing, and reporting tools which are combined with a dedicated workflow.
e-Lung can be used to support the physician in the examination of radiological findings that may be indicative of chest diseases e.g. when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. These radiological findings can then be evaluated by the physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses.
e-Lung is designed to analyze pulmonary CT slice data and display analysis results. Each voxel of the scan is measured by Hounsfield units (HU), a measurement of x-ray attenuation that is applied to each volume element in three dimensional space. The HU are utilized to distinguish between air, water, tissue and bone, such distinction is common in the industry.
e-Lung provides computed tomography (CT) viewing, and parenchymal density analysis in one application. e-Lung provides quantitative measurements and tabulates quantitative properties.
e-Lung focuses on what is visible to the eye and applies volumetric methods that might otherwise be too time consuming to use.
The software does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods; the software does not reconstruct a 3D rendering image of the lung; the intent of the software is to enhance the workflow by saving time and automating potential error prone manual tasks.
e-Lung has functions for loading, and saving datasets, and will generate screen displays, computations and aggregate statistics. e-Lung data output may be exported to a CSV, Excel or PDF file.
Here is an analysis of the acceptance criteria and study for the Brainomix 360 e-Lung device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Lung Segmentation | Average Dice Similarity Coefficient (DSC) across all cases of over 0.95 (defined by the lower bound of the confidence interval) | Median DSC: 0.978 (IQR: 0.974-0.980); all cases showed a DSC above 0.95. |
| Density Evaluation | Good Dice score (min 0.80) between the e-Lung structural densities and histogram densities and those pre-defined parameters generated in the digital phantom dataset. | "The density evaluations are validated by ensuring a good Dice score (min 0.80) between the e-Lung structural densities and histogram densities and those pre-defined parameters generated in the digital phantom dataset." (Implicitly, this means the criterion was met.) |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Lung Segmentation Study:
- Test Set Sample Size: 100 cases (N=38 from Boston Medical Center, N=62 from a commercial database).
- Data Provenance: Retrospective study. Cases were selected from a research registry at Boston Medical Center and a commercial database of clinical imaging data. The demographic and clinical variables were enriched to allow generalizability. The hospital locations mentioned for the cases are Massachusetts, New York, Ohio, New Jersey, Wisconsin, Florida, Maryland, and South Dakota (all in the USA), indicating the data origin is the USA.
-
Density Evaluation Study:
- Test Set Sample Size: Not explicitly stated, but involved "synthetic digital phantom data" and a "real-world data bridging study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Lung Segmentation Study:
- Number of Experts: Three (3)
- Qualifications: Experienced US board certified radiologists.
4. Adjudication Method for the Test Set
- Lung Segmentation Study: The ground truth mask was generated from the consensus of the three experienced US board certified radiologists. This implies an adjudication method where agreement among the experts was used to define the ground truth. The specific "2+1" or "3+1" approach is not explicitly detailed, but "consensus" indicates multiple readers informing the final ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study evaluated the device's accuracy against a ground truth created by human experts, not the improvement of human readers with AI assistance versus without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Yes, the lung segmentation study described is a standalone study. The device's lung mask generation was compared directly to the expert-derived ground truth, without human interaction with the device's output during the evaluation phase.
7. The Type of Ground Truth Used
- Lung Segmentation Study: Expert consensus, specifically from three experienced US board certified radiologists who segmented the lungs.
- Density Evaluation Study: Synthetic digital phantom data and a real-world data bridging study to establish pre-defined parameters.
8. The Sample Size for the Training Set
- The document does not explicitly state the sample size for the training set. It only describes the validation set (test set).
9. How the Ground Truth for the Training Set was Established
- The document does not explicitly describe how the ground truth for the training set was established. It focuses on the validation (test) set. Given the algorithm is described as "non-adaptive deterministic," it's possible that a formal "training set" with ground truth in the machine learning sense wasn't used for an adaptive algorithm, but rather a set of cases for algorithm development and refinement, which would typically involve expert annotations for ground truth. However, the document does not provide these details.
{0}------------------------------------------------
May 13, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized eagle emblem. To the right of this emblem, there is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and below that, the word "ADMINISTRATION" in a smaller font size, also in blue.
Brainomix Limited % Thais Sala Senior Quality Assurance and Regulatory Affairs Manager First Floor, Seacourt Tower West Way OXFORD. OX2JJ UNITED KINGDON
Re: K233875
Trade/Device Name: Brainomix 360 e-Lung Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: December 7, 2023 Received: April 15, 2024
Dear Thais Sala:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
{1}------------------------------------------------
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Rav Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K233875
Device Name Brainomix 360 e-Lung
Indications for Use (Describe)
The e-Lung software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support in the examination of radiological findings. These radiological findings can then be evaluated by the physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses. The e-Lung software package is intended to be a workflow enhancement and for the assessment of CT thoracic datasets. e-Lung can be used to support the physician when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. 3D segmentation, volumetric measurements, density evaluations, and reporting tools are combined with a dedicated workflow.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is a gradient of light blue to dark blue. The letters "B", "R", "N", "O", "M", "X" are dark gray, while the letters "A" and "I" are a gradient of light blue to dark blue.
K233875
510(K) Summary Brainomix Limited – Brainomix 360 e-Lung
| Date Prepared: | 07Dec2023 |
|---|---|
| Applicant's Name: | Brainomix Limited |
| Applicant's Address: | First Floor, Seacourt Tower, West WayOxford, OX2 0JJUnited Kingdom |
| Official Contact: | Thais Sala+44 (0) 7375 967 695tsala@brainomix.com |
| Device Proprietary Name: | Brainomix 360 e-Lung |
| Regulation Name: | Computed tomography x-ray system |
| Regulatory Class: | Class II |
| Product Code: | JAK |
| Regulation Number: | 21 C.F.R. §892.1750 |
1. Predicate Device
Brainomix 360 e-Lung is Substantially Equivalent to the following Legally Marketed device:
Trade Name: Vida | Vision Manufacturer: VIDA Diagnostics Inc. Regulation Number: 21 C.F.R. §892.1750 Regulatory Class: Class II Regulation Name: Computed tomography x-ray system Product Code: JAK Submission Number: K200990
2. Device Description
Brainomix 360 e-Lung is a software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. e-Lung is a CT processing module which operates within the integrated Brainomix 360 platform.
Brainomix 360 e-Lung is a stand-alone software device which uses a set of image processing algorithms to perform evaluation (3D segmentation and isolation of sub-compartments, volumetric measurements, and density evaluations), editing, and reporting tools which are combined with a dedicated workflow.
e-Lung can be used to support the physician in the examination of radiological findings that may be indicative of chest diseases e.g. when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. These radiological findings can then be evaluated by the
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is a gradient of light blue, while the letters "AI" in "BRAINOMIX" are also in the same light blue gradient, contrasting with the rest of the word which is in a dark gray color.
physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses.
e-Lung is designed to analyze pulmonary CT slice data and display analysis results. Each voxel of the scan is measured by Hounsfield units (HU), a measurement of x-ray attenuation that is applied to each volume element in three dimensional space. The HU are utilized to distinguish between air, water, tissue and bone, such distinction is common in the industry.
e-Lung provides computed tomography (CT) viewing, and parenchymal density analysis in one application. e-Lung provides quantitative measurements and tabulates quantitative properties.
e-Lung focuses on what is visible to the eye and applies volumetric methods that might otherwise be too time consuming to use.
The software does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods; the software does not reconstruct a 3D rendering image of the lung; the intent of the software is to enhance the workflow by saving time and automating potential error prone manual tasks.
e-Lung has functions for loading, and saving datasets, and will generate screen displays, computations and aggregate statistics. e-Lung data output may be exported to a CSV, Excel or PDF file.
3. Intended Use / Indications for Use
The e-Lung software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support in the examination of radiological findings. These radiological findings can then be evaluated by the physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses. The e-Lung software package is intended to be a workflow enhancement and visualization tool for the assessment of CT thoracic datasets. e-Lung can be used to support the physician when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. 3D segmentation, volumetric measurements, density evaluations, and reporting tools are combined with a dedicated workflow.
4. Performance Data
4.1 Clinical Study (lung segmentation)
A retrospective study has been carried out to validate the lung segmentation functionality of e-Lung. The study evaluated the accuracy of the e-Lung lung mask generation compared to a ground truth mask generated from the consensus of three experienced US board certified radiologists, who segmented the lungs following their usual standard of care. The similarity between the device lung masks and the ground truth lung masks was evaluated using Dice Similarity Coefficients (DSC), which index the amount of overlap between the two masks. The acceptability criterion for the study was an average DSC across all cases of over 0.95 (defined by the lower bound of the confidence interval).
The dataset for this validation study comprised tomography (CT) chest studies performed in the clinical context of evaluation of lung disease. Cases were selected from two sources: from a research registry held at Boston Medical Center (N=38) and from a commercial database of clinical imaging data (N=62). The number of cases from different scanner manufacturers and models
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The "A" in "BRAINOMIX" is designed with a gradient fill, transitioning from blue to green.
is shown in Table 1. A range of convolution kernels and acquisition parameters were included in the dataset, including 24 cases acquired with contrast.
The dataset was enriched to ensure a distribution of clinical and demographic variables (e.g. age, gender, race/ethnicity, clinical site, BMI, smoking history and radiological findings) that allows generalizability to the patient population for whom use is intended. The median age was 61 years (inter-quartile range [IQR]: 52.5-70, total range: 23-100). The number of cases in relevant demographic or clinical subgroups is shown in Table 2.
All cases were successfully processed by the device. All cases showed a DSC of above the acceptability criterion (DSC=0.95). The distribution of DSC is shown in Figure 1. The median DSC was 0.978 (IQR: 0.974-0.980). Hence, the study met the acceptability criterion. Performance was consistent for the left and right lungs (left: median DSC=0.976, IQR: 0.972-0.978; right: median DSC=0.979, IQR: 0.976-0.981). Table 3 reports the median (and IQR) DSC for clinically-relevant subgroups, including age, gender, race/ethnicity, BMI, smoking status, radiological findings, hospital location, scanner manufacturer, slice thickness, KvP and contrast. Lung segmentation performance of the device was consistent across all subgroups.
| Manufacturer | Model | N |
|---|---|---|
| SIEMENS | All | 36 |
| SOMATOM Perspective | 22 | |
| SOMATOM go.Up | 6 | |
| SOMATOM Definition AS+ | 3 | |
| SOMATOM Definition AS | 2 | |
| Sensation 16 | 2 | |
| SOMATOM go.Top | 1 | |
| GE | All | 28 |
| Revolution Apex | 9 | |
| Revolution Frontier | 8 | |
| Revolution CT | 7 | |
| LightSpeed VCT | 2 | |
| BrightSpeed S | 1 | |
| Discovery STE | 1 | |
| Philips | All | 23 |
| IQon - Spectral CT | 12 | |
| Brilliance 16 | 4 | |
| Brilliance 64 | 4 | |
| Brilliance 6 | 2 | |
| Gemini | 1 | |
| Toshiba | All | 13 |
| Aquilion | 9 |
Table 1. Table showing the number of cases in the lung segmentation different scanner manufacturers and models.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain image on the left, followed by the word "BRAINOMIX" in a sans-serif font. The "A" and "I" in "BRAINOMIX" are in a lighter blue color, while the rest of the letters are in a darker gray color. The brain image is also in the lighter blue color.
Aquilion ONE 4
Distribution of DSC, Ground Truth vs Device
Image /page/6/Figure/4 description: This image is a histogram showing the distribution of DSC values. The x-axis represents the DSC values, ranging from 0.95 to 0.99, while the y-axis represents the frequency, ranging from 0 to 40. The histogram shows a distribution that is skewed to the left, with the highest frequency of DSC values around 0.97 to 0.98. The image also includes the text 'W = 0.913, p < .001'.
Figure 1.Histogram showing the distribution of Dice Similarity Coefficients (DSC) between ground truth lung masks and e-Lung device lung masks. The results of the Shapiro-Wilks normality test is also shown.
Table 2. Median Dice Similarity Coefficients (DSC) and interquartile ranges (IQR) for cases stratified by relevant demographic, clinical and imaging variables. The number of cases per subgroup (N) is also shown.
| Subgroup Variable | N | Median DSC [IQR] |
|---|---|---|
| Age: | ||
| Under 60 | 45 | 0.978 [0.974 - 0.980] |
| 60 or over | 55 | 0.978 [0.974 - 0.980] |
| Gender: | ||
| Female | 55 | 0.978 [0.973 - 0.979] |
| Male | 45 | 0.978 [0.976 - 0.981] |
| Race / Ethnicity: | ||
| Black or African American | 14 | 0.974 [0.970 - 0.978] |
| White | 11 | 0.978 [0.976 - 0.978] |
| Hispanic or Latino | 7 | 0.974 [0.970 - 0.978] |
| Asian | 3 | 0.980 [0.979 - 0.981] |
| Subgroup Variable | N | Median DSC [IQR] |
| Other | 3 | 0.974 [0.972-0.978] |
| Unknown / declined | 62 | 0.978 [0.975 - 0.980] |
| BMI: | ||
| Underweight | 3 | 0.985 [0.980 - 0.985] |
| Healthy Weight | 6 | 0.977 [0.973 - 0.978] |
| Overweight | 17 | 0.977 [0.972 - 0.980] |
| Obese | 12 | 0.974 [0.971 - 0.978] |
| Unknown | 72 | 0.978 [0.975 - 0.980] |
| Smoking Status: | ||
| Current smoker | 25 | 0.978 [0.977 - 0.981] |
| History of smoking | 18 | 0.978 [0.978 - 0.979] |
| Non-smoker | 23 | 0.975 [0.972 - 0.978] |
| Unknown | 34 | 0.978 [0.972 - 0.980] |
| Radiological Findings: | ||
| Ground Glass | 20 | 0.979 [0.972-0.979] |
| Linear Opacities | 35 | 0.978 [0.977-0.981] |
| Airways Abnormalities | 22 | 0.979 [0.978-0.981] |
| Extrapulmonary Findings | 18 | 0.978 [0.974-0.979] |
| Nodules | 48 | 0.978 [0.976-0.980] |
| Atelectasis | 12 | 0.974 [0.971-0.978] |
| Hospital Location: | ||
| Massachusetts | 38 | 0.976 [0.972 - 0.978] |
| New York | 31 | 0.978 [0.978 - 0.980] |
| Ohio | 17 | 0.978 [0.976 - 0.980] |
| New Jersey | 4 | 0.962 [0.958 - 0.966] |
| Wisconsin | 4 | 0.980 [0.978 - 0.980] |
| Subgroup Variable | N | Median DSC [IQR] |
| Florida | 3 | 0.972 [0.970 - 0.976] |
| Maryland | 2 | 0.974 [0.971 - 0.976] |
| South Dakota | 1 | 0.980 [NA] |
| Scanner Manufacturer: | ||
| SIEMENS | 36 | 0.979 [0.977 - 0.979] |
| GE Medical Systems | 28 | 0.976 [0.976 - 0.981] |
| Philips | 23 | 0.975 [0.970 - 0.978] |
| Toshiba | 13 | 0.980 [0.977 - 0.981] |
| Slice Thickness: | ||
| Under 3mm | 70 | 0.978 [0.973 - 0.979] |
| 3mm or over | 30 | 0.979 [0.977 - 0.980] |
| KvP: | ||
| 100 | 3 | 0.978 [0.976 - 0.978] |
| 110 | 24 | 0.979 [0.978 - 0.980] |
| 120 | 55 | 0.978 [0.972 - 0.980] |
| 130 | 5 | 0.977 [0.972 - 0.978] |
| 140 | 13 | 0.975 [0.974 - 0.981] |
| Contrast: | ||
| Without contrast | 76 | 0.978 [0.976 - 0.980] |
| With contrast | 24 | 0.974 [0.970 - 0.978] |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is teal, and the letters "AI" in "BRAINOMIX" are also teal, while the rest of the letters are dark gray.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is a gradient of blue and green, while the letters "AI" in the word "BRAINOMIX" are also in the same gradient of blue and green, while the rest of the letters are in black.
Digital Phantom (Density Evaluations) 4.2
Specific validation has been carried out to test the density analysis output (structural density filtering and density histogram evaluation). This testing made use of synthetic digital phantom data together with a realworld data bridging study created to provide a ground truth against which the performance of the density evaluations can be assessed and demonstrated.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the word "BRAINOMIX" in all caps. To the left of the word is a blue and white graphic that resembles a brain. The "A" in "BRAINOMIX" is also blue, while the rest of the letters are black.
The density evaluations are validated by ensuring a good Dice score (min 0.80) between the e-Lung structural densities and histogram densities and those pre-defined parameters generated in the digital phantom dataset.
5. Prescriptive Statement
Caution: Federal law restricts this device to sale by or on the order of a physician.
6. Safety and Effectiveness
Brainomix 360 e-Lung has been designed, verified and validated in compliance with 21 CFR, Part 820.30 requirements. The device has been designed to meet the requirements associated with ISO 14971:2019 (risk management).
7. Summary of Technological Characteristics
The proposed device (Brainomix 360 e-Lung) have the same intended use and substantially similar indications for use, core functionalities and outputs compared to the predicate device (VIDA | vision). Both devices have substantially equivalent indications for use, technical approaches and roles within a clinical workflow relative to the analysis of pulmonary tissue on CT Thoracic datasets. The proposed device does not introduce any new risks when compared to the predicate.
Where the proposed device and predicate device differ in technical characteristics is that:
- . e-Lung offers a subset of the intended use and functionality offered by the predicate (e.g., proposed device does not provide reconstruction of two-dimensional images into a threedimensional image format) and therefore, the risks associated with these types of analysis are not applicable to the proposed device.
- e-Lung offers a peripheral sub-compartment of the lungs which is generated based on the lung segmentation and a depth selected by the user from a range of 5 and 25mm at 5mm increments. In the proposed device, the preferred depth is defined by a trained clinical professional with an admin user privilege, the user can also choose not to have a peripheral sub-compartment. Describing the distribution of radiographic features in terms of their proximity to the center of the body or the periphery can be helpful in diagnosing the causative disease. This device is intended to support the user in the examination of radiological findings as an enhancement and visualization tool which provides reproducible CT values for pulmonary tissue. Therefore, the technical differences in sub-compartment method between the proposed and predicate device do not raise different questions of safety and effectiveness.
- . e-Lung offers density histogram evaluation and structural density filtering evaluation where the metrics for the density evaluations are defined by a trained clinical professional with an admin user privilege. The density evaluations support the intended use of the device (examination of the pulmonary and thoracic tissue) and are volumetric calculations of imaging features with parameters defined by a trained user. Furthermore, the outputs of the density evaluation have been validated as part of this submission. Therefore, the technical
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain image on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain image is a gradient of light blue to dark blue, and the letters "AI" in the word "BRAINOMIX" are also in the same gradient of blue, while the rest of the letters are in a dark gray color.
differences in density evaluations between the proposed and predicate device do not raise different questions of safety and effectiveness.
- . The proposed device uses a non-adaptive deterministic algorithm to automatically segment the lung mask, similarly to the predicate device, with comprehensive validation so therefore does not add any new risks or raise different questions of safety and effectiveness given the minor difference in algorithms.
We conclude that Brainomix 360 e-Lung is safe and effective, raises no unanswered questions with regards to safety and efficacy and is substantially equivalent to the chosen predicate, VIDA|vision.
8. Substantial Equivalence
| Characteristics/Para | Proposed Device | Predicate Device |
|---|---|---|
| meter | Brainomix 360 e-Lung | VIDA vision |
| 510(k) Number | K233875 | K200990 |
| Product Code | JAK | JAK |
| Regulation Number | 21 CFR §892.1750 | 21 CFR §892.1750 |
| Regulation Name | System, X-Ray, Tomography,Computed | System, X-Ray, Tomography,Computed |
| IntendedUse/Indications forUse | The e-Lung software providesreproducible CT values forpulmonary tissue, which is essentialfor providing quantitative support inthe examination of radiologicalfindings. These radiological findingscan then be evaluated by thephysician in conjunction with a rangeof ancillary information to form apotential diagnosis or list of likelydiagnoses. The e-Lung softwarepackage is intended to be aworkflow enhancement andvisualization tool for the assessmentof CT thoracic datasets. e-Lung canbe used to support the physicianwhen examining the pulmonary andthoracic tissue (i.e. lungparenchyma) in CT thoracic datasets.3D segmentation, volumetricmeasurements, density evaluations,and reporting tools are combinedwith a dedicated workflow. | The VIDA vision software providesreproducible CT values for pulmonarytissue, which is essential for providingquantitative support for diagnosis andfollow up examinations. VIDA visioncan be used to support the physician inthe diagnosis and documentation ofpulmonary tissue images (e.g.,abnormalities) from CT thoracicdatasets. Three-D segmentation andisolation of sub-compartments,volumetric analysis, densityevaluations, low density clusteranalysis and reporting tools arecombined with a dedicated workflow.The VIDA vision software package isalso intended to be a real-timeinteractive evaluation in space andtime for CT volume data sets thatprovides the reconstruction of twodimensional images into a three-dimensional image format. |
| Characteristics/Parameter | Proposed DeviceBrainomix 360 e-Lung | Predicate DeviceVIDA vision |
| Image SourceModalities | CT | CT |
| DICOMConformance | Yes | Yes |
| ComparativeReview | 2D | 2D, 3D |
| 3D Lung Mapping | No | Yes |
| 3D Measurements | 3D volume of masks | Volume Effective Diameter |
| 2D Measurements | None | Line and ROI tools with statisticsDiameter 2DArea |
| DensityMeasurements | Admin user defined densityhistogram evaluation and structuraldensity filtering evaluation | Minimum, maximum and average HU |
| Deployment | Standard off-the-shelf server orvirtual server | Standalone computer / distributed |
| OS | Ubuntu Linux | Windows |
| User Interface | Yes | Yes |
| Algorithm | Each voxel of the scan is measuredby Hounsfield Units (HU), ameasurement of x-ray attenuationthat is applied to each volumeelement in three dimensional space('voxel'). The HU are utilised todistinguish between air, water,tissue and bone, such distinction iscommon in the industry.A (non-Al) image processingapproach is applied to CT imagingdata to automatically segment lungmask. | Each voxel of the scan is measured byHounsfield Units (HU), a measurementof x-ray attenuation that is applied toeach volume element in threedimensional space ('voxel'). The HU areutilised to distinguish between air,water, tissue and bone, suchdistinction is common in the industry.A non-adaptive deep learning-basedalgorithm is applied to the CT imagingdata to automatically segment lungregions. |
| Workflow | Automated segmentationAutomated measurements(including those based on userconfigurations) | Automated contouringAutomated measurementsManual CorrectionDistinct user workflows: |
| Characteristics/Parameter | Proposed Device | Predicate Device |
| Brainomix 360 e-Lung | VIDA vision | |
| Graphic UserInterface | Yes | Yes |
| Interactive 3DVisualisation | No | Yes |
| Input/Output | Users can browse, select, and load CT scan files. Users can save and load analyses, export via reporting tools. CT scan files are organized by patient in the scan viewer. User can generate a report that displays quantitative data items that can be saved. DICOM info displayed. Data import through DICOM query/retrieve available. | Users can browse, select, and load CT scan files. Users can save and load analyses, export via reporting tools. CT scan files can be organized by user-defined projects, and tracked by usage. User can generate a report that displays quantitative data items that can be saved. DICOM info displayed. Data import through DICOM query/retrieve available. |
| Path Planning | No | Yes – airways and lung tissue |
| User Editing | Yes | Yes |
| Reports | Yes – CSV, Excel and PDF format | Yes – CSV and PDF format configurable for specific use cases |
| Scan QualityAssessment | Scan protocol is assessed for compatibility with software Incompatibility issues flagged during import and on report | Scan protocol is assessed for compatibility with software Incompatibility issues flagged during import and on report Scanner calibration assessment Warning issued for out-of-range air/blood measurements |
A table comparing the key features of the subject and predicate devices is provided below.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for Brainomix. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is a gradient of blue and green, and the "A" in "BRAINOMIX" is also in the same gradient.
Head office
First Floor, Seacourt Tower, West Way Oxford OX2 0JJ, United Kingdom
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The "A" in "BRAINOMIX" is a gradient of blue and teal, while the rest of the letters are gray.
Oxford OX2 0JJ, United Kingdom
9. Conclusion
In conclusion, Brainomix 360 e-Lung has the same intended use and is substantially equivalent in technological characteristics, safety, and performance characteristics to the legally marketed predicate device, VIDA|vision (K200990). Brainomix 360 e-Lung is therefore substantially equivalent to the selected legally marketed predicate device and does not raise any questions of safety or effectiveness.
§ 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.