(245 days)
Brainomix 360° e-CTA is an image processing software package to be used by trained professionals, including, but not limited to physicians and medical technicians. The software runs on standard "off-the-shel" hardware (physical or virtualized) and can be used to perform image viewing, processing and analysis of images are acquired through DICOM compliant imaging devices.
Brainomix 360° e-CTA provides viewing and analysis capabilities for imaging datasets acquired with CTA (CT Angiography).
Brainomix 360° e-CTA is not intended for mobile diagnostic use.
Brainomix 360° e-CTA is a medical image visualization and processing software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server.
Brainomix 360° e-CTA allows for the visualization, analysis and post-processing of DICOM compliant CTA images which, when interpreted by a trained physician or medical technician, may yield information useful in clinical decision making.
Brainomix 360° e-CTA provides a wide range of basic image viewing, processing and manipulation functions, through multiple output formats. Functionality includes image registration and visualization of large cerebral vessels to provide an analysis of hemispheric difference via contralateral comparison (displayed as a relative percentage).
Brainomix 360° e-CTA can connect with other DICOM-compliant devices, for example to transfer CTA scans from a Picture Archiving and Communication System (PACS) to Brainomix 360° e-CTA software for processing.
Results and images can be sent to a PACS via DICOM transfer and can be viewed on a PACS workstation or via a web user interface on any machine contained and accessed within a hospital network and firewall and with a connection to the Brainomix 360° e-CTA software (e.g. a LAN connection)
Brainomix 360° e-CTA notification capabilities enable clinicians to preview images through via e-mail notification with result image attachments.
Images that are previewed via e-mail are compressed, are for informational purposes only, and not intended for diagnostic use beyond notification.
Brainomix 360° e-CTA is not intended for mobile diagnostic use. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests.
The provided text, a 510(k) summary for Brainomix 360° e-CTA, states that no clinical testing or non-clinical bench performance testing was carried out, submitted, or referenced for this submission. Instead, the device's performance is demonstrated through software and algorithm verification and validation. Therefore, it's not possible to provide acceptance criteria or details about a study proving the device meets those criteria from this document in the way typically expected for clinical validation.
The document focuses on demonstrating substantial equivalence to a predicate device (iSchemaView RAPID) based on similar technological characteristics and intended use, rather than presenting a performance study with specific acceptance criteria and detailed results.
However, based on the information provided regarding the Brainomix 360° e-CTA, I can infer the implied acceptance criteria related to its software and algorithm functionality, and describe what the document says about its performance:
Implied Acceptance Criteria and Reported Device Performance (Based on Software/Algorithm Verification and Validation)
| Acceptance Criteria Category (Implied) | Specific Criteria (Inferred from device description) | Reported Device Performance (Summary from document) |
|---|---|---|
| Image Processing and Visualization | Accurate and reliable processing of DICOM compliant CTA images. | "Brainomix 360° e-CTA provides viewing and analysis capabilities for imaging datasets acquired with CTA (CT Angiography)." |
| "Brainomix 360° e-CTA includes similar CTA processing features and technological characteristics as compared to the predicate device." | ||
| "Algorithm validation testing has additionally been performed using phantom data with known properties." | ||
| Output Interpretation Support | Generation of information useful for clinical decision making (e.g., contralateral comparison for hemispheric difference). | "Functionality includes image registration and visualization of large cerebral vessels to provide an analysis of hemispheric difference via contralateral comparison (displayed as a relative percentage)." |
| "When interpreted by a trained physician or medical technician, [results] may yield information useful in clinical decision making." | ||
| Interoperability | Adherence to DICOM standard for image acquisition, transfer, and viewing. Compatibility with PACS. | "Data and images are acquired through DICOM compliant imaging devices." |
| "Brainomix 360° e-CTA can connect with other DICOM-compliant devices, for example to transfer CTA scans from a Picture Archiving and Communication System (PACS) to Brainomix 360° e-CTA software for processing." | ||
| "Results and images can be sent to a PACS via DICOM transfer and can be viewed on a PACS workstation..." | ||
| "Design, risk management, verification and Validation for Brainomix 360° e-CTA has been carried out... in adherence to the DICOM standard." | ||
| System Compatibility | Software runs on standard "off-the-shelf" hardware (physical or virtualized). | "The software runs on standard 'off-the-shelf' hardware (physical or virtualized)." |
| Safety and Effectiveness | No new questions of safety or effectiveness compared to predicate; suitable for intended use. | "The differences in technological characteristics for the proposed device do not raise any new or unanswered questions of safety or effectiveness." |
| "Software verification and validation and algorithmic testing and risk management demonstrates that Brainomix 360° e-CTA is safe and effective for use as intended and described in its indications for use." |
Addressing Specific Information Requests based on the provided text:
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A table of acceptance criteria and the reported device performance: See table above. It is derived from the descriptions of device functionality and the overall conclusion that software/algorithm verification and validation was performed.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the document. The document states "Algorithm validation testing has additionally been performed using phantom data with known properties." This implies a test set of phantom data, but the size is not given.
- Data Provenance: Not specified. "Phantom data" suggests simulated or manufactured data, rather than patient data with a country of origin. The document does not indicate if this was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for phantom data, as ground truth for phantom data is defined by its known properties. The document does not mention any expert review or ground truth establishment by human readers for the algorithm validation described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable based on the description of testing (software and algorithm verification/validation with phantom data). No human adjudication process is mentioned.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No. The document explicitly states: "No clinical testing or non-clinical bench performance testing has been carried out, submitted or referenced for this submission." This indicates no MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, implicitly. The "Algorithm validation testing" using "phantom data with known properties" would represent a standalone performance evaluation of the algorithm's ability to process and analyze the images based on the defined properties of the phantom data. However, quantitative performance metrics (e.g., accuracy, precision, sensitivity, specificity) specific to this standalone performance are not provided in the summary.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for the "Algorithm validation testing" was based on "known properties" of phantom data. This is a controlled, synthetic ground truth, not derived from clinical expert consensus, pathology, or outcomes data.
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The sample size for the training set: Not specified. The document does not provide details about a training set, as it focuses on verification and validation rather than the development and training of a machine learning model. While it uses the term "algorithmic testing," it doesn't describe an AI model development cycle with explicit training data.
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How the ground truth for the training set was established: Not applicable, as detailed information on a training set or its ground truth establishment is not provided in this regulatory summary.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).