(195 days)
Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical technical integration platform Olea S.I.A. V1.0 and is designed to be used by trained radiologists and surgeons.
Olea S.I.A. Neurovascular V1.0 is intended to:
- display MR and CT series and outputs provided by compatible docker applications processing, through the technical integration platform,
- . allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display can be updated with the reprocessed outputs.
The device does not alter the original image information and is not intended to be used as a diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes. The information displayed is intended to be used in conjunction with other patient information and based on professional judgment, to assist the clinician in the medical imaging assessment.
Trained radiologists and surgeons are responsible for viewing the full set of native images per the standard of care.
Olea S.I.A. Neurovascular V1.0 is a visualization of docker applications results. It is an interface embedded on Olea S.I.A. V1.0 platform and uses the components of Olea S.I.A. V1.0 platform to display the outputs of docker applications to which it is entirely dedicated.
Olea S.I.A. Neurovascular V1.0 allows the user to visualize native DICOM series and docker applications outputs and to modify parameters that are optional inputs of these applications.
Olea S.I.A. Neurovascular V1.0 interaction with the Olea S.I.A. technical platform and docker applications
To be used, Olea S.I.A. Neurovascular V1.0 needs:
- o a technical base, which is provided by Olea S.I.A. V1.0 platform; and
- 0 one or more applications installed on the Olea S.I.A. V1.0 platform that provide outputs that can be managed by Olea S.I.A. Neurovascular V1.0.
The technical platform:
- receives outputs from docker applications; ●
- o makes these outputs available to related DICOM viewers. If the docker applications are compatible with Olea S.I.A. Neurovascular V1.0, they are proposed as the default software to visualize the outputs;
- 0 retrieves the modified parameters in Olea S.I.A. Neurovascular V1.0 to be able to relaunch the concerned docker applications with these new input parameters.
Olea S.I.A. Neurovascular V1.0 does not contain any calculation feature or any algorithm (deterministic or Al).
Olea S.I.A. Neurovascular V1.0 operating principles and technological characteristics
Olea S.I.A. Neurovascular V1.0 is an interface embedded on Olea S.I.A. V1.0 platform. Olea S.I.A. Neurovascular V1.0 communicates with API that exists on Olea S.I.A. V1.0 platform only. Olea S.I.A. Neurovascular V1.0 is launched via a link to a web browser and a secure connection.
Olea S.I.A. Neurovascular V1.0 receives data coming from docker applications. These data can either be maps, VOIs, or metrics. Olea S.I.A. Neurovascular V1.0 is able to display these results on a dedicated user interface designed in accordance with the clinical need that provides tools to visualize and manipulate images. There is no Olea S.I.A. Neurovascular V1.0 functionality on top of the applications cleared functionalities: the subject device only serves for display of cleared outputs and/or information.
Olea S.I.A. Neurovascular V1.0 also gives the possibility to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display is updated with the reprocessed outputs.
The provided text describes Olea S.I.A. Neurovascular V1.0, a device that primarily serves as a user interface for displaying outputs from compatible docker applications and allowing users to modify parameters for reprocessing. It does not perform any calculations or algorithms itself.
Here's an analysis of the acceptance criteria and study information provided (or lacking thereof):
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria for Olea S.I.A. Neurovascular V1.0 beyond demonstrating substantial equivalence to the predicate device, Olea Sphere® V3.0. Since the device's function is primarily visualization and parameter modification, and it contains no algorithms, the performance criteria are focused on its functionality and safety rather than diagnostic accuracy.
| Acceptance Criteria (Implied / Functional) | Reported Device Performance |
|---|---|
| Display MR and CT series and docker application outputs | Confirmed: Olea S.I.A. Neurovascular V1.0 displays MR and CT series and outputs provided by compatible docker applications. |
| Allow user to edit and modify optional input parameters, and update display with reprocessed outputs | Confirmed: Allows editing and modification of optional parameters, and updates the display with reprocessed outputs. |
| Does not alter original image information | Confirmed: Stated in the intended use. |
| Not intended for diagnostic use or to take sole diagnostic/therapeutic decisions | Confirmed: Stated in the intended use. |
| Provides visualization tools comparable to predicate (e.g., standard viewing tools, 3D MIP, manual side selection, manual AIF/VOF selection, dedicated report) | Confirmed: Explicitly compared to Olea Sphere V3.0 and found to have "essentially equivalent features" with minor differences not impacting intended use or safety/efficacy. |
| Operates according to intended use and in a manner substantially equivalent to the predicate device | Confirmed: Validation testing concludes that the system provides all capabilities necessary and is substantially equivalent. |
| Meets product specifications | Confirmed: Internal verification and validation testing confirms product specifications are met. |
| Passes product risk assessment | Confirmed: Product risk assessment was conducted. |
| Passes software modules verification tests | Confirmed: Software modules verification tests were conducted. |
| Passes software validation test | Confirmed: Software validation tests were conducted. |
| Safety and effectiveness profile similar to predicate device | Confirmed: Based on performance testing, similarities are established. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide information on the sample size used for the test set, nor the data provenance (country of origin, retrospective or prospective). This is because the device is a visualization and interface tool, not a diagnostic algorithm that processes patient data for clinical outcomes. The validation focuses on software functionality and equivalence rather than clinical performance on a dataset of patient images.
3. 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)
This information is not applicable and therefore not provided in the document. Olea S.I.A. Neurovascular V1.0 does not perform any interpretations or generate diagnostic outputs that would require a ground truth established by experts. Its function is to display results from other (compatible docker) applications, and the validation focuses on the correct display and interaction functionality, not on evaluating diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Since the device does not make diagnostic interpretations or classifications that would require expert consensus or adjudication on a test set, no such method was employed.
5. 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is consistent with the device's intended use as a visualization and parameter modification interface, rather than an AI-assisted diagnostic tool. No AI enhancement for human readers is described or evaluated.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation (algorithm only) was not done for Olea S.I.A. Neurovascular V1.0. This device explicitly states it "does not contain any calculation feature or any algorithm (deterministic or AI)." Its primary role is to serve as an interface for outputs from other applications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
No "ground truth" in the diagnostic sense (expert consensus, pathology, outcomes data) was used. The validation was based on internal verification and validation testing to confirm that the product specifications are met and that the device operates as intended and in a manner substantially equivalent to the predicate. This would involve checking the correct display of images and outputs, the functionality of interface tools, and the ability to modify parameters as designed.
8. The sample size for the training set
This information is not applicable and therefore not provided. Olea S.I.A. Neurovascular V1.0 does not contain any AI algorithms and thus does not have a "training set."
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided, as the device does not have a training set or AI algorithms requiring ground truth establishment.
§ 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).