(64 days)
Ziostation is an image processing workstation software package designed to run on standard PC hardware. It provides for the viewing, quantification, manipulation, printing, and management of medical images. It is intended for use by trained medical professionals to aid in their reading and review of such data. In addition, Ziostation has the following indication:
The CT Brain Perfusion for Ziostation option is an image analysis software package providing additional image processing capabilities to the basic Ziostation device. The CT Brain Perfusion Option is intended for post-processing based on dynamic CT images continuously acquired during the injection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.
CT Brain Perfusion for Ziostation is an add-on software feature designed to provide a color map of cerebral blood flow and pictorial illustration of perfusion-related parameters obtained on CT images of the brain. This software is designed to work within the currently cleared Ziostation image management device.
The provided text does not contain detailed information about specific acceptance criteria, comprehensive study results, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or adjudication methods. The document is primarily a 510(k) summary for a "CT Brain Perfusion for Ziostation" software, describing its intended use, predicate device, and confirming substantial equivalence.
Here's an analysis of what can be extracted and what information is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "All devices met the required specifications for the completed tests." However, it does not detail what those specifications or acceptance criteria were, nor does it provide specific metrics for device performance beyond this general statement.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Met all required specifications for completed tests. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "1000" under the "Testing Summary" section, but it's unclear if this refers to the number of tests performed, the size of a dataset, or something else entirely. It does not explicitly state it as the test set sample size.
- Data Provenance (country of origin, retrospective/prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set:
- Adjudication method: Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- The document does not mention an MRMC comparative effectiveness study. The device is described as an "image analysis software package providing additional image processing capabilities" and "pictorial illustration...to aid in the assessment," suggesting it's a tool for professionals rather than a standalone diagnostic or a direct comparison of human performance with vs. without AI. No effect size is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document does not explicitly state whether a standalone performance study was conducted. Given its description as "image analysis software package providing additional image processing capabilities" and intended "to aid in their reading and review," it implies human-in-the-loop use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not specified.
8. The sample size for the training set:
- Sample Size for Training Set: Not specified.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not specified.
In summary, the provided 510(k) summary is very high-level regarding testing and validation. It states that all specifications were met but does not offer the granular detail about the study methodology, data characteristics, or performance metrics that your questions are looking for.
§ 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).