(315 days)
Ziostation is an image processing workstation software package designed to run on standard PC hardware. It provides for the viewing, quantification, manipulation, communication, 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 indications:
The CT PULMONARY ANALYSIS software option is an independent image analysis software tool providing additional image process capabilities to the Ziostation system. The CT PULMONARY ANALYSIS option is intended to assist the physician in assessing possible airway obstruction.
CT PULMONARY ANALYSIS is an optional software package designed to be used with the basic Ziostation DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation software. The added capabilities provided by this additional software option for use with CT DICOM compliant images are:
- Segmentation of lung and bronchial airway
- Contour detection of airway walls
- Evaluation of bronchial dimensions
- Observation of cross-sectional image and variance of diameter/thickness/area of airway wall along airway
- Integrated 3D visualization with MPR or A/C/S slice/slab viewing
- Low Attenuation Analysis by Lung Sections
This 510(k) submission for the Qi Imaging CT Pulmonary Analysis software provides limited detail on the study and acceptance criteria. Based on the provided text, a comprehensive description including all requested fields cannot be fully constructed.
Here's an analysis of what is available and what is missing:
1. Table of acceptance criteria and reported device performance:
The document explicitly states: "The CT PULMONARY ANALYSIS software package successfully completed integration testing/verification testing prior to Beta validation. Software Beta testing/validation was successfully completed prior to final testing and release." However, no specific quantitative acceptance criteria or reported device performance metrics are provided in the document. This information is crucial for understanding the device's performance against predefined thresholds.
2. Sample size used for the test set and data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set:
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
- MRMC Study Conducted: Not mentioned in the provided text. The document only states the software "is intended to assist the physician in assessing possible airway obstruction." It does not provide any comparative effectiveness data with or without AI assistance.
- Effect Size of Human Readers Improvement with AI vs. without AI: Not applicable, as no MRMC study or comparative effectiveness data is presented.
6. Standalone (algorithm only without human-in-the-loop performance) study:
- Standalone Study Conducted: The document does not explicitly state whether a standalone study was performed. The description of "Segmentation of lung and bronchial airway," "Contour detection," "Evaluation of bronchial dimensions," and "Observation of cross-sectional image and variance of diameter/thickness/area of airway wall along airway" suggests automated functions, but performance metrics for these in a standalone context are not provided.
7. Type of ground truth used:
- Type of Ground Truth: Not specified.
8. Sample size for the training set:
- Training Set Sample Size: Not specified.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not specified.
Summary of available information regarding the "study" that proves the device meets acceptance criteria:
The document briefly mentions a "Testing Summary":
"The CT PULMONARY ANALYSIS software package successfully completed integration testing/verification testing prior to Beta validation. Software Beta testing/validation was successfully completed prior to final testing and release. In addition, potential hazards have been addressed by the Qi Imaging Risk Management process."
This statement confirms that internal testing (integration, verification, and beta validation) was performed, indicating a development and testing process was followed. However, it does not provide details on the methodology, data, or results of these tests that would demonstrate compliance with specific acceptance criteria. The submission largely relies on demonstrating substantial equivalence to predicate devices (VIDA Pulmonary Workstation 2.0 and Myrian v1.11.2 XP-Lung) rather than detailed clinical performance studies for its own product.
§ 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.