(22 days)
syngo InSpace 4D - Software Package is a self-contained image analysis software package. This real-time interactive evaluation in space and time for CT volume data sets provides the reconstruction of two-dimensional images into a three-dimensional image format.
InSpace 4D can be used to assist the physician in the diagnosis of blood vessels on the basis of a CT Angiography dataset (CTA). For a CTA examination a contrast media (CM) is administered into the patient's blood vessels to enhance the contrast of the vessels in the CTA dataset, i.e. high values for the Hounsfield Unit (HU).
The goal is to visualize the blood vessels without other interfering anatomical structures.
The syngo InSpace 4D is developed to facilitate a precise diagnosis by removing bone structures from a CTA data set. It can be used in the same way for Non CTA datasets to remove bones or extract and display selected bones, e.g. for the analysis of a fracture.
Further, syngo InSpace 4D can be used to support the physician in the diagnosis and documentation of chest diseases, e.g. when examining the pulmonary tissue (i.e. lung parenchyma) in CT thoracic datasets. Evaluation tools (3D segmentation & isolation of subcompartments, volumetric analysis, density evaluations, low density cluster analysis) and reporting tools are combined with a dedicated workflow.
syngo InSpace 4D - Software Package is a self-contained image analysis software package. This real-time interactive evaluation in space and time for CT volume data sets provides the reconstruction of two-dimensional images into a three-dimensional image format.
InSpace 4D can be used to assist the physician in the diagnosis of blood vessels on the basis of a CT Angiography dataset (CTA). For a CTA examination a contrast media (CM) is administered into the patient's blood vessels to enhance the contrast of the vessels in the CTA dataset, i.e. high values for the Hounsfield Unit (HU).
The goal is to visualize the blood vessels without other interfering anatomical structures.
The syngo InSpace 4D is developed to facilitate a precise diagnosis by removing bone structures from a CTA data set. It can be used in the same way for Non CTA datasets to remove bones or extract and display selected bones, e.g. for the analysis of a fracture.
Further, syngo InSpace 4D can be used to support the physician in the diagnosis and documentation of chest diseases, e.g. when examining the pulmonary tissue (i.e. lung parenchyma) in CT thoracic datasets. Evaluation tools (3D segmentation & isolation of subcompartments, volumetric analysis, density evaluations, low density cluster analysis) and reporting tools are combined with a dedicated workflow.
This 510(k) submission for the Siemens InSpace 4D Software Package does not contain a detailed study proving the device meets acceptance criteria.
The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (Siemens InSpace 4D K043469 and Siemens Pulmo CT K960635) rather than presenting a performance study against specific acceptance criteria.
The "Safety and Effectiveness Information Supporting the Substantial Equivalence Determination" section states that "The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing." This suggests that the device's safety and effectiveness were primarily supported by adherence to established industry practices, risk management, and internal verification/validation, rather than a specific clinical performance study with predefined acceptance criteria.
Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, and comparative effectiveness studies are not present in this document.
Here's how the requested information would be addressed based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission focuses on substantial equivalence to predicate devices, implying that its performance is implicitly acceptable if it functions similarly to those already cleared. No specific quantitative acceptance criteria or reported performance metrics are listed.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. There is no mention of a test set with expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document. No adjudication method is mentioned as there is no described test set.
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
This information is not provided in the document. There is no mention of an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is intended to "assist the physician" but no quantitative data on this assistance is provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not provided in the document. The device is described as an "image analysis software package" intended to "assist the physician," implying it is not a standalone diagnostic tool without human oversight. No standalone performance data is presented.
7. The Type of Ground Truth Used
This information is not provided in the document. Since no specific performance study against a ground truth is detailed, the type of ground truth used is unknown.
8. The Sample Size for the Training Set
This information is not provided in the document. There is no mention of a training set or its size.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. As no training set is described, the method of establishing its ground truth is unknown.
§ 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.