(49 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 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.
syngo InSpace 4D- Software Package is a self-contained image analysis software oying mopular and time interactive evaluation in space and time for CT volume data patenager This he reconstruction of two-dimensional images into a three-dimensional image format.
InSpace can be used for 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 also be used to extract and display selected bones, e.g. for the analysis of a fracture.
The provided text lacks specific information regarding acceptance criteria and a detailed study report proving the device meets those criteria. The 510(k) summary focuses on establishing substantial equivalence to a predicate device (InSpace 3D) rather than presenting a performance study with defined acceptance metrics.
Therefore, most of the requested information cannot be extracted from the given document.
Here's what can be gathered, with limitations noted:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, processing time). The document implies that the acceptance criteria are met by demonstrating "substantial equivalence" to the predicate device and adhering to general safety and effectiveness concerns through hazard analysis, software development, verification, and validation testing.
- Reported Device Performance: Not reported in terms of quantifiable metrics. The document states that the "syngo InSpace 4D Software Package does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate software components and the predicate device." This is a qualitative statement of equivalence, not a quantitative performance report against specific criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
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)
- Not specified. The document does not describe the methodology for establishing ground truth or the involvement of experts in any testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. No details on test set evaluation or adjudication are provided.
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
- No MRMC comparative effectiveness study is mentioned or described. The document primarily focuses on the device's functionality (bone removal for CTA data) and its substantial equivalence to a previous version, not on assessing human reader performance with or without the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone performance study with specific metrics is described. The device is referred to as "intended to assist the physician," implying a human-in-the-loop context. However, no performance data is provided for either standalone or assisted use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. The document does not detail how the accuracy of bone removal or vessel visualization was assessed or what method was used to establish ground truth for any testing conducted.
8. The sample size for the training set
- Not specified. The document does not mention any "training set" or machine learning aspects that would typically involve such a set. The device is described as "image analysis software" but does not indicate the use of AI/ML models that would require training data in the modern sense.
9. How the ground truth for the training set was established
- Not applicable, as no training set or related ground truth establishment is mentioned.
Summary of available information:
The provided 510(k) summary focuses on demonstrating the substantial equivalence of the "syngo InSpace 4D" software package to its predicate device, "InSpace 3D," primarily based on its functionality without introducing new safety risks. It highlights the device's purpose: real-time interactive evaluation of CT volume data, reconstruction into 3D format, and specifically, the ability to remove bone structures from CTA datasets (and non-CTA datasets) to facilitate precise diagnosis of blood vessels or analysis of fractures.
The document does not contain the detailed performance study information, acceptance criteria, sample sizes, ground truth methodologies, or expert involvement details typically found in submissions for novel devices or those requiring a comprehensive effectiveness study. This is common for 510(k) submissions that rely heavily on substantial equivalence to a previously cleared device, where extensive new performance data may not be required to establish equivalence for a modification or updated version.
§ 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.