(154 days)
CT perfusion 4 is an image analysis software package that allows the user to produce dynamic image data and to generate information with regard to changes in image intensity over time. It supports the analysis of CT Perfusion images, obtained by cine imaging (in the head and body) after the intravenous injection of contrast, in calculation of the various perfusion-related parameters (i.e. regional blood flow, regional blood volume, mean transit time and capillary permeability). The results are displayed in a user-friendly graphic format as parametric images.
This software will aid in the assessment of the extent and type of perfusion, blood volume and capillary permeability changes, which may be related to stroke or tumor angiogenesis and the treatment thereof.
CT Perfusion 4 is an image analysis software package that allows the evaluation of dynamic CT data following an injection of a compact bolus of contrast material, generating information with regards to changes in image intensity over time. It provides a quick and reliable assessment of the type and extent of perfusion disturbances by providing qualitative information on various perfusion related parameters.
The results are displayed in a user-friendly graphic format as parametric images (single image calculated from a set of time course images at a single location).
The provided text is a 510(k) summary for the GE Healthcare CT Perfusion 4 device. It primarily focuses on demonstrating substantial equivalence to a predicate device (CT Perfusion 2) rather than providing detailed acceptance criteria and a study to prove device performance against those criteria.
Therefore, many of the requested details are not present in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not available in the provided document. The 510(k) summary states that "CT Perfusion 4 does not result in any new potential safety risks and performs as well as devices currently on the market." It also mentions that "The algorithms used to calculate the perfusion parameters are similar to CT Perfusion 2 device." This implies a comparison to the predicate, but specific acceptance criteria or performance metrics are not given.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not available in the provided document.
4. Adjudication Method for the Test Set
This information is not available in the provided document.
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 available in the provided document. Given the age of the document (2006) and the nature of the device (image analysis software producing parametric images, not a diagnostic aid that directly improves human reader performance), an MRMC study with human readers assisting with AI is unlikely to have been the primary focus for this 510(k) clearance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The document describes CT Perfusion 4 as "an image analysis software package" that "generates information" and "provides a quick and reliable assessment." It produces "parametric images" for "evaluation." This implies a standalone algorithm performing the analysis. However, specific standalone performance metrics or a study dedicated to standalone performance (beyond comparison to a predicate) are not explicitly described in the provided text. The statement that "The algorithms used to calculate the perfusion parameters are similar to CT Perfusion 2 device" suggests that the standalone performance is considered equivalent to the predicate.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
This information is not available in the provided document.
8. The Sample Size for the Training Set
This information is not available in the provided document.
9. How the Ground Truth for the Training Set Was Established
This information is not available in the provided document.
In summary, the provided 510(k) summary for CT Perfusion 4 primarily focuses on demonstrating substantial equivalence to its predicate device, CT Perfusion 2, by highlighting similar algorithms and functionality. It does not provide detailed information on specific acceptance criteria, performance studies with explicit metrics, sample sizes, expert involvement, or ground truth methodologies that would typically be associated with extensive performance validation studies.
§ 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.