(117 days)
From user specified sets of CT or MR images, Fly Through can be used for
- 3D presentation of segmented anatomic models (e.g., tracheas, bones, vessels, colon, etc.);
- navigating interactively through 3D segmented models that represent body cavities (e.g., vessels, colon, spine, lung, etc.);
- for viewing the inner surface of organ models (vessels, colon, etc.). Fly Through offers advantages over real endoscopy. For example, Fly Through can be performed within models of organs or blood vessels inaccessible to a real endoscope;
- a training tool for surgeons to practice endoscopic procedures;
- surgical planning;
- feasibility study of an actual endoscopic procedure; and
- a 3D positioning and orientation tool for Multiplanar reconstruction, thus assisting diagnosis from Multi-Planar-Reconstructions (MPRs): the Fly Through tool can help the user to position and visualize the 3-dimensional location of the MPR within the segmented dataset.
The Siemens Fly Through is a software package that provides 3D, MPR of anatomic structures, and interactive endoscopic views of organs with cavities. By navigating within the 3D imaging data, the user can tour the patient anatomy and make adjustments to provide the best view.
Fly Through can be installed onto medical viewing and post-processing workstations that meet minimum system requirements such as patient database, filming, and networking, 24 bits true color graphics display, realtime polygon rendering graphics, and real-time texture mapping graphics.
This Siemens 510(k) submission (K971717) for the Fly Through Software Package does not contain a study that describes acceptance criteria and how a device meets them. Instead, it focuses on demonstrating substantial equivalence to predicate devices (GE's Navigator and Prominence Workstation) based on shared technological characteristics and intended use.
Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided document.
Here's an overview of what can be gleaned from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. The submission does not define specific performance acceptance criteria or report performance against such criteria. The basis for clearance is substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. No specific test set or associated sample size is mentioned. The submission relies on a comparison of technological characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. No ground truth establishment activity for a test set is described.
4. Adjudication Method:
- Not Applicable. No adjudication method is mentioned as there is no test set or ground truth establishment process described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. No MRMC study is mentioned. The submission is focused on demonstrating equivalence in technological characteristics and intended use, not on comparative effectiveness with human readers.
6. Standalone (Algorithm Only) Performance Study:
- Not Applicable. The document does not describe a standalone performance study. The focus is on the software's capabilities and its relationship to predicate devices.
7. Type of Ground Truth Used:
- Not Applicable. No specific ground truth is mentioned as no performance study is detailed.
8. Sample Size for the Training Set:
- Not Applicable. The document does not provide details about a training set for the software, as this filing predates the common practice of detailed AI/ML validation studies. The software is described as a 3D visualization and navigation tool.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. No information is provided regarding a training set or its ground truth establishment.
§ 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.