(30 days)
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool.
The superDimension/Bronchus Premium is a device that guides a bronchoscope and bronchial tool to a target in or adjacent to the bronchial tree on a path indicated by CT scan, and visualizes target and the interior of the tree. It has been modified to permit connection to PACS and import of PET/CT image data. Other minor improvements have been made also.
The provided text states, "Since no new technology is used, clinical tests are not required." Therefore, the device did not undergo clinical testing to establish acceptance criteria or demonstrate performance.
Here's a breakdown of the requested information based on the provided document, even though a clinical study fulfilling these criteria was not conducted:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. No acceptance criteria or performance metrics derived from clinical trials are mentioned.
2. Sample Size for Test Set and Data Provenance
Not applicable. No clinical test set.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. No ground truth established from expert review in a clinical study.
4. Adjudication Method
Not applicable. No clinical test with adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study was performed or reported.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a guidance system, and the document explicitly states "It does not make a diagnosis and is not a bronchial tool." It's not an AI algorithm performing a diagnostic task in a standalone manner.
7. Type of Ground Truth Used
Not applicable. No clinical ground truth was established through expert consensus, pathology, or outcomes data as clinical tests were not required.
8. Sample Size for the Training Set
Not applicable. This device is a guidance system, not an AI algorithm trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set for an AI algorithm.
Summary of Device Information provided in the text:
- Device Name: superDimension/Bronchus Premium 2
- Intended Use: To image the upper airways and tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not a bronchial tool.
- Modifications from Predicate: Modified to permit connection to PACS and import of PET/CT image data. Other minor improvements.
- Performance Data: Non-clinical tests included satisfying EN60601-1 and EN 60601-1-2 requirements and extensive bench testing.
- Reason for no Clinical Tests: "Since no new technology is used, clinical tests are not required." This indicates that the FDA deemed the changes to the device minor enough that new clinical data was not necessary to demonstrate substantial equivalence to the predicate device (superDimension/Bronchus Premium, K052852).
§ 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.