(20 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 4.1 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.
The information provided indicates that no clinical studies were performed for the superDimension/Bronchus 4.1 device due to its classification as not using new technology. Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics are not available in the given text.
Here's a breakdown of the available information and the details that are not provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical tests: | Satisfies the requirements of EN60601-1 and EN 60601-1-2. Extensive bench testing has been performed on the entire system. |
| Clinical tests: | None required as "no new technology is used." |
2. Sample size used for the test set and the data provenance
- Not Applicable: No clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: No clinical test set was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No clinical test set was used.
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
- Not Applicable: No MRMC study was performed as no clinical studies were conducted. The device (superDimension/Bronchus 4.1) is a tool to guide a bronchoscope, not an AI for interpretation or improvement of human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: The device is a guidance system for endoscopic tools, not a standalone diagnostic algorithm. No standalone performance study was mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: Since no clinical studies were performed, no ground truth types were established from patient data. The "ground truth" for non-clinical testing refers to meeting technical standards (EN60601-1 and EN 60601-1-2) which are objective engineering specifications.
8. The sample size for the training set
- Not Applicable: No training set for an algorithm was mentioned, as "no new technology is used" and no clinical studies were conducted. The device is a guidance system, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable: No training set was used.
§ 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.