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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).

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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 nearnet aod the interior of the tree. It has been modified to permit external video monitoring and recording devices. Other minor improvements have been made also.

The provided text describes the superDimension/Bronchus Premium device but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The document is a 510(k) summary for a Special 510(k), which implies that the device is substantially equivalent to a previously cleared device (superDimension/Bronchus 4.1, K052260) and incorporates minor modifications.

Here's a breakdown of why the requested information is absent based on the provided text:

• Acceptance Criteria and Reported Device Performance: This information is not present. The document states, "Since no new technology is used, clinical tests are not required." This indicates that the device's performance was not evaluated through a new clinical study with pre-defined acceptance criteria, but rather by demonstrating substantial equivalence to a predicate device.
• Sample size for the test set and data provenance: No test set is mentioned because no new clinical testing was deemed necessary.
• Number of experts and their qualifications: Not applicable as no new ground truth establishment process is described.
• Adjudication method: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or mentioned.
• Standalone (algorithm only) performance: Not applicable, as this is a device for guiding a bronchoscope, not a diagnostic algorithm.
• Type of ground truth used: Not applicable as no new clinical study to establish ground truth was performed.
• Sample size for the training set: Not applicable as "no new technology is used."
• How the ground truth for the training set was established: Not applicable.

Summary from the provided text:

Reasoning for "Not applicable":

The document explicitly states: "Since no new technology is used, clinical tests are not required." This means that the device's clearance was based on its substantial equivalence to a predicate device, rather than new clinical data demonstrating its performance against specific acceptance criteria. The modifications were minor, primarily allowing external video monitoring/recording and other minor improvements. Therefore, the detailed information about clinical studies, test sets, ground truth establishment, and expert involvement is not present in this 510(k) summary.

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