(44 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. Not for pediatric use.
The superDimension/Bronchus Premium 2 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 the target and the interior of the tree.
The provided text is a 510(k) summary for the superDimension/Bronchus Premium 2 device, dated July 12, 2007. It describes changes made to an already cleared device (K062315).
Based on the document, the following observations can be made regarding acceptance criteria and the study:
1. A table of acceptance criteria and the reported device performance:
The document states: "Appropriate verification and validation tests were performed to assure that the design output met the design input requirements and that the modified device continues to meet its user needs and intended uses." However, specific quantitative acceptance criteria and reported device performance are not detailed in this 510(k) summary. This summary focuses on the administrative aspects of a special 510(k) and asserts that the device continues to meet its previous requirements rather than establishing new ones or reporting specific performance metrics for the modified device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document explicitly states: "Clinical tests were not required to validate the changes made to the superDimension/Bronchus Premium 2." This indicates that no new clinical test data was generated, and therefore, there is no sample size for a test set or data provenance to report from this specific submission. The submission relies on the substantial equivalence to the predicate device and the verification and validation (V&V) activities against design inputs for the modified components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
As no clinical tests were required, no experts were used to establish ground truth for a test set related to this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Since no clinical tests were required, there was no adjudication method employed for a test set in this submission.
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:
The device described is a navigation system for bronchoscopy, not an AI or imaging interpretation device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted for this device, and there is no mention of AI assistance or its effect size.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is not an algorithm that performs standalone analysis. It is a system that aids a physician in guiding endoscopic tools. Therefore, no standalone algorithm-only performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
As no clinical testing was performed for this specific 510(k) submission, no new ground truth data was generated or used. The assessment relies on the existing clearance of the predicate device and the V&V activities.
8. The sample size for the training set:
The document does not describe any machine learning or AI components that would require a training set. Therefore, no sample size for a training set is provided.
9. How the ground truth for the training set was established:
As there is no mention of a training set, the question of how its ground truth was established is not applicable to this document.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.