(8 days)
The EB-1830T3. Video Bronchoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Pulmonary Tract. The Pulmonary Tract includes, but is not restricted to, the organs; tissues; and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, and bronchial Tree (including access beyond the stem). The instrument is introduced per oral or per nasal when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.
The EB-1830T3. Video Bronchoscope, must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube, a control body, and umbilicus. The umbilicus provides connection to the video processor and connections for suction. The umbilicus provides connection to the video processor. The control body includes controls for up/ down angulation, suction, and an accessory inlet port. The device contains light carrying bundles, to illuminate the body cavity, and a charge couple device (CCD) to collect image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The video processor contains an illumination system that is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the video processor illumination to the body cavity and the CCD collects image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
The provided document is a 510(k) summary for the Pentax EB-1830T3 Video Bronchoscope, indicating its substantial equivalence to a predicate device. However, this document does not contain information on acceptance criteria or the study that proves the device meets those criteria, as it explicitly states that the submission for substantial equivalence was not based on an assessment of clinical performance data.
Therefore, I cannot provide the detailed information requested in your prompt based solely on the provided text. The document focuses on regulatory approval based on comparison to an existing device, rather than detailed performance study results.
Here's a breakdown of why each point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: Not available. The document states, "The submission for substantial equivalence was not based on an assessment of clinical performance data." This means performance metrics and acceptance criteria for those metrics are not presented.
- Sample size used for the test set and the data provenance: Not applicable, as no clinical performance data assessment was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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. This device is a bronchoscope, not an AI-assisted diagnostic tool, and no clinical performance studies are mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (bronchoscope), not a standalone algorithm.
- The type of ground truth used: Not applicable, as no performance data based on ground truth is presented.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set in that context.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (VB-1830, K934920) through comparisons of intended use, device description, and design control activities, without including performance data from a clinical study.
§ 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.