(144 days)
The Vathin® H-SteriScopeTM I Single use flexible Video Bronchoscope has been designed to be used with the Vathin® Displaying Unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Vathin® Video Bronchoscope System is for use in a hospital environment.
Not Found
I am sorry, but the provided text from the FDA 510(k) clearance letter for the Vathin® Video Bronchoscope System does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The letter is a standard FDA clearance document that states the device has been found substantially equivalent to a legally marketed predicate device. It discusses regulatory aspects, such as general controls, potential additional controls for Class II/III devices, and compliance with various FDA regulations.
It does not include details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets, nor data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (e.g., expert consensus, pathology).
- How ground truth for any set was established.
Therefore, I cannot fulfill your request for this information based on the provided text. To obtain such details, you would typically need to refer to scientific publications, clinical trial reports, or other technical documentation directly submitted to the FDA, which are not part of this clearance letter.
§ 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.