(28 days)
Endoscope Model EB-710XT is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians. Never use this product for any other purposes.
The proposed device consists of a non-insertion portion. The insertion portion is insertion portion is inserted trans-nasally or perorally into the trachea and bronchial tree during clinical use. The insertion portion is flexible and consists of the bending portion") and the insertion tube (hereinafter "flexible portion"). The bending portion features a mechanism that bends the tip up and down. The insertion portion can also be rotated so that the distal end of the endoscope is steered to the anatomic region of interest. The insertion portion of the endoscopes comes into contact with the mucosal membrane. The tip of the insertion portion is called the "Distal end" which contains the lmaging section, Distal cap, Instrument channel outlet, Objective lens, and Light guide. The bending portion is controlled by lever on the control portion section to angulate the distal end to certain angles. The flexible portion contains light guides), an instrument/suction channel, a complementary metal-oxide semiconductor (CMOS) image sensor, and cabling. The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image on a monitor. The control portion provides a grip on the endoscopes and contains mechanical parts to operate the endoscopes. The control portion features an angle lever and a rotation ring which control the angulation and the distal end. The instrument/suction channel runs through the control portion for introducing the endoscopic accessories or electrosurgical instrument, as well as providing suction.
The provided text does not contain information about an AI/ML-powered device, a test set, ground truth establishment, or multi-reader multi-case studies. It describes a conventional medical device (FUJIFILM Endoscope Model EB-710XT) and its regulatory clearance process based on substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the document pertains to a traditional endoscope and not an AI/ML-powered device.
The document discusses:
- Device: FUJIFILM Endoscope Model EB-710XT
- Classification: Class II Bronchoscope
- Predicate Device: FUJIFILM Endoscope Model EB-710P (K220957)
- Testing: Non-clinical performance testing was conducted according to ISO 8600-1:2015 to demonstrate substantial equivalence, focusing on physical parameters like diameter, working length, bending capability, resolution, etc.
Since the prompt asks for details specifically related to AI/ML device testing (e.g., sample size for test set, expert adjudication, MRMC studies, standalone performance, training set ground truth), and none of this information is present in the provided text, I must state that the information is not available in the given context.
§ 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.