(265 days)
This product is used in combination with Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) to process the image collected by the electronic endoscope and transfer them to the monitor for imaging.
Full HD Endoscopic Image Processor is used in combination with Single-use Broncho Videoscope (SBV-1A-B, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) to process the image collected by the electronic endoscope and transfer them to the monitor for imaging.
This product is composed of Full HD Endoscopic Image Processor host, foot switch, power cable. Video cable includes SDI video cable and DVI video cable. The foot switch is optional.
There are four models (HDVS-S200B, HDVS-S200B, HDVS-S200D) for Full HD Endoscopic Image Processor, and the difference between the four models is only the difference in structure configuration.
The provided text is a 510(k) Summary for a medical device (Full HD Endoscopic Image Processor). It details the device's characteristics, intended use, and substantial equivalence to a predicate device. However, it does not contain information about the acceptance criteria and the detailed study results that specifically prove the device meets these criteria in the way you've outlined for AI/human performance studies.
The document states:
- "The following performance data were provided in support of the suivalence determination. The test results demonstrated that the subject device complies with the standard requirements."
- "The nonclinical test were conducted to demonstrate that the subject is as safe and effective as the predicate."
- "The clinical data is not applicable."
This indicates that the submission relies on non-clinical performance testing (electrical safety, EMC, optical performance, service life, package validation) to demonstrate substantial equivalence, rather than clinical studies or studies involving human readers/AI assistance in the manner of a diagnostic AI device. The device is an image processor, not a diagnostic AI algorithm that interprets images.
Therefore, I cannot extract the information requested for acceptance criteria and study proving device meets acceptance criteria, as the document does not provide this type of data. The questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are typically relevant for diagnostic AI/CADe devices, which is not what this device appears to be based on the provided summary.
In summary, the provided text does not contain the information required to answer your prompt because the device (Full HD Endoscopic Image Processor) is not a diagnostic AI device that would undergo such types of performance evaluations.
§ 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.