Search Results

The PENTAX Medical Video Colonoscope EC38-i20cWL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel.

This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.

The PENTAX Medical Video Colonoscope EC38-i20cWL is designed to be used with a PENTAX Medical Video Processor, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the lower digestive tract.

The provided text is a 510(k) summary for the PENTAX Medical Video Colonoscope (EC38-i20cWL). It describes the device, its intended use, comparison to predicate devices, and non-clinical performance data supporting its substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of an AI-powered device or a study involving human readers and AI assistance (MRMC).

The document specifically states: "The subject device is functionally equivalent to the predicate/reference devices, and the differences between the devices are minor technological changes such as the application of wide field of view for the new endoscope. There is no new technological feature in the subject device in comparison to the reference device, K231249." This indicates that the device is a refined version of an existing product, not a novel AI-powered diagnostic or assistive tool.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, training set details) from the provided text, as this type of information is generally specific to the validation of AI/ML-based medical devices or comparative studies of diagnostic performance against established benchmarks, which are not described in this 510(k) summary. The summary focuses on engineering and safety validation, not on diagnostic performance or AI integration.

Ask a specific question about this device