Search Results

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal and pulmonary endoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes.

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.

The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.

The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is found in the instructions for use (IFU) and/or in the commercial materials such as brochures.

The provided FDA 510(k) clearance letter for the PENTAX Medical Video Processor (EPK-i8020c) does not contain the information requested regarding acceptance criteria and the detailed study proving the device meets those criteria.

This document primarily focuses on establishing substantial equivalence to a predicate device based on minor software modifications and changes to instructions for use. It states that "The changes to the subject device were evaluated through performance testing in design validation/verification. This testing did not raise any issues regarding the safety and effectiveness of the device, as these differences do not affect the performance, function, or general intended use of the device."

However, it does not provide any specific acceptance criteria, reported device performance metrics against those criteria, or the details of the study methodology (sample size, data provenance, expert involvement, adjudication, MRMC, standalone performance, ground truth, training set specifics).

Therefore, based on the provided text, I cannot complete the requested information. The document explicitly states:

• "NON-CLINICAL PERFORMANCE DATA" section, point iii. "System Performance": "The system performance of the subject device demonstrated the equivalence to the predicate device."
• This suggests that the performance verification for this 510(k) relied on demonstrating equivalence to an already cleared predicate, rather than a de novo clinical or rigorous standalone performance study with specific acceptance criteria that would then be detailed.

Without access to the actual design validation/verification reports that were submitted to the FDA detailing the performance testing, it's impossible to answer the specific questions about acceptance criteria and the study that proves the device meets them.

The sections for acceptance criteria, study details, and related information would be empty or marked as "Not Provided in Document" if I were to adhere strictly to the given text.

In summary, the provided FDA 510(k) clearance letter does not describe the acceptance criteria or a dedicated study proving device performance against those criteria in the level of detail requested.

Ask a specific question about this device