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The EPK-i5020 Video Processor is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to be used with PENTAX Video Endoscopes to provide illumination, control air pump to supply air through the video endoscope to help clear visualization, convert data from video endoscope into standard video output for visualization via video monitor, and interfacing with external peripheral devices.

The EPK-i5020 Video Processor is consists of light source with 300 W Xenon Lamp to provide illumination, video processor to convert data from video endoscope into standard video output for visualization via video monitor, and interfacing with external peripheral devices. The processor controls the lamp brightness, white and color balance adjustments, and air pump to supply air through the video endoscope to help clear visualization. In addition, the EPK-i5020 Video Processor indicates the operating status and lamp life in the front panel. This device operates with 120 ±10% VAC, 50 -60 Hz power supply.

The provided text describes the PENTAX EPK-i5020 Video Processor and its substantial equivalence determination. However, it explicitly states that clinical tests were "Not Applicable to support substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them, as no such study is described in the provided document. The device's approval appears to be based on non-clinical testing and substantial equivalence to a predicate device, rather than a study demonstrating clinical performance against specific acceptance criteria.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

Information that CANNOT be provided from the text:

• A table of acceptance criteria and reported device performance (no clinical performance criteria mentioned).
• Sample size used for the test set (no clinical tests described).
• Data provenance for the test set (no clinical tests described).
• Number of experts used to establish ground truth for the test set (no clinical tests described).
• Qualifications of experts (no clinical tests described).
• Adjudication method for the test set (no clinical tests described).
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with vs. without AI assistance (not relevant as this is not an AI device, and no clinical studies were performed).
• If a standalone (algorithm only) performance study was done (not relevant as this is not an AI device, and no clinical studies were performed).
• The type of ground truth used (no clinical tests described).
• Sample size for the training set (not an AI device, no training set mentioned).
• How ground truth for the training set was established (not an AI device, no training set mentioned).

Information that CAN be extracted or inferred from the text (though it directly addresses the lack of a clinical study):

• Summary of Nonclinical Tests: The device complies with voluntary standards and underwent various quality assurance measures:

  • Risk Management (Analysis & Mitigation)
  • Requirements Reviews
  • Design Reviews
  • Unit Testing (Software & Hardware Verification)
  • Integration testing (Software & Hardware Verification)
  • Performance testing (Software & Hardware Verification)
  • Safety testing (System level Verification & Validation)
  • Simulated use testing (System level QA Validation)
  • Electrical testing according to IEC 60601
  • Software validation performed in accordance with IEC 62304

• Summary of Clinical Tests: "Not Applicable to support substantial equivalence." This explicitly states that clinical studies were not performed to demonstrate performance against acceptance criteria for this 510(k) submission. The device received clearance based on its substantial equivalence to a predicate device (Fuilnon EPX-4440HD Digital Processor and Light Source - K102466).

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