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The Medical Endoscope Image Processing System is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.

The Medical Endoscope Image Processing System is a portable hysteroscope. It includes a sterile single use disposable Electronic Hysteroscope and a reusable Medical Endoscope Image Processor. The Disposable Electronic Hysteroscope contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and two channels for infusion of irrigating fluid and aspiration of tissue. The Disposable Electronic Hysteroscope is sterilized and packaged in a sealed pouch. The Medical Endoscope Image Processor is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the Disposable Electronic Hysteroscope. The Medical Endoscope Image Processor contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or start/stop a video of the procedure, a video processor, microcontrollers, and firmware.

The provided text is a 510(k) summary for a medical device called the "Medical Endoscope Image Processing System." This document primarily focuses on demonstrating substantial equivalence to a predicate device and outlines various non-clinical performance tests.

*However, the document does not contain information about studies evaluating the device's performance against specific acceptance criteria for diagnostic accuracy, sensitivity, specificity, or human reader improvement with AI assistance.

The "Summary of Non-Clinical Performance Testing" section details tests related to:

• Software validation: Ensuring the software conforms to user needs and intended purposes. This is a general statement about software development practices, not specific performance metrics.
• Biocompatibility testing: Proving the device is safe for biological contact (e.g., non-cytotoxic, non-irritating).
• Safety, Electrical Safety, and Electromagnetic Compatibility (EMC): Compliance with relevant IEC standards.
• Sterility: Verification of the sterilization method.
• Cleaning and Disinfection: Protocols for reusable components.
• Packaging/Shelf Life: Validation of shelf life and package integrity.

These are all crucial for device safety and functionality but do not measure diagnostic or clinical performance in the way requested by the prompt (e.g., accuracy against ground truth, impact on human reader performance).

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth for a diagnostic AI/algorithm.

The document's conclusion states: "Based on the verification and validation as documented in the non-clinical performance testing, the Medical Endoscope Image Processing System was found to have a safety and effectiveness profile that is similar to the predicate device." This reinforces that the focus was on non-clinical aspects for 510(k) clearance, not necessarily a clinical performance study involving diagnostic accuracy metrics.

In summary, the provided text does not contain the information required to answer the prompt regarding acceptance criteria and a study proving the device meets those criteria for analytical or clinical performance.

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