Search Results

The EvoEndo Model LE Gastroscope is intended for the upper digestive tract in adults and pediativ patients, specifically for the observation, diagnosis treatment of the esophagus, stomach, and duodenal bulb in patients over the age of five years. The gastroscope is a sterile single-use device and can be inserted orally or transnasally.

The EvoEndo Controller is intended for use with an EvoEndo Endoscopic diagnosis, treament, and video observation.

The EvoEndo Endoscopy System is comprised of two regulated components:

• EvoEndo Model LE Single-Use Gastroscope (hereafter referred to as the EvoEndo Endoscope)
• EvoEndo Controller (hereafter referred to as the Controller) ●

The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. The EvoEndo Endoscope is ethylene oxide (EO) sterilized and is comprised of:

• o Handle
• Umbilical Bundle that includes air, water, and suction lines, as well as the video connector ●
• Endoscope shaft with HD Camera ●

The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable.

The provided document, an FDA 510(k) clearance letter for the EvoEndo Single-Use Endoscopy System, describes various tests conducted to demonstrate the device's safety and effectiveness and its substantial equivalence to predicate devices. However, this document does not contain information about an AI/ML-driven medical device. Therefore, it does not include acceptance criteria or a study design for evaluating algorithmic performance.

The document discusses performance criteria for the physical endoscope and its control system, such as:

• Biocompatibility Testing: Cytotoxicity, sensitization, acute systemic toxicity, and material-mediated pyrogenicity testing based on ISO 10993-1. (Acceptance criteria: No concerns in these areas).
• Sterilization Validation: Ethylene oxide (EO) sterilization validation. (Acceptance criteria: Met all criteria, no impact on product safety or effectiveness).
• Electrical Safety and EMC Testing: Conformance to IEC 60601-1:2005/(R)2012, A1:2012, IEC 60601-1-2:2014, and IEC 60601-2-18:2009. (Acceptance criteria: All met).
• Software Testing: Firmware in the EvoEndo Controller determined to be a "moderate level of concern" and documented per FDA guidance "Off-The-Shelf Software Use in Medical Devices". (Acceptance criteria: Documentation in accordance with guidance).
• Bench Performance Testing: Visual, dimensional, functional (camera/video, tip deflection, air/water/suction flow rates, accessory compatibility, 360° bend, simulated repeated use), and transit simulation. (Acceptance criteria: Met, deflection consistent with predicate, equivalent optical performance (resolution, depth of field, geometric distortion, image intensity uniformity, color performance)).
• Photobiological Safety Testing: Per IEC/TR 62471. (Acceptance criteria: Below limits of exempt risk group).
• Human Factors / Usability Engineering Testing: Two-stage usability study with representative intended users on a benchtop model and animal model. (Acceptance criteria: No significant device or user malfunctions or errors resulting in patient harm).

Since the request specifically asks for details related to an AI/ML device and human reader improvement with AI assistance, which are not present in this document, I cannot fulfill those parts of the request based on the provided text.

Specifically, the document does not provide the following information relevant to AI/ML device evaluation:

• A table of acceptance criteria for an AI/ML device's performance.
• Sample sizes, data provenance, number of experts, adjudication methods, or types of ground truth used for AI/ML test sets.
• Information on MRMC studies or the effect size of AI assistance on human readers.
• Standalone performance for an algorithm.
• Training set details (sample size, ground truth establishment) for an AI/ML model.

This is a clearance for a traditional medical device (an endoscope), not a software as a medical device (SaMD) or an AI/ML device that provides diagnostic or therapeutic outputs based on complex algorithms.

Ask a specific question about this device