Search Results

The ENDOtube devices are a combination of tubes, fittings and valves intended to provide sterile water and/or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healtheare professional only. In procedure room, all ENDOtube devices are 24 hours use disposable products except the one-way valves which are single use products and the insufflation connectors which are multiple patient use.

The ENDOtube kits are a combination of tubes, fittings and valves intended to provide sterile water and/or CO2 and/or air to an endoscope during a GI endoscopic procedure. The ENDOtube products are compatible with various endoscopes (FujiFilm® 500/600 series and 700 series, OLYMPUS® 140, 160, 180 and 190 and PENTAX®), and irrigation pumps (OLYMPUS®, Erbe® and EMED®). The ENDOtube products include several families: ENDOtube for Wash Bottle, ENDOtube for Insufflation, ENDOtube for Wash Pump, and ENDOtube for Wash Bottle CO2 Insufflation.

Based on the provided text, the device in question, ENDOtube, is an endoscopic tubing kit, not an AI/ML-driven device. Therefore, the information requested about acceptance criteria and studies that prove the device meets those criteria (especially points related to AI/ML, such as ground truth, expert adjudication, MRMC studies, and training/test sets) is not applicable to this document.

The document describes the submission to the FDA for 510(k) premarket notification for a medical device (ENDOtube) which is a combination of tubes, fittings, and valves. The acceptance criteria and the studies performed are related to the performance, safety, and compatibility of this physical medical device, not software or AI/ML algorithms.

Here's an analysis of the "acceptance criteria" and "proof" based on the provided text, adapted to the nature of the device:

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML)

The "acceptance criteria" for this device are primarily demonstrated through non-clinical testing to ensure its functionality, safety, and compatibility with other medical equipment. The document reports "Pass" for all tested parameters, indicating the device meets the established criteria.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: The document does not specify exact sample sizes for each "Connection and usability testing," "Leak test and usability testing," "Cross-contamination test," "Durability test," "Operational test," "Performance test," "Sterilization validation," or "Biocompatibility testing." These are typically standardized tests performed on a representative number of units or materials according to relevant standards (e.g., ISO, AAMI).
• Data Provenance: The tests are non-clinical (laboratory/bench) tests. The manufacturer, Nissha Medical Technologies SAS, is based in France. The tests would likely have been conducted in controlled laboratory environments. The data is prospective in the sense that it's generated for the purpose of the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. This is a non-AI/ML device. "Ground truth" in the context of device performance refers to verified operational parameters and safety compliance, which are established through adherence to engineering specifications and regulatory standards, not expert medical opinion on image interpretation.

4. Adjudication Method for Test Set:

• Not applicable. As this is not an AI/ML diagnostic device, there is no "adjudication" of expert interpretations. Device performance is objectively measured against engineering and safety specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This type of study is relevant for AI/ML diagnostic aids that assist human readers in interpreting medical images. The ENDOtube is a physical medical accessory.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. The ENDOtube is a physical device, not an algorithm.

7. Type of Ground Truth Used:

• Not applicable in the AI/ML sense. The "ground truth" for this device's performance is established by engineering specifications, relevant industry standards (e.g., ISO 10993 for biocompatibility), and regulatory requirements. Functional tests confirm the device operates as intended (e.g., no leaks, proper connections, durability).

8. Sample Size for Training Set:

• Not applicable. This device does not involve a training set for an AI/ML algorithm.

9. How Ground Truth for Training Set Was Established:

• Not applicable.

Ask a specific question about this device