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The Everest 20cc Inflation Device/ Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to be used to inflate/ deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adaptor with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for introduction of fluids into the interventional system. The Guide Wire Insertion Tool is designed to facilitate placement of a guide wire tip through the Y/ Tri-Adapter and into the wire lumen of an interventional catheter. The Guide Wire Steering Handle is designed to hold a small diameter guide wire and provide a handle for manipulating the wire.

Medtronic's Everest™ Disposable Inflation Device is a sterile 20cc inflation device with a locking mechanism that is operated via a trigger. Normally, the locking mechanism is engaged. Once the trigger is pulled back, the locking mechanism is released and the piston can be manually manipulated. The Everest™ 20 Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20 bars in 0.5bar increments. The Everest™ 30 Device is outfitted with a manometer with measuring pressure reading from vacuum to 30bars in 1 bar increments. A high pressure connecting tube with a male rotating adapter and a disposable 3-way stopcock are also included to aid in preparation of the device. When purchased as a “Survival Kit", the package includes a Y-/ Tri- Adapter with hemostasis valve, a Guide Wire Insertion Tool and a Steering Handle.

The provided document is a 510(k) premarket notification for a medical device: Medtronic's Everest™ Inflation Devices. It describes the device's technical characteristics, indications for use, and a summary of performance and biocompatibility testing conducted to demonstrate substantial equivalence to legally marketed predicate devices.

However, this document does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss ground truth established by experts for a test set. The device in question is an Angiographic Injector and Syringe, a mechanical device used in interventional procedures.

Therefore, I cannot provide the detailed information requested in the prompt, as the document does not contain:

1. A table of acceptance criteria and reported device performance for an AI/ML study. The performance criteria listed are for mechanical integrity and compatibility (Lubrication break away test, Pressurization test, Rubber Tip and Insert Tensile test, Compatibility with Contrast Media, Saline).
2. Sample size used for an AI/ML test set or data provenance related to AI/ML. The tests mentioned are bench tests.
3. Number of experts and their qualifications for establishing ground truth.
4. Adjudication method for a test set in the context of AI/ML.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about standalone (algorithm only) performance.
7. Type of ground truth used in an AI/ML context.
8. Training set sample size or how ground truth for a training set was established for an AI/ML model.

The document explicitly states under "Summary of Clinical Data": "No clinical investigations have been performed on the modified device." This confirms that there are no human-in-the-loop or AI component studies to discuss in this context.

In summary, the provided text describes the regulatory clearance for a mechanical medical device and does not contain information relevant to AI/Machine Learning device performance criteria or comparative effectiveness studies that involve human readers and AI assistance.

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