(177 days)
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:
- 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).
- Sample size used for an AI/ML test set or data provenance related to AI/ML. The tests mentioned are bench tests.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for a test set in the context of AI/ML.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about standalone (algorithm only) performance.
- Type of ground truth used in an AI/ML context.
- 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.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.