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The Guide extension family catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices. The Guide extension family catheters are contraindicated in vessels less than 2.5mm in diameter, vessels in the neurovasculature, and the venous system.

The FlowGuide and GuidionShort are single lumen rapid exchange catheters being compatible with 6F and larger guide catheters and may be placed over either an exchange length or 180cm guide wire. The 150cm long device has a stainless-steel shaft section. The stainless-steel shaft is followed distally by a 15 cm lumen section.

The catheters have a radiopaque distal end which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm and 105cm from the distal tip, respectively.

The catheters are delivered through a guiding catheter resulting in an inner diameter that is approximately 1 French smaller than the guide catheter. The catheters have a proximal hub which indicates guide catheter compatibility.

The FlowGuide has 9 perfusion holes in the distal shaft intended to reduce pressure dampening.

This FDA 510(k) clearance letter pertains to a new medical device, the FlowGuide and GuidionShort catheters. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/ML powered device meets certain performance criteria. The document describes the physical and functional characteristics of the catheters and the tests performed to ensure their safety and performance. However, there is no mention of an "AI/ML device" or any study related to its performance, human reader improvement, or ground truth establishment.

Therefore, I cannot fulfill the request as it is based on the premise of an AI/ML powered medical device, which is not what this FDA clearance letter is about.

To clarify, the document describes the device as a "percutaneous catheter" (Page 1) and its function as being "intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices" (Page 4). The "Device Description" (Page 5) further explains that it is a "single lumen rapid exchange catheter." These descriptions all point to a hardware medical device, not a software or AI/ML-powered device.

The "Summary of Studies" section (Page 7) lists a series of performance and biocompatibility tests. These are standard engineering and biological tests for physical medical devices (e.g., kink resistance, radiopacity, bond strength, cytotoxicity, hemocompatibility), not tests typically associated with AI/ML software performance (like sensitivity, specificity, AUC, or reader studies).

In conclusion, this document does not contain information about an AI/ML device, its acceptance criteria, or performance studies in the context of AI/ML. As a result, I cannot provide the requested table or details about reader studies, ground truth, or training sets for an AI/ML model based on the provided text.

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Guidion catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices.

The Guidion catheter is a single lumen rapid exchange catheter offered in sizes being compatible with 5F; 6F; 7F and 8F guide catheters and may be placed over an guide wire. The 150cm long device has a stainless steel shaft section. The stainless steel shaft is followed distally by a 25cm lumen section.

The Guidion catheter has a radiopaque distal end which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm and 105cm from the distal tip, respectively.

The Guidion catheter is delivered through a guiding catheter resulting in an inner diameter that is approximately 1 French smaller than the guide catheter. The Guidion catheter has a proximal hub which indicates guide catheter compatibility.

The provided document is a 510(k) summary for the Guidion Catheter, a medical device. It does not describe an AI/ML powered device, nor does it detail a study involving AI for diagnostic assistance. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and a study proving an AI device meets those criteria.

The document discusses the substantial equivalence of the Guidion Catheter to a predicate device based on performance and biocompatibility tests. It lists the types of tests performed (e.g., kink resistance, radiopacity, bond strength, biocompatibility), but it does not provide specific acceptance criteria or detailed results of these tests. It simply states that "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues."

Therefore, I cannot provide information for the following points as they are not present in the given text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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