(262 days)
The Shadow Catheter™ is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
The Shadow Guidewire Positioning Catheter is a dual lumen over-the-wire catheter, compatible with a 6F or larger guiding catheter and 0.014" guidewires. The Catheter is designed to support and aim steerable guidewires. The Catheter consists of a distal tip with markers, torque shaft and guidewire introducer. The distal end of the Catheter (the nosecone) has two ports, one to load a tracking guidewire axially (via distal port) and the other for the positioning guidewire to exit radially (via side port). The distal nosecone is coated with a hydrophilic coating.
The Shadow Catheter™ has three markers in the nosecone. The guidewire introducer accommodates an on-axis tracking guidewire, a tracking guidewire flush port, as well as a positioning guidewire introducer port that doubles as a flush port. The handle may be rotated or orientated to adjust or aim the direction of the positioning guidewire exiting the side port at the distal end.
The Catheter is placed in a packaging hoop, sealed in a Tyvek® pouch, and packaged in a shelf carton. There are no diagnostic or therapeutic agents known to be incompatible with the Shadow Catheter™. The Shadow Catheter™ is sterilized with ethylene oxide.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Shadow Catheter™." It details the device's description, intended use, technological characteristics, and non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
However, the text does not contain any information about acceptance criteria or a study that proves the device meets those criteria related to an AI/ML-based medical device. The product is a physical catheter, and the testing described focuses on physical properties and biocompatibility. There is no mention of a test set, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to AI/ML: The document discusses physical device performance (e.g., bond strength, kink test, flow rate), but not AI/ML performance metrics.
- Sample size used for the test set and data provenance: No test set is described for AI/ML evaluation.
- Number of experts used to establish ground truth and qualifications: Not applicable, as there's no AI/ML component.
- Adjudication method for the test set: Not applicable.
- MRMC comparative effectiveness study: Not mentioned, as it's not an AI-assisted device.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable for AI/ML.
- Sample size for the training set: No training set is mentioned.
- How the ground truth for the training set was established: Not applicable.
The document explicitly states: "Clinical Study: Not Applicable. The Shadow Catheter™ was not evaluated in a clinical study." and "The results of the testing met the specified acceptance criteria and did not raise new questions of safety or effectiveness; therefore, the subject device is substantially equivalent to the predicate device." This refers to non-clinical, bench testing of the physical catheter.
In summary, the provided FDA 510(k) document is for a physical medical catheter, not an AI/ML device, and thus does not contain the information required to answer your specific questions regarding AI/ML acceptance criteria and study details.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).