(30 days)
The Magic Torque™ Guidewires facilitate placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. Not intended for use in coronary arteries.
The 315 cm Magic Torque™ DLVR Guidewire facilitates placement of a catheter during diagnostic or interventional procedures. The guidewire contains a stainless steel (SS) core wire. A SS coil is wound over the distal 50 cm of the core wire. The most distal 10 cm of the SS coil is coated with a proprietary hydrophilic coating from Boston Scientific that provides a slippery surface to facilitate negotiation of difficult anatomy and tight lesions. The proximal 40 cm of the coil is coated with polytetrafluoroethylene (PTFE) for lubricity. A PTFE polymer sleeve jackets the proximal end of the core wire. The guidewire is clearly visible under fluoroscopy.
The provided text describes the 510(k) premarket notification for the Magic Torque DLVR Guidewire. It does not describe an AI/ML-driven medical device or a study involving human readers, ground truth establishment by experts, or any of the elements typically associated with an AI/ML performance study.
Instead, this document pertains to a traditional medical device (a guidewire) and its clearance based on non-clinical performance data demonstrating substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance as the provided document explicitly states:
- Clinical Performance Data: "Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data."
The document focuses on:
- Bench Testing: Overall Length Measurement, Guidewire Withdrawal from the Carrier Tube.
- Biological Safety Testing: Biocompatibility (ISO 10993-1), microbial assessments (bioburden, endotoxin, pyrogenicity), and sterility assurance testing.
There is no information in this document about:
- AI/ML performance metrics (e.g., sensitivity, specificity, accuracy).
- Sample sizes for test sets or training sets related to imaging data.
- Experts establishing ground truth for image interpretation.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth (e.g., pathology, outcomes data).
- How ground truth for a training set was established.
This device's clearance is based on its physical and biological characteristics being equivalent to a previously cleared guidewire, not on its performance in interpreting medical images or assisting human readers with diagnoses.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.