(197 days)
The device is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide is needed.
The subject device, the Lunderquist Extra Stiff DC Wire Guide with an extended double curved tip, is considered a line extension of the predicate Lunderquist Extra Stiff DC Wire Guides. The subject device is a PTFE-coated 0.035 inch stainless steel wire with a 4 cm flexible tip that includes an inner gold coil for enhanced visibility. The length of the device is either 260 cm or 300 cm and the J-curve radius is 15 mm. The devices have the body and stiffness required to control large diameter, stiff devices without causing damage to the patient's anatomy or the lumen of the delivery system.
The provided text describes a 510(k) premarket notification for a medical device, the Lunderquist Extra Stiff Wire Guide. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria in the manner of an AI/software device.
Therefore, the information required to answer your questions regarding acceptance criteria and a study proving device capability, specifically for an AI device, is not present in this document. This document pertains to a traditional medical device (a guide wire), not an AI-powered device.
Here's why the required information is absent:
- Type of Device: The Lunderquist Extra Stiff Wire Guide is a physical medical instrument. The questions you've posed (acceptance criteria for AI, training sets, adjudication, MRMC studies, ground truth establishment) are relevant to the validation of AI/Machine Learning devices.
- Regulatory Pathway: A 510(k) submission for a physical device emphasizes performance data to show the device functions as intended and is as safe and effective as a legally marketed predicate device. This is different from the rigorous clinical validation required for many AI/ML-based medical devices, which would involve the type of studies you're asking about.
- Performance Data Provided: The "Performance data" section (page 5) lists various physical tests (Biocompatibility, Surface test, Tape adhesion, Friction, Flexing, Peak tensile force, Ultrasound test, Simulated Use Test, Torque test). These are standard engineering and material tests for a wire guide, not AI model performance metrics. Each test simply states "The predetermined acceptance criteria were met," without detailing what those criteria were or specific performance values.
In summary, this document does not contain the information needed to answer your questions about acceptance criteria and study data for an AI device.
§ 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.