(95 days)
The Guide Wire Torque Device is intended to facilitate guide wire manipulation during interventional procedures.
The Guide Wire Torque Device is a guide wire accessory developed to assist in the manipulation and placement of hydrophilic and other typical guide wires during interventional procedures. It accomodates guide wires from .018 to .038 inches and is composed of three components: 1. An ABS plastic body; 2. A polypropylene "core" which grips the guide wire; and 3. A stainless steel spring which supplies the force to grip the guide wire.
The design of the Guide Wire Torque device allows single-handed operation. The wire gripping actuator is depressed while the guide wire is threaded through the device's lumen. When the Guide Wire Torque Device is located on the guide wire in the appropriate location, the actuator is released allallowing the device to grip the guide wire.
The provided text describes a medical device, the Guide Wire Torque Device, which is an accessory to assist in manipulating guide wires during interventional procedures. However, it does not contain any information regarding specific acceptance criteria, performance studies, or test results (such as accuracy, sensitivity, or specificity metrics) that would typically be found in a study proving a device meets acceptance criteria.
The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study data against predefined acceptance criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable for this type of mechanical device.
- The type of ground truth used: Not applicable for this type of mechanical device.
- The sample size for the training set: Not mentioned (and not applicable for this mechanical device).
- How the ground truth for the training set was established: Not mentioned (and not applicable).
The document states:
"Merit believes that the prior use of the component materials of the Guide Wire Torque Device in legally marketed devices, the performance data provided, and the biocompatibility data provided demonstrate that the Guide Wire Torque Device is substantially equivalent to the predicate device."
This indicates that some performance data was submitted, likely focusing on mechanical functionality, material safety (biocompatibility), and design similarity to the predicate device, rather than clinical performance metrics in the way you'd expect for an AI/software device. The summary itself does not elaborate on what that "performance data" entailed.
§ 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.