(238 days)
to facilitate manipulation of a guide wire during a vascular procedure
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Coeur, Inc. Disposable Torque Device." It's a regulatory approval document and does not contain the information requested in your prompt.
The prompt asks for details about a study proving a device meets acceptance criteria, including:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details.
- Standalone performance study details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This FDA letter simply states that the device is "substantially equivalent" to legally marketed predicate devices and is approved for marketing. It does not provide any of the study design, acceptance criteria, or performance data that would be found in a clinical or validation study report.
Therefore, I cannot extract the requested information from the provided text.
§ 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.