(218 days)
The IVT 0.014" PTFE-Coated Trackwire is indicated for use in coronary and peripheral vessels to facilitate the navigation and placement of angioplasty interventional catheters. The 0.014" Trackwire is not indicated for cerebrovascular use.
The IVT 0.014" PTFE-Coated Trackwires have a nominal diameter of 0.014 inches and nominal lengths from 175 to 300 centimeters. The distal 1-3 centimeters of the Trackwire is shapeable. The distal 2-6 centimeters contains a radiopaque coil. The proximal section of the Trackwire is coated with a fluorinated polymer.
The provided document is a 510(k) summary for a medical device, the IVT 0.014" PTFE-Coated Trackwire. It relates to a premarket notification to the FDA for a medical device and not an AI/ML powered device. This type of document is about demonstrating substantial equivalence to existing predicate devices, primarily through physical performance testing and biocompatibility. As such, it does not contain the information requested in your prompt regarding acceptance criteria and studies that prove an AI/ML device meets them.
Specifically, the document does not contain any of the following information:
- A table of acceptance criteria and reported device performance for an AI/ML model.
- Sample size used for the test set or data provenance for an AI/ML model.
- Number of experts used to establish ground truth or their qualifications for an AI/ML model.
- Adjudication method for an AI/ML model test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML model.
- Sample size for the training set of an AI/ML model.
- How the ground truth for an AI/ML training set was established.
The document details the device's description, intended use, and substantial equivalence to physical predicate devices, based on physical performance testing and biocompatibility. It's a regulatory submission for a physical medical product, not a software or AI/ML algorithm.
§ 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.