(107 days)
The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This device is not indicated for neuro, or cardiac use.
The Guidewire is constructed of a stainless steel core wire and a stainless steel or platinum coil welded/brazed in place over the core wire. The coil may cover the entire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum marker bands may be placed under the coil to aid in visualization. Exit markers may be printed on the proximal section of the guidewire to aid the physician in determining the depth of insertion.
The provided text is a 510(k) Premarket Notification for a vascular guidewire, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies or extensive performance testing with acceptance criteria.
Therefore, the document does not contain the information requested for acceptance criteria and a study proving a device meets them in the context of typical AI/software device evaluation.
Here's a breakdown of why the specific questions cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The submission focuses on comparison to predicate devices and bench testing results, not predefined acceptance criteria for a novel performance metric.
- Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the sense of clinical data or image data for an AI algorithm. The testing described is bench testing in a lab.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as this is not an AI/diagnostic device.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical medical device (guidewire), not an AI-powered diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Performance (from the document):
The device's safety and performance were established through:
- Comparison of labeling, physical, and performance design characteristics to predicate devices.
- Results of comparative bench testing, which included:
- Tensile Strength
- Torque Strength
- Torqueability
- Tip Flexibility
- Coating Integrity
The document concludes that "Based on the indications for use, technological characteristics, and comparison to predicate devices, the TechDevice Guidewire has been shown to be safe and effective for its intended use." This statement is based on the substantial equivalence argument and the bench test results against the predicate, not a defined set of quantitative acceptance criteria for clinical performance that would typically be associated with an AI study.
§ 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.