(8 days)
The 0.035'' and 0.025'' Guidewire is indicated for use in the peripheral vasculature. The 0.014'', 0.016'', and 0.018'' guidewires are indicated for use in the peripheral and coronary vasculature.
The guidewire is constructed of nitinol (nickel-titanium alloy). The nitinol core extends from the distal tip of the guidewire to the proximal shaft end. The distal tip is a helically coiled coil gold plated tungsten wire. The guidewire is coated with a coating(s)to help facilitate smooth passage.
Here's an analysis of the provided text regarding the EV3 Nitrex™ Nitinol Guidewire.
Important Note: The provided document is a 510(k) summary for a medical device (guidewire). For this type of device, the "acceptance criteria" and "device performance" usually refer to engineering specifications and physical testing, not clinical performance metrics like sensitivity, specificity, or accuracy which are common for AI/diagnostic devices. Similarly, concepts like "ground truth," "experts," "adjudication," and "MRMC studies" are typically not applicable to guidewires.
The document describes a submission for substantial equivalence based on physical and dimensional testing, comparing it to predicate devices. It does not contain information about studies involving AI, human readers, or clinical outcomes that would typically have the metrics and study design elements requested in the prompt.
Given this context, I will extract the information that is present and indicate where the requested information is not applicable to this type of device submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from "Testing" section) | Reported Device Performance |
|---|---|
| Dimensional inspection of the guidewire yielded acceptable results. | "All testing of the product yielded acceptable results." |
| Verification/validation testing performed on the original device determined that the modification would not affect the original results. | (Implicitly, the modification did not affect the original results, leading to the substantial equivalence determination.) |
| Device is substantially equivalent to predicate devices in intended use, materials, labeling, and principles of operation. | The FDA determined the device is substantially equivalent to legally marketed predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for dimensional or verification/validation testing.
- Data Provenance: Not specified, but likely internal testing by EV3 in the USA, as per their address. This is not a clinical study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device, and "ground truth" in the diagnostic sense is not relevant. The "ground truth" for manufacturing would be adherence to engineering specifications and successful functional testing, typically performed by engineers/technicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication is not relevant for dimensional and functional testing of a guidewire.
5. 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
- No. This is not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device relates to its physical properties meeting design specifications and its functional performance during testing (e.g., ability to advance smoothly, tip flexibility, etc.) compared to predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI or learning-based system.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI or learning-based system.
Summary of Device and Study (Based on 510(k) Summary):
The EV3 Nitrex™ Nitinol Guidewire is a Class II medical device used in peripheral and coronary vasculature. The submission (K031864) is for substantial equivalence to existing predicate guidewires. The "study" mentioned is internal "dimensional inspection" and "verification/validation testing" performed by the manufacturer, EV3. The stated outcome is that "All testing of the product yielded acceptable results" and modifications did not affect original results, leading to the FDA's finding of substantial equivalence based on intended use, materials, labeling, and principles of operation being similar to predicate devices. No clinical trial, AI component, or human reader study is described in this document.
§ 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.