(55 days)
The Back-Up Meier Guidewire is intended to facilitate placement of a catheter during diagnostic or interventional intravascular procedures.
The Back-Up Meier Guidewires are sterile, single-use wires and are available in different tip shapes with overall wire lengths of 185 cm - 300 cm. The distal segment of the wire is radiopaque to aid in visualization of the device under fluoroscopy.
This document is a 510(k) summary for the Back-Up Meier Guidewire. It does not describe an AI medical device or a study that employs acceptance criteria in the typical sense for algorithm performance. Instead, it demonstrates substantial equivalence to predicate devices for a physical medical device. Therefore, most of the requested information regarding AI device acceptance criteria and study particulars is not applicable.
Here's an analysis based on the provided text, focusing on the available information and noting the inapplicable sections:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical guidewire, "acceptance criteria" are related to its physical properties, intended use, and biocompatibility, as demonstrated through comparison with predicate devices. Specific quantitative performance metrics in terms of clinical accuracy (like sensitivity, specificity) for a diagnostic AI device are not applicable here.
| Acceptance Criterion (from document) | Stated Performance / Outcome |
|---|---|
| Intended Use | Facilitates placement of a catheter during diagnostic or interventional intravascular procedures. |
| Biocompatibility | Tested per ISO 10993. All data demonstrate this device is biocompatible for its intended use. |
| Substantial Equivalence | Compared to predicate devices (Platinum Plus Guidewire, Amplatz Super Stiff Guidewire). All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised. |
| Sterility | Sterile. |
| Single-use | Single-use. |
| Tip Shapes | Available in different tip shapes. |
| Overall Wire Lengths | Available in 185 cm - 300 cm. |
| Radiopacity | Distal segment is radiopaque to aid in visualization under fluoroscopy. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. This document pertains to a physical medical device (a guidewire) and its substantial equivalence to existing predicate devices. It does not involve a "test set" of data for algorithm performance evaluation. Testing for such devices typically involves bench testing, material testing, and potentially animal or limited human clinical trials (though not detailed here for this 510(k) summary) rather than data-driven algorithm evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. As above, there is no "test set" requiring expert-established ground truth for an AI algorithm. The evaluation of this device is based on its physical characteristics, materials, and comparison to legally marketed predicate devices, assessed by regulatory bodies and engineers/scientists, not clinical experts establishing ground truth for diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No "test set" or adjudication method for AI algorithm performance is mentioned. The review process for a 510(k) submission involves FDA reviewers assessing the provided documentation and testing results to determine substantial equivalence.
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
- Not applicable. This document is for a physical medical device, not an AI device. Therefore, no MRMC study, human reader improvement with AI assistance, or effect size is relevant or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical guidewire, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For a physical guidewire, "ground truth" doesn't apply in the context of diagnostic accuracy. Its performance is evaluated through engineering tests, biocompatibility testing (ISO 10993 standards), and comparisons of its design and materials to predicate devices to ensure safety and effectiveness for its intended mechanical function within the body.
8. The sample size for the training set
- Not applicable. This document is for a physical medical guidewire, not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This document is for a physical medical guidewire, not an AI device that requires a training set and associated ground truth establishment.
§ 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.