(90 days)
The Merit Hydrophilic Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures.
The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a hydrophilic coating applied to the jacket. The wire will be offered with straight and angled tip configurations in various lengths.
The provided text describes a 510(k) premarket notification for a medical device, the Merit Hydrophilic Guide Wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical trial with specific performance metrics against acceptance criteria. Therefore, most of the information requested in your prompt (especially regarding AI studies, expert ground truth, sample sizes for training/test sets, and human-in-the-loop performance) is not applicable or not provided in this document.
However, I can extract the relevant information about the acceptance criteria and how the device meets them based on the 510(k) summary provided.
Here's the breakdown:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No performance standards established under Section 514 of the Food, Drug and Cosmetic Act for these devices. | A battery of tests was performed according to protocols based on the requirements of industry standards and guidances. |
| Meet acceptance criteria that were determined to demonstrate the safety and efficacy of the device. | The tests were shown to meet the acceptance criteria. |
| Substantial equivalence to predicate devices in: Indication for Use, design, safety, and performance testing. | The Merit Hydrophilic Guide Wire meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate devices (Terumo Radiofocus® Glidewire® [K863138] and Lake Region Medical Hydrophilic Coated Guide Wire [K000011]). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) submission primarily relies on non-clinical performance and substantial equivalence to predicate devices, not on human test sets or data in the way an AI/software device would. The tests performed are likely bench or in-vitro tests on the device itself.
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. This document does not describe the use of human experts to establish ground truth for a test set. The "ground truth" for a medical device like a guide wire would be its physical properties and mechanical performance meeting specified engineering or industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This document does not describe a clinical study requiring an adjudication method.
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 a hardware medical device (guide wire), not an AI/software device. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth, in this context, would be the specified engineering and performance characteristics/measurements (e.g., lubricity, tensile strength, kink resistance, tip shape, coating integrity) derived from industry standards and guidances. The device's performance against these technical specifications forms the "ground truth" for demonstrating safety and efficacy.
8. The sample size for the training set
- Not Applicable. This is a hardware medical device; there is no training set in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.