(23 days)
The Micrus Courier microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.
The Micrus Microcatheters are tubular devices with a single lumen designed for insertion into the cardiovascular system for diagnostic and therapeutic purposes.
This 510(k) summary (K061963) for the Micrus Microcatheters "Courier Pre-Shaped" describes the device and its intended use, and makes a claim of substantial equivalence to predicate devices based on design, materials, function, and non-clinical testing. However, it does not provide the specific quantitative acceptance criteria or detailed results of a study designed to prove the device meets those criteria in the way you've outlined for medical AI/software performance.
Here's an analysis based on the information provided and how it relates to your requested points:
1. A table of acceptance criteria and the reported device performance:
This document does not contain a quantitative table of acceptance criteria and reported device performance. The comparison to predicate devices is qualitative and states that the "Micrus Courier Pre-Shaped microcatheters had lower peak and lower average tension / compression than the predicate Excelsior 1080 and SL-10." This suggests mechanical testing was done, but no specific values or acceptance thresholds are provided.
2. Sample size used for the test set and the data provenance:
No information provided. This document describes a medical device (a microcatheter), not a software or AI device that would typically use "test sets" of data. The "testing" referred to is likely mechanical and bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method for the test set:
Not applicable.
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 is a physical medical device, not an AI/software product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. For a physical device like a microcatheter, the "ground truth" for performance would be derived from engineering specifications, material properties, and mechanical test results (e.g., tensile strength, flexibility, lubricity measurements).
8. The sample size for the training set:
Not applicable. As a physical device, there's no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is provided vs. what is requested:
The provided document is a 510(k) summary for a physical medical device (microcatheter). The questions you've asked are predominantly tailored for the evaluation of medical AI or software as a medical device (SaMD), which requires different types of studies and performance metrics (e.g., sensitivity, specificity, AUC, human reader studies).
For this 510(k) submission, the "study" proving the device meets acceptance criteria is implied to be a series of non-clinical bench and mechanical tests. These tests would likely compare properties such as:
- Mechanical properties: Tensile strength, pushability, trackability, torqueability, flexibility, kink resistance.
- Dimensional accuracy: Inner/outer diameters, length, tip shape.
- Material compatibility: Biocompatibility (though typically covered by material predicate).
- Coating integrity/lubricity.
- Radiopacity.
The document states that the new device "had lower peak and lower average tension / compression than the predicate Excelsior 1080 and SL-10," indicating that specific mechanical tests were performed to demonstrate mechanical performance metrics (like force required to traverse a tortuous path). However, the specific acceptance criteria (e.g., "force must be less than X N" or "within Y% of predicate device") and the detailed quantitative results of these non-clinical studies are not included in this high-level 510(k) summary. These details would typically be found in the full 510(k) submission and the internal test reports of the manufacturer.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).