(144 days)
The MiraFlex™ High Flow Microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.
The MiraFlex™ High Flow Microcatheter is an infusion catheter with a hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures. The device is available with a 2.8 French shaft and is available in 100, 110, 135, and 150 cm lengths. The device is supplied sterile and intended for one-time use.
This document describes the MiraFlex™ High Flow Microcatheter and its substantial equivalence to a predicate device, as well as the testing performed to demonstrate its reliable design and performance. However, it does not provide detailed acceptance criteria or numerical performance results in a way that allows for a direct comparison table as requested. The document also does not describe an AI/ML device, a clinical study with human readers, or the establishment of ground truth in the context of an AI/ML model.
Therefore, many of the requested points cannot be answered based on the provided text.
Here's an attempt to answer what can be gleaned from the text, with clear indications of what information is not present:
1. A table of acceptance criteria and the reported device performance
The document lists types of tests performed but does not provide specific numerical acceptance criteria or reported performance values for these tests. For instance, it states "Tensile tests" were performed, but not "Tensile strength > X N" (acceptance criteria) and "Reported tensile strength = Y N" (device performance).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests described are device performance tests, not clinical studies with patients or data sets.
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)
This information is not applicable as this is a device performance testing report, not an AI/ML study involving expert ground truth labeling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason as point 3.
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
There is no mention of an MRMC study, AI, or human readers in this document. This refers to a medical device's physical and functional performance, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable. The "ground truth" for these tests would be established by validated test methodologies and standards for mechanical, physical, and biocompatibility performance.
8. The sample size for the training set
This information is not applicable as there is no mention of a training set or an AI/ML model.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
Summary of the Study that Proves the Device Meets the Acceptance Criteria (Based on Provided Text):
The provided document (a 510(k) Premarket Notification summary) describes the MiraFlex™ High Flow Microcatheter. The "study" in this context refers to a series of engineering and performance tests conducted to demonstrate the device's reliable design and performance and its substantial equivalence to a predicate device (MiraFlex™ 18 Microcatheter, K060224).
The tests performed include:
- Tensile tests
- Burst and pressure tests
- Kink radius and stiffness tests
- Torque response tests
- Flow rate tests
- Embolic particle tests
- Leakage tests
- Shelf life tests
- Biocompatibility tests
The document states, "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." This indicates that the device met the internal acceptance criteria for each of these tests, leading to the FDA's clearance. However, the specific acceptance criteria and detailed quantitative results are not disclosed in this summary.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).