(132 days)
The LuMend Frontrunner™ CTO Coronary Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) prior to PTCA or stent intervention.
The LuMend Frontrunner™ is a sterile single-use percutaneous coronary catheter consisting of a handle assembly with an integral rotator and a side port for internal device flushing, a proximal and a radiopaque blunt-shaped distal variable-size tip assembly. A handle lever provides manual adjustment of the size of the tip assembly, and the handle rotator provides rotational control for the shaft and distal tip assembly. The distal assembly consists of a set of bilateral hinged tip pieces. The Frontrunner catheter does not have a guide wire lumen. Guidance and tracking of the catheter through the coronary vasculature is accomplished by selective manual shaping of the flexible distal shaft, and controlled torquing of the handle rotator.
The provided text describes the LuMend Frontrunner™ CTO Coronary Catheter. It outlines the device's description, intended use, and comparison to predicate devices, but it does not include a table of acceptance criteria or a detailed study proving the device meets specific performance metrics.
However, the document states:
"Design analysis, in vitro and in vivo data confirm that basic functional characteristics are substantially equivalent to the predicate devices cited. Device evaluation consisted of testing specified in FDA's Coronary and Cerebrovascular Guidance Document (January 1995) and included in vitro tensile, torque strength, torqueability, tip flexibility, coating adherence/integrity, biocompatibility and catheter compatibility. All data fell well within both internal specification requirements, as well as external standard requirements and predicate performance expectations. In addition to the above testing, a series of clinical studies have demonstrated substantial equivalence in terms of device safety and effectiveness."
Based on this information, I can answer some of your questions and explain why others cannot be fully addressed from the provided text.
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "All data fell well within both internal specification requirements, as well as external standard requirements and predicate performance expectations."
However, specific numerical acceptance criteria (e.g., "tensile strength > X N") and the corresponding precise reported device performance values are not provided in this summary. The summary only gives a high-level statement of compliance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "a series of clinical studies" but does not provide details on the sample size for these studies, their design (retrospective or prospective), or the country of origin of the data.
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 provided in the document. The text refers to "clinical studies" but doesn't detail the methodology for establishing ground truth within those studies, nor does it mention expert review processes for a "test set" in the context of AI or diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. The study summary doesn't describe an adjudication process, which is typically relevant for studies involving subjective interpretations or differing expert opinions, often found in diagnostic imaging studies.
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 MRMC comparative effectiveness study is mentioned. This device is a catheter, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical medical instrument (catheter), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "clinical studies" mentioned, the ultimate ground truth would likely be clinical outcomes data, possibly supplemented by angiographic assessments or other objective measures of successful lesion crossing and subsequent intervention. However, the document does not specify the exact nature of the ground truth used. For the in vitro and in vivo testing, the "ground truth" would be the measured physical properties or biological responses against predefined specifications.
8. The sample size for the training set
This question is not applicable as the device is a physical instrument and does not involve AI or machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).