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The LuMend Frontrunner™ CTO Coronary Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lessons (including chronic total occlusions) prior to PTCA of stent intervention.

The LuMend Frontrunner™ CTO Catheter is a sterile single-use percutaneous catheter consisting of a handle assembly with an integral rotator and a side port for internal device flushing, a proximal braided shaft for push and torque control, a flexible distal shaft which may be manually shaped, and a radiopaque blunt-shaped distal variable-size tip assembly in various shapes and sizes. 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 or peripheral vasculature is accomplished by selective manual shaping of the flexible distal shaft, and controlled torquing of the handle rotator.

The provided text describes a medical device, the LuMend Frontrunner™ CTO Catheter, and its substantial equivalence to a predicate device. However, it does not contain detailed acceptance criteria or a study design to prove the device meets those criteria in the format requested. The document outlines general testing performed but lacks specific performance metrics, sample sizes, or expert qualifications for ground truth establishment commonly found in studies proving device performance against acceptance criteria.

The information provided focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving performance against specific acceptance criteria with a detailed study.

Here's an analysis of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific numerical values or ranges for "internal specification requirements" and "external standard requirements" for each test.
• Quantitative data on how the predicate device performed for comparison.

2. Sample Size Used for the Test Set and the Data Provenance:

• Sample Size: Not specified for any of the in vitro or in vivo tests. The document only mentions "in vitro, in situ, and in vivo test data."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Missing: This information is not provided. The document outlines device testing but does not detail a process for establishing "ground truth" with expert review, as would be common for diagnostic or AI-assisted devices. Since this is a catheter for mechanical intervention, expert ground truth labeling might not be directly applicable in the same way as for image-based diagnostic AI.

4. Adjudication Method for the Test Set:

• Missing: Not applicable in the context described. The testing appears to be functional and engineering-focused rather than involving subjective expert interpretation that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No: An MRMC comparative effectiveness study was not mentioned. The device described is a physical catheter, not an AI-assisted diagnostic tool where human reader performance would be a primary metric.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

• Not Applicable: This is not an algorithm or AI device. It is a physical medical device (catheter).

7. The Type of Ground Truth Used:

• Missing (or not directly applicable in the usual sense): For a physical device, "ground truth" typically refers to established engineering standards, physical measurements, and biological responses (e.g., in animal models for in vivo testing). The document states "All data continued to fall well within internal specification requirements, as well as external standard requirements and predicate performance expectations." This implies that the ground truth for these physical and biological tests was defined by these established specifications and the performance of the predicate device.

8. The Sample Size for the Training Set:

• Not Applicable: This is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not Applicable: As above, this is not an AI/machine learning algorithm.

Summary of Missing Information:

The provided document is a 510(k) summary for a medical device (catheter). It details the device's description, intended use, and comparison to a predicate device to establish substantial equivalence. It confirms various in vitro and in vivo tests were conducted to ensure the device meets internal and external specifications and performs comparably to the predicate. However, it does not provide the granular detail typically found in a study designed to demonstrate performance against explicit acceptance criteria, especially concerning sample sizes, expert qualifications, or ground truth establishment in the context of diagnostic or AI-based devices. The focus is on demonstrating safety and effectiveness through substantial equivalence and meeting general engineering and biocompatibility standards.

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