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The LuMend Percutaneous Catheter is intended to be used in conjunction with a steerable guide wire in order to access discreet regions of the coronary vasculature. It may be used to facilitate placement of guide wires and other interventional devices.

The LuMend Percutaneous Catheter is a sterile single-use percutaneous coronary catheter consisting of a guide wire lead and handle assembly, proximal and distal shaft and variably curved distal tip. Guidance and tracking of the catheter through the coronary vasculature is accomplished in conjunction with a steerable guide wire.

The provided text describes the 510(k) summary for the LuMend Percutaneous Catheter. It outlines the device, its intended use, and comparison to predicate devices, but it contains limited information about specific acceptance criteria and the detailed study that proves the device meets those criteria.

However, based on the information provided, here's an attempt to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of explicit, quantifiable acceptance criteria with corresponding performance results. Instead, it states that:

The document mentions "internal specification requirements" and "external standard requirements and predicate performance expectations" as the benchmarks, but it doesn't elaborate on what these specific requirements or expectations were. It broadly states that "All data fell well within" these requirements.

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

The document does not explicitly state the sample size used for the test set. It mentions "in vitro, in situ, and in vivo test data" but provides no details on the number of units tested for each.

The provenance of the data is not specified (e.g., country of origin). The testing seems to be conducted by the manufacturer, LuMend, Inc., likely within their own facilities or contracted labs. The studies are described as "Design analysis and in vitro data," along with some "in situ and in vivo" testing, suggesting a retrospective analysis of device performance against established standards rather than a prospective clinical trial with human subjects for efficacy.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of device performance, as one might see in diagnostic imaging studies. The testing described is focused on physical and mechanical properties of the catheter.

4. Adjudication Method for the Test Set:

Not applicable. The described testing is primarily objective measurement of physical properties against engineering specifications, not subjective assessment requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document describes testing of the device's physical and functional characteristics, not its impact on human reader performance or diagnostic accuracy.

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

Not applicable. This device is a physical medical instrument (a catheter), not a software algorithm.

7. The Type of Ground Truth Used:

For the "test set" (which appears to refer to the device units undergoing performance validation), the "ground truth" was based on:

• "internal specification requirements"
• "external standard requirements" (e.g., "Guidewire Guidance" Document – January 1995 and FDA standards)
• "predicate performance expectations"

These are essentially engineering specifications, regulatory standards, and performance benchmarks derived from the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical instrument (a catheter), not a machine learning algorithm that requires a training set.

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

Not applicable. See point 8.

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