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The SCIMED Luge Guide Wire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Luge Guide Wire is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

The SCIMED Luge Guide Wire utilizes the same materials and methods of construction as currently marketed SCIMED Guide Wires (ChoICE, Sceptor and ChoICE PT Families of Guide Wires).

Here's an analysis of the provided text regarding the SCIMED® Luge™ Guide Wire, focusing on the requested information.

It's important to note that the provided documents are a 510(k) summary and FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical study reports with detailed performance metrics against pre-defined acceptance criteria. Therefore, some of the requested information, particularly regarding specific performance metrics, sample sizes for training/test sets, ground truth establishment for AI/ML models, and detailed adjudication methods, is not present in these documents. The device cleared is a guide wire, which is a medical device, not an AI/ML diagnostic tool, thus many of the AI/ML specific questions are not applicable.

Acceptance Criteria and Study for SCIMED® Luge™ Guide Wire

The SCIMED Luge Guide Wire's acceptance criteria and proven performance are based on its substantial equivalence to previously marketed SCIMED Guide Wires (ChoICE, Sceptor, and ChoICE PT Families). The study primarily involved non-clinical testing and comparison of design and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a clinical trial demonstrating new performance metrics. The comparison is based on the design, materials, manufacturing processes, and non-clinical testing results against existing predicate devices.
• Data Provenance: The data provenance is from non-clinical testing of the Luge Guide Wire and comparison with the design specifications and known performance characteristics of the predicate SCIMED Guide Wires. This is retrospective in the sense that it relies on established data and designs of existing products. The country of origin for the data is implied to be within the US, where SCIMED Life Systems, Inc. is located.

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

• Not Applicable. This device clearance is based on substantial equivalence to predicate devices through non-clinical testing and design comparison, not on establishing a "ground truth" for diagnostic accuracy by a panel of experts.

4. Adjudication Method for the Test Set

• Not Applicable. As there is no clinical "test set" requiring expert judgment for ground truth, no adjudication method is described. The review process is handled by the FDA based on the submitted non-clinical data and comparisons.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC study is not mentioned as part of this 510(k) submission. These studies are typically for AI/ML diagnostic devices where the performance of human readers with and without AI assistance is evaluated. This device is a guide wire, not a diagnostic AI/ML system.

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 (guide wire), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" here is the established safety and effectiveness profile of the predicate devices (ChoICE, Sceptor, and ChoICE PT Families of Guide Wires) in their intended use. The Luge Guide Wire's equivalence is demonstrated against this established standard through physical and engineering comparisons.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" in the conventional sense for model development. The design and manufacturing processes are likely informed by years of experience and testing with previous guide wire designs, but not in the format of a discrete "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

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