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Indicated for atherectomy of infrainguinal arteries.

The Turbo-Tandern™ System (Laser Guide Catheter with Laser Ablation Catheter) is a laser ablation catheter constrained within a guiding catheter to facilitate the offset (biased position) of the laser ablation catheter. The guiding catheter portion of the Turbo-Tandem System is used to offset the distal end of the incorporated laser catheter from the central plane of the vessel lumen allowing for circumferential guidance and positioning of the laser catheter within the vessel. The Turbo-Tandem System is 7F sheath compatible with a maximum crossing profile of 0.160" (4.0mm) with the laser catheter extended or offset position. The incorporated laser catheter is constructed of multiple optical fibers arranged circumferentially around a guidewire lumen and has a fiber optic surface area similar to a 2.0mm laser catheter.

The information primarily describes a 510(k) premarket notification for a medical device (Spectranetics Turbo-Tandem™ System). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for an AI/ML-based diagnostic device.

Therefore, many of the requested elements for an AI/ML device study (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable to this document. The provided text details the device, its intended use, and its comparison to predicate devices through device integrity testing.

Here's a breakdown of the available information based on your request, highlighting where information is absent or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document states, "Performance standards do not currently exist for these devices. None established under Section 514." Instead of formal acceptance criteria, the study aimed to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion for the premarket notification was that the device integrity test results met "specified requirements," which implies internal company specifications.
• Reported Device Performance: "All device integrity test results for the Spectranetics Turbo-Tandem System met specified requirements."

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

• Not Applicable: This document describes device integrity testing, not a clinical study involving a "test set" of patient data for an AI/ML diagnostic device. The "test set" here refers to the device itself being subjected to various integrity tests. The sample size for these engineering tests is not specified, but it would typically involve a certain number of manufactured units.
• Data Provenance: The data provenance is from internal Spectranetics Corporation testing in the USA. The study is retrospective in the sense that the testing was performed, and the results were then compiled for the submission.

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

• Not Applicable: This type of information is relevant for AI/ML diagnostic devices where expert review is needed to establish ground truth from medical images or clinical data. For device integrity testing, the "ground truth" is established by engineering specifications and objective measurements, not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) in establishing ground truth for diagnostic studies. This is not relevant for basic device integrity testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Performed: An MRMC study is designed to assess the performance of human readers, often with and without AI assistance, on a set of cases. This study is about confirming the physical and functional equivalence of a medical device (catheter system), not evaluating human reader performance or AI's impact on it.

6. Standalone (Algorithm Only) Performance Study

• Not Performed: This is not an AI/ML algorithm. Therefore, a standalone algorithm performance study is not applicable. The performance evaluated here is that of the physical device.

7. Type of Ground Truth Used

• Engineering Specifications and Objective Measurements: For device integrity testing, the "ground truth" refers to established engineering standards, design specifications, and objective measurements (e.g., tensile strength, dimensional accuracy, sterilization efficacy).

8. Sample Size for the Training Set

• Not Applicable: This type of study does not involve a "training set" in the context of machine learning.

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

• Not Applicable: There is no training set for an AI/ML algorithm in this context.

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