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The Spectranetics TURBO-Booster™ guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions. Not for use in the carotid and coronary vasculature.

The TURBO-Booster™ is comprised of a luer hub, strain relief, shaft, hydrophilic coating, and a tip. The strain relief acts as a transition point between the stiff luer hub and flexible shaft. The shaft is comprised of three different components: an FEP inner liner, a stainless steel braid and a Pebax outer jacket. The stainless steep braid improves the torque response of the device and overall strength of the shaft. The tip is constructed of Pebax with varying stiffness (durometer). The proximal portion of the tip includes the biasing ramp that offsets the laser catheter to create the bias. The distal portion provides an atraumatic tip for the device. A hydrophilic coating is applied to the outer surface of the device to reduce friction A nyarophilie device and the crossover sheath. It also provides lubrication during use through the body's vasculature. The TURBO-Booster™ is used to bias (offset) a Spectranetics laser catheter from the central axis (guiding wire axis) during ablation. This allows for a larger lumen to be created than can be created with a laser catheter alone.

Here's a breakdown of the acceptance criteria and study information for the Spectranetics TURBO-Booster™ Guiding Catheter, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: Approximately sixty (60) patients.
• Data Provenance: The study was the CELLO Study (CLiRpath Excimer Laser System to Enlarge Lumen Openings), approved as IDE #G060015. The country of origin is not explicitly stated, but given the FDA submission, it is likely a clinical trial conducted within the United States or under FDA oversight. The data is prospective as it was collected during a clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The study focuses on clinical outcomes and device functionality, not on expert consensus for diagnosing or evaluating images.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done based on the provided text. The study described is a clinical trial evaluating the device's performance directly, not comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done. The TURBO-Booster™ Guiding Catheter is a physical medical device, not an algorithm. Its performance is intrinsically linked to its use in a clinical setting by human operators.

7. Type of Ground Truth Used

The ground truth used was clinical outcomes data. This includes the successful facilitation of laser catheter placement and the absence of major adverse events observed directly in patients during the clinical trial.

8. Sample Size for the Training Set

This information is not applicable/not provided. As a physical medical device, there isn't a "training set" in the context of machine learning or AI. The device's design and manufacturing rely on established engineering principles and testing.

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

This information is not applicable/not provided. For a physical medical device, the "ground truth" for its design and manufacturing is established through engineering specifications, material science, and bench testing, rather than a "training set" with ground truth in the AI sense. The document states that "Device integrity and functionality were qualified and/or validated using samples produced under routine manufacturing conditions," and that the devices meet "Spectranetics in-house requirements, and requirements listed in ISO 1055-1."

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