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Cross-Pilot" Turbo elite Support Catheters are intended to guide and support Spectranetics laser catheters during access of the vasculature and provide a conduit for the delivery of saline solution or diagnostic contrast agents.

The Spectranetics Cross-Pilot™ Turbo Elite® Support Catheters are intravascular catheters. These catheters are available in a variety of lengths and tip configurations. All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating.

The provided document (K090913) is a Special 510(k) Premarket Notification for the Cross-Pilot™ Turbo elite® Support Catheter. This type of submission focuses on documenting that modifications to an already cleared device do not affect its safety or effectiveness, or alter its intended use. Therefore, the "study" described is a revalidation of the device's functional equivalence to its predicate, rather than a clinical trial with acceptance criteria for new performance metrics.

Here's an analysis based on the provided text, addressing your specific points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state a table of acceptance criteria with specific numerical targets for performance metrics. Instead, it refers to "specified requirements" and implicitly relies on the predicate device's performance as the benchmark.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify general "test set" sample sizes, data provenance, or whether the testing was retrospective or prospective. It only mentions "device functional testing." In the context of a Special 510(k) for minor changes, functional testing typically involves in-vitro and bench testing, performed in a controlled laboratory environment. The "data provenance" would therefore be the manufacturer's internal testing facilities, likely in the US (Colorado Springs, CO, as per the contact information).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the described study. The study involves functional testing of a physical medical device (a catheter), not a diagnostic algorithm or image analysis requiring expert ground truth for interpretation. The "ground truth" for functional testing is typically established by engineering specifications and predicate device performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this study is about functional testing of a physical device against engineering specifications and predicate performance, not about clinical outcomes or interpretations that would require an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not a study involving human readers, AI, or comparative effectiveness. It is a submission for a modification to a medical device and relies on functional equivalence to a predicate.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the established performance and specifications of the predicate device (K082559) and engineering design specifications for the modified device. The functional testing aims to show that the modified device performs equivalently to the predicate and meets its own internal design requirements.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI algorithm, and therefore there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

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Cross-Pilot™ Turbo Elite® Support Catheters are intended to guide and support Spectranetics laser catheters during access of the vasculature and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The most distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating. Predicate devices of this type with similar intended uses have been classified into Class II. The support catheters are single-use and provided in sterile packaging.

Acceptance Criteria and Study for Spectranetics Cross-Pilot™ Turbo Elite® Support Catheter

This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the Spectranetics Cross-Pilot™ Turbo Elite® Support Catheter to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on "substantial equivalence" rather than specific numerical acceptance criteria. The performance is assessed through comparative laboratory testing against identified predicate devices.

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

• Sample Size: The document does not explicitly state the specific number of units tested for each physical dimension, infusion rate, or burst pressure test. It refers to "samples produced under routine manufacturing conditions" for device integrity and functionality.
• Data Provenance: All testing appears to be retrospective and conducted in-house by Spectranetics Corporation, Inc. The country of origin for the data is implicitly the United States, given the company's location.

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

Not applicable. This submission is for a medical device (support catheter) based on physical and functional equivalence to predicate devices, not on diagnostic or prognostic performance requiring expert interpretation of results. The "ground truth" is defined by the technical specifications and performance of the predicate devices and relevant industry standards.

4. Adjudication Method for the Test Set

Not applicable, as there is no subjective interpretation of results requiring adjudication. The assessment is based on objective measurements and comparison to established specifications or predicate device performance.

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

Not applicable. This device is a support catheter, not an imaging or diagnostic device requiring human reader interpretation or comparative effectiveness studies of human performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical instrument, not software or an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Predicate Device Performance: The established physical dimensions, infusion rates, burst pressure, and technical characteristics of the legally marketed predicate devices (Terumo 5Fr Radifocus Optitorque and Asahi Angiographic Catheters).
• Industry Standards: Compliance with relevant ISO and ANSI/AAMI standards for biocompatibility (ISO 10993-1:2003), sterilization (ANSI/AAMI/ISO 11135:1994), and intravascular catheters (ISO 10555-1).
• In-house Requirements: Spectranetics' own established internal requirements for device integrity and functionality.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning model requiring a training set.

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

Not applicable, as there is no training set for this device.

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