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The Houdini Cross Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.

The Houdini® Cross Support Catheter is a single use, bi-lumen intravascular catheter intended for percutaneous use. The Houdini® Cross Support Catheter is intended for use in the iliac. femoral, ilio-femoral and popliteal arteries. It is designed for use in conjunction with a standard commercially available off the shelf (OTS) 0.014" - 0.018" quidewire (not included) to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. In addition, the Houdini® Cross Support Catheter provides the option of distal anchoring as well as physician-controlled extension of the inner shaft (up to 2 cm) to support the OTS guidewire during advancement.

The effective length of the Houdini® Cross Support Catheter is a nominal 100 cm. The inner lumen accommodates an OTS 0.014" - 0.018" spring-tipped guidewire. The inner lumen shaft allows for visualization under fluoroscopy due to the radiopague stainlesssteel design and additionally allows for continuous clinician control of the OTS guidewire for appropriate positioning.

If distal anchoring is desired, the Houdini® Cross Support Catheter requires the use of a commercially available OTS manual inflation device (not included). Once positioned within 2 cm of the user's target location, the catheter is inflated to 6 atm using diluted radiopaque contrast media to anchor the distal end of the catheter in the blood vessel. For additional support of the quidewire, the clinician may extend the location of the inner lumen shaft up to 2 cm distally without the need to reposition the anchoring balloon.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Houdini Cross Support Catheter." It focuses on demonstrating the device's substantial equivalence to previously cleared predicate devices.

Based on the provided text, the document describes the acceptance criteria and study proving the device meets those criteria primarily through a comparison to a predicate device and extensive bench/simulated use testing, rather than a clinical study involving human patients or AI performance metrics.

Therefore, I will extract relevant information where available and state "Not Applicable" or "Information not provided in the document" for aspects that are typically found in studies for AI/diagnostic devices but not for a catheter's 510(k) submission focused on substantial equivalence.

Here's the breakdown of the information requested:

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

The document does not present explicit "acceptance criteria" in a quantitative, tabular format as one might find for a diagnostic or AI device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device and satisfying functional and safety requirements through engineering bench testing and simulated use.

The "criteria" are implicitly tied to meeting the performance characteristics of the predicate device and established international standards (e.g., ISO 10555-1, ISO 10993-1). The "reported performance" is a general statement that the device "satisfies" these requirements.

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

• Sample Size for Test Set: The document does not specify a "test set" in terms of patient data or clinical images, as this is a 510(k) for a medical catheter based on engineering and simulated use testing. For bench testing, samples of the physical device were used, but the exact number of units tested for each specific test is not provided.
• Data Provenance: The data provenance is from laboratory bench testing and simulated use. No patient data (retrospective or prospective) from specific countries or populations is mentioned because a clinical study with patients was not required for this type of device and submission.

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)

• Not Applicable. This document pertains to a medical catheter, not a diagnostic device or AI algorithm requiring expert interpretation of medical images or patient data to establish ground truth. Ground truth for device performance is established through engineering specifications, validated test methods (e.g., ISO standards), and comparative performance with predicate devices.

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

• Not Applicable. As there is no clinical test set requiring expert interpretation for ground truth, there is no adjudication method described.

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 document is for a medical catheter, not an AI algorithm or a diagnostic device that would involve human readers or AI assistance.

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

• Not Applicable. This is not an AI algorithm.

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

• The "ground truth" for the device's performance is established through:
  • Engineering Specifications: The device is designed to meet specific physical and performance parameters (e.g., diameter, length, pressure resistance, guide wire compatibility).
  • International Standards: Compliance with ISO standards (e.g., ISO 10555-1 for intravascular catheters, ISO 10993-1 for biocompatibility) where the "ground truth" is adherence to these established safety and performance benchmarks.
  • Predicate Device Performance: The predicate device serves as a benchmark for "ground truth" in terms of expected functionality and safety. The new device must demonstrate that its performance characteristics are substantially equivalent.

8. The sample size for the training set

• Not Applicable. This document does not describe the development of an AI algorithm thus there is no "training set" in the machine learning sense.

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

• Not Applicable. As there is no AI training set, this question is not applicable.

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