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The RayFlow catheter is intended to be used in adults (patients aged 22 years and older) for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the coronary vasculature. The RayFlow is not intended to be used in the neurovasculature.

The RAYFLOW infusion catheter is a rapid exchange (RX) double lumen catheter with a series of holes and a radiopaque marker on its distal part. The outer lumen along the entire length of the catheter is used to inject fluids (saline, medication or contrast media) through the holes. The inner RX lumen is dedicated to the passage of a 0.014" quidewire facilitating the progression of the RAYFLOW catheter through the arteries. Four holes are located between the outer lumen and the surface of the catheter, allowing infusion of fluids into the blood resulting in a homogeneous mixing. Two holes located between the outer and inner lumen of the RAYFLOW catheter allow the measurement of the injected solution temperature by a specific pressure/temperature guidewire (Abbott PressureWire™ X Guidewire) at the moment the solution enters the artery. The hub is standard sized and compatible with any automated pump injector used for the continuous infusion of saline/liquid at room temperature. The RAYFLOW is provided sterilized with ethylene oxide. This device is for a single use only and packed in individual unit. A mandrel is inserted into the inner lumen to protect the integrity of the device.

The provided text is a 510(k) Premarket Notification for the RayFlow catheter, a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical bench testing and adherence to recognized standards. It explicitly states that the device does not involve artificial intelligence (AI) and therefore, the acceptance criteria and study design elements typically associated with AI/ML-driven medical devices (such as MRMC studies, expert adjudication for ground truth, sample sizes for training/test sets in machine learning, and human reader performance with AI assistance) are not applicable.

The "acceptance criteria" for this device are its performance in various bench tests, demonstrating that it meets the requirements of relevant ISO and ASTM standards, and that any differences from predicate devices do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text:

Device: RayFlow Catheter
Device Type: Continuous flush catheter, intravascular diagnostic catheter, percutaneous catheter.
Intended Use: Introduction of interventional devices and infusion of diagnostic or therapeutic agents into the coronary vasculature in adults (22 years and older). Not for neurovasculature.

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

Since this is a non-AI device relying on bench testing, the acceptance criteria directly relate to meeting the specifications of recognized standards. The document summarizes the performance by stating the device "showed no sign of leakage," "is able to advance through a coronary anatomical model," "is conform to ISO 10555-1," and that all biocompatibility tests were passed. Precise numerical acceptance criteria and reported values for each test are typically detailed in the full test reports (e.g., TR 20-014, not provided here), which are summarized in this 510(k) document.

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Each Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.

The Langston dual lumen catheters have two lumens, both with distal sideholes, to allow simultaneous pressure measurements from two sites. The high-pressure inner lumen, which extends the entire length of the catheter, can be used for pressurement and rapid delivery of contrast medium. The outer lumen ends proximal to the distal end of the catheter and is used for pressure measurement only. A side port fitted with an extension tube and a stopcock assembly is used for fluid flow and pressure measurement within the outer lumen. The Langston dual lumen catheter will accommodate a standard ≤ 0.038" diameter guidewire and is supplied with a single use pigtail straightener. The Langston dual lumen catheter is sterilized with ethylene oxide.

This document describes the FDA's 510(k) clearance for the Langston dual lumen catheter (K221470). It's a medical device submission, not a study proving the device meets acceptance criteria for an AI or diagnostic algorithm. Therefore, the questions related to AI/algorithm performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the physical device based on the provided text.

Here's the breakdown of what can be found and what cannot:

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

Study that proves the device meets the acceptance criteria:

The study was a series of bench tests and biocompatibility evaluation to demonstrate substantial equivalence to a predicate device, focusing on a design modification to the strain relief to hub bond.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the document for any of the bench tests.
• Data Provenance: The tests were performed internally by Vascular Solutions LLC ("Performance Data" section). The country of origin and retrospective/prospective nature of data collection for these specific tests are not detailed, but they are generally considered prospective bench tests performed for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This document concerns a physical medical device (catheter) and its design validation via bench testing and biocompatibility, not an AI or diagnostic algorithm requiring expert "ground truth" for interpretative accuracy.

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

• Not Applicable. As above, this is about physical device performance, not diagnostic interpretations requiring adjudication.

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 an AI-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm.

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

• For Bench Testing: The "ground truth" was defined by the specified acceptance criteria for each individual physical performance test (e.g., a minimum tensile strength, a maximum leak rate). These criteria are objective measurements, not subjective expert interpretations or biological outcomes.
• For Biocompatibility: Compliance with ISO 10993-1 is the standard used, which involves a series of tests to assess biological safety.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set."

In summary, this document is a regulatory clearance for a physical medical device. The "acceptance criteria" and "performance data" provided relate to the manufacturing and physical characteristics of the catheter, not to the diagnostic accuracy of an algorithm or the improvement of human readers with AI assistance.

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