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The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.

The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the peripheral and coronary vasculature. The Twin-Pass catheter consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has a working length of 135cm and have white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a platinum-iridium marker band located 1mm from the distal tip and a second platinum-iridium marker band located 11mm from the distal tip, identifying the distal end of the OTW lumen.

The provided text is a 510(k) summary for the Twin-Pass Dual Access Catheter. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a report of a clinical study or performance evaluation with human subjects that would typically involve acceptance criteria for AI/ML devices or specific clinical endpoints.

Therefore, the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, and human reader performance for an AI/ML device is not applicable to this document.

The document describes device performance verification tests to demonstrate substantial equivalence to a predicate device, rather than clinical efficacy/effectiveness trials for an AI/ML diagnostic or prognostic tool.

Here's a breakdown of the available information:

• 1. A table of acceptance criteria and the reported device performance: This information is not presented in a table with specific quantitative acceptance criteria and reported performance values. Instead, the document lists various verification tests performed and states that "The results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness." The specific numerical acceptance criteria and corresponding numerical results are not detailed in this summary.

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not provided. The "test set" in this context refers to physical device samples for engineering and biocompatibility testing, not patient data.

• 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. "Ground truth" in this context would relate to the validation of a diagnostic or prognostic capability, which is not the purpose of this device's submission. The tests are engineering and biocompatibility evaluations.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for clinical endpoint assessment by multiple experts, which is not described here.

• 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 device is a catheter, not an AI-powered diagnostic tool.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a catheter, not an algorithm.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for the device's performance is based on established engineering standards (e.g., ISO 10555-1, ISO 594) and biocompatibility testing.

• 8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.

• 9. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance Verification (as provided in the document):

The device performance was verified through the following tests, and the results "met the specified acceptance criteria":

• Deliverability:
  • Track Force
  • Kink Resistance
  • Guide Catheter Compatibility
  • Guidewire Movement
• Hydrophilic Coating Evaluation:
  • Particulate
  • Coating Lubricity/Durability
  • Drops of Fluid
• Tensile Strength:
  • Shaft
  • Tip
  • Hub
• Torque Robustness
• Hub Markings
• ISO 10555-1 Verification:
  • Working Length
  • Crossing Profile
  • Radiopacity
  • Aspiration
  • Liquid Leak
  • Static Pressure
  • Dynamic Pressure
  • Surface Defects
• ISO 594 Hub Verification:
  • Luer Gage
  • Air Leakage During Aspiration
  • Liquid Leakage Under Pressure
  • Separation Force of Luer Fitting
  • Unscrewing Torque
  • Ease of Luer Fitting Assembly
  • Resistance to Overriding
  • Stress Cracking

Biocompatibility Tests (in accordance with ISO 10993-1):

• Cytotoxicity
• Sensitization
• Irritation
• Systemic Toxicity
• Material Mediated Pyrogenicity
• Hemolysis
• Complement Activation
• Thrombogenicity

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The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.

The Skyway support catheters are intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The Skyway OTW also may be used to subselectively infuse/deliver therapeutic agents.

The Twin-Pass™ Dual Access Catheter is a hydrophilically coated, dual lumen catheter designed for use in the arterial vasculature. The catheter provides support for 0.014"/0.36mm guidewires, and the dual lumen design allows for the delivery of a second guidewire into distal vasculature while leaving the initial guidewire in place. The Twin-Pass catheter comes with a stiffening mandrel to provide support and pushability during catheter insertion.

The SKYWAY catheters are single lumen, hydrophilically coated catheters designed for use in the arterial vasculature. The catheters provide support for 0.014"/0.36mm guidewires during interventional procedures, and allow for the exchange of one distally located guidewire for another one while maintaining access to distal vasculature.

This document is a 510(k) summary for the Twin-Pass and Skyway Catheters, which are intravascular catheters. It presents a "Summary of Non-Clinical Testing" and explicitly states "No clinical evaluations of this product were conducted."

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be provided from the given document, as no such study was conducted or reported. The 510(k) relies on substantial equivalence to predicate devices rather than direct demonstration of performance against specific acceptance criteria through a study.

The document indicates:

1. Summary of Non-Clinical Testing: Flow-rate testing was conducted using saline and a 76% contrast medium. This constitutes non-clinical testing, not a study to prove acceptance criteria in the context of device performance as one might expect for a diagnostic or AI-based device.
2. Summary of Clinical Testing: "No clinical evaluations of this product were conducted."

Therefore, the sections of your request regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for a study are not applicable to the provided document.

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The Twin-Pass Dual Access Catheter is to be used in conjunction with steerable quidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement of guidewires and other interventional devices, and for use during two guidewire procedures.

The Twin-Pass Dual Access Catheter is a 3F O.D. catheter that has two lumens-a short distal lumen and a second full length lumen-each of which are compatible with a 0.014" standard quide wire. The Twin-Pass catheter has a working length of 135cm and contains positioning markers at 95 and 105cm which provide a visual indication of the relative positions of Twin Pass and the end of a standard 105cm guide catheter. Two radiopaque marker bands at the end of each wire lumen provide for a radiographic means of locating the position of each lumen. The softer, distal end of the catheter is coated with a hydrophilic coating to assist passage through the guide catheter and vessels while the proximal end of the catheter contains a strain relief and a standard luer hub. A 126cm stiffening mandrel is included which provides support and pushability to the Twin-Pass.

This document does not contain an acceptance criteria table or information about a study proving device performance in the context of device outputs (e.g., diagnostic accuracy metrics like sensitivity, specificity, or AUC) against a set of predetermined criteria. This is primarily because the submitted document is a 510(k) premarket notification for a medical catheter (Twin-Pass Dual Access Catheter), not a diagnostic algorithm or AI-powered device.

For a medical device like the Twin-Pass Dual Access Catheter, performance is generally established through design verification testing (non-clinical testing) and substantial equivalence to predicate devices, not through studies that involve human readers, ground truth consensus, or metrics like sensitivity/specificity for disease detection.

Here's why the requested information is not applicable or cannot be extracted from the provided text:

• Acceptance Criteria & Reported Device Performance (Table): Not present. The document summarizes non-clinical testing for design verification and states the device is suitable for its intended use based on these tests. It does not provide specific performance metrics in the way a diagnostic algorithm would (e.g., "Sensitivity > X%").
• Sample Size for Test Set & Data Provenance: No clinical test set as such was used for performance evaluation that would require this. The non-clinical tests would have involved samples of the device itself.
• Number of Experts & Qualifications for Ground Truth: Not applicable, as there was no clinical study involving human assessment of device outputs against a ground truth.
• Adjudication method for Test Set: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating diagnostic algorithms, not passive medical devices like catheters.
• Standalone (algorithm only) Performance: Not applicable. This device is a catheter, not an algorithm.
• Type of Ground Truth Used: Not applicable. The "ground truth" for a catheter is its ability to perform its mechanical function as intended during design verification.
• Sample Size for Training Set: Not applicable. There is no algorithm to train.
• How Ground Truth for Training Set Was Established: Not applicable.

What the document does state regarding device evaluation:

• Non-Clinical Testing: "Testing conducted included assessments of the design verification of the Twin-Pass Dual Access Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Twin-Pass Dual Access Catheter for its intended use." This indicates engineering and materials testing, not accuracy testing against a clinical "ground truth."
• Clinical Testing: "No clinical evaluations of this product have been conducted." This explicitly states that clinical studies were not performed to evaluate this product's performance in humans.
• Predicate Device: The device demonstrates "substantial equivalence" to existing legally marketed predicate devices (Lumend Percutaneous Catheter, Quick-Cross Catheter, and Dual Lumen Catheter). This is the primary means of clearance for this type of device.

In summary, the provided document describes a 510(k) clearance for a medical catheter based on non-clinical testing and substantial equivalence to predicate devices, not on a clinical performance study with human readers or AI algorithms.

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