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The RAILWAY™ Sheathless Access System is indicated for use in radial arterial procedures requiring percutaneous introduction of intravascular devices.

The RAILWAY™ Sheathless Access System (hereafter referred to as "RAILWAY System" or "RAILWAY") facilitates the direct radial access of separately sold Cordis quiding catheters. Each RAILWAY System consists of two 136 cm nylon vessel dilators (0.021" and 0.035" quidewire compatible), a 20 Gauge IV cannula needle and/or a 21 Gauge stainless steel access needle, and a 45 cm 0.021" mini-guidewire (either stainless steel or hydrophilic coated Nitinol). The system configurations containing the hydrophilic guidewire do not contain a bare needle. The RAILWAY System has been dimensionally optimized for use with Cordis quiding catheters. The compatible guiding catheters and 0.035" guidewire are not included in the system.

The RAILWAY dilators have a tapered tip and a lubricious hydrophilic coating on the distal 20 cm section to facilitate access and ease of insertion. The geometry of the RAILWAY dilator taper and outer diameter (OD) have been optimized to provide atraumatic transitions between the dilator and a quiding catheter and between the dilator and quidewire. The dilator compatible with a 0.021" quidewire is intended for use in combination with a compatible guiding catheter to initiate sheathless (i.e. without a catheter sheath introducer) radial vascular access via insertion over a guidewire into the skin, subcutaneous tissue, and artery. After access is achieved, using either RAILWAY or a traditional catheter sheath introducer, the 0.035" RAILWAY dilator can be used to support the tracking of a compatible guiding catheter over a guidewire up to but not beyond the subclavian artery.

RAILWAY is available in ten (10) product configurations which differ on the basis of guiding catheter compatibility (catheter brand and French size) and the specific wire and needle(s) included in the system, as indicated in the table below. The dilators are color coded by size to align with accepted conventions for the guiding catheters to which the dilators are compatible. The RAILWAY System is a single-use sterile device, sterilized by ethylene oxide.

The RAILWAY System is compatible with 5F, 6F and 7F guiding catheters of 90 cm and 100 cm lengths. The dilators have been optimized for fit with either the Cordis VISTA BRITE TIP® or Cordis ADROIT® guiding catheters and have not been dimensionally optimized for compatibility with other guiding catheters. The appropriate RAILWAY dilator must be chosen to match the guidewire and guiding catheter sizes selected for the procedure. The RAILWAY System is for professional use in a hospital, catheterization laboratory, or other suitable healthcare facility only.

The provided text describes the RAILWAY Sheathless Access System, a medical device for radial arterial procedures. It is a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device, not necessarily a new clinical performance study in the way an AI/software device would have. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable or provided in this document.

However, I can extract information related to the device's technical specifications, testing, and regulatory claims:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a medical device (a catheter introducer), the "acceptance criteria" are not framed as a discrete performance metric (like sensitivity/specificity for AI), but rather as successful completion of various engineering, biocompatibility, and sterilization tests to demonstrate safety and effectiveness equivalent to a predicate device. The "reported device performance" is the successful completion of these tests.

• Sensitization
• Irritation
• Systemic toxicity
• Pyrogenicity
• Genotoxicity
• Hemocompatibility | RAILWAY is biocompatible for its intended use, based on testing in accordance with FDA Guidance Use of International Standard ISO 10993-1. |
  | Sterilization | - Validation per ISO 11135:2014 for Sterility Assurance Level (SAL) of 10-6
• Ethylene oxide and ethylene chlorohydrin residuals meet ISO 10993-7:2008 requirements (levels not exceeding 4 mg EO/device or 9 mg ECH/device). | Sterilization cycle validated to provide SAL of 10-6. Residuals meet requirements for limited exposure devices. |
  | Bench Testing (Dilators) | - Dimensional verification
• Visual inspection
• Dilator and guiding catheter insertion force
• Hydrophilic coating integrity
• Outer surface friction
• Flushability
• Force at break
  (Per ISO 11070:2014, FDA PTCA Guidance, USP 788) | Passing results provide reasonable assurance that the device meets its intended use and raises no different issues of safety and effectiveness vs. predicate. |
  | Bench Testing (Needles) | - IV Cannula Needle: Dimensional verification, Visual inspection, Strength of union of needle tube and needle hub, Function, Tension/pressure (Per ISO 10555-1:2013 and ISO 10555-5:2013)
• Stainless Steel Needle: Visual inspection, Strength of union of needle tube and needle hub (Per ISO 11070:2014) | Passing results provide reasonable assurance that the device meets its intended use and raises no different issues of safety and effectiveness vs. predicate. |
  | Bench Testing (Wires) | - Hydrophilic Coated Wire: Visual inspection, Hydrodurability, Particulate, Fracture, Flexing (Per ISO 11070:2014)
• Stainless Steel Wire: Visual inspection, Fracture, Flexing, Peak Tensile Force (Per ISO 11070:2014) | Passing results provide reasonable assurance that the device meets its intended use and raises no different issues of safety and effectiveness vs. predicate. |
  | Bench Testing (Packaging)| - Visual inspection
• Component position
• Peel strength
• Bubble test
• Dye leak
• Particulate
  (Per ISO 11607-1:2009/A1:2014 and ISO 11607-2:2006) | Passing results provide reasonable assurance that the device meets its intended use and raises no different issues of safety and effectiveness vs. predicate. |
  | Substantial Equivalence | - Same intended use
• Same principle of operation
• Same mechanism of action
• Same method of sterilization and sterility assurance level
• Same biocompatibility classification
• Biocompatible for intended use
• Labeled non-pyrogenic
• Similar materials
• Similar components
• Similar device dimensions
• Similar packaging configuration
• Similar compatibility with other devices used in radial access procedures | Concluded that the RAILWAY™ Sheathless Access System is appropriate for its intended use and is substantially equivalent to Glidesheath Slender®. |

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

• Sample Size for Test Set: This document does not specify a "test set" in the context of an AI algorithm based on patient data. Instead, the "testing" refers to bench testing of physical device characteristics. The sample sizes for these engineering tests are not directly provided but are implied to be sufficient for design verification and validation under the cited ISO standards.
• Data Provenance: Not applicable in the context of patient data as this is a physical medical device. The "data" comes from various laboratory and engineering tests.

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

• Not applicable. This device is not an AI/software device that requires expert-established ground truth from clinical images or data. The "ground truth" for this device's performance is objective measurements from engineering and biocompatibility tests against industry standards.

4. Adjudication Method for the Test Set

• Not applicable. (See #3)

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 device. No MRMC study was performed or required.

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

• Not applicable. This is not an AI device.

7. The Type of Ground Truth Used

• Ground truth: For this physical medical device, the "ground truth" is established by:
  • Objective measurements and physical properties: e.g., dimensions, force at break, friction, sterility assurance level.
  • Compliance with recognized international standards: e.g., ISO 10993, ISO 11135, ISO 11070, ISO 10555, ISO 11607.
  • Biocompatibility test results: demonstrating absence of cytotoxicity, irritation, etc.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device. There is no "training set."

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

• Not applicable. (See #8)

Summary of Clinical Studies (from the document):

• Clinical Studies: "No clinical studies were deemed necessary to support substantial equivalence. Appropriate verification and validation of the device requirements were achieved based on the similarities of the subject device to the predicate and from the results bench testing." This means the FDA accepted that the extensive bench testing and comparison to the predicate device (Terumo Glidesheath Slender) were sufficient to demonstrate safety and effectiveness without requiring human trials for this 510(k) submission.

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The ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters are intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular in the neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this cather other than for use in the neurovasculature.

ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters consists of a guide catheter, available in the following sizes: ASAHI FUBUKI 043 (4.2 Fr), ASAHI FUBUKI 6Fr (6 Fr), ASAHI FUBUKI 7Fr (7 Fr), ASAHI FUBUKI 8Fr (8 Fr). The ASAHI FUBUKI Neurovascular Guide Catheter Dilator Kit consists of a Catheter and Dilator components, available in the following sizes: ASAHI FUBUKI Dilator Kit 4Fr (Catheter 6 Fr, Dilator Shaft 1.75 mm), ASAHI FUBUKI Dilator Kit 5Fr (Catheter 7 Fr, Dilator Shaft 2.00 mm), ASAHI FUBUKI Dilator Kit 6Fr (Catheter 8 Fr, Dilator Shaft 2.21 mm). The catheter consists of three main sections including a tube, a protector section, and a connector. The proximal part of the tube is covered by the protector and the connector is bonded to the proximal end of the tube. A soft tip is bonded to the distal end of the catheter. The inner lumen of the tube (excluding the connector portion) is lined with PTFE to facilitate movement of the guide wire and other devices. The tube is made of polymer resin and is reinforced by a stainless steel and tungsten braid wire. The outer surface of the tube is partially coated with a hydrophilic polymer.

The provided document discusses a 510(k) premarket notification for the "ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters." This is a regulatory submission to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, not a study designed to prove the device meets acceptance criteria in the context of an AI/ML medical device.

The document describes non-clinical testing performed on the device to establish substantial equivalence to predicate devices, but it does not contain information regarding acceptance criteria for an AI/ML device, nor does it detail a study proving an AI/ML device meets such criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes for a test set or data provenance for an AI/ML model.
• The number or qualifications of experts used to establish ground truth for an AI/ML test set.
• Adjudication methods for an AI/ML test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes for AI assistance.
• Details about a standalone (algorithm-only) performance study for an AI/ML device.
• The type of ground truth used for an AI/ML model (e.g., pathology, outcomes data).
• The sample size for a training set (relevant for AI/ML).
• How ground truth for a training set was established (relevant for AI/ML).

Instead, the document focuses on non-clinical laboratory testing to compare the new catheter device to existing predicate devices. The tests performed are related to the physical and mechanical properties of the catheter, as listed under "NON CLINICAL TESTING / PERFORMANCE DATA":

• Corrosion resistance
• Force at break
• Liquid leakage under pressure
• Air leakage into hub assembly during aspiration
• Leak and damage under high static pressure
• Radio-detectability
• Kink resistance
• Appearance/Dimensions
• Biocompatibility

The conclusion drawn is that the new catheter device is "substantially equivalent" to the predicate devices based on shared intended use, technological characteristics (components, design, materials, sterilization, shelf life, operating principles), and performance data demonstrating it functions as intended with a similar safety and effectiveness profile.

Therefore, I cannot provide the requested information as it pertains to AI/ML device acceptance criteria and study details because the provided text describes a 510(k) submission for a physical medical device (catheter), not an AI/ML-driven device.

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