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The NHancer Rx Dual Lumen Rapid Exchange catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature and allows for exchange of guide wires and provides a conduit for the delivery of diagnostic contrast agents. The catheter is not intended for use in the neurovasculature.

The NHancer™Rx is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The NHancer™Rx is a 0.014" Rapid Exchange (Rx) guide wire support catheter. The NHancer™Rx has an over the wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal end. The NHancer™Rx has an effective length of 135 cm and is compatible with 0.014"/0.36mm or smaller guide wires. The NHancer™Rx has two depth markings located at 95 cm and 105 cm from the distal tip. The NHancer™Rx has a radiopaque marker identifying the distal end of the catheter and a second radiopaque marker located 8 mm from the distal tip identifies the distal end of the OTW lumen.

To reduce friction in the guide catheter and vasculature, the distal 15 cm of the shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the entire lumens of the NHancer Rx are coated with MDX (silicone) coating.

To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet (9) is placed in the OTW lumen

The provided document is a 510(k) premarket notification for a medical device (NHancer Rx Dual Lumen Rapid Exchange catheter). It details the device's characteristics, intended use, and a comparison to a predicate device, along with a summary of performed studies.

However, this document does not contain information about an AI/ML-based medical device study. Therefore, I am unable to provide a response that directly addresses the specific requirements of your prompt regarding acceptance criteria and a study proving device performance for an AI/ML system.

The "studies" mentioned in the document are performance and biocompatibility tests for a physical medical catheter, not a software algorithm. These tests verify physical properties like flexibility, tensile strength, and material biocompatibility, which are fundamentally different from the performance metrics (e.g., sensitivity, specificity, AUC) and study designs (e.g., MRMC, standalone) associated with demonstrating the effectiveness of an AI/ML device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance for an AI/ML system.
• Sample sizes, data provenance, or ground truth details for an AI/ML test set.
• Information on experts, adjudication methods, or MRMC studies for AI/ML.
• Details on training set size or ground truth establishment for an AI/ML model.

Therefore, paraphrasing or extracting information from the given text to fit your prompt's structure for an AI/ML device would be misrepresentative.

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The IMDS NHancer™ Guide Wire Support Catheter with Hydrophilic Coating is a guidewire exchange and infusion device designed for use in the vascular system. The IMDS NHancer™ guidewire support catheter is intended to support a guidewire during access of vasculature and allows for exchange of guidewires and provides a conduit for the delivery of diagnostic contrast agents.

The purpose of the NHancer™ guidewire support catheter is to facilitate the placement of a guide wire through an occluded vessel during Percutane Transluminal Coronary Intervention procedures. The NHancer™ is a single use device, consisting of a shaft, a distal tip and a female luer (hub) on the proximal end. On the shaft are two depth markings applied to indicate the length of the device that is in the body. On the distal tip of the device a radiopaque marker band is applied. The distal part of the shaft is fitted with a hydrophilic coating. On the shaft a torquer is placed. With this component the catheter can be locked on to the guide wire that is in the device. The torquer is initially placed on a strain relief which is located on the proximal end of the shaft, near the female luer (hub).

The provided text describes the 510(k) submission for the NHancer™ guidewire support catheter. The device is a traditional guidewire support catheter, not an AI/ML device, and therefore the acceptance criteria and study information typically associated with AI/ML device submissions are not directly applicable.

However, I can extract the performance criteria and the study approach used to demonstrate substantial equivalence to a predicate device, which is the regulatory pathway for this type of medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the NHancer™ guidewire support catheter met all acceptance criteria. Specific quantitative acceptance criteria are not detailed in the provided text. Instead, the document focuses on demonstrating that the NHancer™ performed similarly or was substantially equivalent to the predicate device, the Spectranetics QuickCross® Support Catheter, for a range of performance characteristics.

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

The document details performance testing for both the NHancer™ and a predicate device. However, it does not specify the sample sizes used for the in-vitro and in-vivo tests. It only states that "Comparison testing was performed on the IMDS NHancer™ guidewire support catheter and the Spectranetics QuickCross Support Catheter" and that various "bench tests were performed on NHancer™ guidewire support catheter."

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these tests would typically be laboratory-based (in-vitro) and animal studies (in-vivo) conducted prospectively for the purpose of demonstrating regulatory compliance.

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

This information is not applicable to this type of device and submission. "Ground truth" established by experts is typically a concept used in the evaluation of AI/ML diagnostic or prognostic devices, where human expert labels are used to train and validate AI algorithms. For a guidewire support catheter, the "ground truth" is determined by objective performance measurements against engineering specifications and predicate device performance, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in AI/ML studies to resolve disagreements among human labelers for establishing ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Improvement with/without AI Assistance:

This information is not applicable as the NHancer™ is a physical medical device, not an AI/ML diagnostic or prognostic tool. Therefore, there are no "human readers" interpreting data with or without AI assistance, and no MRMC study would be conducted.

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

This information is not applicable as the NHancer™ is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For the NHancer, the "ground truth" is based on:

• Engineering specifications: For various dimensions, material properties, and functional tests (e.g., usable length, outer diameter, pull strength, burst strength, flow rate).
• Performance relative to a predicate device: For clinical performance characteristics like crossability, guidewire friction, torqueability, marker visibility, guidewire exchangeability, and contrast administration. The predicate device's established performance serves as the benchmark.
• International Standards: For biocompatibility (ISO 10993), sterility (ISO 11137, ISO 11737), and non-pyrogenicity (Ph. Eur. Chapter 2.6.14 Method C, USP).

8. The Sample Size for the Training Set:

This information is not applicable. The concept of a "training set" refers to data used to train an AI/ML algorithm. The NHancer™ is a physical device and does not involve AI/ML.

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

This information is not applicable for the same reasons as point 8.

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