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The Chocolate™ XD PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion including in-stent restenosis.

The Chocolate XD PTCA Balloon Catheter is a Rapid Exchange (RX) angioplasty balloon catheter. It consists of a stainless steel hypotube and a nylon shaft, a semi compliant balloon at the distal end of the catheter with a metal constraining structure (CS) and an atraumatic distal tip. Upon inflation, the CS expands with the balloon to a certain diameter; the balloon continues the expansion beyond the CS. Upon deflation, the CS returns to its original shape, and is removed from the vessel along with the balloon catheter. Two Radiopaque markers define the working length of the Chocolate Balloon. The proximal end of the catheter is comprised of a hub used to inflate the balloon that can be connected to a standard inflation device. The catheter will be 140 ±5cm in length, compatible with 0.014" guidewire.

The provided document is a 510(k) summary for the TriReme Medical Chocolate XD PTCA Balloon Catheter. This document does not contain information on the acceptance criteria, study design, or results for an AI/ML powered device. It describes a medical device, a balloon catheter, and its equivalence to a predicate device, based on standard performance testing for devices of this type, not for an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/ML device from this document.

The document discusses standard device performance testing for a physical medical catheter, such as:

• Dimensional Verification
• Balloon Preparation, Deployment & Retraction
• Flexibility & Kink
• Balloon Rated Burst Pressure (RBP)
• Rate Burst Pressure in Stent
• Balloon Fatigue
• Balloon Fatigue in Stent
• Balloon Compliance
• Balloon Inflation and Deflation
• Catheter Bond Strength
• Tip Pull Test
• Torque Strength
• Radiopacity
• Particulate Evaluation
• Biocompatibility Testing

These are physical and material property tests to ensure the catheter functions safely and effectively, not diagnostic performance metrics for an AI system.

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The Chocolate™ PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The hydrophilic coated Chocolate PTCA Balloon Catheter is a Rapid Exchange (RX) angioplasty balloon catheter. It consists of a stainless steel hypotube and a nylon shaft, a semi compliant balloon at the distal end of the catheter with a metal constraining structure (CS) and an atraumatic distal tip. Upon inflation, the CS expands with the balloon to a certain diameter; the balloon continues the expansion beyond the CS. Upon deflation, the CS returns to its original shape, and is removed from the vessel along with the balloon catheter. Two Radiopaque markers are added to define the working length of the Chocolate Balloon. The proximal end of the catheter is comprised of a hub used to inflate the balloon that can be connected to a standard inflation device. The catheter will be 140 ±5cm in length, compatible with 0.014" guidewire. The catheter shaft is hydrophilic coated.

This document describes the application for a 510(k) premarket notification for the "Chocolate™ PTCA Balloon Catheter." It is a medical device application, not an AI/ML device, and therefore the requested information regarding acceptance criteria and study details for AI/ML performance is not applicable. The document outlines the device's indications for use, description, and the performance testing conducted to demonstrate substantial equivalence to predicate devices.

Not Applicable: The provided document describes a medical device, specifically a PTCA balloon catheter, and not an AI/ML-based device. Therefore, the questions related to AI/ML acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not relevant to this submission.

Summary of Device and Testing (as provided in the document):

Device Name: Chocolate™ PTCA Balloon Catheter

Intended Use / Indications:
The Chocolate™ PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Device Description:
The hydrophilic coated Chocolate PTCA Balloon Catheter is a Rapid Exchange (RX) angioplasty balloon catheter. It consists of a stainless steel hypotube and a nylon shaft, a semi-compliant balloon at the distal end of the catheter with a metal constraining structure (CS) and an atraumatic distal tip. Upon inflation, the CS expands with the balloon to a certain diameter; the balloon continues the expansion beyond the CS. Upon deflation, the CS returns to its original shape and is removed from the vessel along with the balloon catheter. Two Radiopaque markers are added to define the working length of the Chocolate Balloon. The proximal end of the catheter is comprised of a hub used to inflate the balloon that can be connected to a standard inflation device. The catheter will be 140 ±5cm in length, compatible with 0.014" guidewire. The catheter shaft is hydrophilic coated.

Technological Characteristics/Performance Testing/Substantial Equivalence:
The subject device has classification information, indication for use, fundamental design features, mechanism of action, materials, and principle of operation identical to the predicate device. The device specifications are all similar and within the range of the predicate devices. Testing requirements for this device were based upon the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010).

The following tests were performed:

• Dimensional Verification
• Balloon Preparation, Deployment & Retraction
• Flexibility & Kink
• Balloon Rated Burst Pressure (RBP)
• Balloon Fatigue
• Balloon Compliance
• Balloon Inflation and Deflation
• Catheter Bond Strength
• Tip Pull Test
• Torque Strength
• Radiopacity
• Particulate Evaluation
• Biocompatibility Testing

Conclusion:
No new questions of safety or effectiveness were identified during device testing; therefore, the hydrophilic coated Chocolate PTCA Balloon Catheter is considered substantially equivalent to the predicate devices.

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