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The FOXTROT™ NC PTCA Balloon Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. FOXTROT™ NC PTCA Balloon Catheters are also indicated for the post-delivery expansion of balloon expandable stents.

Device Description

The FOXTROT NC PTCA Balloon Catheter device is a sterile, single-use, rapid exchange percutaneous transluminal coronary angioplasty catheter. The design is an integrated shaft system with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. Two radiopaque markers aid in positioning the balloon catheter under fluoroscopy during the procedure. The distal portion of the shaft is coated with a hydrophilic coating to provide lubrication. The effective length of the FOXTROT NC device is 145 cm and it is compatible with a 0.014" guide wire. The FOXTROT NC PTCA balloon catheter is available with balloon diameters of 2.5-4.0 mm and balloon lengths of 10 mm and 15 mm.

AI/ML Overview

This document describes the FOXTROT™ NC PTCA Balloon Catheter and its non-clinical testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria alongside reported device performance values. Instead, it lists the types of tests performed and states that the data supports the safety of the device and that mechanical testing results demonstrate it performs as intended.

Acceptance Criteria Type	Reported Device Performance Summary
Biocompatibility Testing	Evaluation conducted in accordance with current standards.
Cytotoxicity	Not explicitly stated, but implied to meet standards.
Sensitization	Not explicitly stated, but implied to meet standards.
Irritation/Intracutaneous Reactivity	Not explicitly stated, but implied to meet standards.
Systemic Toxicity	Not explicitly stated, but implied to meet standards.
Pyrogenicity	Not explicitly stated, but implied to meet standards.
Hemolysis	Not explicitly stated, but implied to meet standards.
Complement Activation	Not explicitly stated, but implied to meet standards.
Partial Thromboplastin Time	Not explicitly stated, but implied to meet standards.
Thrombogenicity	Not explicitly stated, but implied to meet standards.
Bench Testing (Mechanical)	Performed per FDA Class II Special Controls Guidance Document for Certain PTCA Catheters (September 2010). Results demonstrate the device performs as intended and is substantially equivalent to the predicate device.
Dimensional Verification	Not explicitly stated, but implied to meet standards/comparable to predicate.
Balloon Preparation, Deployment and Retraction	Not explicitly stated, but implied to meet standards/comparable to predicate.
Balloon Rated Burst Pressure	Not explicitly stated, but implied to meet standards/comparable to predicate.
Balloon Fatigue	Not explicitly stated, but implied to meet standards/comparable to predicate.
Balloon Compliance	Not explicitly stated, but implied to meet standards/comparable to predicate.
Balloon Inflation and Deflation Time	Not explicitly stated, but implied to meet standards/comparable to predicate.
Catheter Bond Strength	Not explicitly stated, but implied to meet standards/comparable to predicate.
Tip Pull Test	Not explicitly stated, but implied to meet standards/comparable to predicate.
Flexibility and Kink Test	Not explicitly stated, but implied to meet standards/comparable to predicate.
Torque Strength	Not explicitly stated, but implied to meet standards/comparable to predicate.
Radiopacity	Not explicitly stated, but implied to meet standards/comparable to predicate.
Coating Integrity	Not explicitly stated, but implied to meet standards/comparable to predicate.
Particulate Evaluation	Not explicitly stated, but implied to meet standards/comparable to predicate.
Balloon Rated Burst Pressure (in Stent)	Not explicitly stated, but implied to meet standards/comparable to predicate.
Balloon Fatigue (in Stent)	Not explicitly stated, but implied to meet standards/comparable to predicate.
Corrosion Resistance	Not explicitly stated, but implied to meet standards/comparable to predicate.
Smoothness of the guidewire lumen	Not explicitly stated, but implied to meet standards/comparable to predicate.

2. Sample sizes used for the test set and the data provenance

The document does not specify the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that mechanical testing was performed on "both the subject device and the predicate device."

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

This information is not applicable. The study described is entirely non-clinical bench testing and biocompatibility testing. There are no human experts involved in establishing ground truth in the context of diagnostic interpretation for this type of device submission.

4. Adjudication method for the test set

This information is not applicable. As stated above, this is a non-clinical study.

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

This information is not applicable. The device is a PTCA Balloon Catheter, not an AI diagnostic device. No MRMC study was mentioned.

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

This information is not applicable. The device is a PTCA Balloon Catheter, not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for this submission is based on established industry standards and regulatory guidance for medical device testing. For biocompatibility, it's the outcome of standardized biological tests. For bench testing, it's the performance against predefined physical and mechanical specifications as outlined in the "FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 2010)." The ultimate "ground truth" for demonstrating substantial equivalence is that the new device performs comparably to the predicate device in these tests.

8. The sample size for the training set

This information is 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

This information is not applicable. There is no "training set" as this is not an AI/machine learning device.

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