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The NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Device Description

The NanoCross catheter is an over-the-wire (OTW) coaxial lumen percutaneous transluminal angioplasty (PTA) balloon catheter compatible with 0.014"guidewires with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. The distal portion of the catheter has a lubricious coating. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon.

The NanoCross Elite catheter is available in balloon sizes ranging from 1.5 mm to 4 mm in diameter, and from 20 mm to 210 mm in length; reference labeling for introducer sheath compatibility.

AI/ML Overview

The provided text describes the 510(k) summary for the NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study measuring clinical performance or AI algorithm accuracy.

Therefore, many of the requested categories for AI/clinical studies are not applicable to this type of regulatory submission. The information below will detail what is available in the provided text.

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

The document lists "bench testing" and "biocompatibility testing" as the studies performed to support substantial equivalence. The acceptance criteria for these tests are implicitly that the device performs "similarly to the predicates" and "met all acceptance criteria." Specific quantitative acceptance criteria or detailed device performance metrics are not provided in this summary.

Acceptance Criteria (General)	Reported Device Performance
Met acceptance criteria for all bench tests	"The NanoCross Elite catheter met all acceptance criteria for the bench testing with results similar to the predicates."
Biocompatibility per ISO 10993-1 for short duration contact with blood (<24 hours)	"The device was tested for biocompatibility per ISO 10993-1... The testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, complement activation, thromboresistance, partial thromboplastin time, and platelet/leukocyte count." (Implies meeting acceptance criteria, though not explicitly stated for individual tests)

List of specific tests performed (acceptance criteria not detailed):

Performed for the NanoCross™ Elite:

Balloon Dimensional Verification
Catheter Dimensional Verification
Balloon Rated Burst Pressure (Unconstrained and In Stent)
Balloon Fatigue (Unconstrained and In Stent)
Balloon Compliance
Inflation/Deflation Time
Catheter Bond Strength
Kink
Device Tracking
Insertion Force
Balloon Pull-back Force
Torque Strength
Radiopacity
Presence of Coating
Re-Insertion Force
Pushability

Leveraged from predicate devices (implying the NanoCross Elite is expected to perform similarly):

Balloon Dimensional Verification
Balloon Rated Burst Pressure (Unconstrained and In Stent)
Balloon Fatigue (Unconstrained and In Stent)
Balloon Compliance
Coating Durability
Particle Generation

The following items are NOT APPLICABLE or NOT PROVIDED in this 510(k) summary, as it is a submission for a medical device (PTA balloon catheter) based on substantial equivalence, not an AI algorithm or clinical trial with specific performance metrics such as accuracy, sensitivity, or specificity against a ground truth.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided. This document describes bench and biocompatibility testing, not a clinical study with a test set of 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 / Not Provided. No ground truth for a clinical test set was established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided. No adjudication for a clinical test set was performed.

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.

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 (expert consensus, pathology, outcomes data, etc)

Not Applicable / Not Provided. The "ground truth" for the non-clinical tests would be the established engineering and ISO standards for device performance, but not clinical ground truth as specified in the question.

8. The sample size for the training set

Not Applicable. This is not an AI device.

9. How the ground truth for the training set was established

Not Applicable. This is not an AI device.

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