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The Conquest™ 40 PTA Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Atlas™ Gold PTA Dilation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the illac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Vida™ PTV Dilatation Cather is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in the following:
· A patient with isolated pulmonary valve stenosis.
· A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

The Vida™ BAV Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

The Conquest™ 40 PTA Dilatation Catheter is a high-performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary ultra non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes a tapered atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the quidewire lumen. The over-the-wire catheter is compatible with 0.035" guidewires and is available in 50cm and 75cm working lengths. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in re-wrap/refolding of the balloon. This product is not manufactured with any latex.

The Atlas™ Gold PTA Dilatation Catheter is a high-performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes a tapered atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. The over-the-wire catheter is compatible with .035" guidewire and is available in 80 cm and 120 cm working lengths.
Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft to aid in re-wrap/refolding of the balloon. This product is not manufactured with any natural rubber latex.

The Vida™ PTV Dilatation Catheter is a high-performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary, noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" guidewire and is available in 100 cm working length. The proximal portion of the catheter includes a female luer-lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen.
Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.

The Vida™ BAV Balloon Valvuloplasty Catheter is a high-performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary, non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" guidewire and is available in 100 cm working length. The proximal portion of the catheter includes a female luer-lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen.
Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.

The provided document describes the substantial equivalence determination for several medical devices, specifically balloon dilatation and valvuloplasty catheters. It does not present acceptance criteria or performance data for an AI/ML-driven medical device. Instead, it focuses on the engineering and material characteristics of physical medical devices and their comparison to previously cleared predicate devices.

Therefore, I cannot provide a response based on the requirements of your prompt, as the document does not contain information related to:

1. AI/ML performance testing: The document details physical device performance tests (e.g., trackability, burst strength, fatigue, biocompatibility), not AI model performance metrics like sensitivity, specificity, or AUC.
2. Test/training sets for AI/ML: There is no mention of data sets, sample sizes for AI training or testing, data provenance, or ground truth establishment relevant to an AI algorithm.
3. Expert adjudication or MRMC studies: These are concepts specific to the evaluation of AI systems, typically involving human readers or experts, which are not applicable to the physical devices described in this submission.

The document states: "The subject devices...met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not specify what those "predetermined acceptance criteria" are for each test, nor does it present the reported device performance in detail (e.g., actual burst pressures achieved vs. minimum required). It lists the types of tests performed.

To fulfill your request, the input document would need to describe the development and validation of an AI/ML component, including its specific acceptance criteria and the results of studies demonstrating its performance.

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