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The Athletis™ PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature including upper extremity, renal, iliac, and infrainguinal vessels and the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Athletis™ PTA Balloon Dilatation Catheter is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature.

The Athletis™ Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is an over-the-wire (OTW), non-compliant, high performance balloon catheter for peripheral indications. The catheter is compatible with 0.035 in (0.89 mm) guidewires.

The Athletis™ PTA Balloon Dilatation Catheter features a dual lumen shaft ending in a Y-connector manifold with luer lock fittings. The manifold port marked "WIRE" is used to deliver the catheter over a 0.035 in (0.89 mm) guidewire. The manifold port marked "BALLOON" is used to inflate and deflate the balloon during the procedure. Two radiopaque marker bands, in conjunction with fluoroscopy, aid in the visualization of the balloon. A lubricious hydrophobic coating is applied from the distal tip to just proximal of the balloon to assist with delivery of the device. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the treatment site. The working lengths of the balloon catheter are 50 cm, 75 cm and 135 cm to allow device selection for various anatomies.

The provided text describes a 510(k) premarket notification for a medical device, the Athletis™ PTA Balloon Dilatation Catheter. The document focuses on demonstrating substantial equivalence to a predicate device (Mustang Balloon Dilatation Catheter) through comparisons of technological characteristics and performance data (bench testing, biocompatibility, and animal study).

However, the provided text does not contain the kind of information requested in the prompt regarding acceptance criteria and study details for an AI/algorithm-based device. The prompt asks about elements typical for AI/ML medical devices, such as:

• Acceptance criteria table with reported device performance (e.g., accuracy, sensitivity, specificity, AUC).
• Sample sizes for test sets, data provenance (country, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes).
• Training set sample size and ground truth establishment for training.

Since the document is for a physical medical catheter (Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter) and not an AI/ML diagnostic or assistive device, the requested information about AI model performance, human reader improvement with AI assistance, and specific AI training/testing methodologies is not applicable and not found within the provided text.

The performance data mentioned in the document are related to the physical and biological characteristics of the catheter itself, such as:

• Bench testing: Working Length, Shaft Outer Diameter, Balloon Crossing Profile, Preparation/Deployment/Retraction, Balloon Rated Burst Pressure and Burst in Stent, Balloon Fatigue/Fatigue in Stent, Balloon Compliance and OD at nominal, Balloon Inflation/Deflation Time, Particulate Evaluation, Device Tensile, Balloon Protector Removal Force, Shaft Kink Resistance, Torque Strength, Radiopacity, Guidewire Compatibility, Sheath Insertion and Withdrawal Force, Coating Integrity, Particulate in Stent.
• Biocompatibility testing: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, USP Physicochemical, Direct Contact Hemolysis, Complement Activation, In Vitro Hemocompatibility, Ames Mutagenicity, Mouse lymphoma Assays.
• GLP Animal Study (porcine): Evaluation of in vivo thrombogenicity and acute performance and safety.

The summary states that "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing." This implicitly serves as the "acceptance criteria" for this type of device – demonstrating that it performs as intended and is safe, comparable to the predicate, through these physical and biological tests.

In conclusion, I cannot provide the requested information because the input text describes the clearance of a physical medical device (a balloon catheter), not an AI/ML-based device, and therefore does not contain data related to AI model performance or associated study methodologies.

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