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To provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collection.

The vanSonnenberg™ Sump Catheter is designed for use as a percutaneously placed drain for intra-abdominal fluid collections. Such conditions include abscesses, cysts, pseudocysts, bilomas, seromas, urinomas, or any loculated fluid collection.

All Purpose Drainage catheters are designed to provide constant, unobstructed fluid drainage from various fluid accumulations to an external and/or internal collection sites and to ensure stability during treatment. These ends are met through the choice of drainage material and by incorporating a secure fixation method in the drainage site (internally by pig-tail or "J" style tips and externally, by means of suture or adhesive). Percutaneous placement is accomplished with radiological guidance.

Select Boston Scientific All Purpose Drainage catheters are coated with a hydrophilic material, Glidex™ , for the reduction of surface friction during placement.

Some of these catheters are also available with a biocompatible, distal tip (Temp-Tip™). The tip's internal diameter allows the guidewire to direct the tip for accurate catheter placement; however, soon after placement, the Temp-Tip™ material dissolves, allowing the full diameter of the catheter lumen to contribute to site drainage.

All Purpose Drainage catheters are manufactured with one of two types of resins, Flexima or Percuflex.

• Flexima is a biocompatible polyurethane (Tecoflex) known for its flexibility, strength, and kink resistance. Flexima comes in durometers ranging in Firm, Regular and Soft and uses a radiopacifier for visualization under fluoroscopy.
• Percuflex is an ELVAX™ 460, ethylene vinyl acetate (EVA) copolymer for patient comfort. This material is available in firm (white in color) and regular (blue in color) durometers. The firmer durometers provide more pushability during device placement. A radiopaque additive, bismuth subcarbonate, incorporated throughout the catheter tube also aids radiopacity and percutaneous placement.

The provided text is a 510(k) summary for the Boston Scientific APDL Drainage Catheter System and related products. It outlines the regulatory clearance process for drainage catheters and accessories. However, this document does not contain information about an AI/ML-driven device or a study assessing its performance using acceptance criteria related to AI/ML metrics (e.g., sensitivity, specificity, AUC).

Instead, the document details a traditional medical device submission, focusing on establishing substantial equivalence to existing predicate devices. The "performance testing" described refers to:

• Engineering and materials testing to support the addition of Magnetic Resonance (MR) compatibility information and to justify cumulative changes in manufacturing materials (e.g., resin types, coatings). This includes tests for radio frequency heating, force measurement, and image artifact in an MR environment, as well as packaging integrity and aging tests.
• Biological Endotoxin (BET) assessment.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The document does not describe such a device or study.

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