(188 days)
The MultiStage Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. Also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
The MultiStage Balloon Dilatation Catheters are indicated for use to endoscopically dilate strictures of the alimentary tract and the Sphincter of Oddi with or without prior sphincterotomy. It consists of an inflatable balloon on a catheter shaft with multiple lumens for inflation and passage of a guidewire. The MultiStage balloon is designed with three-in-one technology and provides successive, gradual dilation of strictures. The balloon is made of Pebax material. The MultiStage Balloon Dilatation is designed to pass over a 0.035in (0.89mm) guidewire through its guidewire lumen or through an minimum working channel of a 2.8mm alimentary tract, or a 3.7mm biliary tract. The hub is made of polycarbonate (PC). Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture. Accordingly, product models, are divided into those with a wireguided (MSW) and non-wireguided (MSO) component. The MSW model allows the guidewire and catheter to be introduced into the endoscope together. The MSO model as a traditional operation method, the guidewire is first inserted into the endoscope for positioning and then the catheter is inserted through the guidewire for good passability. The physician can choose the model as needed.
The provided text is a 510(k) summary for a medical device called the "MultiStage Balloon Dilatation Catheter." This document describes the device, its intended use, and its comparison to a predicate device to establish substantial equivalence for regulatory clearance. It does not contain information about an AI/ML algorithm or a study proving that an AI/ML device meets acceptance criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes or data provenance for an AI/ML test set.
- Number of experts or their qualifications for establishing ground truth for an AI/ML test set.
- Adjudication method for an AI/ML test set.
- MRMC comparative effectiveness study results for an AI/ML device.
- Standalone performance of an AI/ML algorithm.
- Type of ground truth used for an AI/ML study.
- Sample size for the training set of an AI/ML algorithm.
- How the ground truth for an AI/ML training set was established.
The document focuses on the non-clinical testing of a physical medical device (balloon catheter), which includes:
- Biocompatibility testing (Cytotoxicity, Sensitization, Intracutaneous reactivity test)
- Shelf life testing
- Sterilization validation
- Performance characteristics (Visual Inspection, Bacteriostasis performance of pouch, Dye penetration, Tension test, Guidewire compatibility, Channel compatibility, Product Dimensional Inspection, Compliance, Balloon fatigue, Balloon rated burst pressure (RBP), Peak tensile, Kink resistance, Leakage Test, Hydratability, Hub Corrosion resistance, X-ray detectability, Chemical properties).
All of these non-clinical tests were reported to have "passed." The document explicitly states: "No clinical study is included in this submission."
For an AI/ML-based medical device, the information you requested would typically be found in sections detailing performance studies, often referred to as "clinical performance" or "algorithm performance" studies, which are absent here.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.