(53 days)
The Esophageal Brachytherapy Applicator is intended for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to the esophagus. This device is sterile, disposable and single-use.
[BKMI2001]
The device has 6 independently balloons. Each balloon corresponds to a specified needle free connector (valve). The #1 valve is connected to the most distal balloon and the #6 valve corresponds with the proximal balloon. There is an indication balloon on each valve unit, which can indicate the inflated balloon. The distance between first marker printed on the main catheter and the distal tip is 19.8 cm. This device is disposable and designed for sterile and single use.
[BKMI2002]
The device has 8 independently balloons. Each balloon corresponds to a specified needle free connector (valve). The #1 valve is connected to the most distal balloon and the #8 valve corresponds with the proximal balloon. The distance between first marker printed on the main catheter and the distal tip is 40 cm. This device is disposable and designed for sterile and single use.
The provided text is a 510(k) summary for the "BRAXX" Esophageal Brachytherapy Applicator. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, the document does not describe a study involving an AI/software device that requires acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance improvement.
The "Performance Testing" section refers to mechanical tests for the physical device (Balloon Burst, Balloon Fatigue, Balloon Diameter and Volume, Leakage, Tensile Strength). These are not related to an AI algorithm's performance on a test set of data.
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study proving device meets criteria for an AI/software device. The provided text is solely for a physical medical device.
To answer your request, if this were an AI/software device, the information would typically be found in a section detailing clinical performance studies or algorithm validation studies.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.