(235 days)
The Axxent Electronic Brachytherapy System is intended to deliver high dose rate X-ray radiation for brachytherapy.
The Axxent Vaginal Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver intracavitary brachytherapy in the vagina and rectum.
The Axxent Vaginal Applicator is a component of the Axxent Electronic Brachytherapy System which utilizes a proprietary miniature X-ray source and does not require radioactive isotopes. Each applicator provides a channel for the Axxent HDR X-ray Source-2.2 to deliver high-dose rate, low energy radiation treatment. The source mimics the penetration and dose characteristics of Iridium 192 within the target volume. The Axxent Vaginal Applicators are available in 4 different sizes. The applicators are reusable and sterilizable. An Applicator Clamp and Base Plate are provided as a required accessory to stabilize the Vaginal Applicator during radiation treatment.
The provided text describes a 510(k) premarket notification for the "Axxent® Vaginal Applicator Set" and does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document is primarily focused on establishing substantial equivalence to a predicate device, which is a regulatory pathway used when a new device is similar in intended use, technological characteristics, and safety and effectiveness to a legally marketed predicate device.
Therefore, I cannot provide the requested information as it is not present in the given text. The document confirms that the device is substantially equivalent in terms of design, materials, principles of operation, and product specification to the predicate device, but it does not detail specific performance studies with acceptance criteria, sample sizes, expert ground truth, adjudication methods, or comparative effectiveness studies.
§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.