(56 days)
The Vienna Ring CT/MR Applicator is intended for use with Nucletron remote afterloading equipment for gynaecological brachytherapy procedures.
The Vienna Ring CT/MR Applicator is based on the Ring CT/MR Applicator set enhanced with the addition of nine guide holes in the ring tube (seven holes for part number 189.699). These guide holes allow placement of interstitial titanium needles using the ring tube as a needle template while still maintaining the treatment on the dose distribution. The addition of interstitial needles makes it possible to achieve asymmetric dose distributions around the ring and are parallel to the tandem. The applicator is fully CT/MR compatible. Its design uses composite fiber tubing, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artifacts on the acquired images.
This document is a 510(k) premarket notification for a medical device (Vienna Ring CT/MR Applicator). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study design, or performance metrics that would be used to "prove the device meets the acceptance criteria."
The 510(k) submission process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on presenting raw performance data or clinical study results in the same way a PMA or de novo submission might.
Therefore, I cannot fulfill your request for the tables and information about study design, sample sizes, ground truth establishment, or expert adjudication, as this information is not present in the provided text.
The document mainly includes:
- Device Identification: Name, classification, and manufacturing information.
- Predicate Device: Identification of the legally marketed device to which the new device claims substantial equivalence.
- Description of Modifications: Details how the new device differs from the predicate.
- Intended Use Statement: Clarifies the medical purpose of the device.
- FDA Clearance Letter: Official communication from the FDA confirming clearance.
To answer your request, a document detailing the verification and validation testing for this device would be needed.
§ 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.