(80 days)
The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is intended for use in Brachytherapy. The delivery of intra-cavitary radiation therapy requires not only proper visualization and localization of the applicator within the treatment volume, but precise dosimetry and a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear CT HDR Tandem/Ring Applicator with Rectal Retractor meets these requirements.
The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is indicated for High Dose Rate irradiation of the uterus and cervix.
The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is intended for use in Brachytherapy. The delivery of intra-cavitary radiation therapy requires not only proper visualization and localization of the applicator within the treatment volume, but precise dosimetry and a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear CT HDR Tandem/Ring Applicator with Rectal Retractor meets these requirements.
The provided document is a 510(k) premarket notification for a medical device (CT HDR Tandem/Ring Applicator with Rectal Retractor). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices in the US. This pathway generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical studies to prove specific performance criteria.
Therefore, I cannot extract the requested information from this document. The sections you asked for, such as:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- Sample size for training set
- How ground truth for the training set was established
... are not present in this regulatory filing. This type of filing typically provides a summary of safety and effectiveness based on comparison to existing devices, design similarities, and sometimes bench testing, but not detailed clinical study reports with acceptance criteria and performance data in the way you've described for an AI/software-based device.
§ 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.