(27 days)
The MicroSelectron HDR Version 2 is intended to enable an operator to apply, by remote control, a radionuclide source into the body (including Interstitial, Intracavitary, Intraluminal, Bronchial, Endovascular and Intra-operative) or to the surface of the body for radiation therapy.
The microSelectron-HDR is a remote afterloading system for high dose rate brachytherapy treatment using a single iridium-192 radioactive source. The MicroSelectron-HDR delivers a radiation dose distribution conforming to treatment data, r he Miorooolouren . Alle workstation or imported from a treatment planning system. The modifications to the cleared device K953946 are: - Increase of maximum source strength for treatment of patients from 10 Ci (aprox. 40.000 . μGy.m²/h) to 12Ci (aprox. 48.000 μGy.m²/h).
The provided text is a 510(k) summary for the MicroSelectron HDR Version 2, a remote afterloading system for high dose rate brachytherapy. It details the device's technical specifications, intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain information on acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details about multi-reader multi-case studies or standalone algorithm performance.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- MRMC comparative effectiveness study results (effect size)
- Standalone (algorithm only) performance
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily focuses on regulatory approval based on substantial equivalence to an existing device, rather than detailed performance studies against specific acceptance criteria.
§ 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.