(239 days)
The GC Medtech Esophageal Applicator (E-App) is an applicator used to facilitate delivery of a prescription of radiation to the esophagus when used in conjunction with a high dose rate after-loader.
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I apologize, but the provided text is a 510(k) premarket notification letter from the FDA to GC Medtech, LLC, for their E-App device. This document primarily focuses on the FDA's decision regarding substantial equivalence and regulatory compliance.
The document does not contain any information about:
- Acceptance criteria for device performance.
- Any study details, including sample sizes, data provenance, expert qualifications, or adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or how it was established for training or testing sets.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text.
§ 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.