(78 days)
The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.
The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
Not Found
I am sorry, but the provided text from the FDA 510(k) summary does not contain the specific information required to answer your request about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The document is a clearance letter for a device called "Explorer 3D Stereotactic Irradiation Software" (K991815) and an "Indications For Use" statement. It primarily focuses on the substantial equivalence determination to a predicate device (pReference TPS, K970464) and the regulatory classification.
To answer your questions, I would need a more detailed study report or a different section of the 510(k) submission that specifically addresses the performance testing and validation of the device.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in 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. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.