(215 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 expanded indications for use are also applicable as previously presented for pReference Treatment System (K983793), including hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.
The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
Not Found
I apologize, but the provided text is a 510(k) premarket notification letter from the FDA regarding the "pReference IMRT Treatment Planning Module" and its indications for use. It primarily focuses on the regulatory approval and substantial equivalence to predicate devices.
The document does NOT contain information about specific acceptance criteria, a study proving the device meets those criteria, or the detailed methodology of such a study.
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported performance, nor can I answer questions about:
- Sample sizes (test, training) or data provenance
- Number of experts or their qualifications
- Adjudication methods
- MRMC comparative effectiveness study or effect size
- Standalone performance
- Type of ground truth used
- How ground truth for training was established
The letter only states that the device is "substantially equivalent" to legally marketed predicate devices for its stated indications for use. This means the FDA determined it performs as safely and effectively as existing, legally marketed devices, but it does not detail the specific performance metrics or studies that would typically be associated with defined acceptance criteria.
§ 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.