(20 days)
EQUAL Dose 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.
MUV 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.
The software requires beam data for individual treatment plans to be imported through the DICOM RT Plan format. The parameters associated with the treatment delivery on the accelerator can not be edited within the software, although parameters reliated to the calculation inside the patient/phantom, such as the coordinates and depths of the calculation points, are open for editing.
The software is validated for broad megavoltage photon beams in the range from 4 up to 30 MV, delivered by standard medical linear accelerators (linacs),
The software runs on a Windows XP platform.
The provided text describes a 510(k) premarket notification for the "Nucletron EQUAL Dose 1.0" device, a Radiation Therapy Verification Tool. However, the document does not contain specific information regarding acceptance criteria, a detailed study proving device performance against those criteria, or the methodology used for establishing ground truth or expert involvement.
The document primarily focuses on:
- Substantial equivalence to a predicate device (MDS Nordion DCM1.0).
- Description and intended use of EQUAL Dose 1.0 as a Quality Assurance (QA) tool for verifying dose calculations in external beam therapy.
- Administrative details of the 510(k) submission and FDA's clearance letter.
Therefore, I cannot provide the requested table or detailed study information based on the given text. The text explicitly states that EQUAL Dose 1.0 is "merely a verification tool" and validates it for "broad megavoltage photon beams in the range from 4 up to 30 MV". This implies that its "performance" would likely be assessed by how accurately its dose calculations compare to accepted physics models and/or measurements, but the document does not provide the acceptance criteria for these comparisons or the study results.
§ 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.