(430 days)
ArcCHECK, Model 1220 is a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance.
ArcCHECK, Model 1220 is a three dimensional diode sensor used for ionizing radiation measurement for radiotherapy quality assurance. The cylindrical diode array is embedded in a cylindrical plastic phantom that allows for dosimetry measurements to be made from all gantry angles as the therapy beam rotates about the diode array.
The provided GUI 'SNC Patient' software application installed on the user's computer and connected to the Model 1220 ArcCHECK by an 8 pin DIN cable, includes the following functions:
- . Array and dose calibration.
- Measurement and display of the spatial distribution of the dose resulting from delivery of a radiation treatment plan.
- . Save measurements.
- Import treatment plan dose map in the phantom and compares with the measurement dose points.
- . Compare the measured and planned dose distribution using the analysis methods of gamma or dose difference and distance to agreement (DTA) with user specified analysis criteria.
- Report of the analysis including a percent pass rate. ●
- Perform quality assurance (QA) on the planned versus delivered multi leaf ● collimator (MLC) pattern as a function of time. The MLC QA is capable of detecting an error of 5mm or greater in the planned position of an MLC leaf.
This submission introduces a 'primary' software modification to the cleared Model 1220 ArcCHECK device (K131466). Sun Nuclear intends to introduce a software feature which allows for the user to perform quality assurance (QA) on the planned versus delivered Multi Leaf Collimator (MLC) pattern. The MLC QA is capable of detecting an error of 5mm or greater in the planned position of an MLC leaf. This 'primary' modification which is believed to affect the indications for use, but not the intended use, is the subject of this premarket notification.
I am sorry, but the provided text is a 510(k) summary for a medical device (ArcCHECK Model 1220 from Sun Nuclear Corporation) and does not contain the specific information required to answer your request regarding acceptance criteria and a study that proves the device meets those criteria.
The document focuses on:
- Regulatory classification and predicate device information.
- Description and intended use of the device.
- Technological characteristics.
- A general statement about performance data and comparison with the predicate device.
It explicitly states: "Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate K131466 ArcCHECK device." However, it does not provide a table of acceptance criteria, reported performance, details of a specific study, sample sizes, data provenance, expert qualifications, adjudication methods, or specific ground truth information.
Therefore, I cannot extract the requested information from this document.
§ 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.