(25 days)
The PTS with the Device Modification is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
The device is designed to: (1) create and deliver the proton beam to the patient treatment location; (2) produce a transverse and longitudinal dose distribution appropriate for the patient's treatment; and (3) deliver the designated dose to the patient's treatment site. The PTS has two primary components: (1) the beam delivery equipment, which directs the proton beam to the patient's treatment site within the patient treatment location and ensures the patient critical functions are properly and safely accomplished; and (2) the beam production equipment, which includes a cyclotron and delivery system to produce the proton beam and deliver it to the patient treatment locations. In addition to these primary components, the PTS includes a Therapy Safety System to protect against unsafe conditions, having both automatic and manual controls to shut down the PTS in the event problems occur; and a computer-based Therapy Control System which controls the parameters of the proton beam.
This Device Modification submission describes a necessary change in the Patient Positioning Verification System (PPVS). In the original 510(k) system that was cleared for marketing, referred to above (K983024), the patient positioning devices involved stand-alone hardware and the software for calculating a 6-axis patient positioning correction vector. Once that calculation was completed, the positioning correction vector had to be set manually in the proton therapy user interfaces.
With this Device Modification, the process will be similar to that in the original submission. The modification is that the Patient Positioning Verification System (PPVS) will be interfaced to a Treatment Planning System (TPS) or an Oncology information system (OIS) for downloading the treatment plan and the associated Digitally Reconstructed Radiographs (DRR) from the TPS in DICOM format. This contrasts with the original submission that transferred the PPVS via file servers or by using memory sticks. For this filing, we name the PPVS "DICOM Interfaced PPVS System."
This Device Modification primarily involves software changes, while the hardware generally is unchanged.
The provided text is a 510(k) summary for a device modification to an Ion Beam Applications' Proton Therapy System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies.
The "Device Modification" section only describes a software change to interface the Patient Positioning Verification System (PPVS) with a Treatment Planning System (TPS) or an Oncology Information System (OIS) for downloading treatment plans and Digitally Reconstructed Radiographs (DRR). It explicitly states that "This Device Modification primarily involves software changes, while the hardware generally is unchanged."
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 input. This document serves as a regulatory submission (510(k)) to demonstrate substantial equivalence, not a detailed technical report on performance testing and acceptance criteria for a new or modified device feature.
§ 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.