(22 days)
The PTS 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 PTS has two primary components: (1) the beam delivery equipment, which directs the proton beam to 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. The modification in this submission is the addition of an automatic network-based interface from an Oncology Information System (OIS) to the PTS for the input of patient information, which information initially is entered into the OIS by means of a Graphical User Interface. After the patient treatment is completed, the treatment data is transferred from the PTS to the OIS through the automatic network-based interface.
This document is a 510(k) summary for the Ion Beam Applications S.A. Proton Therapy System (PTS). It is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the information required to answer your request in detail.
Specifically, the document does not describe or contain:
- Acceptance criteria and reported device performance in a table format.
- Details about a specific study proving the device meets acceptance criteria.
- Sample sizes for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
- Standalone (algorithm-only) performance results.
- Type of ground truth used (pathology, expert consensus, outcomes data).
- How ground truth for a training set was established.
This document focuses on establishing substantial equivalence to previously cleared predicate devices (Loma Linda University Medical Center Proton Beam Therapy device K872369 and Harvard University Cyclotron Laboratory Proton Beam Therapy device) based on intended use, principles of operation, and technological characteristics. It describes the device and its modifications (an automatic network-based interface from an Oncology Information System to the PTS), but not a performance study as you've requested.
§ 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.