(120 days)
The SC360 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.
Using a beam of protons, the SC360 is designed to accurately and safely deliver a prescribed dose to a Treatment Volume in a patient with a solid tumor or other disease susceptible to radiation. The SC360 includes a method to; 1) accelerate protons to a fixed energy; 2) vary the proton beam energy to adjust its range in the patient; 3) transport the protons; 4) deliver the dose; 5) image the patient using Cone Beam CT (CBCT) or planar images; 6) position the patient relative to the proton beam delivery; and 7) record the details of the dose delivery.
The functions of each treatment room of the SC360 are performed by six independent systems that may be described as the Beam Production System (BPS), the Beam Modification System (BMS), the Dose Delivery System (DDS), the Positioning System (POS), the Independent Safety System (ISS), and the Treatment Room Control System (TRCS). The primary user interface is presented by the TRCS where treatment workflow and clinical Quality Assurance activities may be controlled. Servicing is accomplished through Service Interfaces for each independent system. Access to the service interfaces may be through the TRCS or the individual system control computer, all accessible only by qualified service engineers.
In the SC360, the cyclotron and fixed energy portion of the beamline make up the BPS and are independent of the BMS, which degrades the beam energy and finally transports the protons to the DDS through either a fixed beamline or 360-degree rotating gantry beamline. The ISS monitors all safety related signals and uses a high confidence method to control beam admission into a Treatment Room.
In each Treatment Room, prior to patient setup and treatment, information from a treatment plan is downloaded to the SC360. Next, the patient is immobilized on a robotic couch and moved to a treatment position as specified in the treatment plan. Volumetric (or orthogonal planar) x-ray images are acquired using a couch-mounted CBCT imaging ring. These images are used to determine the current location/orientation of the Treatment Volume by comparing and aligning with reference images and regions of interest provided in the treatment plan. The couch position/orientation is adjusted to bring the treatment isocenter to beam isocenter (in the prescribed orientation). The proton beam is delivered to the Treatment Volume in accordance with the treatment plan. During irradiation, the DDS controls and monitors the dose delivered to each spot, the spot location, and the total dose delivered. Results are recorded and stored in a format compatible with an Oncology Information System (OIS).
I'm sorry, but the provided text does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format you requested, including a table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth type, and training set details.
The document is a 510(k) summary for the ProNova SC360 Proton Therapy System. It discusses substantial equivalence to a predicate device, device description, technological characteristics, and a summary of non-clinical performance testing.
Here's what I can extract related to performance testing, but it does not meet the detailed requirements of your request:
Acceptance Criteria and Device Performance (based on general statements in the document):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use Essential Performance Requirements | The SC360 was found to meet these requirements. |
| Patient Safety Essential Performance Requirements | The SC360 was found to meet these requirements. |
| Intended Use - Additional Requirements | The SC360 was found to meet these requirements. |
| Design Outputs met Design Specifications | The performance testing verified that design outputs met the design specifications of the system and components. |
Missing Information:
- Specific quantitative acceptance criteria: The document only mentions categories of requirements, not the actual numerical or qualitative criteria.
- Sample sizes used for the test set: Not mentioned.
- Data provenance: Not mentioned.
- Number of experts and their qualifications: Not applicable, as this was non-clinical performance testing of the system itself, not diagnostic image interpretation.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study details: The document explicitly states "No clinical testing was performed or required."
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical device (proton therapy system), not a software algorithm for interpretation.
- Type of ground truth used: Not explicitly stated beyond "design specifications" and "Essential Performance and Safety Requirements" for the physical system. It would likely involve engineering standards and measurements.
- Sample size for the training set: Not applicable, as it's a physical device, not an AI model.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is focused on demonstrating substantial equivalence of a physical proton therapy system through non-clinical performance testing against internal design specifications and general safety/performance requirements, rather than clinical efficacy through studies involving human readers or AI algorithms with detailed statistical endpoints.
§ 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.