(90 days)
SEQUENCER is to be used to facilitate the delivery of defined radiotherapy treatment plans. SEQUENCER verifies the settings on a radiotherapy treatment machine prior to treatment and records the actual parameters after treatment. SEQUENCER can be used whenever radiotherapy treatment is prescribed.
The primary function of SEQUENCER is to assist in setting up the patient for treatment and verifying that the treatment setup is correct for a patient undergoing radiation therapy. SEQUENCER may be used to help in the setup of geometric and console parameters and verify the set parameters on the treatment machine with the planned values. After treatment the actual values can be recorded. This assists in tracking the dose given to the specified location.
This document is a 510(k) Pre-market Notification for a device called "SEQUENCER." It describes the intended use and development process of the software. However, the provided text does not contain any information about specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
The document focuses on:
- Intended Use: To assist in setting up and verifying radiation therapy treatment parameters and recording actual values after treatment.
- Context: Used in radiation therapy to reduce setup errors and track dose delivery.
- Development Process: Developed under IMPAC's Quality System, adhering to 21 CFR 820, with Software Requirements Specifications, Design Descriptions, and Hazard Analysis.
- Regulatory Status: A 510(k) clearance (K981313) from the FDA, indicating substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them because this information is not present in the provided text.
The document is primarily a regulatory submission outlining the device's purpose and compliance with quality systems, not a clinical or performance study report.
§ 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.