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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.

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