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The Acuity Radiation Therapy Simulator is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field to be applied.

The Varian Acuity is a Radiation Therapy Simulator. Its main function is to provide the means of planning the subsequent treatment of patients on therapy machines capable of delivering tumorcidal doses of photons or electron to specific target volumes in the human body. It achieves this by providing low dose level x-ray images (either radiographic or fluoroscopic) to duplicate the therapy treatment fields, along with machine coordinates and patient positional information. It is capable of simulating single, multiple or dynamic treatment fields. Some version of the Simulator will also be able to provide digital tomographic imaging and real-time image capture, viewing and enhancement. The Acuity consists of a drive stand which supports a vertically rotatable gantry. The stand also provides a housing for much of the simulator's electronics and its 3-phase xray generator. The stand is itself supported on a sub-floor-level baseframe which also extends forward from the stands area to provide support and horizontal rotation for a patient support couch. The gantry provides mounting for an x-ray tube and beam shaping collimator and diametrically opposite these, a detector support arm assembly. All of which can be positioned anywhere around the simulator's isocenter via rotation of the gantry. The detector support arm is a robotic type mechanism providing support and positional adjustment for a flat panel digital image acquisition device and film cassette holder. Mechanical movements of the simulator are controlled either from an in-room handheld pendant or from a control room console. In addition, control panels mounted on each side of the couch provide control of couch movements, laser lights and contain emergency off buttons.

The provided document is a 510(k) Premarket Notification for the Varian Acuity Radiation Therapy Simulator. It describes the device's intended use and technological characteristics, and states its substantial equivalence to a predicate device. However, this document does not contain a detailed study proving the device meets acceptance criteria in the way a clinical trial or performance study report would.

510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials or performance studies that define and meet specific acceptance criteria with detailed statistical analysis. The "acceptance criteria" referred to in your request are typically part of a comprehensive performance study, which is not present in this type of regulatory submission.

Therefore, for your specific requests, most of the information is not available in this document:

1. A table of acceptance criteria and the reported device performance: This information is not provided. The 510(k) submission states the device's function and intended use, but not specific performance metrics against defined acceptance criteria.
2. Sample size used for the test set and the data provenance: Not applicable/not provided. This document doesn't detail a specific test set or clinical study of this nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
4. Adjudication method: Not applicable/not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This document does not mention an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This device is a radiation therapy simulator, not an AI algorithm.
7. The type of ground truth used: Not applicable/not provided.
8. The sample size for the training set: Not applicable/not provided. This is a hardware device, not an AI algorithm requiring a training set in this context.
9. How the ground truth for the training set was established: Not applicable/not provided.

Summary based on the provided document:

The document describes the Varian Acuity Radiation Therapy Simulator, a device designed to provide low-dose x-ray images (radiographic or fluoroscopic) to duplicate therapy treatment fields and obtain machine coordinates and patient positional information for radiation therapy planning.

The predicate device for establishing substantial equivalence is the "Varian Ximatron C-Series Radiation Therapy Simulatory with Version 4.2 Software, K964138."

The intended use of the Acuity is for radiation therapy simulation, using fluoroscopic and/or radiographic x-ray systems for visualizing the volume to be exposed and confirming the position and size of the therapeutic irradiation field.

The basis for regulatory clearance (510(k)) is demonstrating substantial equivalence to the predicate device, not necessarily meeting a pre-defined set of objective performance acceptance criteria through an independent study as one might see for novel technologies or AI devices. The substantial equivalence relies on comparing technological characteristics with those of the predicate. The document mentions an attached "Specification Comparison Chart" (Tab G), which would outline these characteristic comparisons, but this chart is not included in the provided text.

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