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Desktop Pro™ is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

This Traditional 510(k) describes enhancements to the integral software performing the graphical interface and machine control functions for the range of medical digital linear accelerators. These enhancements enable existing control functions to be continuously varied during the delivery of radiation therapy. Thus gantry rotation and speed of rotation, multi-leaf collimator - leaf position and head rotation, back-up diaphragms and dose rate can be continuously and simultaneously varied during treatment delivery. The suffix (VMAT) is used commercially to differentiate this version of the software.

Desktop Pro™ (VMAT) is an integrated digital control system, providing interface and machine control functions for the Elekta range of digital accelerators. It comprises a dedicated control cabinet on which the interface and machine control software is executed.

The provided document is a 510(k) summary for the Elekta Desktop Pro™ (VMAT) device. This document focuses on establishing substantial equivalence to a predicate device for regulatory clearance rather than presenting a study demonstrating performance against specific acceptance criteria in the context of AI/ML device evaluation.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies, is not available within this document. The document primarily describes the device, its intended use, and argues for its substantial equivalence to an existing, legally marketed predicate device (Elekta Synergy® K051932) based on technological characteristics and functional similarity. It does not detail a study designed to quantify and prove the device's performance against predefined acceptance criteria using clinical data.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on feature equivalence rather than performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable, as there's no performance study described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a control system for linear accelerators, not an AI-powered diagnostic or assistive tool for human readers in the sense of image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an integral control system for a linear accelerator, not a standalone algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set in that context.
9. How the ground truth for the training set was established: Not applicable.

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