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The Elekta Synergy®, Elekta Synergy® S, and XVI R3.5 are intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

This Premarket Notification Special 510(k) describes modifications to the Elekta Synergy® System; a combination of the specially prepared Elekta medical linear accelerator, Elekta Synergy® Platform, with the XVI on-board kV imaging accessory. The primary reasons for the modifications to this product are to provide:

• Hardware & software support for increased patient throughput
• Easier selection of parameters & provision of clinical presets to improve efficiency
• Improved image quality and image management
• Improved tools for device set-up and image processing
• Improved connectivity with other systems through DICOM

This 510(k) summary does not contain the information needed to answer the request. The document describes modifications to an existing medical linear accelerator system, Elekta Synergy®, Elekta Synergy® S, and XVI R3.5, and focuses on substantial equivalence to a predicate device (K032996).

Specifically, the document lacks:

• Acceptance criteria: No specific performance metrics or thresholds are mentioned for the device.
• Study details: There is no description of any new study conducted to prove the device meets acceptance criteria. The document states "There has been no change made to the underlying technological characteristics of the product." which suggests that performance evaluation beyond verifying the modifications function as intended may not have been required or specifically detailed for this 510(k). The focus is on the modifications providing "Hardware & software support," "Easier selection of parameters & provision of clinical presets," "Improved image quality and image management," "Improved tools for device set-up and image processing," and "Improved connectivity." These are feature improvements rather than specific quantitative performance criteria.
• Sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for a study.

The document is a regulatory submission focused on demonstrating substantial equivalence of a modified device, rather than a detailed report of a performance study against specific acceptance criteria.

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