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The Precise™ Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products.

The Precise™ Treatment Table is an enhancement to the previously reported EOS RAM and Pedestal devices that have been cleared for commercial distribution. These devices have established and proven track records for safety. This enhancement offers improved directional accuracy and repeatability to provide for easier and more efficient patient set up. The Precise™ Treatment Table is further considered as an enhancement to the RAM and Pedestal devices.

The provided text is a summary of safety and effectiveness information for the Elekta Oncology Systems Precise™ Treatment Table, not a study that proves a device meets acceptance criteria. It primarily focuses on regulatory compliance, quality management, and the device's substantial equivalence to previously cleared devices.

Therefore, the requested information cannot be extracted from the provided text as it does not contain details about:

• Specific acceptance criteria metrics for performance.
• A study design, sample sizes for test or training sets.
• Data provenance, expert qualifications, or adjudication methods.
• MRMC comparative effectiveness study or standalone algorithm performance.
• The type of ground truth used or how it was established.

The text emphasizes that the Precise™ Treatment Table is an "enhancement" to existing devices with established safety records and that it meets international safety standards and quality system requirements (IEC 60601-1, IEC 60601-2-1, ISO 9001, EN 46001, Medical Device Directive 93/42/EEC Annex II, and 21 CFR 820). It also states that the device offers "improved directional accuracy and repeatability," but it does not provide quantitative metrics or the study results to back up this claim.

In summary, the provided document is a regulatory submission for premarket notification (510(k)) and not a detailed study report. It confirms the device's regulatory compliance and safety profile based on its design, quality system, and substantial equivalence to predicate devices, rather than presenting the results of a performance study with specific acceptance criteria.

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