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MOBILETT Elara Max is a mobile device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. MOBILETT Elara Max enables radio-graphic exposures of the whole body and may be used on pediatric. adult and bariatric patients. It can also be used for emergency applications. MOBILETT Elara Max is not indicated for mammographic imaging.

The MOBILETT Elara Max is a mobile X-ray system with a solid state x-ray imager (SSXI). The system is designed to provide X-ray imaging by healthcare professionals. Rechargeable batteries support cable less operation and motor-driven movements to the point of care. The mobile generator is positioned at bedside and the X-ray system is directed to the anatomical area to be imaged. The image detector is placed perpendicular to the central beam behind this anatomical area. The system features a collimator with a light field that mimics the x-ray field to limit the field of exposure to the area to be imaged. Exposure may be released via remote control. The image data acquired by the detector are send wireless to the mobile unit.

The purpose of this submission is a new software version VF10, some minor hardware changes and the new device name MOBILETT Elara Max. The new software VF10 will introduce the following new features:

• The operating system will be MS Windows 10
• New cybersecurity features
• Additional pediatric programs
• Implementing a "Virtual Machine" that supports hospital IT
• The SSXIs have been updated
• The EMC (Electromagnetic Compatibility was tested according to the IEC 4th edition)
• The image processing algorithms (Diamond View MAX) will be used for exposures without grid.
• The Mobilett Elara will be coated with an anti-microbial paint

The provided text is a 510(k) summary for the Siemens MOBILETT Elara Max, a mobile X-ray system. The document focuses on demonstrating substantial equivalence to a predicate device (MOBILETT MIRA), primarily through non-clinical testing and comparison of technical characteristics, particularly regarding a new software version (VF10) and minor hardware changes.

*Crucially, this document does not contain any information about an AI-powered medical device or a clinical study that establishes acceptance criteria and then proves the device meets those criteria using expert consensus, MRMC studies, or specific performance metrics like sensitivity/specificity.

The device, MOBILETT Elara Max, is a standard X-ray imaging system. The updates described (new software, cybersecurity features, updated SSXIs, antimicrobial paint) are enhancements to the existing X-ray system, not features that introduce AI for diagnostic interpretation or require a clinical study with expert readers to establish diagnostic performance.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving an AI device meets them based on the provided text. The document is primarily a regulatory submission demonstrating substantial equivalence for a conventional medical imaging device.

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