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The Ortelius 800 is a prescriptive device intended to measure the angle of spinal deformity as an aiding tool for the diagnosis and monitoring of spinal deformities such as scoliosis and kyphosis.

The Ortelius 800 may be used in medical clinics/institutes.

The Ortelius 800 is a device designed for the measuring and monitoring spine deformities.

The Ortelius 800 enables the following features:

• · Spine curve reconstruction based on the points sampled by the Sensor.
• · Automatically calculated spine deformity angles of the primary curve.
• · Indication of the extreme vertebra from which the spine deformity angle was calculated.

The provided text describes the Ortelius 800, a goniometer intended to measure spinal deformity angles. However, it does not include detailed information regarding acceptance criteria, a specific study proving device performance against those criteria, or the methodology for such a study.

Therefore, I cannot populate the table or answer the specific questions requested, as the necessary information is not present in the provided document.

The document primarily focuses on:

• The device's general description and intended use.
• Its classification and regulatory aspects (510(k) submission, substantial equivalence to predicate devices).
• Compliance with general performance standards (IEC 60601-1, etc.) which are related to electrical safety and electromagnetic compatibility, not clinical performance for angle measurement accuracy.

To provide the requested information, a document detailing the clinical or performance validation study would be required.

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