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The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood.

The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.

The ALARA BMA Neuro Access Kit utilizes a neuromonitoring platform in providing the surgeon with nerve / root location feedback during the approach to a pedicle to support a guidewire placement.

The ALARA BMAN and ALARA BMAC Kit includes various single-use needles designed for bone marrow aspiration and aspiration of autologous blood.

The provided text describes the regulatory clearance of the ALARA BMA Neuro Access Kit, focusing on its substantial equivalence to predicate devices based on design, materials, and non-clinical testing. However, it does not include acceptance criteria, reported device performance, or details of a study that proves the device meets specific performance criteria.

Therefore, I cannot populate the table or answer questions 2 through 9 based on the provided document. The document primarily focuses on regulatory approval based on comparison to existing legally marketed devices, rather than a detailed performance study against predefined acceptance criteria.

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