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The Mercury® II Spinal System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (TI-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is interior/anterolateral nonpedicle fixation, posterior non-pedicle fixation pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Spinal Elements Mercury II Spinal System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Mercury II or Overwatch Fixation Systems may be connected to the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Mercury II or Overwatch Spinal Systems. Refer to the Lotus Posterior Cervical/Thoracic Spinal System package insert for a list of Lotus indications for use.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mercury II and Overwatch implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatic pedicle screw fixation is limited to a posterior approach.

Spinal Elements' fenestrated screws are intended to be used with saline or radiopaque dye.

These devices are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Spinal Elements' Navigated Instruments are intended to be used during the preparation and placements' Mercury® II screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Spinal Elements' Mercury II Spinal System is comprised of a variety of screws and rods that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with screws.

Screws and rods are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F136 or ISO 5832-3. Additionally, some rods may be manufactured from cobalt-chrome alloy (Co-Cr) conforming to ASTM F1537 or ISO 5832-12.

Navigated instruments are surgical instruments manufactured from stainless steel, as specified in ASTM F899 or ASTM A564. Navigated instruments are non-sterile and are intended to be used with the Medtronic StealthStation® S7 and S8 System.

The provided text is a 510(k) premarket notification summary for the "Mercury® II Spinal System," a medical device. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or performance data related to an AI/Software as a Medical Device (SaMD).

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies that would be typical for an AI/SaMD product.

The performance data mentioned is related to mechanical testing of the spinal system (screws and rods), not to the performance of a diagnostic or interventional AI.

To answer your request, I must state that the provided text does not contain the necessary information. The document is a regulatory submission for a physical medical device (spinal system and instruments), not an AI/SaMD.

If you have a document describing an AI/SaMD for me to analyze, please provide it.

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