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The Primus Spinal Fixation 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 (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is interior/ anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior 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 Primus Spinal Fixation System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Primus 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 Primus 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 pediative patients, the Primus and Overwatch implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric 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' Primus 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 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' Primus Spinal Fixation System is comprised of a variety of screws, hooks, rods, and connectors 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.

Navigation instruments are non-sterile and are intended to be used with the Medtronic StealthStation® S7 and S8 System.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria. Instead, the document is a 510(k) premarket notification letter from the FDA regarding the "Primus Spinal Fixation System," stating its substantial equivalence to a legally marketed predicate device.

The document discusses:

• The FDA's review and determination of substantial equivalence.
• General controls and additional controls applicable to the device.
• Requirements for quality systems, reporting adverse events, and unique device identification.
• The indications for use of the Primus Spinal Fixation System.
• A 510(k) summary, including:
  • Submitter and device information.
  • Device description (screws, hooks, rods, connectors, navigation instruments).
  • Detailed indications for use.
  • Technological characteristics and comparison to a predicate device (Mercury® II Spinal System K222516).
  • Performance Data: This section only mentions mechanical testing (Static and Dynamic Compression Bending, Static Torsion, Tensile Dissociation, Neutral and Max Angle testing per ASTM standards) to demonstrate substantial equivalence to the predicate device. It explicitly states, "The subject device has the same performance characteristics as the previously cleared predicate device..." and "Testing conducted demonstrates substantial equivalence to the predicate device."

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as this information is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence, primarily supported by mechanical testing against established ASTM standards, not clinical performance studies with acceptance criteria as typically understood for AI/ML-driven medical devices (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement).

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