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When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Sniper® Spine System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Sniper® Spine System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

The Sniper® Spine System percutaneous instruments are intended to be used with the Sniper® Spine System implants. The percutaneous instruments when used with the percutaneous cannulated screws and percutaneous rods, are intended to provide the surgeon with a percutaneous approach for posterior spinal surgery for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). As well as, for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

The Sniper Spine System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw components of the Sniper® Spine System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

The provided text is a 510(k) premarket notification for the Sniper® Spine System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than proving the device meets a set of acceptance criteria through a clinical or performance study in the way an AI/ML diagnostic or prognostic device would.

Therefore, the requested information regarding "acceptance criteria" and "the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is not directly applicable to this document. This document describes a traditional medical device (spinal implant system) and its regulatory clearance process.

Specifically, the document states:

• Purpose of Submission: "The purpose of this submission is to gain clearance for the additional length rods to the cleared Sniper® Spine System." (page 3)
• Performance Data: "Performance evaluations were previously conducted on constructs representing the worst case components (including static torsion, static axial compression and dynamic axial compression bending in accordance with ASTM F1717). Engineering rationales determined that the proposed implants were substantially the same as the predicate devices." (page 4)

This indicates that:

• The "performance data" refers to mechanical and material testing (e.g., static torsion, static axial compression, dynamic axial compression bending) of the physical implant components, not a study evaluating human or AI performance.
• The "acceptance criteria" for this device would be tied to the mechanical specifications and safety standards (like ASTM F1717) for spinal implants, ensuring they can withstand physiological loads. The document states that engineering rationales determined the new implants were "substantially the same" as the predicate based on these tests. This means the device met the existing standards already established for the predicate.

The questions regarding "sample size for the test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set" are all relevant to the evaluation of AI/ML or diagnostic devices. They are not applicable to the regulatory review of a physical implant system like the Sniper® Spine System, which relies on demonstrating substantial equivalence in design, materials, and established mechanical performance to a predicate device.

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