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The BWM Spine System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screw fixation is limited to L3 to S1 or the ilium.

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the system is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

The system consists of rods, screws, pedicle screws, sacral/iliac screws, hooks, articular screws, closure screws, nuts, and cross bridge components. The components are manufactured from titanium.

The provided text is a 510(k) summary for the BWM Spine System, a medical device. It describes the device, its intended use, and states that its substantial equivalence to predicate devices is based on intended use, materials, designs, and operational principles. It also mentions that "Bench testing demonstrates that the device will meet its mechanical functional requirements."

However, the document does not provide the detailed information requested regarding acceptance criteria and a study proving those criteria are met for the device's clinical performance. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, and details about ground truth establishment for clinical efficacy or safety.
• Details about experts, adjudication methods, or MRMC studies.
• Information on standalone algorithm performance (as this is a physical device, not an AI/algorithm).
• Details about training sets for any algorithm (again, not applicable here).

The "Bench testing" mentioned is likely mechanical testing to ensure the components meet strength and durability standards, but no specifics are given, nor does it relate to the clinical performance aspects typically inquired about for acceptance criteria.

Therefore, based on the provided text, I cannot complete the requested tables and information. The document focuses on regulatory approval based on substantial equivalence to existing devices and mechanical safety, not on a detailed clinical performance study with defined acceptance criteria for the outcomes of interest.

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