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The Spinal Stabilizing Sphere System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Stabilizing Sphere System is intended to be used with bone graft.

The Spinal Stabilizing Sphere System consists of two types of CoCrMo spheres (full and trimmed), which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.

The provided documents (K063139) for the Biomet Spinal Stabilizing Sphere System do not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

Instead, the documents describe:

• The device (Spinal Stabilizing Sphere System) and its intended use.
• The fact that it is a preamendment, unclassified device.
• A summary of the substantial equivalence claim, citing predicate devices.
• The determination by the FDA that it is substantially equivalent to legally marketed predicate devices, with a specific labeling limitation: "The safety and effectiveness of this device for use in motion sparing, non-fusion procedures has not been established."
• Non-clinical testing was performed to determine substantial equivalence, but "The results indicated that the device was functional within its intended use." No specific details or acceptance criteria for this non-clinical testing are provided.
• Crucially, it explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, I cannot provide the requested table and study information because it is not present in the given text. The device's approval was based on substantial equivalence to predicate devices, not on meeting specific performance criteria demonstrated through a clinical study presented in this 510(k) submission.

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