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The SATELLITE™ Spinal 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 SATELLITE™ Spinal System is intended to be used with bone graft.

The SATELLITE™ Spinal System consists of spheres manufactured from either cobalt chrome or medical grade PEEK-OPTIMA LT1, which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.

The provided text describes the regulatory classification and marketing authorization for the SATELLITE™ Spinal System. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary and the FDA's clearance letter for the device, focusing on its substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, reported device performance, study details (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods), MRMC studies, or standalone algorithm performance, as these details are not present in the provided text.

The information provided only discusses:

• Device Name: SATELLITE™ Spinal System
• Manufacturer: Medtronic Sofamor Danek
• Product Description: Spheres manufactured from cobalt chrome or PEEK-OPTIMA LT1, implanted from L3-S1 for temporary stabilization and to promote fusion.
• Indications for Use: Inserted between vertebral bodies L3-S1 to provide stabilization and promote intervertebral body fusion, used with bone graft. Designed solely for holding bone parts in alignment while they heal.
• Regulatory Classification: Unclassified (at the time of clearance), later reclassified as Class III (Premarket Approval) on March 30, 2023.
• Substantial Equivalence: Demonstrated the PEEK-OPTIMA LT1 spheres with Tantalum markers were substantially equivalent to previously cleared cobalt chrome SATELLITE™ Spinal System devices (K051320).
• FDA Clearance: K060415/S1 on January 5, 2007, with a specific labeling limitation: "The safety and effectiveness of this device for use in motion sparing, non-fusion procedures has not been established."

To answer your questions about acceptance criteria and study data, information beyond what is supplied in these specific documents would be required. This type of information would typically be found in detailed clinical study reports or premarket approval (PMA) applications, which are generally more comprehensive than a 510(k) summary.

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