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The SOCON® Spinal System is intended for patients: a.) having severe spondylolisthesis (Grades 3 and 4) at the Lg-S, vertebral joint; b.) who are receiving fusions using autologous bone grafts 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. Levels of pedicle screw fixation for this indication are from L3 to S1.

The SOCON® Spinal System is a construct composed of implant-grade 6mm transpedicular bone screws of varying lengths (35mm to 65mm), straight and pre-bent rods, cross bars and specially designed clamps that are tightened by only one locking screw.

The provided text discusses the "Aesculap SOCON® Spinal System," a medical device. While it details the product's intended use, materials, and substantial equivalence to other devices, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

Instead, the document primarily focuses on regulatory approval (510(k) clearance) based on substantial equivalence. This type of clearance often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new performance studies against predefined acceptance criteria for novel claims.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving the device meets them because that data is not present in the provided text.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, number of experts for ground truth, or adjudication methods.
3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study.
4. The type of ground truth used, sample size for the training set, or how ground truth was established for a training set.

The section "Biomechanical Testing" states: "The implants and construct has undergone a variety of biomechanical testing, including static and dynamic testing for spinal implant assemblies in accordance with a draft ASTM standard. The test results show that the device components and system are able to provide significant stability with comparative realignment forces as other comparative devices." This indicates some testing was performed, but it lacks the specific details and quantitative results necessary to answer your questions thoroughly. It refers to comparing its performance to "other comparative devices" rather than predefined acceptance criteria.

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