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The SOCON® Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the SOCON® Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The SOCON® Spinal System is a multiple component system comprised of a variety of single-use, non-sterile devices that allow the surgeon to build a spinal implant construct in order to provide stabilization and promote spinal fusion. The implants are manufactured from titanium alloy, Ti6A14V, in accordance to ISO 5832/3 and include pedicle bone screws, straight and pre-bent rods, cross bars and self-locking clamps. Specialized instrumentation made from surgical grade stainless steel in accordance to ISO 7153/1 is available for the application and removal of the SOCON implants.

The provided text is a 510(k) summary for the SOCON® Spinal System Expanded Pedicle Screw Indications. It focuses on regulatory clearance for expanded indications based on FDA's final rule for pedicle screw systems and establishes substantial equivalence to a predicate device.

There is no study described in this document that proves the device meets acceptance criteria.

The document states: "There have been no design modifications or technological changes to the current SOCON® Spinal System since receiving FDA clearance under #K970285, and therefore it is substantially equivalent to itself." This explicitly indicates that no new performance testing was conducted for this specific 510(k) submission.

Therefore, I cannot provide information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided for this submission. The device is cleared based on substantial equivalence to a previously cleared device and updated indications for use.
2. Sample size used for the test set and the data provenance: No new test set data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable (this is not an AI device).
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable (this is not an AI device).
9. How the ground truth for the training set was established: Not applicable (this is not an AI device).

Summary of available information from the document:

This 510(k) submission (K993551) for the SOCON® Spinal System Expanded Pedicle Screw Indications is a regulatory submission for expanding the "Indications for Use" of an already cleared device (K970285). The expansion is based on an FDA final rule for pedicle screw systems. The device is deemed substantially equivalent to its previous clearance (K970285) because there have been no design modifications or technological changes. It is also found substantially equivalent to the VSP System (Pedicle Screw Indications) by DePuy AcroMed, Inc. (K984350) for the purpose of the expanded indications.

The document does not contain any information about new performance studies, acceptance criteria, or testing data for the device.

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