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Transon General Spinal System (GSS) is intended for posterior pedicle screw fixation (GSS-VII can be applied for anterior or anterolateral fixation) of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.

When used as a posterior spine thoracic/lumbar system, Trauson General Spinal System (GSS) is indicated for one or more of the following: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pscudarthrosis, (6) spinal stenosis.

Trauson General Spinal System (GSS) is not intended for pedicle screw fixation above T8.

The applicant device of Trauson General Spinal System (GSS) made of Titaniuim Alloy (Ti-6AL-4V) that meet ASTM 136 is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients.

The applicant devices are not provided sterile. The materials are wildly used in the industry with well know biocompatibility. No new materials are used in the development of this implant. No surface modified or coated.

All variants use the same material, same design principle and are constant thickness.

No chemical for the enhancement of its clinical performance is applied on or incorporated into applicant device.

The provided text is a 510(k) summary for the Trauson General Spinal System (GSS), a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed acceptance criteria table and a study proving device performance against those criteria.

Therefore, the input does not contain the information requested in the prompt (acceptance criteria, device performance table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details). The document states "Performance tests demonstrate that the specifications of the proposed device meet its design input," but it does not elaborate on what those specifications or performance tests were.

Without explicit information from the provided text, I cannot complete the requested tables and descriptions based on this submission. This is a common characteristic of 510(k) summaries, which aim to establish equivalence rather than present full validation study results.

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