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When used as a posterior pedicle screw fixation system, the Synthes Small Stature USS and the Dual-Opening USS are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including small statue) 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, the Synthes Small Stature USS and the Dual-Opening USS are intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients (including small stature) and pediatric patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2.

When used as a posterior non-pedicle screw fixation system in skeletally mature patients (including small stature) and pediatric patients, the Synthes Small Stature USS and the Dual-Opening USS are intended for scoliosis, Schuermann's disease, degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar spine.

The anterior components of the Synthes Small Stature USS and the Dual-Opening USS when used in skeletally mature patients (including small stature) and pediatric patients are intended for anterolateral screw and/or staple fixation for the correction of anterolateral lordotic deformities for the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine (levels T8-L5).

In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix™ System. When used with 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Universal Spinal System and the Dual-Opening USS.

Synthes Dual-Opening USS consists of rods, plate/rods, clamps, screws, nuts and transconnectors. The implants are composed of Titanium or Stainless Steel.

The provided text is a 510(k) summary for the Synthes Dual-Opening USS. It outlines the device's components, indications for use, and the FDA's clearance of the device based on substantial equivalence to a predicate device.

However, the document does not contain any information regarding acceptance criteria or a study that rigorously proves the device meets specific performance metrics.

Therefore, I cannot fulfill your request for the following information:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample size used for the test set and the data provenance: This information is not present. The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical studies with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set or ground truth establishment in this context.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

• Device Description: Synthes Dual-Opening USS consists of rods, plate/rods, clamps, screws, nuts, and transconnectors made of Titanium or Stainless Steel.
• Indications for Use:
  • Posterior pedicle screw fixation system: For immobilization and stabilization of spinal segments in skeletally mature patients (including small stature) as an adjunct to fusion for acute and chronic instabilities or deformities (degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion).
  • Specific for severe spondylolisthesis (Grade 3 and 4) of L5-S1: In skeletally mature and pediatric patients receiving fusion by autogenous bone graft, with implants attached to L3-S2 and removal after solid fusion.
  • Posterior non-pedicle screw fixation system: In skeletally mature and pediatric patients for scoliosis, Scheuermann's disease, degenerative disc disease (back pain of discogenic origin with degeneration confirmed by history and radiographs), and fractures of the posterior thoracolumbar spine.
  • Anterior components: In skeletally mature and pediatric patients for anterolateral screw and/or staple fixation for correction of anterolateral lordotic deformities, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine (T8-L5).
  • Connectivity: Can be linked to CerviFix™ System (with 3.5/5.0 mm parallel connectors) and Universal Spinal System and Dual-Opening USS (with 5.0/6.0 mm parallel connectors).
• Regulatory Clearance: The FDA found the device substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. The regulatory number is K020517.

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