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The RELIANCE Spinal Screw System is a pedicle screw systems 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, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The RELIANCE Spinal Screw System is also indicated for pedicle screw fixation 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.

When used posteriorly, the RELIANCE Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for, spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The RELIANCE Spinal Screw System when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

When used in a percutaneous, posterior approach with MIS Instrumentation, the RELIANCE Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications:spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Posterior RELIANCE Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated poly axial screws, cannulated reduction screws, hooks, reduction hooks, set screws, transverse connectors.

The Anterior RELIANCE Spinal Screw System consists of two spinal rods, monoaxial screws, staples, and set screws. The Anterior RELIANCE staples and screws are intended to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section.) The RELIANCE Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the RELIANCE Spinal Screw System are available in Cobalt Chrome conforming to ASTM F-75 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

The provided document is a 510(k) summary for the Reliance Spinal Screw System, a spinal fixation device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria through clinical studies in the same way an AI/software device would.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance from a test set, expert involvement, or details about training sets, as these are typically applicable to performance-based evaluations for AI/ML or diagnostic devices.

Here's why the requested information isn't available in this document:

• Device Type: The Reliance Spinal Screw System is a physical medical device (spinal implant), not a software or AI-driven diagnostic tool. Its evaluation relies on mechanical testing and comparison to existing, legally marketed similar devices, not on diagnostic accuracy metrics.
• 510(k) Pathway: The 510(k) premarket notification pathway aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing indications for use, technological characteristics (materials, design), and performance data (often non-clinical, such as mechanical testing). It does not usually require clinical studies to prove performance against specific acceptance criteria for diagnostic accuracy, sensitivity, or specificity.
• Non-Clinical Testing: The document mentions "Non-Clinical Testing including Static Compressive, Static Torsion, and Dynamic Compressive in accordance with ASTM F1717." These are mechanical strength tests, common for implants, to ensure they can withstand physiological loads. The acceptance criteria for these tests would be defined by the ASTM standard, but the document does not elaborate on specific values or results.

Summary of requested information as found/not found in the document:

1. A table of acceptance criteria and the reported device performance: Not found. The document describes non-clinical mechanical testing (Static Compressive, Static Torsion, Dynamic Compressive per ASTM F1717) but does not provide specific acceptance criteria or performance values from these tests. These mechanical tests are to demonstrate structural integrity, not diagnostic performance.
2. Sample size used for the test set and the data provenance: Not applicable/Not found. As this is a mechanical device, performance is evaluated through non-clinical mechanical testing, not a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not found. Ground truth based on expert consensus is relevant for diagnostic or AI devices, not for a spinal screw system whose performance is assessed mechanically.
4. Adjudication method: Not applicable/Not found.
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/Not found. This is for AI-assisted diagnostic devices.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not found. This is for AI-driven algorithms.
7. The type of ground truth used: Not applicable/Not found.
8. The sample size for the training set: Not applicable/Not found. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable/Not found.

In conclusion, the document provides information relevant to the regulatory approval of a spinal implant device, focusing on its materials, design, intended use, and substantial equivalence to predicate devices, supported by non-clinical mechanical testing. It does not address the types of performance criteria or study designs typically associated with AI or diagnostic imaging devices.

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