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The APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).

The APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers 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.

The APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the confirmed by by history and radiographic disc studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

The APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers is a rod-based system designed to interface with various spinal anatomies. The 5.50mm Rods are available in various lengths and are designed for use with the previously cleared titanium alloy components of the APEX Spine System which can accept a 5.50mm spinal rod, including monoaxial, polyaxial screws, hooks, and connectors. The polyaxial screw washers are available in 2 sizes. The smaller washer size is for use with the APEX Polyaxial Screws with shaft diameter from 4.75mm to 7.00mm and the larger washer size to be used with the APEX Polyaxial Screws with shaft diameters 7.75mm and 8.50mm.

Here's a breakdown of the acceptance criteria and study information for the SpineCraft APEX Spine System 5.5mm Rod & Polyaxial Screw Washers (K092825), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• APEX Spine System: K062513 - SpineCraft
• MONARCH Spine System: K010576, K024348 - DePuy AcroMed, Inc.
• MOSS MIAMI Spinal System: K013296 - DePuy AcroMed, Inc. | The APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers is substantially equivalent to the listed predicate devices. The fundamental scientific technology is identical to previously cleared systems. |
  | Mechanical Performance: Mechanical and dynamic performance (e.g., strength, durability, fatigue resistance) must be at least comparable to, or better than, predicate devices. (Specific quantitative acceptance criteria are not provided in this summary, but are the underlying basis for the conclusion.) | "The test results demonstrate that the mechanical performance of the APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers is at least comparable to, if not better than, those of the predicate devices." (Specific quantitative results are not provided in this summary.) |

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the given 510(k) summary. The document focuses on mechanical and dynamic testing, not clinical studies with human patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable as the "test set" here refers to mechanical testing of the device itself, not a clinical dataset requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for mechanical testing.

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

An MRMC study is not applicable to this type of device (spinal fixation system) or the testing described (mechanical and dynamic performance). This device is hardware, not an AI diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the mechanical and dynamic testing, the "ground truth" would be established by engineering standards and validated test methods. This involves material specifications (e.g., ASTM F-136, ISO 5832-3 for Ti-6Al-4V) and specific mechanical test protocols designed to simulate in vivo conditions and evaluate properties like fatigue life, static strength, and torsional rigidity. The results are then compared to established performance benchmarks for similar devices or predicate device performance.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable as the device is not an AI/ML algorithm.

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