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When used as a pedicle screw fixation system in skeletally mature patients, the Cadence™ Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments 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, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Cadence Spinal Fixation System is indicated for use in patients:
a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
b) who are receiving fusions with autogenous graft only
c) who are having the device fixed or attached to the lumbar or sacral spine; and
d) who are having the device removed after the development of a solid fusion mass
When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

When used as a hook and sacral screw system, the Cadence Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Cadence Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Cadence™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varving diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed and adjustable widths. The implants in this system are manufactured from titanium allov (Ti-6Al-4V) that conforms to ASTM F-136.

The Cadence™ Spinal Fixation System is a medical device, and the provided document is a 510(k) premarket notification. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving performance through extensive clinical studies with acceptance criteria in the same way a novel AI algorithm might. Therefore, many of the requested fields about AI-specific study design (e.g., sample size for training/test sets, expert ground truth, MRMC studies, standalone performance) are not applicable or directly addressed in this document.

Here's an analysis based on the provided text, focusing on the evidence presented to support the device's acceptance:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated. The study involved mechanical testing of components, not human patient data in the context of this 510(k) summary. The "test set" here refers to the actual physical components tested.
• Data Provenance: Not applicable in the context of a clinical test set. The data originates from laboratory mechanical testing.

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

• Number of Experts: Not applicable. Ground truth for mechanical properties is established by adherence to standardized testing protocols (ASTM F 1717-96 and ASTM F 1798-97), not expert consensus on clinical findings.
• Qualifications of Experts: Not applicable. The "ground truth" is defined by the physical properties measured according to the ASTM standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Mechanical testing results are objective measurements based on standardized methodologies, not subject to human interpretation requiring adjudication in this context.

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:

• MRMC Study: No. This is a spinal fixation system, not an AI or imaging diagnostic device. MRMC studies are not relevant to its evaluation.
• Effect Size of AI Improvement: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Standalone Performance: No. This is a physical implantable device, not an algorithm.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The ground truth for the device's performance is based on standardized mechanical performance metrics outlined in ASTM F 1717-96 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model) and ASTM F 1798-97 (Standard Guide for Evaluation of Spinal System Constructs in a Vertebrectomy Model). These standards define the expected biomechanical behavior and material characteristics for such devices.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence for a physical medical device. The "training" in manufacturing comes from established engineering principles and quality control processes.

9. How the Ground Truth for the Training Set Was Established:

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of the Study and How the Device Meets Acceptance Criteria:

The study that proves the Cadence™ Spinal Fixation System meets acceptance criteria is a series of mechanical tests conducted according to established industry standards: ASTM F 1717-96 and ASTM F 1798-97.

The acceptance criteria are implicitly derived from the performance of the predicate device, the Silhouette™ Spinal Fixation System, and the requirements of the ASTM standards themselves. The core acceptance criterion for this 510(k) submission is "substantial equivalence" in mechanical properties to the predicate device.

The study demonstrated that the Cadence™ Spinal Fixation System's components exhibited "substantially equivalent mechanical properties" when compared to the previously cleared Silhouette™ Spinal Fixation System components. This means that the Cadence™ system passed the mechanical tests (likely involving dynamic and static loading, fatigue, and material strength) at levels comparable to, or better than, the predicate device. The use of titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 further supports its material suitability and biocompatibility, aligning with established standards for implantable medical devices.

The FDA's clearance (K022374) confirms that based on this mechanical testing and comparison, the device is considered substantially equivalent to the predicate device for its stated indications for use.

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