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When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ 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 Silhouette™ Spinal Fixation System is indicated for use in patients:

• having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
• who are receiving fusions with autogenous graft only
• who are having the device fixed or attached to the lumbar or sacral spine, and
• who are having the device removed after the development of a solid fusion mass

When used as a hook and sacral screw system, the Silhouette™ 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 Silhouette™ 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 Silhouette™ 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. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F-136.

Here's a breakdown of the acceptance criteria and study information for the Sulzer Spine-Tech Silhouette™ Spinal Fixation System, based on the provided document:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the test set. It mentions "Fatigue Testing of Silhouette™ Spinal Fixation System/adjustable transverse connector construct." The data provenance is not specified beyond being generated by Sulzer Spine-Tech for regulatory submission. It is a non-clinical, in-vitro test.

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

This information is not applicable. The study is a non-clinical, in-vitro device performance test against a predefined engineering standard (ASTM Provisional Standard PS 5-94), not a clinical study involving expert interpretation of data or patient outcomes. Therefore, there's no "ground truth" in the sense of expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are typically relevant for clinical studies where there may be disagreements among human reviewers. This was a physical performance test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This document describes non-clinical engineering performance testing of a spinal fixation system.

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

Yes, in a sense, a "standalone" test was performed. The device, specifically the adjustable transverse connector and the system construct, was subjected to a standalone physical performance test without human involvement in its operation or interpretation during the test itself. The test was to evaluate the physical properties of the device against an established standard.

7. The Type of Ground Truth Used

The ground truth used was based on an established engineering standard: ASTM Provisional Standard PS 5-94, Test Method for Static and Dynamic Spinal Implant Assembly in a Corpectomy Model. The acceptance criteria (no failures, 156 N run-out load, 5,000,000 cycles) are derived directly from this standard.

8. The Sample Size for the Training Set

This information is not applicable. This document describes performance testing of a physical medical device, not an AI/ML algorithm that would require a training set.

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

This information is not applicable, as there is no training set for an AI/ML algorithm.

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