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The Spine-Tech Silhouette Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the LS-S1 joint; b) who are receiving fusion using 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 Spine-Tech Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined 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 sacral/iliac attachment only, screws of the Spin-Tech 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 Spine-Tech Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitates the biological process of the spine. This system is intended for posterior use in the thoracic, lumbar and sacral regions of the spine. Implants of this system consist of hooks and/or screws, polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors, both fixed and variable. All implants in this system are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V), conforming to ASTM F-136.

The implants of this system are for single use only. An implant should never be reused after being removed from the body or sterilized after coming into contact with body fluids or tissues.

The provided document is a 510(k) summary for the Spine-Tech Silhouette™ Spinal Fixation System. It describes the device, its intended use, and the basis for its substantial equivalence to predicate devices. However, it does not contain information regarding specific acceptance criteria, a formal study demonstrating the device meets those criteria, or details about a test set, ground truth, or expert involvement typically associated with AI/software device evaluations.

Instead, this document focuses on a medical device (spinal implant system) rather than a software or AI-based diagnostic/predictive device. The "testing" mentioned refers to biomechanical testing of the physical implants.

Therefore, many of the requested categories are not applicable to the content provided.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not specify quantitative acceptance criteria in terms of performance metrics commonly associated with software/AI (e.g., sensitivity, specificity, AUC). The performance reported is that the physical device components showed "equivalent mechanical performance" to predicate devices.

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

• Sample Size for Test Set: Not applicable. The "testing" refers to biomechanical tests on device components, not a clinical test set from human data for an AI/software.
• Data Provenance: Not applicable. The biomechanical testing would have been conducted in a lab setting, not using human data from a specific country or in a retrospective/prospective manner.

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

• Number of Experts: Not applicable. Ground truth, in the context of AI/software, refers to clinically verified labels or outcomes. For biomechanical testing, the "ground truth" would be established by engineering standards and measurements, not clinical experts.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there is no clinical test set or ground truth adjudication process described.

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

• MRMC Study: No, this type of study is typically conducted for diagnostic imaging devices where human readers interpret medical images, often with AI assistance. This document describes a physical spinal implant system.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable, as this is a physical medical device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the biomechanical testing, the "ground truth" would be the established engineering and materials science standards for spinal implants (e.g., ASTM F-136 for titanium alloy, specifications for load-bearing, fatigue, etc.). This is a physical or engineering "ground truth," not a clinical ground truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document is not about an AI/ML model, so there is no training set in that sense. The design and manufacturing processes are informed by engineering principles and possibly prior iterations, but not a "training set" of data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model. The design and manufacturing of the physical device components are based on established engineering and medical device standards.

Summary of Document's Focus:

The K980288 document is a premarket notification for a physical medical device. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, primarily through comparison of materials, design, function, and biomechanical testing. It does not involve software or artificial intelligence, and therefore, the requested information pertaining to AI/software validation studies is not present.

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