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The UNI-T Uni-Thread Spinal System is a pedicle screw system indicated for skeletally mature patients who:

• have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; .
• receive fusions using autogenous bone graft only; .
• · have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
• have the device removed after the development of a solid fusion. .

In addition, the UNI-T Uni-Thread Spinal System is a pedicle screw system intended to provide In addition, the UNF-1 Unl-Tiread Spinal System is a pkelers on on adjunct to fusion in fusion in fusion in immobilization and Sabilization of Spiralis in Skolouny Industry Industry of the thoracic, lumbar, and sacral spine:

• Degenerative spondylolisthesis with objective evidence of neurologic impairment .
• fracture ◆
• . dislocation
• scoliosis .
• kyphosis .
• spinal tumor .
• failed previous fusion (pseudoarthrosis) .

The UNI-T Uni-Thread Spinal System instrumentation consists of screws, rods and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The UNI-T System components are available in titanium alloy, manufactured according to ASTM F136.

The provided text is a 510(k) summary for the UNI-T™ Uni-Thread Spinal System. This document describes a medical device (spinal instrumentation) and its indications for use, and it declares substantial equivalence to existing devices.

The information you are requesting, specifically acceptance criteria and a study proving a device meets acceptance criteria, is typically associated with performance studies for diagnostic devices or those with quantifiable performance metrics that are clinically assessed. For a spinal implant system like this, the "acceptance criteria" and "study" are primarily focused on mechanical testing to demonstrate equivalence and safety, rather than a clinical performance study with specific sensitivity, specificity, or similar metrics.

Based on the provided text, here's an attempt to extract relevant information according to your request, but please note that some of your requested categories are not directly applicable or explicitly detailed for this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. "Mechanical testing" typically involves a specific number of constructs tested under various loading conditions, but the exact number of samples is not detailed in this summary.
• Data Provenance: Not specified, but likely refers to laboratory testing data (in-vitro mechanical tests) rather than clinical patient data.

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

This category is not applicable for this type of device and submission. "Ground truth" established by experts in the context of diagnostic performance (e.g., radiologists interpreting images) is not relevant for a mechanical implant. For mechanical testing, the "ground truth" is defined by established engineering standards and test protocols.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used in clinical studies involving interpretation or outcome assessment by multiple experts, which is not described for this device.

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. This is not an AI/diagnostic device.

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

Not applicable. This is not an algorithm/diagnostic device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" for mechanical performance is established through adherence to recognized mechanical testing standards and protocols (e.g., ASTM standards for medical implants). This involves measuring properties like fatigue strength, pull-out strength, and bending stiffness according to predefined methods, and comparing these results to predicate devices or established minimum performance criteria. The text explicitly mentions "Mechanical testing was performed to demonstrate the equivalence."

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device that requires a training set.

Summary of the Study Discussed (Mechanical Testing):

The primary "study" mentioned to support the UNI-T™ Uni-Thread Spinal System's safety and effectiveness is mechanical testing.

• Objective: To demonstrate the equivalence of the construct design to currently marketed spinal systems.
• Methodology (implied): The mechanical testing would have involved subjecting samples of the UNI-T System components (screws, rods, connectors) and assembled constructs to various mechanical loads and conditions (e.g., static and dynamic loading, fatigue testing) as specified by relevant industry standards (e.g., ASTM F1717 for Spinal Implant Constructs, ASTM F1798 for fatigue testing of pedicle screw spinal systems).
• Conclusion: The tests demonstrated the device's equivalence, implying that its mechanical performance characteristics are comparable to the predicate devices (SCS Claris Spinal System, Orthotec, Inc., and CD Horizon Sofamor Danek) which have already been cleared by the FDA. This equivalence in mechanical performance provides the scientific basis for demonstrating the device's safety and effectiveness for its intended use, as it suggests the device can withstand the physiological forces it will encounter in the body.

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