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The Cervical Spine Truss System Plating Solution (CSTS-PS) is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1.

The Cervical Spine Truss System Plating Solution (CSTS-PS) is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Cervical Spine Truss System Plating Solution (CSTS-PS) is comprised of cervical plates and screws. The cervical plates have a rotating locking tab for each double screw position to prevent back-out of the screw. The plates are available in 1-level, 3-level, 4-level, and 5-level configurations. Each plate is available in multiple lengths to accommodate varying patient anatomy. The screws are available in two diameters and various lengths. All CSTS-PS plates and screws are made from Ti6Al4V alloy.

The provided text describes the Cervical Spine Truss System Plating Solution (CSTS-PS), a medical device intended for anterior interbody screw fixation of the cervical spine. It focuses on demonstrating the device's substantial equivalence to predicate devices, particularly regarding its mechanical performance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The study described is focused on the mechanical performance of the device, not a clinical study involving patients or human data.

• Sample Size for Test Set: The text does not explicitly state the number of devices or components tested for each mechanical test (static compression bending, dynamic compression bending, static torsion, screw push out). It only indicates that "4WEB has conducted" these tests. For these types of biomechanical tests, sample sizes are typically determined by established standards like ASTM F1717 and ASTM F543, which would specify the number of samples required.
• Data Provenance: The data is generated from in-vitro (benchtop) testing in a laboratory setting by the manufacturer, 4WEB Medical, Inc. It is not patient data, and therefore, concepts like "country of origin" or "retrospective/prospective" do not apply in the typical sense for clinical trials.

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

This question is not applicable in the context of this submission. The "ground truth" for mechanical performance tests is established by the specified ASTM standards (F1717, F543, F2503) and the FDA Guidance Document, Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway. These standards and guidelines dictate the testing methodologies and acceptance thresholds, which are developed through a consensus process involving engineers, scientists, and regulatory bodies. The compliance is against these pre-defined, objective criteria, not based on expert consensus on individual test outcomes in the same way clinical ground truth is established.

4. Adjudication Method for the Test Set:

Not applicable. Mechanical testing results are objectively measured against pre-defined numerical or qualitative criteria specified in the ASTM standards and FDA guidance. There is no human adjudication process involved in interpreting these mechanical test results beyond verifying that the measurements fall within the acceptable ranges.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-interpretation AI devices where human readers' performance is being evaluated with and without AI assistance. The CSTS-PS is a physical medical implant, and its evaluation revolves around its mechanical and material properties, not its interpretive capabilities.

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

Not applicable. The CSTS-PS is a surgical implant, not an algorithm or AI system. Its "performance" is assessed through its physical and mechanical properties in a standalone, benchtop testing environment.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is derived from established engineering standards and regulatory guidance. Specifically:

• ASTM F1717: Standard Test Methods for Static and Fatigue Testing of Spinal Implant Constructs in a Corpectomy Model.
• ASTM F543: Standard Specification for Metallic Medical Bone Screws.
• ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
• FDA Guidance Document, Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway (December 11, 2020): This document provides the specific acceptance criteria for the various mechanical tests.

These documents establish the objective performance benchmarks against which the device's mechanical integrity and MR compatibility are evaluated.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its development and testing are based on engineering principles and materials science, not machine learning.

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

Not applicable, as there is no "training set" for this device.

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