(44 days)
The ILLICO® FS System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The ILLICO FS System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1 inclusive. The ILLICO FS System is indicated for treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies; degenerative disease of the facets with instability; trauma (i.e. fracture or dislocation); spondylolisthesis; spondylolysis; pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity.
The ILLICO FS System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The system is comprised of the Facet Screw and Facet Lag Screw offered in two diameters (4.5mm and 5.0mm) and instrumentation. The implant provides bilateral facet fixation, with or without bone graft, at single or multiple levels and can be used in conventional or percutaneous surgical procedures. The implants are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The facet screw is a dual lead self-tapping titanium screw with a positive (male) hexalobular drive feature. The spherical feature of the screw mates with the spherical surface of the washer allowing for angulations of the washer to accommodate differences in the anatomy between patients. The washer also distributes the compression force across a larger surface area, reducing the stress on the dorsal surface of inferior facet joint. The internal threads located in the hexalobular feature are used if axial force is needed during the removal of the screw. The ILLICO® FS Facet Fixation System thread profile is designed to the standard for cortical bone screws (ASTM F543-07). The thread is also a dual lead, which minimizes the number of rotations needed to implant the screw. The integral tapping flutes allow the screw to be placed without tapping prior to screw placement.
The provided 510(k) summary describes a spinal fixation system, not an AI/ML powered medical device. Therefore, many of the requested criteria related to AI/ML device performance and validation (such as human readers improvement with AI, standalone performance, training set details, and expert qualifications for ground truth) are not applicable.
Here's an analysis of the provided information, focusing on the relevant criteria for a non-AI medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Torsion Yield Strength | Acceptable Results |
| Pull Out Force | Acceptable Results | |
| Static Bending Testing | Acceptable Results | |
| Dynamic Testing | Acceptable Results | |
| Substantial Equivalence | Comparison to Predicate Devices | Demonstrated substantial equivalence based on acceptable mechanical test results. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria is a series of non-clinical mechanical tests.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable to mechanical testing of a spinal implant. The "test set" in this context would refer to the number of devices or components subjected to each mechanical test. The document does not specify the exact number of samples tested for each mechanical assessment, but it implies standard practices for such testing were followed. Data provenance is not relevant as it's not a clinical or imaging study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This is not applicable as the acceptance criteria are based on objective mechanical properties, not expert-interpreted "ground truth." The "ground truth" for mechanical testing is derived from quantitative measurements of physical properties against established standards.
4. Adjudication Method for the Test Set
This is not applicable to mechanical testing. Mechanical tests have predefined pass/fail criteria based on measured physical properties.
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
This is not applicable. The ILLICO® FS Facet Fixation System is a physical spinal implant, not an AI/ML powered device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The ILLICO® FS Facet Fixation System is a physical spinal implant, not an AI/ML powered device.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance was:
- Mechanical Performance Standards: Specifically, ASTM F 543-07 (Standard Specification for Cortical Bone Screws) and ASTM F 2193-02 (Standard Practice for Evaluation of Spinal Intervertebral Fusion Devices). These standards dictate acceptable performance thresholds for the various mechanical properties tested.
- Predicate Device Performance: The mechanical test results were also compared to the performance characteristics of its predicate devices (RaptorTM Facet Fixation System - K110170 and Chameleon Fixation System - K071420) to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable as this is not an AI/ML powered device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as this is not an AI/ML powered device.
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