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510(k) Data Aggregation
(132 days)
4S SPINAL SYSTEM
The 4STM SPINAL SYSTEM is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bon graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the 4STM SPINAL SYSTEM is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
The 4STM SPINAL SYSTEM is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, bolt, and a transverse (cross) linking mechanism. The 4STM SPINAL SYSTEM will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The 4STM SPINAL SYSTEM implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4STM SPINAL SYSTEM.
The provided text describes a 510(k) submission for the 4STM SPINAL SYSTEM, a pedicle screw spinal fixation device. The focus of the performance data in this submission is on mechanical testing rather than AI/software performance. Therefore, many of the requested categories related to AI model evaluation (such as sample size for test/training sets, expert adjudication, MRMC studies, standalone performance with AI, and ground truth establishment) are not applicable to this specific submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|
| Demonstrates equivalence to predicate devices in mechanical testing, specifically to the Global Spinal Fixation System (K001668) and OPTIMA™ Spinal System (K031585). | Mechanical testing conducted in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The study involved mechanical testing of components, not human subject data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth was established through mechanical testing standards, not expert clinical assessment.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for human interpretation tasks, not mechanical testing.
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 a medical device for physical implantation, not an AI-assisted diagnostic or interpretative tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not have an "algorithm only" component in the context of AI performance. The device itself is a standalone physical implant.
7. The Type of Ground Truth Used
The ground truth or performance standard used was established by mechanical testing protocols, specifically ASTM F1717. This standard defines the methods for bending and torsion testing of spinal implant constructs.
8. The Sample Size for the Training Set
Not applicable. There is no AI model or training set described.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no AI model or training set described.
Summary of the Study:
The study proving the device meets its acceptance criteria is a mechanical testing study. This study was conducted in accordance with ASTM F1717, a standard specification for spinal implant constructs in vitro. The results of this testing demonstrated that the 4STM SPINAL SYSTEM is mechanically equivalent to its legally marketed predicate devices: the Global Spinal Fixation System (K001668) and the OPTIMA™ Spinal System (K031585). The specific number of implants or test specimens used in this mechanical testing is not detailed in the provided text (though typically, ASTM standards require a certain number of samples for statistically valid results). The data provenance is from the manufacturing site in the Republic of Korea.
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