(87 days)
The EOI Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to spinal fusion of the thoracic, lumbar, and/or sacral spine. The EOI Spinal System is limited to non-cervical, pedicle use and is specifically indicated for treatment of one or more of the following acute and chronic instabilities or deformities:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- Spondylolisthesis;
- Trauma (fracture or dislocation);
- Deformities or curvatures (scoliosis, kyphosis, and/or lordosis);
- Tumor;
- Spinal stenosis;
- Pseudoarthrosis; and/or
- Failed previous fusion.
The EOI Spinal System consists of polyaxial pedicle screws in varying diameters and lengths, Ø5.5mm straight and pre-bent rods in varying lengths, and cross connectors in adjustable widths to build a spinal construct. EOI Spinal System components are manufactured from implant grade titanium alloy [Ti-6Al-4V ELI] in accordance with ASTM F-136. Instrumentation is also available to facilitate implantation of the device components. The EOI Spinal System can be rigidly locked into a variety of configurations suitable to the patient's unique anatomy. Implant components and instrumentation are provided non-sterily and must be sterilized prior to use. As with all orthopedic implants, all implant components in this system are single-use and should never be reused.
The EOI Spinal System is a pedicle screw fixation system that provides immobilization and stabilization of spinal segments.
Here's an analysis of its acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet ASTM F1717 mechanical testing standards for static axial compression bending. | The EOI Spinal System functioned as intended and demonstrated substantially equivalent mechanical properties to the predicate. |
| Meet ASTM F1717 mechanical testing standards for dynamic axial compression bending. | The EOI Spinal System functioned as intended and demonstrated substantially equivalent mechanical properties to the predicate. |
| Substantial equivalence to predicate device (CD HORIZON Spinal System from Medtronic Sofamor Danek, K063670) in intended uses, indications, technological characteristics, and principles of operation. | The EOI Spinal System was found to have the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. Minor technological differences raised no new issues of safety or effectiveness. |
Study Information
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Sample Size and Data Provenance:
- Test Set Sample Size:
- Static axial compression bending: n=6
- Dynamic axial compression bending: n=6
- Data Provenance: Not explicitly stated, but given that it's mechanical testing of a device, it's typically performed in a laboratory setting. This is a prospective test specifically for this device.
- Test Set Sample Size:
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Number and Qualifications of Experts for Ground Truth: Not applicable, as this is mechanical performance testing against a standard and comparison to a predicate device, not a diagnostic or clinical study requiring expert review for ground truth.
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Adjudication Method: Not applicable, as this is mechanical performance testing.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC study was not conducted. This is a pre-market notification (510(k)) for a medical device focusing on mechanical performance and substantial equivalence, not a clinical trial evaluating human reader performance with or without AI.
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Standalone Performance Study: Yes, a standalone mechanical performance study was done. The device's components were tested according to ASTM F1717 standards.
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Type of Ground Truth Used:
- Mechanical Test Standards: The ground truth for mechanical performance was established by adherence to ASTM F1717 standards for static and dynamic axial compression bending.
- Predicate Device Performance: Substantial equivalence was based on direct comparison of the EOI Spinal System's mechanical properties to those of the previously cleared CD HORIZON Spinal System (K063670).
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Sample Size for Training Set: Not applicable. There is no "training set" in the context of mechanical testing for a spinal implant. The device design and manufacturing processes are refined based on engineering principles and material science, not machine learning training data.
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How Ground Truth for Training Set was Established: Not applicable, as there is no training set in this context.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.