(137 days)
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The EXPEDIUM Spine System is a 5.5mm and 6.35mm rod based system offered in both titanium and stainless steel. Both systems consist of the following: Monoaxial Screws, Polyaxial Screws, Reduction screws, Reduction hooks, Hooks, Extended Tab Implants, Sacral Extenders, Lateral connectors, Washers.
The proposed addition to the EXPEDIUM Spine System is a 5.5 and 6.35mm rod and plate offset system offered in both titanium and stainless steel. The EXPEDIUM Spine System will also include the following: Fixed Bolts, Polyaxial Bolts, Closed screws, Slotted connectors, Plates, Nuts, Washers, Drop-entry connectors, Modular cross connectors, Transverse rod connectors, Wires.
These additional components are available in various geometries and sizes to accommodate patient anatomy. They will be provided non-sterile and sterile.
The provided document is a 510(k) premarket notification for additions to the EXPEDIUM® Spine System. This document describes a medical device (spinal implant components) and its substantial equivalence to previously cleared predicate devices, rather than a diagnostic device or AI/ML-driven system. Therefore, many of the requested criteria such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this type of submission.
However, I can extract the acceptance criteria and the "study" (in this case, mechanical testing) that demonstrates the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static compression bending | The acceptance criteria was/were met (as per ASTM F1717-04 standard). | Met |
| Static torsion | The acceptance criteria was/were met (as per ASTM F1717-04 standard). | Met |
| Dynamic compression bending | The acceptance criteria was/were met (as per ASTM F1717-04 standard). | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not specified in terms of number of samples, but the "test set" refers to the new components of the EXPEDIUM Spine System (closed screws, fixed bolts, polyaxial bolts, cross connectors, nuts, washers, wires, and plates) that underwent mechanical testing.
- Data Provenance: The tests were conducted according to ASTM F1717-04 standard, which is an international standard. The submission is from Medos International Sárl, located in Switzerland, with a contact person in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a mechanical device, and "ground truth" is established by adherence to engineering performance standards (ASTM F1717-04) rather than expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Mechanical testing results are objective measurements against a standard, not subject to adjudication.
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 physical spinal implant system, not a diagnostic or AI-assisted system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical spinal implant system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device is based on established mechanical engineering performance standards, specifically ASTM F1717-04, for spinal implant constructs in a vertebrectomy model.
8. The sample size for the training set:
Not applicable. This is a physical device, not an AI/ML system.
9. How the ground truth for the training set was established:
Not applicable. This is a physical device, not an AI/ML system.
In summary, the study proving the device meets its acceptance criteria involved nonclinical mechanical testing (Static compression bending, Static torsion, Dynamic compression bending) in accordance with the ASTM F1717-04 standard. The acceptance criteria for these tests were simply "the acceptance criteria was/were met" as defined by that standard. No clinical testing was performed for this 510(k) submission. The submission relies on substantial equivalence to predicate devices and the successful completion of these mechanical tests to demonstrate safety and effectiveness.
§ 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.