(29 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 subject EXPEDIUM Spine System components consist of designs that interface to 5.5mm and 6.35mm rods and are available in various geometries and sizes.
This document describes a 510(k) premarket notification for the EXPEDIUM Spine System, a medical device for spinal fixation. It is not a traditional AI/ML device approval, therefore much of the requested information about AI model performance, training sets, and ground truth establishment is not applicable.
Here's the relevant information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document states that "Performance data per ASTM F 1798 were submitted to characterize the subject EXPEDIUM Spine System components addressed in this notification." This implies that the acceptance criteria are tied to the standards outlined in ASTM F 1798. However, the specific quantitative acceptance criteria (e.g., maximum deflection, fatigue life, strength) and the reported performance values are not provided in the summary. The document only confirms that data was submitted, not the results themselves.
| Acceptance Criteria (Based on ASTM F 1798) | Reported Device Performance |
|---|---|
| Specific details not provided in summary | Specific details not provided in summary |
| Adherence to mechanical and material standards for spinal implant assemblies | Data submitted to characterize components (per ASTM F 1798) |
Note: For medical devices like spinal fixation systems, acceptance criteria typically involve detailed mechanical testing (e.g., static and dynamic compression, bending, torsion), biocompatibility, and material characterization to ensure safety and effectiveness. The ASTM F 1798 standard specifically deals with the fatigue testing of intervertebral body fusion devices.
2. Sample Size Used for the Test Set and Data Provenance
The document describes mechanical performance testing, not data analysis or human subject testing in the traditional sense of a "test set" for an AI model. Therefore, the concept of sample size for a "test set" and "data provenance" (country of origin, retrospective/prospective) as it applies to an AI/ML device is not applicable here. The "test set" for this device would refer to the physical components subjected to mechanical tests. The specific number of components tested is not provided in the summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as this is a physical medical device (spinal fixation system) and not an AI/ML product. The "ground truth" for such a device is established through adherence to engineering specifications, material science principles, and mechanical testing standards (like ASTM F 1798). Experts involved would be engineers, material scientists, and potentially surgeons for clinical relevance, but their role is not in establishing a data "ground truth" as it would be for an AI model.
4. Adjudication Method for the Test Set
This concept is also not applicable as this is a physical medical device. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert labeling or diagnoses for AI/ML training or evaluation datasets.
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-analysis AI/ML systems where human readers interpret cases with and without AI assistance to measure improved performance. This device is a physical implant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
This question is not applicable as the device is a physical spinal implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering standards and mechanical test results. Specifically, the summary states "Performance data per ASTM F 1798 were submitted." ASTM F 1798 is a standard specification for fatigue test performance of spinal artificial disc prostheses and components. Therefore, the ground truth is derived from objective mechanical testing outcomes compared against established engineering standards.
8. The Sample Size for the Training Set
This information is not applicable as this is a physical medical device, not an AI/ML product. There is no "training set" in the context of machine learning. The design and manufacturing process would involve iterative engineering and testing, but not in the sense of an AI training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
§ 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.