(87 days)
The EBI Omega 21™ System is a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.
When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, 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 neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (psuedarthrosis).
In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or turnor resection.
When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.
The EBI Omega 21™ System is a spinal fixation device that uses rods, screws, and couplers. This submission is for expanding the range of screw sizes to offer an additional 7 and 8mm expansive screw.
The provided text is a 510(k) Summary of Safety & Effectiveness for the EBI Omega 21™ System, a spinal fixation device. This document is a regulatory submission to the FDA for market clearance, primarily focused on showing substantial equivalence to previously cleared devices.
Based on the information provided in the input, here's a breakdown of the requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: The EBI Omega 21™ System must demonstrate equivalent structural integrity and mechanical properties to the predicate devices. This includes aspects like fixation strength, resistance to fatigue, and general stability under physiological loads. | The submission directly states: "There are no significant differences between the EBI Omega 21™ System and other currently marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to... function." This implies that the device meets the functional expectations and performance characteristics of the predicate devices. The expansion to new screw sizes (7 and 8mm expansive screw) would have been supported by internal testing to demonstrate these new components maintain the equivalent performance of the overall system. |
| Material Biocompatibility: Components must be made from biocompatible materials suitable for long-term implantation. | "The components of the system are manufactured from Ti-6AI-4V ELI per ASTM F136." This material is a widely accepted and established biocompatible material for implantable medical devices. Compliance with ASTM F136 directly addresses this criterion. |
| Dimensions and Specifications: New screw sizes (7mm and 8mm expansive screws) must meet specified dimensional tolerances and be compatible with the existing EBI Omega 21™ System. | While specific dimensions are not listed, the submission is focused on "expanding the range of screw sizes to offer an additional 7 and 8mm expansive screw." This implies these new sizes were specifically designed and manufactured to integrate with the existing system and meet the necessary specifications. |
| Safety Profile: The device should not introduce new safety concerns compared to the predicate devices. | The core of a 510(k) submission is to demonstrate substantial equivalence, which inherently includes safety. By stating "There are no significant differences between the EBI Omega 21™ System and other currently marketed spinal systems," and that it is "substantially equivalent* to the predicate devices," the manufacturer asserts that the safety profile is comparable and acceptable. |
Study Proving Acceptance Criteria:
The document describes a reliance on substantial equivalence rather than presenting a detailed de novo clinical or non-clinical study designed with specific acceptance criteria in the manner of an AI/software device. The entire 510(k) submission itself serves as the "study" or evidence package demonstrating that the EBI Omega 21™ System, with the expanded screw sizes, meets the acceptance criteria by being "substantially equivalent" to its predicate devices (EBI Omega 21™ System, EBI SpineLink™ System).
This type of submission for a spinal fixation device typically involves:
- Bench Testing: Mechanical testing (e.g., static and fatigue testing, pull-out strength, torsional strength) of the new screw sizes and the overall system to demonstrate performance comparable to the predicate devices and relevant ASTM standards. Although not explicitly detailed in this summary, such testing would be included in the full submission.
- Material Characterization: Verification that the materials meet ASTM F136 standards.
- Comparison to Predicate Devices: A detailed comparison of design, materials, intended use, and performance characteristics between the new device (with expanded screw sizes) and the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. For mechanical testing of medical devices like spinal implants, samples would typically consist of a certain number of devices or components tested according to relevant ASTM or ISO standards to ensure statistical validity. This is not a "test set" in the context of clinical data for AI, but rather a set of physical devices subjected to engineering tests.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The "studies" for this type of submission are primarily non-clinical (bench) tests and material analyses, not human clinical trials in the conventional sense for the aspect of adding new screw sizes. The provenance would be the manufacturing site and testing laboratories of Electro-Biology, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable in the context of the provided document. Ground truth, in this context, would be established by:
- Engineering standards (e.g., ASTM F136 for materials, other ASTM/ISO standards for mechanical performance).
- Performance data from the legally marketed predicate devices.
- Regulatory requirements for spinal fixation devices.
The "experts" involved are likely internal engineering and regulatory teams at Electro-Biology, Inc., and potentially external independent testing labs. The FDA reviewers (Celia M. Witten, Ph.D., M.D., Director, Division of General and Restorative Devices) are the regulatory experts who evaluate the submission.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth from expert readings of medical images or clinical outcomes, which is not the type of data or study described here. Acceptance is based on meeting pre-defined engineering and material standards, and demonstrating substantial equivalence.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, this type of study was not done. MRMC studies are specific to evaluating the diagnostic performance of imaging devices or AI algorithms when interpreted by multiple human readers, often comparing performance with and without AI assistance. This submission is for a physical orthopedic implant.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No, this is not applicable. This is not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Engineering Standards: Compliance with ASTM F136 for materials and other relevant biomechanical standards for spinal implants.
- Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices, particularly the existing EBI Omega 21™ System and EBI SpineLink™ System. The new components are expected to perform comparably.
- Regulatory Requirements: Fulfillment of FDA's regulatory requirements for spinal fixation devices as outlined in 21 CFR sections pertaining to classification, manufacturing, and labeling.
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of AI or machine learning for this physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied for this physical medical device.
§ 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.