(23 days)
The EBI® Omega21™ Spinal Fixation System is a spinal fixation device for pedicle screw fixation and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical 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 (pseudarthrosis).
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 is 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); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor 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); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection.
The EBI® Omega21 Spinal Fixation System is a spinal fixation device that utilizes rods, screws, couplers and hooks. This submission is for the addition of 'Angulating Cross Connector' to the existing System.
This document, K023204, is a 510(k) summary for the EBI® Omega21™ Spinal Fixation System. It describes the addition of an "Angulating Cross Connector" to the existing system. The document focuses on demonstrating substantial equivalence to previously marketed devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study proving the device meets acceptance criteria, as this information is not present in the provided text. The submission is for a modification to an existing device, and the evaluation is based on substantial equivalence, not a new performance study against defined criteria.
Here's a breakdown of why the requested information cannot be fully extracted based on the provided text:
- Acceptance Criteria and Reported Device Performance: This type of information is typically found in a clinical study report or a design verification and validation report for a novel device. For a 510(k) submission seeking substantial equivalence to predicate devices, the focus is on comparing the new device's characteristics (intended use, materials, function) to the predicate, not establishing new performance metrics against predefined acceptance criteria.
- Sample size for test set and data provenance: No test set is described as part of a performance study.
- Number of experts and their qualifications for ground truth: Not applicable as no ground truth creation process for a performance study is described.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance study: Not applicable as this is a physical medical device (spinal fixation system), not an algorithm or AI.
- Type of ground truth: Not applicable.
- Sample size for training set: Not applicable as this is not an AI/algorithm-based device requiring a training set.
- How ground truth for training set was established: Not applicable.
What the document does indicate regarding "proving the device meets acceptance criteria" (in the context of a 510(k) for substantial equivalence):
The "acceptance criteria" in this context are interpreted as the requirements for demonstrating substantial equivalence to predicate devices. The "study" (or rather, the justification) provided is a comparison of technological characteristics and intended use to previously cleared EBI® Omega21™ Systems.
Here's what can be gathered from the document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (Comparison) |
|---|---|
| Similar Intended Use | The EBI® Omega21™ Spinal Fixation System, with the addition of the 'Angulating Cross Connector', maintains the same intended uses as the predicate devices: Pedicle screw fixation, non-pedicle hook and sacral/iliac screw fixation, and anterior fixation in the non-cervical spine for various indications (e.g., spondylolisthesis, fracture, scoliosis, kyphosis, spinal tumor, pseudarthrosis, degenerative disc disease, stenosis). |
| Similar Technological Characteristics | The submission states: "There are no significant differences between the proposed EBI® Omega21™ Spinal Fixation System and the currently marketed EBI Omega21 Spinal Fixation System. It is substantially equivalent to the predicate devices in regards to intended use, materials, and function." The addition is specifically an 'Angulating Cross Connector'. The components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, which is a common and established material for such devices. Implicitly, the performance of the new component (Angulating Cross Connector) is deemed equivalent to existing cross connectors or appropriately integrated within the predicate system's established performance envelope. |
| Similar Materials | The System components, including the new connector, are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, which is stated to be consistent with the predicate device materials. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not applicable. This 510(k) is based on demonstrating substantial equivalence to existing devices, not a new performance study requiring a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. No ground truth for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable. No test set requiring adjudication is described.
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 fixation device, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a physical spinal fixation device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* Not applicable. The basis for approval is substantial equivalence to legally marketed predicate devices, meaning their established safety and effectiveness serve as the "ground truth" for the new device's characteristics.
8. The sample size for the training set:
* Not applicable. This is a physical spinal fixation device, not an AI or machine learning model.
9. How the ground truth for the training set was established:
* Not applicable.
§ 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.