(87 days)
The EBI Ornega 21™ System is a spinal fixation device for pedicle screw fixation and a nombedicle 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 of neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (psuedarthrosis).
In addition, when used as a pedicle system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first saxral (LS-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 spine (1,3 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/iliar screw fixation system, the levels of attachment are the lumbar and thoracc spine, and screw fixation limited to the sacrum and ilium. The System is intended for the treatment of degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scollosis; 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). Psuedarthrosis; stenosis; 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 to revise the labeling in accordance with the FDA Final Rule dated July 27, 1998, "Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems", and introduce the availability of two shorter length rods.
This document is a 510(k) summary for the EBI Omega 21™ System, a spinal fixation device. It describes the device, its intended use, and its substantial equivalence to previously cleared devices.
Here's an analysis of the document concerning acceptance criteria and supporting studies, based on the provided text:
Acceptance Criteria and Device Performance
The provided document does not explicitly state specific acceptance criteria in terms of discrete performance metrics (e.g., accuracy, sensitivity, specificity, mechanical strength thresholds, etc.) nor does it present a study demonstrating the device meets such criteria with reported performance values.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" are implied by the regulatory requirements for spinal fixation devices and the comparison to established predicate devices.
Implied Acceptance Criteria and Device Characteristics:
| Acceptance Criteria (Implied by Regulatory Standards & Predicate Comparison) | Reported Device Performance (from K990303) |
|---|---|
| Material Composition Compliance: Components meet relevant ASTM standards for biocompatibility and mechanical properties. | Components manufactured from Ti-6Al-4V ELI per ASTM F136. Compliance with biocompatibility standards (stated as a special control). |
| Mechanical Testing Compliance: Device components withstand mechanical stress relevant to spinal fixation applications (e.g., fatigue, static strength). | Compliance with mechanical testing standards (stated as a special control). No specific performance data (e.g., load capacity, cycles to failure) is provided within this summary. |
| Intended Use Equivalence: Device indications for use are the same as or very similar to predicate devices, addressing similar spinal conditions. | Intended Use is unchanged from previously cleared EBI Omega 21™ System (K973683). Indications include degenerative spondylolisthesis, fracture, dislocations, scoliosis, kyphosis, spinal tumor, failed previous fusion, severe spondylolisthesis (Grades 3 & 4 L5-S1), degenerative disc disease, pseudarthrosis, stenosis, etc. These match predicate's use. |
| Technological Characteristics Equivalence: Device technology (design, function) is similar to predicate devices. | "No significant differences between the EBI Omega 21™ System and other currently marketed spinal systems." "Substantially equivalent to the predicate devices in regards to intended use, materials and function." |
| Labeling Compliance: Adheres to FDA labeling regulations, including specific warnings and precautions for pedicle screw systems. | Revised labeling in accordance with FDA Final Rule (July 27, 1998, "Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems"). Includes specific warnings and precautions. |
Study Details (Based on available information in the K990303 document):
The document does not describe a clinical study or a standalone performance study with a test set, ground truth, or expert involvement. The primary "study" or evidence presented for this 510(k) submission is a comparison to predicate devices and adherence to recognized standards.
Here's an attempt to address the requested points based solely on the provided text, noting where information is absent:
-
Sample size used for the test set and the data provenance: Not applicable. No specific test set data is mentioned for performance evaluation in a clinical or standalone study. The substantiation is based on material compliance, mechanical testing standards, and predicate device equivalence.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No specific test set requiring ground truth establishment by experts is described.
-
Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.
-
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 device is a mechanical spinal fixation system, not an AI-assisted diagnostic or analysis tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm. Standalone performance, in this context, would refer to mechanical testing, which is mentioned as a "special control" that the device "meets", but no specific study results are provided in this summary.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a performance study for this device as described in the summary. For a spinal implant, "ground truth" might refer to long-term clinical outcomes or successful fusion, but this document does not present such data for this submission; it relies on the predicate device's established safety and effectiveness.
-
The sample size for the training set: Not applicable. This is not an algorithm requiring a training set.
-
How the ground truth for the training set was established: Not applicable. This is not an algorithm requiring a training set.
Summary of the Document's Approach to Demonstrating Safety and Effectiveness:
The K990303 submission for the EBI Omega 21™ System demonstrates safety and effectiveness primarily through substantial equivalence to predicate devices. This means the manufacturer argues that:
- The device's materials, design, and function are highly similar to devices already legally marketed.
- Its intended use is identical or very similar to the predicate device.
- It complies with relevant consensus standards for materials and mechanical testing (though specific results are not detailed in this summary).
- Its labeling meets current regulatory requirements.
The mention of "Compliance with mechanical testing standards" indicates that such testing was done, and the device met those standards, serving as the primary technical performance "study" for a device of this type in a 510(k) submission. However, the details of those tests (e.g., number of samples, specific loads, pass/fail criteria, actual performance results) are not included in this high-level summary.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.