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The EBI Omega21 Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

The EBI® Omega21 Spinal Fixation System is a spinal fixation device that utilizes rods, screws, couplers and hooks. This submission is for the modification to the Indications for Use.

The provided document is a 510(k) summary for a spinal fixation system, not a study evaluating an AI/ML device. Therefore, it does not contain information related to acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies typically associated with AI/ML device evaluations.

The document is primarily focused on demonstrating substantial equivalence of the EBI® Omega21™ Spinal Fixation System to previously marketed predicate devices, as required for FDA clearance. It describes the device, its intended use, materials, and compares its technological characteristics to existing devices.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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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:

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.

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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 "short taper" screws to the existing System.

The provided text is a 510(k) summary for a medical device called the EBI® Omega21™ Spinal Fixation System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria or a study proving that the device meets such criteria.

This regulatory submission focuses on demonstrating substantial equivalence to existing, legally marketed devices based on intended use, materials, and function, rather than presenting a performance study with specific acceptance criteria.

Therefore, I cannot provide the requested information from the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. A standalone (algorithm-only) performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

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