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The EBI Omega 21™ 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 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 nuerologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion. (pseudoarthrosis).

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 (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/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 disk disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, stenosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral bodies of the lumbar and thoracic spine. The system is intended for the treatment of degenerative disk disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.

The EBI Omega 21™ System is a spinal fixation device that uses rods, screws, couplers, and hooks. This submission is for the addition of top loading hooks to supplement the existing system. The components of the system are manufactured from Ti-6AI-4V ELI per ASTM F136.

Here's an analysis of the provided text regarding the EBI Omega21™ System, focusing on acceptance criteria and the supporting study, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (510(k) summary) does not explicitly state acceptance criteria or provide quantifiable device performance metrics in the typical sense of a diagnostic study. Instead, it focuses on demonstrating substantial equivalence to previously marketed devices. The "performance" assessment is based on mechanical testing to ensure the new component (top-loading hooks) meets functional requirements and applicable standards, implying that if it functions similarly and meets standards, it is acceptable.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not describe a clinical "test set" in the context of diagnostic performance evaluation with patient data. The "testing" mentioned refers to mechanical and functional testing of the new top-loading hooks. The sample size for such mechanical tests is not specified, nor is the provenance of data as it pertains to patient or clinical outcomes. This is a 510(k) for a medical device (spinal fixation system), not a diagnostic algorithm.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this document. The "ground truth" for a mechanical device is its specifications, design, and adherence to engineering principles and standards, not clinical expert consensus on patient data.

4. Adjudication Method for the Test Set

This information is not applicable to this document. Adjudication methods (like 2+1, 3+1) are used in clinical studies with human readers or evaluators, not for mechanical device testing where performance is often measured by objective engineering metrics.

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

This information is not applicable to this document. This is a submission for a spinal fixation device, not an AI or diagnostic imaging tool. There is no mention of AI assistance or human reader studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable to this document. This is a medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance, as implied by the document, is based on:

• Engineering specifications and standards: ASTM F136 for materials.
• Functional requirements: Demonstrated through "testing comparing the modifications to the previous system."
• Regulatory compliance: Adherence to FDA requirements for spinal fixation devices.
• Substantial equivalence: Comparison to predicate devices already established as safe and effective.

No pathology, expert consensus, or outcomes data is mentioned as a "ground truth" for this specific 510(k) submission.

8. The Sample Size for the Training Set

This information is not applicable to this document. "Training set" refers to data used to train algorithms, which is not relevant here.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable to this document.

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