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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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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

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.

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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 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; 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 4.75mm-8.5mm diameter.

This 510(k) submission describes the EBI Omega 21™ System, a spinal fixation device. The submission is for expanding the range of screw sizes. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices based on intended use, materials, and function. There is no performance data, clinical study results, or information regarding an AI component in this submission. Therefore, it's not possible to extract the requested information about acceptance criteria or a study proving device performance as it does not exist in the provided text.

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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:

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:

1. 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.

2. 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.

3. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.

4. 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.

5. 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.

6. 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.

7. The sample size for the training set: Not applicable. This is not an algorithm requiring a training set.

8. 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.

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