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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 SpineLink™ Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. The System is indicated fogense in the temporary stabilization of the anterior spine during the development of cervical spinal fusions with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. WARNING: This device is not approved for screw attachments of the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The EBI SpineLink™ Anterior Cervical Spinal System is an anterior cervical spinal fixation system.

The provided 510(k) summary (K973923) for the EBI SpineLink™ Anterior Cervical Spinal System focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics, intended use, and materials. It explicitly states that "Bench testing comparing the system to a predicate system demonstrated that the device complies with applicable standards and meets all of its functional requirements."

However, this document does not contain specific acceptance criteria, reported device performance metrics (e.g., in a table), sample sizes for test or training sets, details on ground truth establishment, expert qualifications, adjudication methods, or results of MRMC studies common for AI/diagnostic devices.

This type of submission predates the common requirements for AI-based diagnostic devices or those involving clinical studies with detailed performance metrics. The focus is on mechanical and material equivalence.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the document. The study involved "bench testing."
• Data Provenance: Not applicable in the context of bench testing for a mechanical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This was bench testing of a mechanical device, not a diagnostic or AI device requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable.

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

• No. This is a spinal fixation system, not an AI or diagnostic device that would typically involve MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This refers to a mechanical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable. The "ground truth" for bench testing would be engineering specifications, material properties, and mechanical load limits, not clinical "ground truth."

8. The sample size for the training set

• Not applicable. There is no training set for a mechanical device undergoing bench testing.

9. How the ground truth for the training set was established

• Not applicable.

Summary based on the provided document:

The EBI SpineLink™ Anterior Cervical Spinal System's acceptance criteria were primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices. This was achieved through:

• Comparison of intended use, materials, and functional characteristics.
• Bench testing to show compliance with applicable standards and functional requirements when compared to a predicate system.

The document K973923 is a 510(k) summary from 1997 for a medical device (a spinal fixation system), not a diagnostic algorithm or AI product. Therefore, the detailed information typically requested for AI/diagnostic studies (like expert consensus, sample sizes for training/test sets, MRMC studies) is not present in this type of submission. The "study" mentioned is "bench testing" which demonstrated mechanical and material performance consistent with predicate devices and established standards.

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The Omega 21™ System is a spinal fixation device for pedicle screw fixation and nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

When used as a pedicle screw fixation system, 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; and (d) who are having the device removed after the development of a solid fusion mass. The screws of the system are limited to L3- S1 or iliac screw fixation with the fusion only at L5-S1.

When used as an unterior fixation system or as a posterior hook and sacral/iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracic, lumbar and sacral segments of the spine, in cases of: Degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.

The Omega 21™ System is a rod system spinal fixation device. The components of the system are manufactured from Ti-6Al-4V ELI per ASTM F136.

The provided text describes the Omega 21™ System, a spinal fixation device, and its 510(k) summary for safety and effectiveness. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software.

The document primarily focuses on:

• Device Description: What the Omega 21™ System is.
• Intended Use/Indications for Use: The medical conditions and patient types for which the device is intended.
• Materials: What the device components are made from.
• Comparison to Predicate Devices: How it is similar to other legally marketed spinal fixation systems.
• FDA Clearance Details: The FDA's decision regarding substantial equivalence, specific limitations, warnings, and regulatory requirements.

The "Bench testing comparing the system to a predicate system demonstrated that the device complies with applicable standards and meets all of its functional requirements" statement (in section 7) is the closest thing to a "study" mentioned. However, this is a very general statement about mechanical testing for a physical device, not a performance study for an AI/ML system with quantifiable metrics like sensitivity, specificity, or F1-score against a ground truth dataset, which are typical for your requested format.

Therefore, I cannot extract the specific information requested in your bulleted list (acceptance criteria table, sample sizes, expert details, adjudication, MRMC, standalone performance, ground truth types, training set details) because the provided text is about a physical medical device (spinal fixation system) and its regulatory clearance, not an AI/ML-driven diagnostic or prognostic device.

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