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The EBI SpineLink™ System is a spinal fixation device 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-servical spine of skeletally mature patients, the System is intended to provide immobilization of stinal 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 pedice system in skeletally mature patients, it is intended for patients: (a) having severe spondylolistheis (Grades 3 and 4) of the fifth lymbar - first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the desice 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 saxral/ibac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and illum. The System is intended for the treatment of degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; scollosis; spondylouisthesis, fracture; previous failed fusion; or tumor resection.

W hen 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 disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosisthesis, fracture; previous failed fusion; or tumor resection.

The EBI SpineLink™ System is a spinal fixation device that uses interconnecting links and/or rods. This submission is for the addition of rods and couplers (pinchblocks) to supplement the existing system.

The provided text is a 510(k) Summary of Safety & Effectiveness for a spinal fixation device, the EBI SpineLink™ System. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe a clinical study in the typical sense with acceptance criteria, sample sizes, ground truth establishment, or expert involvement to evaluate device performance against specific metrics like sensitivity or specificity.

Instead, the "study" mentioned is mechanical testing to demonstrate performance of the device's new components.

Here's an breakdown of the information that can be extracted or inferred from the provided text, and what cannot:

1. Table of acceptance criteria and reported device performance:

2. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. This typically refers to the number of patient cases or images in an AI/diagnostic study, which is not applicable here as it's mechanical testing of a physical device.
• Data Provenance: Not applicable. The "data" comes from mechanical testing performed on device components.

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

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by engineering specifications and testing protocols, not medical experts.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations in diagnostic studies, which is not relevant to mechanical testing.

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:

• MRMC Study: No. This is a mechanical device, not an AI or diagnostic imaging device.

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

• Standalone Study: No. This is not applicable to a spinal fixation device.

7. The type of ground truth used:

• Type of Ground Truth: Engineering specifications and established mechanical testing standards. The "ground truth" for a mechanical device relates to its ability to withstand specified forces, resist corrosion, etc., as defined by relevant ASTM standards or internal design requirements.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of mechanical testing of a physical device.

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

• Ground Truth Establishment for Training Set: Not applicable.

Summary of what the document does communicate:

The document focuses on establishing substantial equivalence to previously cleared devices based on:

• Intended Use: The EBI SpineLink™ System's intended use has not changed from previously cleared versions.
• Materials: Components are manufactured from Ti-6A1-4V ELI per ASTM F136.
• Function: Mechanical testing was performed on new components (rods and couplers/pinchblocks) to ensure they comply with applicable standards and meet functional requirements. This is the "study" referred to in the context of device performance. The specific standards or detailed results of this mechanical testing are not provided in this summary but would have been part of the full 510(k) submission.

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The EBI SpineLink™ 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 anterior 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, trauma, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.

The EBI SpineLink™ System with Link Tie is a spinal fixation device for the interconnection of two links.

The provided text describes a 510(k) premarket notification for a medical device (EBI SpineLink™ System with Link Tie), not a study analyzing device performance against acceptance criteria. A 510(k) is a submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This process does not typically involve detailed studies with acceptance criteria in the manner requested for a new device's efficacy or accuracy.

Therefore, most of the requested information (such as acceptance criteria, reported performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) cannot be extracted from the provided document. The document focuses on establishing substantial equivalence through comparison of technological characteristics, intended use, and materials, rather than presenting a performance study with detailed statistical outcomes.

Here's what can be gathered from the text, indicating the type of assessment rather than the specifics of a performance study:

1. A table of acceptance criteria and the reported device performance:

Explanation: The "acceptance criteria" here are not numerical performance thresholds but rather the regulatory requirement of demonstrating substantial equivalence to predicate devices, supported by bench testing results that show compliance with standards and functional requirements. Specific numerical performance metrics are not provided.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size: Not applicable/Not mentioned. The document refers to "bench testing," which typically involves mechanical testing of device components, not a clinical "test set" in the context of diagnostic or AI performance evaluation.
• Data Provenance: Not applicable/Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Number of Experts: Not applicable/Not mentioned. This type of information is pertinent to studies involving human interpretation or clinical data, which is not the subject of this 510(k) summary.
• Qualifications of Experts: Not applicable/Not mentioned.

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

• Adjudication Method: Not applicable/Not mentioned.

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:

• MRMC Study: No, an MRMC study was not done. This is a medical device for spinal fixation, not an AI or diagnostic imaging device.

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

• Standalone Performance: Not applicable. This is a physical medical implant, not an algorithm.

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

• Type of Ground Truth: Not applicable. The "bench testing" mentioned compares the device to a predicate system against "applicable standards" and "functional requirements," indicating objective engineering and material property measurements rather than clinical "ground truth."

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable/Not mentioned. This pertains to machine learning models, not mechanical devices.

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

• Ground Truth Establishment for Training Set: Not applicable/Not mentioned.

Summary:

The provided text is a 510(k) submission for a physical spinal fixation device. Its purpose is to demonstrate substantial equivalence to existing devices through comparison of intended use, materials, and general function, supported by "bench testing." It does not contain the detailed performance study information typically requested for AI-enabled diagnostic devices or software, such as clinical test sets, expert ground truth, or statistical performance metrics.

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