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The Gibralt® Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Gibralt® Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Gibralt® Spine System may be connected to the Gibralt® Occipital Spine System with rod-to-rod connectors. The Gibralt® Spine System may also be connected to the Exactech® Proliant® System, Exactech® Silverbolt® and Mainframe® Spinal Screw Systems, or Exactech® Hydralok® Exactech, using rod-to-rod connectors and transitional rods. Refer to the specific system package inserts for a list of their indications for use.

When used with the Gibralt® Spine System, the Gibralt® Occipital Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7), and the thoracic spine from T1 - T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Gibralt® Occipital Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Gibralt® Occipital Spine System may be connected to the Gibralt® Spine System, using rod-to-rod connectors. Refer to the Gibralt® Spine System package insert for a list of the Gibralt® Spine System indications of use.

The Occipital Bone Screws are limited to occipital fixation only.

The line extension and device modifications for the Gibralt® Spine System are intended to provide immobilization and stabilization of spinal segments in the upper thoracic, cervical, and occipital spine. The system components are manufactured from titanium and cobalt chromium. The modifications included in the scope of this submission are: expanded indications for use for both systems, incorporation of design changes, and addition of new components.

This document is a 510(k) Pre-Market Notification from the FDA regarding the "Gibralt® Spine System and Gibralt® Occipital Spine System." It is primarily a regulatory approval document and does not contain the detailed study information typically found in a clinical trial report or a comprehensive technical performance study.

Therefore, the specific information requested about acceptance criteria, detailed study design, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance of an AI/algorithm-based device cannot be fully provided from this document alone. This document describes a medical device (spinal fixation system) which is a physical implant, not an AI or algorithm-based diagnostic/prognostic device.

However, based on the provided text, I can extract information related to the device's performance data which serves as the "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission, and the "acceptance criteria" can be inferred from the nature of the tests and the conclusion of substantial equivalence.

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. The document mentions "the Gibralt® Spine System" and "the proposed line extensions and modified Gibralt® Spine System" were tested, implying multiple units or configurations were tested, but an exact number of samples (e.g., number of constructs tested) is not provided.
• Data provenance: Not explicitly stated, but the testing would have been conducted by or for Exactech, Inc. or Empirical Testing Corp. in a laboratory setting. Since it's device testing, it is prospective in the sense that the tests were specifically performed for this submission according to established ASTM standards. It is not clinical data from patients/countries.

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

• Not applicable. This document pertains to mechanical testing of a spinal implant, not the assessment of medical images or patient data that would require expert consensus for ground truth. The "ground truth" here is the physical performance of the device under mechanical load, measured by objective instruments according to specified ASTM standards.

4. Adjudication method for the test set

• Not applicable. See point 3. Mechanical tests follow predefined protocols and objective measurements.

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 device is a physical spinal implant system, not a diagnostic or prognostic AI/algorithm requiring human reader evaluation.

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

• Not applicable. This is a physical device, not an algorithm.

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

• For this type of device, the "ground truth" for the mechanical performance testing is the objective measurement of physical properties and strength when subjected to various loads and cycles, as defined by the ASTM F1717-14 standard. There is no expert consensus, pathology, or outcomes data involved in generating the mechanical performance data in this context.

8. The sample size for the training set

• Not applicable. This document describes the mechanical testing of a physical medical device. There is no "training set" in the context of an AI/algorithm. The device design might be informed by previous designs and engineering principles, but this is not analogous to an AI training set.

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

• Not applicable. See point 8.

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