(106 days)
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
| Acceptance Criteria (Inferred from testing standards and regulatory conclusion) | Reported Device Performance (from "PERFORMANCE DATA" section) |
|---|---|
| Device strength sufficient for intended use, substantially equivalent to predicate devices. | Non-clinical testing showed: |
| Consistency with ASTM F1717-14 standards for static and dynamic axial compression and compression bending. | - Static axial compression per ASTM F1717-14 |
| - Static axial compression bending per ASTM F1717-14 | |
| - Dynamic axial compression per ASTM F1717-14 | |
| - Dynamic axial compression bending per ASTM F1717-14 | |
| Conclusion: "The results of this non-clinical testing show that the strength of the Gibralt® Spine System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." |
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.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are 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.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.