(26 days)
The Innovasis Gibralt Spine System is intended to provide immobilization 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 Innovasis Excella II® Spinal System, Excella 3® Spinal System and Excella III-D® Spinal Deformity System using rod-to-rod connectors and transitional rods. Refer to the specific system Instructions for Use for a list of their indications for use.
The Innovasis® Gibralt® Spine System is a posterior system intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical, and/or upper thoracic spine. The system consists of a variety of sizes of rods, hooks, poly-axial screws and connecting components, which can be rigidly locked to the rod in various configurations. The Gibralt Spine System components are manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136), with rods being available in both titanium alloy and cobalt chrome alloy (CoCr per ASTM F1537) options.
No modifications have been made to the design, materials or principles of operation when compared to the predicate.
This document describes the regulatory clearance (510(k)) for the Innovasis® Gibralt® Spine System. The focus of this clearance is on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical performance data for a novel AI/software medical device.
Therefore, the specific information about acceptance criteria, study design for proving device performance, sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details as requested in the prompt cannot be found in this document. This is because the device (a spinal implant system) is a physical orthopedic device, not an AI or software medical device. The regulatory pathway for such devices typically relies on mechanical testing, material specifications, and comparison to existing predicate devices, rather than clinical performance studies involving AI algorithms.
The document explicitly states under "7. Performance Data":
"Nonclinical testing was performed on the subject Gibralt Spine System as part of K160697. The results demonstrated in K160697 that the subject Gibralt Spine System was substantially equivalent to the predicate. This information has been provided to Innovasis and no changes have been made to the system components to necessitate additional mechanical testing."
This confirms that the clearance is based on nonclinical mechanical testing ensuring the device's physical properties are equivalent to the predicate, not on a clinical study of its performance in human subjects, especially not in the context of an AI/software device.
Therefore, I cannot provide the requested information regarding acceptance criteria and study proving device performance in the context of an AI/software medical device from the provided text. The prompt's questions are tailored for a different type of medical device (AI/ML) than the one described in the provided FDA 510(k) clearance document.
§ 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.