(90 days)
The NorthStar™ OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, cervical spine (C1-C7) and upper thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations;
- Instability or deformity;
- · Failed previous fusion (e.g. pseudoarthrosis);
- · Tumors involving the cervical/thoracic spine;
• Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
· Degenerative disease of the facets with instability.
The NorthStar OCT 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.
The NorthStar OCT System can also be linked to other SeaSpine Screw Systems including Mariner, NewPort, Sierra, Atoll, Daytona, Malibu, Mariner Outrigger, and Mariner Midline Systems with the use of transitional rods and/or transitional rod connectors.
The NorthStar™ OCT System is a spinal fixation system intended to improve the stability of the occipital, cervical, and thoracolumbar areas of the spine. The NorthStar™ OCT System consists of screws, hooks, rods, offset connectors, set screws, cross connectors, transition implants, occipital plates and associated instruments. Implant components are available in a variety of sizes and can be constructed into a variety of configurations to suit the individual pathology and anatomical conditions of the patient. The scope of this submission includes indication for the use of bone screws in the occipital, cervical spine (C1-C7), and upper thoracic spine (T1-T3). The implants are manufactured from medical grade titanium alloy and cobalt chrome.
The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the NorthStar™ OCT Spinal System. It details the device, its indications for use, and its substantial equivalence to previously marketed predicate devices.
However, this document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device. The device described is a spinal implant system with mechanical components (screws, rods, etc.). The non-clinical testing mentioned refers to mechanical performance tests against ASTM standards (e.g., static and dynamic axial compression, torsion testing), not the performance of an AI algorithm on a test set.
Therefore, I cannot provide the requested information from the given text because it is a submission for a hardware medical device, not a software/AI medical device. The concepts of "test set," "ground truth," "expert consensus," "MRMC study," and "standalone algorithm performance" are specific to the evaluation of AI/ML-based medical devices, which are not relevant to this 510(k) submission for a spinal implant.
§ 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.