(44 days)
The Z-LINKpc System implants are 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 (T1-T3): traumatic spinal fractures and/or traumatic dislocations: instability or deformity; failed previous fusions (e.g. pseudoarthrosis); 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. These implants 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.
To achieve additional levels of fixation, the Z-LINKsc System may be connected to the Zavation Spinal System using rod connectors and tapered rods.
When used with the occipital plate, the Z-LINKpc System is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic juction (occiput-T3) in treatment of the instabilities mentioned above, including occipitocervical dislocation.
The Z-LINKsc System is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consist of polyaxial screws, hooks, rods, cross-connectors, rod connectors, offsets, occipital plates, bone screws, and cap screws. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.
This document describes the Z-LINKpc System, a medical device, and its marketing authorization, not an AI/ML powered device. As such, the information requested regarding acceptance criteria and study proving the device meets those criteria (especially related to AI/ML specific aspects like training/test sets, ground truth establishment, expert adjudication, or MRMC studies) is not present in the provided text.
The document discusses the substantial equivalence of the Z-LINKpc System to legally marketed predicate devices based on:
- Indications for Use: The intended purpose of the device (immobilization and stabilization of spinal segments as an adjunct to fusion for various instabilities).
- Technological Characteristics: Basic design (rod-based fixation system), materials (titanium alloy/cobalt chrome alloy), mechanical safety, and performance.
- Performance Data: Static compression bending and torsion, dynamic compression bending, and dynamic torsion tests performed according to ASTM F2706 on a worst-case construct.
Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device performance evaluation as the provided text does not contain that information. The "acceptance criteria" here are implicitly the demonstration of substantial equivalence to predicate devices through mechanical performance testing and similar indications for use and technological features.
§ 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.