(431 days)
The Edge upper cervical 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 to C7) and the thoracic spine (T1 to T3):
· Traumatic spinal fractures and/or traumatic dislocations;
- · instability or deformity:
- · failed previous fusions (e.g., pseudarthrosis);
- · tumors involving the cervical/thoracic spine;
· degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and
· degenerative disease of the facets with instability.
The Edge UCS 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 Edge UCS is intended for use only with the Innosys Anax™ OCT Spinal System.
The Edge UCS consists of a main body that clamps on to the posterior arch of C1 to provide fixation and stability. The Edge UCS is then connected to the Innosys Anax OCT instrumentation using polyaxial rods to form a posterior cervical construct, similar to that of the predicate devices. The Edge device is an additively manufactured clamp composed of two fixation jaws superior to the C1 posterior arch, an inferior jaw base, and two receiving joints for polyaxial rods. The Edge UCS accommodates varying patient anatomy by providing three implant sizes. The Edge UCS is additively manufactured from titanium alloy Ti6Al4V ELI and is designed with areas for bone graft to be placed on the medial and lateral bone contacting regions of the device.
The provided text describes a medical device, the "Edge Upper Cervical System," and its clearance by the FDA based on a determination of substantial equivalence to predicate devices. However, the document does not contain the information requested regarding the acceptance criteria, specific study details, sample sizes, expert qualifications, or ground truth establishment for AI/algorithm performance.
The "Performance Data" section solely outlines mechanical performance tests conducted on the physical device (e.g., ASTM F1717 Static Axial Compression, ASTM F1717 Dynamic Torsion, Custom Sawbones Pull Off Test) to demonstrate its structural integrity and suitability for its intended use. These tests are not related to an AI/algorithm's performance.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance for an AI/algorithm.
- Sample sizes for a test set or data provenance related to AI.
- Number of experts and their qualifications for AI ground truth.
- Adjudication method for an AI test set.
- MRMC comparative effectiveness study results for AI.
- Standalone performance of an AI algorithm.
- Type of ground truth used for AI.
- Sample size for an AI training set.
- How ground truth for an AI training set was established.
This document is for a physical spinal implant system, not a software or AI-driven medical device.
§ 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.