(100 days)
The CarboClear® Posterior Cervical Screw System is 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 CarboClear® Posterior Cervical Screw System ("CarboClear® System") is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The CarboClear® System is a posterior, cervical screw fixation system, intended to provide immobilization and stabilization of cervical spinal segments in oncological patients.
The CarboClear® System implants include posterior screws, rods and locking elements (set screw). The implants are made mainly of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion and the spherical head of the screw are encased within a thin titanium shell, and may include a tantalum marker.
I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets acceptance criteria in the context of an AI/ML-driven medical device. The document is a 510(k) clearance letter from the FDA for a CarboClear® Posterior Cervical Screw System, which is a physical implant, not a software or AI/ML device.
The document discusses:
- Device Name: CarboClear® Posterior Cervical Screw System
- Regulation Number: 21 CFR 888.3075 (Posterior Cervical Screw System)
- Regulatory Class: Class II
- Product Code: NKG
- Indications for Use: Restoring spinal column integrity in patients with advanced stage tumors involving the cervical spine for a limited time.
- Device Description: Implants (screws, rods, locking elements) made of carbon fiber-reinforced PEEK, with titanium shells and tantalum markers, and associated instruments.
- Substantial Equivalence: Comparison to predicate devices (Synapse OCT System, Mesa Mini Spinal System, CarboClear® X Pedicle Screw System) based on indications for use, design, materials, technological characteristics, principles of operation, and performance characteristics (static and dynamic tests according to ASTM standards).
There is no mention of an AI/ML component, algorithm performance, ground truth establishment, expert review, or any of the specific criteria related to an AI/ML performance study as requested in your prompt.
Therefore, I cannot extract the information required to populate the table or answer the questions related to acceptance criteria and study proving device meets acceptance criteria for an AI/ML device from this 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.