(253 days)
The VERTICALE Cervical 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 (occiput-C2), the cervical spine (C1 to 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
- 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 VERTICALE Cervical System is a posterior double rod fixation system for immobilization and stabilization of the spinal seqments of the craniocervical junction (occiput-C2), cervical spine (C1-C7), and thoracic spine (T1-T3).
The system may only be used in the field of human medicine and consists of polyaxial screws, favored anqle polyaxial (FA) screws, rods, occiput plates, connectors and the related instrumentation.
The VERTICALE Cervical System will be used in patients with occiput cervical and upper cervical spine instabilities.
The implants of the VERTICALE Cervical System are manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3. They are delivered in a sterile condition and can be used without any further preparations. The implants are packaged in accordance with EN ISO 11607 Part 1+2 and sterilized with gamma irradiation at a minimum dose of 25 kGy.
Implants delivered by the manufacturer in a sterile condition may not be sterilized. They are intended for single use.
I am sorry, but based on the provided text, I cannot find the specific information regarding the acceptance criteria, reported device performance, sample sizes, data provenance, expert details, adjudication methods, MRMC study, standalone performance, or ground truth details for a device that relies on AI.
The document you provided is an FDA 510(k) clearance letter for the VERTICALE® Cervical System, which is a posterior double rod fixation system for spinal immobilization. This device is a traditional medical implant, not an AI/ML-driven device. The document primarily discusses:
- Substantial Equivalence: Comparing the device to a predicate device (Mountaineer OCT Spinal System) based on indications for use, principles of operation, technological characteristics, materials, and performance testing.
- Non-Clinical Performance Data: It lists mechanical performance tests (e.g., ASTM F1717-18, ASTM F2706-18, ASTM F1798-13), biocompatibility (ISO 10993-1), cleaning and sterilization (ISO 11137), and shelf-life testing. These are standard tests for medical implants.
- Clinical Performance Data: States explicitly, "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."
Therefore, the requested information about acceptance criteria, study details, expert qualifications, and ground truth for an AI/ML device is not present in 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.