(64 days)
The VySpan™ PCT System, which is used to promote fusion of the cervical spine and the cervicothoracic (C1-T3), and is indicated for the following: ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), Spondylolisthesis, Spinal stenosis, Fracture/dislocation, Revision of previous cervical spine surgery, Tumors. The use of the mini polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Hooks and Rods: The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The VySpan™ PCT System can also be linked to the VyLink™ Screw System using the dual diameter rods and rod-to-rod connectors.
The VySpan™ PCT System is comprised of implant and instrument components. The implant component, the VySpan™ device, consists of posterior attachments with a set screw and rod. The VySpan™ pedicle screw component is offered in both poly-axial and mono-axial configuration. In addition to these components, there are also ancillary components such as hooks, connectors, crosslinks, and lateral offset connectors. All of the components discussed above are fabricated from Titanium alloy and should not be used with implants of different materials. The purpose of this submission is to add additional connectors to the VySpan™ PCT System.
The provided text is a 510(k) summary for the VySpan™ PCT System, which is a spinal fixation device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria for a diagnostic or AI-based medical device.
Therefore, many of the requested points, such as acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not applicable or available in this document.
The document states that "Engineering rationale was used to determine no new worse-case was introduced; therefore, no new performance testing was performed on the subject VySpan™ PCT System." This indicates that the device's substantial equivalence is based on its similarity to a predicate device and not on new, specific performance studies directly demonstrating its efficacy against defined acceptance criteria.
Here's an attempt to address the applicable points based on the provided text:
1. Table of acceptance criteria and the reported device performance
Not applicable. The document states "no new performance testing was performed on the subject VySpan™ PCT System." The basis for clearance is substantial equivalence to a predicate device in terms of material, intended use, levels of attachment, size range, and strength.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new performance testing was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth was established for a test set as no new performance testing was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a mechanical spinal fixation system, not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical spinal fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth was established as no new performance testing was conducted.
8. The sample size for the training set
Not applicable. No training set was used as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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.