FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Device Description

The Vy Spine™ VySpan™ PCT System is comprised of implant and instrument components. The implant component, the VySpan™ device, consists of posterior attachment elements with a set screw and rod. The VySpan™ pedicle screw component is offered in both poly-axial and monoaxial configuration. In addition to these components, there are also ancillary components such as hooks, connectors, cross-links, 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.

AI/ML Overview

This document describes the Vy Spine™ VySpan™ PCT System, a posterior cervical screw system. The provided text is a 510(k) premarket notification and does not contain information typically found in a study proving a device meets acceptance criteria related to its performance in vivo or clinical outcomes. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of design characteristics.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth establishment for training set, training set size) are not applicable to the information provided in this regulatory document.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it implicitly relies on demonstrating that the subject device's non-clinical performance and characteristics are substantially equivalent to legally marketed predicate devices. The "performance" described refers to mechanical and material characteristics tested non-clinically.

Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Implicit from Substantial Equivalence Basis)	Reported Device Performance (as stated in document)
Material	Similar material composition to predicate devices.	Fabricated from Titanium alloy, similar to predicate devices.
Design	Similar design to predicate devices.	Similar design to predicate devices.
Sizes	Similar size range to predicate devices.	Similar sizes to predicate devices.
Intended Use	Same intended use as predicate devices.	Same as predicate devices: to promote fusion of the cervical spine and cervicothoracic (C1-T3) for various indications (DDD, Spondylolisthesis, Spinal stenosis, Fracture/dislocation, Revision, Tumors). Hooks and rods for stabilization following reduction of fracture/dislocation or trauma in C1-T3.
Biocompatibility	Similar biocompatibility to predicate devices.	Similar biocompatibility to predicate devices.
Non-Clinical Testing	Expected to meet standards or equivalent performance as predicate devices when tested using various ASTM Standard tests.	Undergone Non-Clinical Testing using various ASTM Standard tests at a third-party facility.
Strength	Similar strength characteristics to predicate devices.	Similar strength to predicate devices.

Study Proving Device Meets Acceptance Criteria

Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the actual physical devices undergoing non-clinical mechanical testing, not a patient dataset. The document doesn't specify the number of devices or components tested. The "provenance" refers to a "third-party facility."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For non-clinical mechanical testing, "ground truth" is typically defined by engineering specifications and objective measurements against ASTM standards, not expert consensus.
Adjudication method for the test set: Not applicable. Formal adjudication methods (like 2+1 or 3+1) are used for clinical data interpretation or image analysis, not for non-clinical mechanical testing.
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 implant, not an AI-assisted diagnostic or therapeutic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
The type of ground truth used: For non-clinical testing, the "ground truth" is adherence to established engineering standards (e.g., ASTM standards) and the measured mechanical properties of the device components compared to those of the predicate devices.
The sample size for the training set: Not applicable. This device is not an AI/ML product developed with training data.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary of the Study:

The "study" referenced is a series of Non-Clinical Tests conducted at a third-party facility using various ASTM Standard tests. The purpose of these tests was to demonstrate the substantial equivalence of the Vy Spine™ VySpan™ PCT System to its predicate devices (Reliance Posterior Cervical-Thoracic System K142867 and K122292) in terms of material, design, sizes, intended use, biocompatibility, and strength. The document explicitly states that the subject device "has similar design, sizes, indication of use & biocompatibility as the predicate devices."

The document does not provide specific results from these ASTM tests (e.g., exact load-to-failure values, fatigue life), but rather summarizes that the testing was performed and supports the claim of substantial equivalence.

Summary

Regulation Number and Section

§ 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.