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

The XIA® 4.5 Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications:

Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
. Spondylolisthesis:
. Trauma (i.e., fracture or dislocation);
. Spinal stenosis;
. Curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
Tumor; .
. Pseudoarthrosis; and
. Failed previous fusion.
The Stryker Spine DIAPASON™ Spinal System, OPUS™ Spinal System and XIA® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

Device Description

This 510(k) is intended to introduce an extension to the existing XIA® 4.5 Spinal System. The proposed line extension includes the addition of titanium Screws (monoaxial, polyaxial and reduction) and rod-to-rod connectors.

AI/ML Overview

This document describes a 510(k) premarket notification for a line extension of the XIA 4.5 Spinal System. It is not a study that proves a device meets acceptance criteria through clinical or AI performance evaluation. Instead, it demonstrates substantial equivalence to existing predicate devices based on material, design, and indications for use. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and AI performance is not applicable to this submission.

Here's why and what the document does provide:

Nature of the Submission: This is a "Special 510(k) Premarket Notification" for a line extension to an existing Class III spinal system. The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive new clinical trials or performance studies involving algorithms.
Focus of the "Study": The document states: "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed for the systems." This refers to bench testing and engineering analysis (e.g., mechanical strength, fatigue, material compatibility) to ensure the new components (titanium screws and rod-to-rod connectors) meet established performance standards for spinal fixation devices and are comparable to the predicate devices. It is not a clinical study involving patients, or an AI performance study.

Therefore, the following requested information is not present or applicable in this 510(k) submission:

Table of acceptance criteria and reported device performance (in the context of clinical or AI performance): The "acceptance criteria" here are likely mechanical and material specifications met through engineering tests against regulatory guidance, not clinical outcome metrics.
Sample size for the test set and data provenance: No clinical test set involving human subjects or AI algorithms is described.
Number of experts used to establish ground truth and qualifications: Ground truth in the context of clinical or AI performance is not applicable here.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was conducted or reported.
Standalone (algorithm-only) performance: No AI algorithm is part of this device.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an engineering-focused 510(k).
Sample size for the training set: No AI training set.
How the ground truth for the training set was established: Not applicable.

What is present in the document related to "acceptance criteria" and "study":

Acceptance Criteria (Implied - Regulatory & Engineering): The devices are substantially equivalent to predicates, meaning they meet the same safety and performance profiles as those devices. This is demonstrated through adherence to FDA guidance for spinal system 510(k)s, which would involve mechanical testing standards (e.g., fatigue, static bending), material biocompatibility, and sterilization validation. The "Indications for Use" statement also acts as a boundary for acceptance.
Study (Type of "Study" Performed): "Engineering analysis and testing" were performed. This is typically bench testing (in vitro mechanical tests) rather than human clinical trials. These tests ensure the new components perform equivalently to the predicate devices and meet relevant ISO or ASTM standards for spinal implants.

Summary

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.