(29 days)
The Xia Spinal System, which includes the subject Xia Titanium Hooks, and the Xia Stainless Steel System are intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spine System and Xia Stainless Steel Systems are intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint: (b) who are receiving fusions using autogenous bone graft only: (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw fixation system, the Xia Spinal System and Xia Stainless Steel Systems are also 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Spinal System and Xia Stainless Steel Systems are indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
This submission is intended to address a material modification to the Xia Stainless Steel Hooks. The subject components, named the Xia Titanium Hooks, are a line extension of the Xia Spinal System. The predicate Xia Stainless Steel Hooks are fabricated from stainless steel. The subject Xia Titanium Hooks are fabricated from titanium alloy. In addition, dimensional changes were made to the Xia Stainless Steel Hooks to create the subject Xia Titanium Hooks.
This document describes a Special 510(k) Premarket Notification for a line extension to the Xia Spinal System, specifically the introduction of Xia Titanium Hooks. This is a medical device submission, not a study evaluating an AI algorithm's performance. Therefore, most of the requested information (related to AI acceptance criteria, training/test sets, expert ground truth, MRMC studies, and standalone performance) is not applicable.
The document primarily focuses on demonstrating substantial equivalence of the new titanium hooks to the already marketed stainless steel hooks through mechanical testing, not clinical performance.
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Comparison | The Xia Titanium Hooks share the same intended use and basic design concepts as that of the predicate Xia Stainless Steel Hooks. Mechanical testing demonstrated comparable mechanical properties to the predicate device. |
| Material | The subject Xia Titanium Hooks are fabricated from titanium alloy. (Predicate devices were fabricated from stainless steel.) |
| Dimensional Changes | Dimensional changes were made to the Xia Stainless Steel Hooks to create the subject Xia Titanium Hooks. |
| Intended Use | The Xia Spinal System, which includes the subject Xia Titanium Hooks, and the Xia Stainless Steel System are intended for use in the noncervical spine as a pedicle screw fixation system for severe spondylolisthesis (Grades 3 and 4) at L5-S1, adjunct to fusion for acute and chronic instabilities/deformities (degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion/pseudarthrosis). Also indicated as an anterior screw fixation system or posterior hook and sacral/iliac screw fixation system for degenerative disc disease (back pain of discogenic origin with degeneration confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, spinal deformities (scoliosis, kyphosis, tumor, pseudoarthrosis, revision of failed fusion attempts). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a submission for a physical medical device (spinal hooks) and not a data-driven device like an AI algorithm. The evaluation was based on mechanical testing, not a clinical test set with patient data.
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)
This information is not applicable. Ground truth for mechanical testing of a physical device would involve engineering specifications, material properties, and standardized testing protocols, not expert clinical consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for clinical interpretations or AI output, not for mechanical testing of device properties.
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
This information is not applicable. This submission is for a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission would be defined by engineering specifications and validated mechanical testing standards. The new titanium hooks were tested to demonstrate "comparable mechanical properties" to the predicate stainless steel hooks, implying a comparison against established performance benchmarks for similar devices.
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. No training set was used.
§ 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.