(28 days)
The Xia Spinal System 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, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
The Xia Spinal System consists of Monoaxial and Polyaxial Screws, Hooks, Blockers, Rods, and Connectors. This submission is intended to address a material modification to the Xia Spinal System as well as dimensional changes to the components. The subject device, named the Xia Stainless Steel System, is a line extension of the Xia Spinal System. The predicate Xia Spinal System is fabricated from titanium alloy. The subject Xia Stainless Steel System is fabricated from stainless steel.
This document describes a Special 510(k) submission for a line extension to the Xia Spine System, introducing the "Xia Stainless Steel System." The submission focuses on demonstrating substantial equivalence to the predicate device (Xia Spinal System, made of titanium alloy) by addressing a material change to stainless steel and dimensional adjustments.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Properties (Comparable to predicate device) | "Mechanical testing demonstrated comparable mechanical properties to the predicate components." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Mechanical testing." However, it does not specify the sample size for this testing, nor does it provide details about the data provenance (e.g., country of origin or whether it was retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This document describes a safety and effectiveness summary for a medical device (spinal fixation system) based on a line extension with a material change. It does not involve expert review for image interpretation or diagnosis. Therefore, the concepts of "experts to establish ground truth" related to diagnostic accuracy are not applicable here. The "ground truth" for this type of submission is the mechanical performance of the device.
4. Adjudication Method for the Test Set
As this submission does not involve clinical data or diagnostic tests, adjudication methods like 2+1 or 3+1 are not applicable. The assessment of whether the mechanical testing meets the acceptance criteria (comparable properties) would be performed by the manufacturer and reviewed by regulatory bodies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This submission is for a physical medical device (spinal implant).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone study relevant to an algorithm's performance was done. This is a hardware device.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on objective mechanical properties of the device components, measured through established engineering tests. The acceptance criteria essentially dictate that the mechanical properties of the new stainless steel components must be comparable to those of the predicate titanium alloy components.
8. Sample Size for the Training Set
As this is a mechanical device and not an AI/ML algorithm or diagnostic tool, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set, this question is not applicable. The mechanical properties are inherent to the materials and design, and their measurement follows standardized testing protocols.
Summary of Key Findings:
The submission confirms the new Xia Stainless Steel System has "comparable mechanical properties" to the predicate Xia Spinal System. However, it provides limited detail on the specifics of the mechanical testing:
- Acceptance Criteria: "Comparable mechanical properties to the predicate components."
- Study: "Mechanical testing demonstrated comparable mechanical properties..."
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified.
- Experts for Ground Truth: Not applicable (not a diagnostic study).
- Adjudication Method: Not applicable.
- MRMC Study: Not applicable.
- Standalone Study: Not applicable.
- Type of Ground Truth: Objective mechanical properties.
- Training Set Sample Size: Not applicable.
- Training Set Ground Truth Establishment: Not applicable.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.