(28 days)
The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Stainless Steel System is 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 Stainless Steel System is 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, 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 Stainless Steel System is 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 Stainless Steel System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, Connectors and Multi-Axial Cross Connectors (MACs). This submission is intended to address a line extension to the Xia Stainless Steel System. The line extension includes a new range of offset and rod to rod connectors.
This document is a 510(k) summary for a line extension to the Xia Stainless Steel System, a spinal fixation appliance. It explicitly states that the submission is for "a line extension to the Xia Stainless Steel System. The line extension includes a new range of offset and rod to rod connectors."
This means the device in question is a mechanical component, and the regulatory approval process for such devices typically relies on mechanical testing to demonstrate performance and substantial equivalence to a predicate device, rather than clinical studies involving human or even observational data.
Therefore, the requested information regarding acceptance criteria and studies would primarily focus on the results of mechanical testing. The document does support this by stating: "Mechanical testing also demonstrated comparable mechanical properties to the predicate device."
However, the provided text does not contain specific details about the acceptance criteria or the study that proves the device meets those criteria, such as numerical thresholds, sample sizes, or a detailed breakdown of the mechanical tests performed and their results. It only makes a general statement about comparable mechanical properties.
Given the information provided, I cannot populate the requested table or sections related to a study with specific data as it is not present in the document.
Based on the provided text, here's what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated with numerical values. It would likely relate to mechanical properties such as strength, fatigue life, and corrosion resistance, benchmarked against the predicate device.
- Reported Device Performance: Not explicitly stated with numerical values. The text only mentions "comparable mechanical properties to the predicate device."
| Acceptance Criteria (Inferred from device type) | Reported Device Performance (Inferred from statement) |
|---|---|
| Mechanical properties comparable to predicate device (e.g., strength, fatigue, corrosion resistance). | "Comparable mechanical properties to the predicate device." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. For mechanical testing, this would refer to the number of components tested for each property.
- Data Provenance: Not specified. It can be assumed to be from a laboratory setting as part of product development and regulatory submission, typically conducted by the manufacturer or contracted labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for a mechanical device. Ground truth for mechanical testing is established by material and engineering standards, not expert consensus in the medical diagnostic sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for a mechanical device. This pertains to clinical studies involving human interpretation or subjective assessments. Mechanical testing involves objective measurements against predefined engineering standards.
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 type of study is relevant for AI or diagnostic imaging devices, not for mechanical spinal implants.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical devices, the "ground truth" often refers to established engineering standards, material specifications, and the performance of the predicate device under specific test conditions. The document implies comparison to these without detailing them.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical device testing for substantial equivalence. This term is used for machine learning.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set.
In summary: The provided 510(k) summary is for a mechanical device (spinal implant components). It relies on demonstrating "comparable mechanical properties to the predicate device" through mechanical testing for substantial equivalence. However, it lacks the detailed quantitative results and specific acceptance criteria typically found in detailed test reports or studies. The questions provided are largely tailored for diagnostic or AI-driven medical devices, which operate under a different type of evaluation.
§ 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.