(28 days)
The Xia Spinal System and the Xia Stainless Steel System are intended for use in the noncer spine. When used as a pedicle screw fixation system, the Xia Spinal System and Xia C Steel Systems are intended for patients: (a) having severe spondylolisthesis (Grades the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusion 'Iı, autogenous bone graft only; (c) who are having the device fixed or attached to the .nbar 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 line extension to both the Xia Spinal System and the Xia Stainless Steel System. The line extension includes a Dual Staple and modified cross connectors. The new components will be used for anterior fixation.
The provided text describes a Special 510(k) Premarket Notification for a line extension to the Xia Spinal System and Xia Stainless Steel System. This regulatory submission is for medical devices, specifically spinal fixation appliances. For such devices, acceptance criteria and performance are typically demonstrated through mechanical testing and comparison to a predicate device, rather than clinical studies involving human patients, especially for line extensions that introduce minor modifications.
Therefore, many of the typical questions asked for AI/software-based medical devices regarding clinical study design are not applicable here.
Here's a breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Comparable mechanical properties to predicate devices | Mechanical testing demonstrated comparable mechanical properties to the predicate devices. |
Explanation: The primary acceptance criterion for this line extension, which includes new components (Dual Staple and modified cross connectors), is to demonstrate mechanical equivalence to the existing predicate Xia Spinal System and Xia Stainless Steel System.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of this device and submission type. The "test set" here refers to the new components (Dual Staple and modified cross connectors) and their mechanical performance. The "data provenance" would relate to the specific mechanical testing methods and standards used, but this level of detail is not provided in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for mechanical properties is established through standardized engineering tests, not expert consensus in the clinical sense.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically for subjective clinical assessments, not objective mechanical tests.
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 is a hardware medical device (spinal fixation system), not an AI/software device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a hardware medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is the mechanical performance of the predicate devices as established through engineering testing. The new components must demonstrate mechanical properties comparable to these established devices.
8. The Sample Size for the Training Set
Not applicable. This is a hardware medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a hardware medical device, not a machine learning model.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a mechanical testing study. The summary states:
- "Mechanical testing demonstrated comparable mechanical properties to the predicate devices."
This indicates that the new components (Dual Staple and modified cross connectors) underwent a series of standardized mechanical tests designed to assess their strength, durability, and other relevant physical characteristics. The results of these tests were then compared against the established mechanical performance data of the predicate Xia Spinal System and Xia Stainless Steel System components. By demonstrating "comparable mechanical properties," the manufacturer has shown that the new components are mechanically equivalent to the already approved devices, thus meeting the acceptance criteria for this line extension. The specific details of these mechanical tests (e.g., types of tests, number of samples, test parameters, specific standards followed) are not provided in this summary but would have been part of the full 510(k) submission.
§ 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.