(89 days)
The XIA Spine System is intended for use in the noncervical spine. When used as a pedicle screw fixation system. the XIA Spine System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint which is fused; (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. Pedicle screw fixation is limited to L3 to S1 or the ilium.
When used as a pedicle screw fixation system, the XIA Spine 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, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the XIA Spine System is indicated for patients with degenerative disc disease of the thoracic, lumbar, 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, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts. When used in the posterior non-pedicle indication the Xia system is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia system is indicated for use in the thoracic and lumbar spine.
The XIA Spine System is a spinal fixation device for the noncervical spine. It consists of rods, monoaxial and polyaxial bone screws, different types of hooks, closure screws, axial and parallel rod to rod clamps, lateral connectors and cross link components. The components are manufactured from titanium.
The provided text describes a 510(k) summary for the XIA Spine System. It focuses on the device's indications for use and its substantial equivalence to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text because it is a regulatory submission for premarket notification (510(k)) and not a study report.
Here's what can be extracted based on the information given:
Acceptance Criteria and Device Performance (Based on the 510(k) Summary)
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Functional Requirements for Spinal Fixation Devices (as assessed by bench testing) | "Bench testing demonstrates that the device will meet its mechanical functional requirements." |
| Substantial Equivalence in Intended Use to legally marketed predicate devices | The device's intended use is described as spinal fixation for various conditions in the noncervical spine, including pedicle screw fixation (for severe spondylolisthesis, acute/chronic instabilities, deformities, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion) and anterior/posterior screw/hook fixation (for degenerative disc disease, spondylolisthesis, fracture, spinal stenosis, spinal deformities, tumor, pseudoarthrosis, revision of failed fusion). This is explicitly stated to be equivalent to predicate devices. |
| Substantial Equivalence in Materials to legally marketed predicate devices | The XIA Spine System components are manufactured from titanium, which is stated to be substantially equivalent to predicate devices. |
| Substantial Equivalence in Designs to legally marketed predicate devices | The system consists of rods, monoaxial and polyaxial bone screws, different types of hooks, closure screws, axial and parallel rod to rod clamps, lateral connectors and cross link components. These design characteristics are stated to be substantially equivalent to predicate devices. |
| Substantial Equivalence in Operational Principles to legally marketed predicate devices | The operational principle (spinal fixation) is stated to be substantially equivalent to predicate devices. |
| Compliance with general controls provisions of the Act (e.g., annual registration, listing, GMP, labeling, prohibitions against misbranding/adulteration) | The FDA's letter states: "You may, therefore, market the device, subject to the general controls provisions of the Act." It also notes that a "substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions." |
Missing Information from the Provided Text:
- Sample size used for the test set and the data provenance: Not applicable. The submission refers to "bench testing," not a clinical test set with patient data. No details about the number of devices or iterations tested are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Bench testing doesn't typically involve human experts establishing ground truth in this manner.
- Adjudication method for the test set: Not applicable.
- 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 not an AI/imaging device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/imaging device.
- The type of ground truth used: For the "bench testing," the ground truth would be the pre-defined mechanical functional requirements or engineering specifications that the device needed to meet.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to pre-existing devices through comparisons of intended use, materials, designs, operational principles, and bench testing to meet mechanical requirements. It does not describe a clinical study with patients that would typically involve many of the detailed inquiries above, especially those related to AI or clinical effectiveness.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.