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The 8.5mm diameter Xia Polyaxial Screws are intended to be used with the other components of the Xia Spine System.

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; (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 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 as 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 which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

The 8.5mm diameter Xia Polyaxial Screws are available in lengths ranging from 30 mm to 90 mm (in 5 mm increments). The top portion of the screw is threaded to accept a closure screw. The subject 8.5mm diameter Polyaxial Screw is identical to the 7.5 mm diameter Xia Polyaxial Screws except for the following differences: larger diameter bone thread and tapered screw tip. The subject screws are manufactured from titanium alloy.

This 510(k) Premarket Notification is for a line extension to an existing medical device, the Xia Spine System. Specifically, it introduces an 8.5mm diameter polyaxial screw, which is a larger version of an already approved 7.5mm diameter polyaxial screw within the same system.

Because this is a line extension and the manufacturer claims substantial equivalence to an existing predicate device (the 7.5mm diameter Xia Polyaxial Screw), the provided document does not contain independent clinical study data to demonstrate efficacy or safety for the new 8.5mm screw. Instead, the acceptance criteria and proof of meeting those criteria are based on engineering analysis and comparison to the predicate device.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Information (Based on a Substantial Equivalence Submission)

Given that this is a 510(k) submission for a line extension demonstrating substantial equivalence, a traditional "study" in the sense of a clinical trial proving efficacy or safety of the new device was not performed or required as per the documentation.

1. Sample size used for the test set and the data provenance: Not applicable. No distinct "test set" from a patient population was used for the 8.5mm screw's performance evaluation as described. The evaluation was based on engineering analysis comparing the new screw to the predicate. Data provenance would be from internal engineering testing and design specifications.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For an engineering analysis comparing a new component to a predicate, "ground truth" establishment by a panel of clinical experts for a test set is not typically involved in the same way as for a novel device. The "truth" is established by adherence to design specifications, material properties, and mechanical testing standards by engineering and regulatory personnel.
3. Adjudication method for the test set: Not applicable. No clinical test set or adjudication process is described for this line extension.
4. 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 device is a spinal implant, not an AI-assisted diagnostic or imaging device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical spinal implant, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for demonstrating substantial equivalence relied on engineering principles, material specifications, and comparative design analysis. The predicate device's existing regulatory approval and established safety/efficacy record served as the primary clinical "ground truth" reference.
7. The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

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