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The Xia™ Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia™ Spinal 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™ Spinal 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 neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (psuedoarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac fixation system, the Xia™ Spinal 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, tumor, psuedoarthrosis or revision of failed fusion attempts. When used in the posterior non-pedicle indication the Xia™ Spinal System is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia™ Spinal System is indicated for use in the thoracic and lumbar spine.

The Xia™ Spinal System C-C Adaptor is a line extension to the Xia™ Spinal System. It consists of a C-C Adaptor with a set screw. The Xia™ Spinal System C-C Adaptor is a lateral connector. When used with a Xia™ Spinal System I-Connector, it allows for attachment of a hook to the longitudinal rod. The components are manufactured from titanium alloy.

The provided text describes a 510(k) premarket notification for the Xia™ Spinal System C-C Adaptor. This notification focuses on demonstrating substantial equivalence to a predicate device through information on intended use, materials, design, operational principles, and mechanical testing.

However, the document does not contain information about:

• A table of acceptance criteria and reported device performance in the context of clinical or diagnostic accuracy. The "performance" mentioned is limited to meeting mechanical functional requirements.
• Sample sizes for test sets (clinical performance), data provenance.
• Number of experts used or their qualifications for establishing ground truth for a test set.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance studies.
• Type of ground truth used (clinical/diagnostic).
• Sample size for training sets.
• How ground truth for training sets was established.

Instead, the submission relies on mechanical testing results and substantial equivalence to a predicate device for market clearance.

Here's a breakdown of what is provided and what is missing for your request:

1. Table of Acceptance Criteria and the Reported Device Performance:

• Acceptance Criteria Mentioned: The document states, "Mechanical testing demonstrates that the device will meet the mechanical functional requirements." This implies that predefined mechanical performance criteria exist, but the specific values or thresholds are not detailed in this summary.
• Reported Device Performance: The summary explicitly states, "Mechanical testing demonstrates that the device will meet the mechanical functional requirements." However, the actual test results (e.g., specific load capacities, fatigue cycles, etc.) are not provided. This is a summary and likely refers to detailed test reports submitted separately to the FDA.

2. Sample size used for the test set and the data provenance:

• The document describes mechanical testing, not clinical performance studies involving a test set of patient data. Therefore, this information is not applicable/provided in the context of clinical or diagnostic accuracy.
• For mechanical testing, the "sample size" would refer to the number of devices or components tested. This is not specified.
• Data provenance (country of origin, retrospective/prospective) is not applicable as it's mechanical testing, not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable/provided as the study described is mechanical testing, not a study requiring expert clinical interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This information is not applicable/provided as the study described is mechanical testing.

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:

• This information is not applicable/provided. The device is a spinal implant component, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• This information is not applicable/provided. The device is a spinal implant component, not an algorithm.

7. The type of ground truth used:

• For mechanical testing, the "ground truth" would be established by engineering standards and validated physical measurements using calibrated equipment. This is implied but not explicitly detailed as "ground truth" in the clinical sense.

8. The sample size for the training set:

• This information is not applicable/provided. The device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

• This information is not applicable/provided. The device is not an AI algorithm.

Summary of the Study:

The study described for the Xia™ Spinal System C-C Adaptor is mechanical testing.

• Purpose: To demonstrate that the device meets mechanical functional requirements and supports substantial equivalence to the predicate Xia™ Spinal System L-Connector.
• Methodology: Mechanical testing was performed. Although the details of the specific tests (e.g., fatigue, static compression, torsional strength) and the number of samples are not provided in this summary, such tests are standard for spinal fixation devices.
• Outcome: The testing "demonstrates that the device will meet the mechanical functional requirements." This indicates a successful outcome in meeting predefined engineering performance standards.
• Reliance for 510(k) Clearance: The clearance is primarily based on equivalence in intended use, materials, design, and operational principles to the predicate, supported by these positive mechanical test results. The 510(k) process for devices like this typically relies heavily on non-clinical (mechanical, materials, biocompatibility) testing rather than human clinical trials or AI performance evaluations.

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