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The Xia® Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The 6 mm diameter rods from the DIAPASON™ Spinal System and OPUS™ Spinal System are intended to be used with the other components of the Xia® Titanium Spinal System. The Titanium Multi-axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.

This submission is intended to address a line extension to Xia® Spinal System. The line extension includes the addition of Xia Stainless Steel Uni-Planar Screws.

This document, K080928, is a Special 510(k) Premarket Notification for a line extension to the Xia® Spinal System, specifically the addition of Stainless Steel Uni-Planar Screws. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device through material, design, and functional equivalence, often relying heavily on mechanical testing rather than clinical study data.

Due to the nature of this submission (a line extension for a spinal fixation system, focusing on new uni-planar screws), the traditional "acceptance criteria" and "device performance" in terms of clinical accuracy (like in AI/diagnostic devices) are not directly applicable in the same way. Instead, acceptance criteria would relate to the mechanical properties and safety of the new components, proving they are comparable to or meet the standards of the predicate device. The "study" would be mechanical testing.

Here's an analysis based on your categories, adapted for this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Mechanical testing also demonstrated comparable mechanical properties to the predicate device." However, it does not provide specific quantitative acceptance criteria or detailed reported performance values (e.g., stiffness thresholds, fatigue limits, etc.) within the provided text. Such detailed results would typically be found in the full 510(k) submission, not necessarily in the public summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the provided text. For mechanical testing of medical devices like spinal screws, "sample size" refers to the number of screws or constructs tested in various mechanical tests (e.g., static compression, fatigue). These are typically bench-top tests, not human subject tests.
• Data Provenance: The data would be generated from prospective bench-top laboratory mechanical testing conducted by the manufacturer (Stryker Spine). There is no mention of country of origin of data, as it's not a clinical study involving patients from specific geographical locations.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable in the context of this device and submission type. Ground truth, typically established by experts (like radiologists for imaging or pathologists for pathology), is relevant for diagnostic or AI-driven devices. For a spinal implant, the "ground truth" for mechanical performance is established by recognized material science and biomechanical engineering standards (e.g., ASTM, ISO standards) and comparison to the predicate device's established performance. The "experts" would be the biomechanical engineers and quality assurance personnel conducting and interpreting the mechanical tests. The document does not specify the number or qualifications of these internal experts.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert consensus processes to resolve disagreements, particularly in diagnostic assessments. Mechanical testing involves objective measurements against predefined criteria or comparison to predicate device performance; there's no "adjudication" in this sense.

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 question is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation of images or other data, especially in the context of AI assistance. This submission is for a physical orthopedic implant (spinal screws), not a diagnostic or AI device.

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

This question is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For this type of device, the "ground truth" for mechanical testing is established by:

• Industry Standards: Adherence to recognized national and international testing standards for spinal implants (e.g., ASTM F1717 for Spinal Implant Constructs in a Vertebrectomy Model, ASTM F2077 for Mechanical Testing of Spinal Intervertebral Body Fusion Devices, or similar which ensure appropriate stress, fatigue, and torsional testing).
• Predicate Device Performance: The mechanical performance of the legally marketed predicate device (Xia® Spinal System) serves as the benchmark against which the new line extension components are compared. The "ground truth" is that the new device must perform at least as well as or comparably to the predicate device.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of mechanical testing for a spinal implant. Training sets are used in machine learning for AI algorithms.

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the same reasons as #8.

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