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The Lanx Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Lanx Facet Screw System is indicated for treatment of any or all of the following:

• pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity;
• spondylolisthesis;
• spondylolysis;
• degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;
• degeneration of the facets with instability and;
• trauma including spinal fractures and/or dislocations.

The Lanx Facet Screw System consists of various screws and washers designed to compact juxtaposed facet articular processes to enhance spinal fusion and stability. The screws are available partially threaded or fully threaded, cannulated or non-cannulated, and in various diameters and lengths to accommodate patient anatomy. Lanx Facet Screw System implants are fabricated from medical grade titanium alloy (per ASTM F-136).

The provided text describes a 510(k) premarket notification for the Lanx Facet Screw System and not a study assessing the performance of a device against acceptance criteria in the context of AI or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical testing.

Therefore, many of the requested categories are not applicable to this document. I will fill in the available information and indicate where data is not present or relevant for this type of submission.

Acceptance Criteria and Device Performance Study for Lanx Facet Screw System

This 510(k) submission for the Lanx Facet Screw System focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific clinical performance acceptance criteria for diagnostic accuracy or AI-assisted decision-making. The "performance data" presented relates to mechanical testing to ensure the device is physically robust and comparable to existing, legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Ability to withstand cantilever bend (per ASTM F2193).
• Ability to withstand torsion.
• Ability to withstand axial pull-out (per ASTM F543).
• Comparable mechanical properties to predicate devices (NuVasive Facet Screw and Globus Corridor Fixation System). | - Testing performed included dynamic and static three-point bend per ASTM F1264-03, cantilever bend per ASTM F2193, torsion, and axial pull-out testing per ASTM F543.
• "The device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices."
• Mechanical testing and engineering analysis demonstrated comparable mechanical properties to the predicate devices. |
  | Intended Use/Indications | - Stabilize the spine as an aid to fusion through bilateral immobilization of facet joints.
• Used from C2 to S1 (for 3.5mm and 4.0mm screws) and L1 to S1 (for 4.5mm screws).
• Indicated for conditions such as pseudoarthrosis, spondylolisthesis, DDD, degeneration of facets with instability, and trauma. | - The system is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws.
• The system is indicated for the specified conditions. |
  | Material Composition | - Fabricated from medical grade titanium alloy. | - Implants are fabricated from medical grade titanium alloy (per ASTM F-136). |

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

• Sample Size for Test Set: This is a mechanical testing submission, not a clinical study involving patients. The "test set" refers to the number of screws and components subjected to mechanical testing. The document does not specify the exact number of units tested for each mechanical test, but references standard ASTM methods which typically define sample size requirements.
• Data Provenance: The data originates from laboratory mechanical testing and engineering analysis conducted by Lanx, Inc. (the manufacturer). It is not patient or clinical data, retrospective or prospective.

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

• Not Applicable. This is a mechanical testing submission for substantial equivalence. "Ground truth" in the diagnostic or AI context (e.g., expert consensus on medical images or pathology) is not relevant here. The "truth" is established by adherence to ASTM standards and engineering principles for mechanical performance.

4. Adjudication Method for the Test Set

• Not Applicable. As this is mechanical testing, there is no "adjudication" in the sense of reconciling divergent expert opinions or labeling for diagnostic accuracy. The performance is objectively measured against engineering standards.

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

• No. This document describes a medical device (surgical implant) and its mechanical performance evaluation for substantial equivalence, not a diagnostic device or AI system. Therefore, MRMC studies improving human reader performance with AI assistance are irrelevant to this submission.

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

• No. This is not an AI algorithm or software device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable / Engineering Standards: The "ground truth" or reference for evaluating the device's performance is adherence to established ASTM mechanical testing standards (e.g., ASTM F1264-03, ASTM F2193, ASTM F543) and engineering principles, demonstrating comparable mechanical properties to predicate devices.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI system that requires a "training set" of data.

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

• Not Applicable. As above, no training set is involved.

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