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The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.

The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: 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; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis}; tumor; pseudoarthrosis; and failed previous fusion.

The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (TI-SI). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (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); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.

The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient. The modifications contained herein consist of a modification to the threadform of the existing pedicle screws as well as a reduced size offset connector and accompanying set screw.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Lanx Spinal Fixation System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes modifications to an existing device, the Lanx Spinal Fixation System, and states that these modifications do not raise new issues of safety or effectiveness. Therefore, the acceptance criteria are not explicitly numerical performance metrics in the way one might see for a diagnostic device. Instead, the acceptance criteria are based on demonstrating comparable mechanical properties and substantial equivalence to the predicate device.

Note: While specific numerical acceptance values for these mechanical tests are not provided in this summary, they would have been defined within the ASTM standards and the internal study protocols. The summary states the device "functioned as intended" and showed "comparable mechanical properties."

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

This is a mechanical testing study, not a clinical study involving patients or patient data. Therefore, the concept of "test set" in the context of diagnostic AI is not directly applicable here. The "sample size" would refer to the number of individual components tested within the mechanical studies. The document does not specify the exact number of components or samples used for the ASTM F1717 and ASTM F1798 testing.

The "data provenance" is derived from laboratory mechanical testing of the device components. There is no mention of country of origin for data as it's not clinical data, and it's not a retrospective or prospective clinical study.

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

Not applicable. This study involves mechanical testing against engineering standards, not expert-derived ground truth from medical images or clinical observations. The "ground truth" here is the specified performance criteria within the ASTM standards.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or adjudication involved in mechanical testing. The results are quantitative measurements against predefined engineering specifications.

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

Not applicable. This is a mechanical performance study of a spinal fixation system, not an AI-powered diagnostic device. Therefore, no MRMC study with human readers or AI assistance was performed.

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

Not applicable. This device is a physical medical implant, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The Type of Ground Truth Used

The ground truth used for this study is based on established engineering standards and specifications. Specifically, the device's mechanical performance was evaluated against the requirements outlined in:

• ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
• ASTM F1798: Standard Guide for Evaluating the Static and Fatigue Performance of Intervertebral Body Fusion Devices Under Combined Compression-Shear Loading.

The "ground truth" is that the device must meet or exceed the performance parameters defined by these standards and demonstrate comparability to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning algorithm. Therefore, there is no "training set."

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.

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