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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 Lanx SFS is 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). 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 and is not intended for stand-alone use.

The Lanx Spinal Fixation System consists of various screws, 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 purpose of this 510(k) is to add the Spinous Process Fusion Plate to the Lanx SFS.

The provided document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance, nor does it describe a study with many of the requested parameters.

This document is a 510(k) summary for a medical device (Lanx Spinal Fixation System), which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and results.

Here's a breakdown of what can and cannot be extracted from the document:

What can be extracted:

• Device Name: Lanx Spinal Fixation System
• Intended Use/Indications for Use: Clearly stated in the document.
• Technological Characteristics: Describes the components and their purpose.
• Performance Data (General Statement): "Performance testing was performed and submitted to characterize the new components being added to the system. The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices."

What CANNOT be extracted from this document:

• Specific Acceptance Criteria: The document states that performance testing was done, but it does not specify what those criteria were (e.g., specific thresholds for fatigue life, pull-out strength, etc.).
• Reported Device Performance (Quantitative): While it states the device "functioned as intended" and demonstrated "substantial equivalence," it doesn't provide actual numerical results from the performance tests.
• Sample size used for the test set: Not mentioned.
• Data provenance (country of origin, retrospective/prospective): Not mentioned.
• Number of experts used to establish ground truth & qualifications: Not applicable, as this is a mechanical device, not an AI/imaging device requiring expert interpretation for ground truth.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable. This is a spinal fixation system, not an AI/imaging device intended to assist human readers.
• Standalone (algorithm-only) performance: Not applicable.
• Type of ground truth used: Not applicable, as this refers to clinical outcomes or expert labels, which are not detailed for mechanical testing.
• Sample size for the training set: Not applicable (no AI/machine learning model).
• How ground truth for the training set was established: Not applicable.

Summary Table of Unavailable Information:

Explanation:

The document describes a Spinal Fixation System, which is a physical implant, not a software algorithm or AI device. Therefore, many of the requested points related to AI performance, ground truth establishment by experts, and reader studies are not relevant or present in this type of 510(k) submission.

For mechanical devices like this, "performance data" typically refers to biomechanical testing (e.g., fatigue strength, static bending strength, pull-out strength, torsional strength). The 510(k) summary only states that such testing was performed and demonstrated substantial equivalence to predicate devices, without detailing the specific tests, methodologies, acceptance criteria, or quantitative results. This level of detail is often found in the full 510(k) submission and not typically in the publicly available summary.

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