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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; 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 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.

This submission pertains to the Lanx Spinal Fixation System. The provided document is a 510(k) summary and associated FDA correspondence, which primarily focuses on establishing substantial equivalence for a medical device.

Based on the provided text, there is no acceptance criteria or study that proves a device meets specific acceptance criteria in the context of an AI/ML device. This document is for a traditional spinal fixation system, not an AI-powered diagnostic or therapeutic device.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document discusses the performance of a traditional medical device (spinal fixation system) based on engineering analysis and mechanical testing to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the "Performance Data" section in the context of this traditional device:

The document states:
"Performance testing and engineering analysis was performed and submitted to characterize the modified components of the system. The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device."

Summary of Device Performance and Substantial Equivalence:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics in the provided text. The implicitly accepted criterion is that the device, after modifications, "functioned as intended" and demonstrated "comparable mechanical properties" to the predicate device. The ultimate acceptance criterion from an FDA perspective is showing "Substantial Equivalence" to a legally marketed predicate.
• Study Proving Acceptance: "Performance testing and engineering analysis" was performed.
• Specifics of the study (as much as can be inferred from the text):
  • Nature of Study: Mechanical testing and engineering analysis.
  • Purpose: To characterize modified components and demonstrate that the device functioned as intended, and to show comparable mechanical properties to the previously cleared Lanx Spinal Fixation System (the predicate).
  • Outcome: The testing and analysis "demonstrated comparable mechanical properties" leading to the conclusion of "substantial equivalence."

Key points from the document regarding substantial equivalence that replace the requested AI/ML specific information:

• Predicate Device: Lanx Spinal Fixation System (implicitly the pre-modified version).
• Basis for Substantial Equivalence:
  • Same intended use.
  • Same indications for use.
  • Same technological characteristics.
  • Same principles of operation as the predicate device.
  • Modifications do not raise new issues of safety or effectiveness.
  • Testing and engineering analysis demonstrated comparable mechanical properties.

In conclusion, the provided text describes a 510(k) submission for a non-AI spinal fixation system. The "acceptance criteria" and "study" are focused on demonstrating substantial equivalence through mechanical testing and engineering analysis, rather than the performance metrics typically associated with AI/ML device evaluation.

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