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The Lanx Spinal Fixation System (SFS) is intended 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 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 (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 Spinous Process Fusion Plate is intended for use with bone graft material, not intended for standalone use.

The purpose of this Special 510(k) is to add a modified polyaxial pedicle screw configuration in multiple sizes. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.

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 Lanx Spinal Fixation System implants are fabricated from medical grade titanium, titanium alloy and/or cobalt chrome alloy per ASTM F67, ASTM F136 and ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

The provided document describes the Lanx Spinal Fixation System, a medical device, and its regulatory submission. It does NOT contain information about acceptance criteria or a study proving that a device (in the context of AI/software performance) meets acceptance criteria.

The document discusses:

• Device Identification: Proprietary Name, Common Name, Classification, Predicate Devices.
• Intended Use / Indications for Use: What the system is designed to do and for what conditions.
• Device Description & Technological Characteristics: Details about its components, materials, and the purpose of the 510(k) (adding a modified polyaxial pedicle screw configuration).
• Performance Data: States that mechanical performance testing was conducted according to ASTM standards (F1717 and F1798) to characterize the modified components. The results "demonstrate substantial equivalence to the predicate device."
• Substantial Equivalence: A conclusion that the modified components are substantially equivalent to the predicate device based on intended use, technological characteristics, and mechanical testing.
• FDA Letter: A letter from the FDA confirming the 510(k) clearance for the Lanx Spinal Fixation System based on substantial equivalence.

Therefore, I cannot extract the requested information as it pertains to AI/software device performance criteria and studies. The document is about a mechanical orthopedic implant system and its regulatory clearance based on mechanical testing and substantial equivalence to existing devices.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: This document does not specify numerical acceptance criteria for AI/software performance metrics (e.g., sensitivity, specificity, accuracy) or report such performance for an AI/software device. It mentions mechanical testing (ASTM F1717 and F1798) and states that the "observed test results demonstrate substantial equivalence to the predicate device." The acceptance criteria for this mechanical testing would be implicit in the ASTM standards and the demonstration of equivalence, but specific numbers are not provided in terms of "reported device performance" in a table.
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software study. "Test set" in this context would refer to the physical components tested mechanically, not a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving human experts establishing ground truth for software performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI study.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of AI/software. For the mechanical testing, the "ground truth" would be the established performance characteristics and safety profile of the predicate device against which the modified device was compared.
8. The sample size for the training set: Not applicable. This is not an AI study involving a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a Spinal Fixation System and its regulatory clearance based on mechanical testing and substantial equivalence, not the performance of an AI-powered diagnostic/analytic device.

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