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When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.

When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Spinal Fixation System.

When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumalfracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e., T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural lissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this svstem.

Device Description

All implants in the Lanx Fusion System are manufactured from PEEK-OPTIMA® LT1 per ASTM F2026, titanium alloy (Ti-6Al-4V) per ASTM F136, and tantalum per ASTM F560. The implants have a hollowed out area to accommodate autogenous bone graft, and transverse grooves to improve fixation and stability. The implants are offered in a variety of footprints and heights to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Fusion System is provided non-sterile.

AI/ML Overview

Lanx Intervertebral Body/VBR Fusion System - Acceptance Criteria and Study Details

The provided document describes a 510(k) submission for a product line extension of the Lanx Intervertebral Body/VBR Fusion System. As such, the focus of the study is to demonstrate that the modified device is substantially equivalent to previously cleared predicate devices and does not raise new safety or efficacy concerns.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Stated)	Reported Device Performance
Static Compression	Meets established criteria for mechanical properties comparable to predicate devices.	"In all instances, the Lanx Fusion System met the established acceptance criteria and performed as intended."
Dynamic Compression	Meets established criteria for mechanical properties comparable to predicate devices.	"In all instances, the Lanx Fusion System met the established acceptance criteria and performed as intended."
Static Torsion	Meets established criteria for mechanical properties comparable to predicate devices.	"In all instances, the Lanx Fusion System met the established acceptance criteria and performed as intended."
Dynamic Torsion	Meets established criteria for mechanical properties comparable to predicate devices.	"In all instances, the Lanx Fusion System met the established acceptance criteria and performed as intended."
Subsidence Testing	Meets established criteria for mechanical properties comparable to predicate devices.	"In all instances, the Lanx Fusion System met the established acceptance criteria and performed as intended."
Overall Substantial Equivalence	The modified device is as safe and effective as the predicate devices and does not raise new issues related to safety or efficacy.	"Performance data demonstrate that these additions to the Lanx Fusion System do not raise new issues related to safety or efficacy; hence the modified system is as safe and effective as the predicate devices. Thus, the modified device is substantially equivalent."

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

The document describes mechanical testing performed to establish performance. Specific sample sizes for each test are not explicitly stated in the provided text. The data provenance is also not explicitly stated beyond being part of the manufacturer's internal testing process for regulatory submission. It is implicitly prospective data generated to support the 510(k) submission.

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

This type of information is not applicable to the described study. The study consisted of mechanical testing of the device itself, not an evaluation of diagnostic accuracy or clinical outcomes requiring human expert interpretation or a "ground truth" to be established in that sense.

4. Adjudication Method for the Test Set

This is not applicable to mechanical testing. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints where discrepancies in observations need to be resolved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. This study focused on the mechanical performance of the device itself, not on the impact of the device on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable to the described medical device. The Lanx Fusion System is a physical orthopedic implant, not an algorithm or a software device. The "standalone" performance here refers to the device's mechanical integrity on its own.

7. The Type of Ground Truth Used

The "ground truth" for this study was established through recognized industry standards (ASTM F2077 and ASTM F2267) and the performance characteristics of the predicate devices. The criteria against which the mechanical tests were judged were based on these established standards and the expected performance of similar, already cleared devices.

8. The Sample Size for the Training Set

This concept is not applicable to the described study. There is no "training set" in the context of mechanical performance testing of a physical implant. The design and manufacturing process for the device would have been developed and refined, but this is distinct from a "training set" for an algorithm.

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

This is not applicable for the reasons stated in point 8.

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