(29 days)
When used as a cervical intervertebral body fusion device, the Lanx Small Intervertebral Body/VBR 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 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 Small Intervertebral Body/VBR 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 Small Intervertebral Body/VBR Fusion System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. 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 vertebrectory) of a diseased vertebral body resected or excised for the treatment of turnors in order to achieve anterior decompression of the spinal cord and neural tissues, 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 system.
The Lanx Small Intervertebral Body/VBR Fusion system is made of PEEK-OPTIMA® or titanium alloy. The Fusion System has a hollowed out area to accommodate autogenous bone graft, and transverse grooves to improve fixation and stability. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Small Intervertebral Body/VBR Fusion System is provided non-sterile.
The provided text describes a medical device, the Lanx Small Intervertebral Body/VBR Fusion Device, and its 510(k) summary for FDA clearance. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and performance data.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| ASTM F2077-03 | Met acceptance criteria and functioned as intended |
| ASTM F2267-04 | Met acceptance criteria and functioned as intended |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide information regarding:
- The specific sample sizes used for the testing.
- The data provenance (e.g., country of origin of the data, retrospective or prospective) for the performance tests.
The performance data refers to "Performance testing was conducted per ASTM F2077-03 and ASTM F2267-04," which are standard testing methods for intervertebral body fusion devices. These standards typically define the methodologies for mechanical testing (e.g., static and dynamic axial compression, torsion), but the exact number of samples tested by the manufacturer to meet these standards is not specified in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the type of performance data presented. The performance testing described is mechanical, conducted according to ASTM standards, and does not involve human expert evaluation for establishing "ground truth" in the way a clinical study or diagnostic AI would.
4. Adjudication Method for the Test Set:
This information is not applicable as the performance data relates to mechanical testing against engineering standards, not human evaluation or ground truth establishment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned. This document describes the clearance of a physical medical device, not an AI software or diagnostic tool that would typically undergo such a study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical intervertebral body fusion device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" in this context refers to the specified mechanical performance requirements and limits outlined in ASTM F2077-03 and ASTM F2267-04. The device's ability to withstand certain forces, displacements, and cycles without failure (as defined by these standards) serves as the ground truth for its mechanical performance.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical implant, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.