(98 days)
When used as a lumbar intervertebral body fusion device, the Lanx Fusion System -Lateral ("Lanx Lateral") 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-SI. 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 Lateral 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·Fusion System - Lateral ("Lanx Lateral") 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 Lateral 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 tissues, and to restore the height of a collapsed vertebral body. The Lanx Lateral is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Lateral 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 product line includes the Lanx Lateral implant models which include the addition of new footprints and configurations. All devices in the Lanx Lateral are made of PEEK (OPTIMA®) per ASTM F2026. The PEEK components include Tantalum markers per ASTM F560. The Lanx Lateral 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 Lateral is provided non-sterile.
The provided text describes a 510(k) summary for the "Lanx Fusion System - Lateral" and does not contain information about a study involving AI or human readers for diagnostic purposes. Instead, it focuses on the equivalence of a medical device to predicate devices through mechanical testing and engineering analysis.
Therefore, many of the requested categories in your prompt (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the information provided in the document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical properties as demonstrated by compliance with ASTM F2077 | "In all instances, the Lanx Lateral met acceptance criteria and functioned as intended." |
| Mechanical properties as demonstrated by compliance with ASTM Draft Z8423Z | "In all instances, the Lanx Lateral met acceptance criteria and functioned as intended." |
| Comparable mechanical properties to the predicate device (Lanx Intervertebral Body/VBR Fusion Device - K083815) | "Mechanical testing and engineering analysis demonstrated comparable mechanical properties to the predicate device." |
| Does not raise new questions of safety or effectiveness compared to predicate devices. | "Performance data demonstrate that these devices do not raise new issues of safety or effectiveness; hence it is as safe and effective as its predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device submission based on mechanical testing and engineering analysis, not a study of diagnostic performance using patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM) and direct measurement, not expert consensus on patient data.
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 document pertains to the mechanical and design equivalence of a spinal implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical performance, the "ground truth" is defined by the acceptance criteria within the specified ASTM standards (ASTM F2077 and ASTM Draft Z8423Z). This involves objective measurements of material properties and structural integrity under various loads, compared against predefined thresholds in the standards.
8. The sample size for the training set
Not applicable. This is not an AI algorithm submission.
9. How the ground truth for the training set was established
Not applicable.
§ 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.