(78 days)
The Lanx Intervertebral Body Fusion Device ("Lanx Fusion System") is indicated for use 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,
The Lanx Fusion System is made of PEEK-OPTIMA® 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 accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Fusion System is provided non-sterile.
Here's an analysis of the provided text regarding the Lanx, LLC's Intervertebral Body Fusion Device, focusing on acceptance criteria and supporting studies:
Summary of Acceptance Criteria and Device Performance for Lanx Intervertebral Body Fusion Device (K073144)
Based on the provided 510(k) summary, the device is a mechanical implant, and its performance evaluation relies on engineering standards rather than clinical study endpoints that would involve human physiological measures.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM F2077-03 | Met acceptance criteria and functioned as intended. |
| ASTM F2267-04 | Met acceptance criteria and functioned as intended. |
Explanation of the Standards:
- ASTM F2077-03: Standard Test Methods for Intervertebral Body Fusion Devices - This standard covers static and fatigue compression, compression-shear, and torsion testing methods for intervertebral body fusion devices. It establishes a repeatable method for the mechanical evaluation of these implants.
- ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression - This standard describes a method for measuring the subsidence (or sinking) of an intervertebral body fusion device into vertebral bone under static axial compression. It helps assess the short-term stability and potential for implant migration.
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify the exact sample sizes (number of devices tested) for the ASTM F2077-03 and ASTM F2267-04 tests. These standards typically define minimum sample sizes for reliable testing, but the specific number used by Lanx, LLC is not disclosed in this summary.
- Data Provenance: The data is from engineering performance testing, not human clinical data. Therefore, there is no country of origin or retrospective/prospective classification in the context of clinical studies. The testing was conducted by Lanx, LLC or a contracted lab under their purview.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This question is not applicable to this device. As discussed, the device underwent mechanical engineering testing to established ASTM standards. Ground truth for these tests is defined by the physical properties and performance characteristics dictated by the standards themselves, not by expert medical interpretation of images or patient outcomes.
4. Adjudication Method for the Test Set
- This question is not applicable to this device. Adjudication methods (like 2+1, 3+1 consensus) are used for clinical trials or image interpretation studies where expert consensus is needed to establish a "ground truth" for diagnostic accuracy. For engineering tests, the "ground truth" is defined by the measurement protocols and pass/fail criteria of the specified ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the diagnostic performance of software, particularly in imaging, to see how it affects human reader performance. The Lanx Intervertebral Body Fusion Device is a physical implant, not a diagnostic or AI-powered imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable to this device. A standalone performance study refers to the performance of an AI algorithm without human intervention, typically in diagnostic tasks. The Lanx device is a physical implant, so this concept does not apply.
7. The Type of Ground Truth Used
- The "ground truth" for the performance data in this instance is compliance with pre-defined mechanical engineering standards (ASTM F2077-03 and ASTM F2267-04). These standards define the expected mechanical behavior (e.g., strength, stiffness, fatigue resistance, subsidence) of intervertebral body fusion devices. The device met these objective, measurable criteria.
8. The Sample Size for the Training Set
- This question is not applicable to this device. "Training set" refers to data used to train machine learning models. The Lanx Intervertebral Body Fusion Device is a physical implant, not an AI or machine learning product. Its design and performance are based on engineering principles and materials science, not statistical learning from a training dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable to this device for the reasons stated in point 8.
§ 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.