(124 days)
The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).
L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
L-Varlock Lumbar Cage is implanted via a posterior approach and supplemented by posterior fixation. Two devices are used. Main features of the L-Varlock lumbar cage are:
- Different heights for accurate enlargement of the foramina .
- Different widths and lengths to achieve excellent stability at the instrumented level . while preserving the patient's anatomy.
- Large graft space to achieve good bony fusion .
- Large cortical interface to ensure a good bony fusion. .
- Toothed outer walls prevent implant back out. ●
- The rounded geometry of the anterior end of the cage avoids damage to the anterior vascular structures.
Materials:
L-Varlock lumbar Cages are manufactured from titanium alloy (Ti6Al4V-Eli, ASTM norm F136).
Function:
Lumbar interbody cages are one of the treatment options for low back pain.
Here's an analysis of the L-Varlock Lumbar Cages based on the provided 510(k) summary, specifically focusing on acceptance criteria and study details:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ASTM F2077 | Meets required criteria. |
| ASTM F2267 | Meets required criteria. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document refers to "tests performed according to ASTM F2077/F2267." These standards often specify minimum sample sizes for mechanical testing.
- Data Provenance: Not explicitly stated as "country of origin." However, the tests are conducted according to ASTM (American Society for Testing and Materials) standards, which are internationally recognized, implying a general engineering/materials testing context rather than a clinical dataset. The nature of the tests (mechanical) indicates they are laboratory-based, not patient-data driven, and thus are "prospective" in the sense of being planned experiments, not retrospective analysis of clinical data.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This document describes the mechanical testing of a medical device (lumbar cage), not a diagnostic algorithm or image analysis tool that would require expert-established ground truth. The "ground truth" for mechanical testing is defined by the parameters and limits set by the ASTM standards themselves.
4. Adjudication Method for the Test Set
- Not Applicable. As this is mechanical testing against engineering standards, not a diagnostic assessment, there is no need for expert adjudication. The "adjudication" is inherent in the pass/fail criteria of the ASTM standards.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not mentioned as this device is a physical implant, not an AI or diagnostic tool that assists human readers.
6. Standalone (Algorithm Only) Performance Study
- Not Applicable. This device is a physical implant, not an algorithm. Therefore, no standalone algorithm performance study was conducted.
7. Type of Ground Truth Used
- Engineering Standards/Material Properties. The ground truth for the device's performance is established by the specifications and pass/fail criteria defined within the ASTM F2077 (for intervertebral body fusion devices, static and dynamic compression) and ASTM F2267 (for intervertebral body fusion devices, subsidence) standards. These standards define the acceptable mechanical properties and behaviors for such implants.
8. Sample Size for the Training Set
- Not Applicable. This device is a physical product, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (See point 8).
Summary of the Study:
The L-Varlock Lumbar Cage underwent non-clinical mechanical testing to demonstrate that it meets established safety and performance standards for intervertebral body fusion devices. The study involved testing the physical device according to ASTM F2077 and ASTM F2267. These standards are designed to assess the static and dynamic compression behavior and subsidence characteristics of lumbar cages under simulated physiological loading conditions. The results indicated that the L-Varlock Lumbar Cages met the required mechanical acceptance criteria as defined by these ASTM standards. This type of testing is fundamental for demonstrating the structural integrity and mechanical suitability of physical implants before their use in humans.
§ 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.