(178 days)
The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.
The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): spondylolisthesis: trauma (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.
The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.
The Lanx Spinal Fixation System implants are fabricated from medical grade titanium, titanium alloy and/or cobalt chrome alloy per ASTM F67, ASTM F136 and ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.
The provided text describes a 510(k) summary for the Lanx Spinal Fixation System, focusing on mechanical performance testing rather than performance in a clinical or diagnostic setting. Therefore, the questions related to clinical study design, human readers, ground truth establishment, and sample sizes for training sets are not applicable to the information contained in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to a comparison with a predicate device and adherence to ASTM standards. It does not explicitly state numerical acceptance criteria in a table format, but rather indicates that the modified device's performance was comparable to the predicate device and functioned as intended.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static and Dynamic Axial Compression (per ASTM F1717) | "performed on the modified and predicate systems, and the results compared." The modified device functioned as intended and demonstrated substantial equivalence to the predicate device. |
| Static Torsion (per ASTM F1717) | "performed on the modified and predicate systems, and the results compared." The modified device functioned as intended and demonstrated substantial equivalence to the predicate device. |
| Additional Expulsion Tests | "performed on the modified and predicate systems, and the results were compared." The modified device functioned as intended and demonstrated substantial equivalence to the predicate device. |
| Additional Sheer Tests | "performed on the modified and predicate systems, and the results were compared." The modified device functioned as intended and demonstrated substantial equivalence to the predicate device. |
| Additional Compression Tests | "performed on the modified and predicate systems, and the results were compared." The modified device functioned as intended and demonstrated substantial equivalence to the predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the document. The testing involved "the modified and predicate systems," implying an engineering test setup rather than a patient-based test set. The number of samples for each mechanical test (e.g., number of constructs tested) is not provided.
- Data Provenance: The data is generated from laboratory performance testing and engineering analysis of the physical device components. This is not patient-based data, so concepts like "country of origin" or "retrospective/prospective" do not apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1717) and the physical properties of the materials and designs under controlled laboratory conditions, not by expert medical opinion.
4. Adjudication method for the test set:
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when human expert consensus is required for ground truth. For mechanical testing, the "adjudication" is inherent in the adherence to established testing protocols and the direct measurement of physical properties.
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:
This question is not applicable. This document describes a mechanical spinal fixation system, not an AI-based diagnostic or treatment tool that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable. This document describes a physical medical device (spinal fixation system), not an algorithm or software.
7. The type of ground truth used:
The "ground truth" for the performance testing is based on established engineering standards (ASTM F1717) for static and dynamic axial compression and static torsion, as well as additional expulsion, sheer, and compression tests. The performance of the modified device was compared directly to that of a predicate device under these standardized testing conditions.
8. The sample size for the training set:
This question is not applicable. The document describes a physical medical device undergoing mechanical performance tests, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This question is not applicable for the reasons stated in point 8.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.