(30 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 Lanx SFS is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scollosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
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 (TI-SI). 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 provided text describes the Lanx Spinal Fixation System, a medical device for spinal stabilization. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for a diagnostic AI/ML device.
This document is a 510(k) summary for a physical medical implant (spinal fixation system), not a software or AI/ML diagnostic device. Therefore, the questions related to "acceptance criteria" and "performance studies" would be interpreted differently than for an AI/ML product. For a physical device like this, performance is typically demonstrated through engineering analyses and mechanical testing to ensure it meets pre-defined physical and mechanical properties and functions as intended, rather than through clinical studies with human readers or ground truth established by experts.
Given that context, here's an attempt to extract the closest relevant information based on the questions, acknowledging the significant mismatch in the type of device and study described:
1. Table of acceptance criteria and the reported device performance
For this physical device, "acceptance criteria" would typically refer to engineering specifications and mechanical performance benchmarks. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functioned as intended | "The Lanx Spinal Fixation System functioned as intended" |
| Demonstrate substantial equivalence to predicate device | "the observed test results demonstrate substantial equivalence to the predicate device." |
| Comparable properties to previously cleared system | "Testing also demonstrated comparable properties to the previously cleared Lanx Spinal Fixation System." |
| No new issues of safety or effectiveness | "The minor differences in the modified components do not raise any new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable/not mentioned in the context of clinical data for a diagnostic device. The "test set" here would refer to components undergoing mechanical testing. The specific number of components or test specimens is not provided.
- Data Provenance: Not applicable in the context of diagnostic data. The "data" here refers to mechanical test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth for a physical device is established through documented engineering standards, mechanical tests, and material science, not human expert consensus on clinical data.
- Qualifications of Experts: This would involve mechanical engineers, material scientists, and quality control personnel, but their specific roles or qualifications are not detailed in this summary.
4. Adjudication method for the test set
- Adjudication method: Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies to resolve discrepancies in expert readings for diagnostic accuracy. For mechanical testing, results are typically determined by established test protocols and engineering analysis against acceptance limits.
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
- MRMC Study: No. This is a physical spinal fixation system, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. There is no algorithm described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For a physical device, the "ground truth" for performance is defined by engineering specifications, validated mechanical test standards (e.g., fatigue, static strength), and material properties. The document implies compliance with these engineering standards to demonstrate substantial equivalence.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. There is no AI/ML model or training set discussed.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. There is no AI/ML model or training set discussed.
Summary for an AI/ML context:
Based only on the provided text, there is no information about acceptance criteria or a study that typically applies to an AI/ML diagnostic device (e.g., sensitivity, specificity, clinical accuracy, reader studies). The document describes a traditional medical device (spinal fixation system) evaluated primarily through mechanical performance data and substantial equivalence to a predicate device.
§ 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.