(70 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 L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; 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 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 and is not intended for stand-alone use.
The Lanx Spinal Fixation System consists of various screws, 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 purpose of this 510(k) is to add the Spinous Process Fusion Plate to the Lanx SFS.
The provided document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance, nor does it describe a study with many of the requested parameters.
This document is a 510(k) summary for a medical device (Lanx Spinal Fixation System), which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and results.
Here's a breakdown of what can and cannot be extracted from the document:
What can be extracted:
- Device Name: Lanx Spinal Fixation System
- Intended Use/Indications for Use: Clearly stated in the document.
- Technological Characteristics: Describes the components and their purpose.
- Performance Data (General Statement): "Performance testing was performed and submitted to characterize the new components being added to the system. The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices."
What CANNOT be extracted from this document:
- Specific Acceptance Criteria: The document states that performance testing was done, but it does not specify what those criteria were (e.g., specific thresholds for fatigue life, pull-out strength, etc.).
- Reported Device Performance (Quantitative): While it states the device "functioned as intended" and demonstrated "substantial equivalence," it doesn't provide actual numerical results from the performance tests.
- Sample size used for the test set: Not mentioned.
- Data provenance (country of origin, retrospective/prospective): Not mentioned.
- Number of experts used to establish ground truth & qualifications: Not applicable, as this is a mechanical device, not an AI/imaging device requiring expert interpretation for ground truth.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable. This is a spinal fixation system, not an AI/imaging device intended to assist human readers.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used: Not applicable, as this refers to clinical outcomes or expert labels, which are not detailed for mechanical testing.
- Sample size for the training set: Not applicable (no AI/machine learning model).
- How ground truth for the training set was established: Not applicable.
Summary Table of Unavailable Information:
| Section | Information Provided in Document |
|---|---|
| 1. Acceptance Criteria & Reported Device Performance | Acceptance Criteria: Not explicitly stated. The document refers to "performance testing" but does not define specific thresholds (e.g., minimum fatigue cycles, maximum displacement). |
| Reported Device Performance: A general statement is provided: "The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices." No quantitative results (e.g., specific fatigue life in cycles, pull-out strength in Newtons) are presented. | |
| 2. Sample size and data provenance for test set | Not specified. |
| 3. Number and qualifications of experts for ground truth (test set) | Not applicable. This is a mechanical device, not an AI/imaging device requiring expert ground truth for a test set. The "performance data" refers to mechanical testing. |
| 4. Adjudication method for test set | Not applicable. |
| 5. MRMC comparative effectiveness study (effect size with/without AI) | Not applicable. This is a spinal fixation system, not an AI algorithmic device for human reader assistance. |
| 6. Standalone (algorithm-only) performance study | Not applicable. This is a physical medical device. |
| 7. Type of ground truth used (expert consensus, pathology, outcomes data) | Not applicable. For a mechanical device, performance is typically assessed against engineering standards and biomechanical testing, rather than clinical ground truth via expert consensus or pathology. The "ground truth" here would be physical measurements from mechanical tests. |
| 8. Sample size for training set | Not applicable. There is no AI model or training set mentioned. |
| 9. How ground truth for training set was established | Not applicable. There is no AI model or training set mentioned. |
Explanation:
The document describes a Spinal Fixation System, which is a physical implant, not a software algorithm or AI device. Therefore, many of the requested points related to AI performance, ground truth establishment by experts, and reader studies are not relevant or present in this type of 510(k) submission.
For mechanical devices like this, "performance data" typically refers to biomechanical testing (e.g., fatigue strength, static bending strength, pull-out strength, torsional strength). The 510(k) summary only states that such testing was performed and demonstrated substantial equivalence to predicate devices, without detailing the specific tests, methodologies, acceptance criteria, or quantitative results. This level of detail is often found in the full 510(k) submission and not typically in the publicly available summary.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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 L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.