(162 days)
When used with pedicle screw fixation systems of the noncervical spine in skeletally mature patients, the Annex™ Adjacent Level System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Annex™ Adjacent Level System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.
The Annex™ Adjacent Level System can be linked to 5.5mm diameter rod systems, including the CapSure® or Sniper® Spine Systems.
The Annex™ Adjacent Level System consists of a selection of non-sterile, single use connectors manufactured from titanium alloy (ASTM F136) and cobalt chrome alloy (ASTM F1537), for attachment to an existing 5.5mm diameter rod construct to extend a rigid spinal construct. The connectors are provided in a variety of sizes and shapes to accommodate variations in anatomy and spacing/positioning of existing screw and rod hardware.
The Spine Wave Annex™ Adjacent Level System is a medical device, and the provided document details its 510(k) submission to the FDA. For medical devices seeking 510(k) clearance, the "acceptance criteria" are typically demonstrating substantial equivalence to a predicate device, primarily through performance testing and comparison of technological characteristics, rather than meeting specific statistical metrics against a ground truth as would be common for AI/ML devices.
Here's an analysis based on the provided text, structured to answer your questions where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrates Substantial Equivalence via Performance Testing) | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Static axial compression bending
- Dynamic axial compression bending
- Static torsion testing | The device underwent static axial compression bending, dynamic axial compression bending, and static torsion testing according to ASTM F1717. These tests were performed to demonstrate that the Annex™ Adjacent Level System is substantially equivalent to the predicate devices. |
| Material Compatibility: - Materials used in the device are suitable for the intended use and similar to predicate devices. | The device consists of connectors manufactured from titanium alloy (ASTM F136) and cobalt chrome alloy (ASTM F1537). These materials are commonly used in spinal implants and are consistent with industry standards and predicate devices. |
| Intended Use Compatibility: - The system's use for extending existing 5.5mm diameter rod constructs is functionally sound. | The system is designed to attach to an existing 5.5mm diameter rod construct to extend a rigid spinal construct. It can link to 5.5mm diameter rod systems, including the CapSure® or Sniper® Spine Systems, demonstrating compatibility with existing spinal fixation systems. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes mechanical performance testing (static and dynamic axial compression bending, static torsion) of the device itself, not a clinical study involving human patients or a software algorithm evaluating data. Therefore, there isn't a "test set" of patient data or data provenance in the typical sense for algorithm evaluation.
The "sample size" for the mechanical tests would refer to the number of physical device units tested for each specific test (e.g., how many screws, rods, or connectors were subjected to compression bending). This information is not provided in the summary. The provenance is the testing laboratory that performed the ASTM F1717 tests, but specific details are not given.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable to this 510(k) submission. The "ground truth" for this device is its mechanical integrity and performance, established through standardized ASTM F1717 testing, not through expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This concept is not applicable. Mechanical testing results are objective measurements (e.g., load at failure, displacement under load) and do not require expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (e.g., AI in radiology) to assess human reader performance with and without AI assistance. The Annex™ Adjacent Level System is a physical spinal implant, not a diagnostic or AI-powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" employed in this submission is the specified mechanical performance standards outlined in ASTM F1717. The device's performance was compared against these objective engineering standards and against the established performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
There is no training set for this device submission. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set.
§ 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.