(116 days)
The APEX Spine System 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 (pseudoarthrosis).
The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The APEX Spine System is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis). tumor, and previous failed fusion (pseudo-arthrosis).
The APEX Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
The APEX Spine System is a rod-based system designed to interface with various spinal anatomies. The system consists of spinal rods, monoaxial screws, polyaxial screws, bolt-type pedicle screws, various lateral connectors, and various cross (transverse) connectors.
The provided text describes the APEX Spine System, a spinal fixation system, and its substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, the information requested regarding acceptance criteria, study details, ground truth establishment, sample sizes for training/test sets, expert involvement, and MRMC studies, is not applicable to this submission. The submission pertains to a traditional medical device (spinal implants) and relies on mechanical and dynamic testing for performance data, as opposed to clinical study data involving human readers or AI algorithms.
Here's a breakdown of the relevant information from the provided text for a traditional medical device:
1. Acceptance Criteria and Device Performance (for this traditional device):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical and dynamic performance demonstrating equivalence or superiority to predicate devices. | "The test results demonstrate that the mechanical performance of the APEX Spine System is at least comparable to, if not better than, those of the predicate devices." |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission describes a physical medical device (spinal implants) and its mechanical and dynamic testing, not a study involving a test set of data. The "test set" here refers to the physical samples of the device and predicate devices used in mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth is not established by experts in the context of mechanical testing for a physical device. Performance is determined by objective engineering standards and measurements.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical data analysis, not for mechanical testing of a physical device.
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:
- Not applicable. An MRMC study is relevant for AI/ML-powered diagnostic or assistive devices involving human readers. This submission describes a physical spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This question pertains to AI algorithm performance.
7. The type of ground truth used:
- Not applicable/Objective Mechanical Measurements. For this device, "ground truth" would be the scientifically established physical and mechanical properties and performance standards for spinal fixation systems.
8. The sample size for the training set:
- Not applicable. Training sets are used for machine learning algorithms.
9. How the ground truth for the training set was established:
- Not applicable. Training sets and their ground truth are specific to machine learning.
Summary of the Study and Device Proof:
The APEX Spine System's compliance is demonstrated through mechanical and dynamic testing. The study's objective was to show that the device's performance is substantially equivalent to legally marketed predicate devices. The performance data explicitly states: "The test results demonstrate that the mechanical performance of the APEX Spine System is at least comparable to, if not better than, those of the predicate devices." This statement serves as the proof that the device meets the implicit acceptance criterion of being mechanically equivalent or superior to existing, cleared devices.
The basis for substantial equivalence also relies on similarities in design, material, manufacturing standards, intended use, indications, and contraindications compared to the predicate devices. The fundamental scientific technology is described as "identical to previously cleared systems."
§ 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.