(92 days)
The APEX Spine System is intended to provide immobilization 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; 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, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.
The APEX Spine System is also a sacraliliac 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).
When used in a percutaneous posterior approach with AIM MIS instrumentation, the APEX Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis. trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.
The purpose of this submission is to add x-large and uniplanar pedicle screws, open iliac connectors and open-closed side-by-side connectors to the APEX Spine System. The APEX Spine System X-Large Screws are similar to the APEX screws and are available in a variety of diameters and lengths and can be used of the components of the previously cleared APEX Spine System. The APEX Uniplanar Pedicle Screw is similar in principle to the APEX Polyaxial Pedicle Screw; however the design restricts motion to the sagittal plane. The Open Iliac Connectors and Open-Closed Side-by-Side Connectors are utilized when pedicle screws are not vertically aligned.
The provided document describes a 510(k) submission for the APEX Spine System Line Extension, which is a spinal fixation system. This type of submission relies on demonstrating substantial equivalence to predicate devices rather than proving safety and effectiveness through clinical trials with specific acceptance criteria related to a device's performance metrics like sensitivity, specificity, accuracy, etc.
Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to AI/ML or diagnostic devices does not apply in this context. This submission focuses on mechanical performance and substantial equivalence.
Here's an analysis based on the information provided, framed to address the spirit of your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a spinal implant system and not an AI/ML or diagnostic device, the acceptance criteria are based on mechanical testing standards and comparison to predicate devices, rather than performance metrics like sensitivity or specificity.
| Acceptance Criteria (Mechanical Testing Standards) | Reported Device Performance |
|---|---|
| ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (Static Compression Bending Tests, Static Torsion Tests, Dynamic Compression Bending Tests) | Results were equal or higher than the predicate systems. |
| ASTM F1798: Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies used in Spinal Arthrodesis Implants (Static Axial Gripping, Static Axial Torque, Dynamic Flexion-Extension) | Results were equal or higher than the predicate systems. |
| Substantial Equivalence: In terms of intended use, design, materials used, mechanical safety, and performance compared to predicate devices. | The APEX Spine System Line Extension was deemed substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated in terms of number of screws or constructs, but the testing was performed on representative samples of the new components (x-large and uniplanar pedicle screws, open iliac connectors, and open-closed side-by-side connectors) added to the APEX Spine System. The ASTM standards dictate specific specimen requirements for each test.
- Data Provenance: The mechanical testing was performed in a laboratory setting, not on patient data. Thus, there is no "country of origin" or "retrospective/prospective" distinction in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Ground Truth for Mechanical Testing: For mechanical performance criteria, the "ground truth" is established by the ASTM standards themselves. These standards are developed by committees of engineers, scientists, and medical professionals. Compliance with these established standards demonstrates mechanical integrity.
- Experts: While not explicitly listed as "experts" for ground truth in the conventional sense, the underlying expertise comes from the materials scientists and biomechanical engineers who perform and interpret the mechanical tests, as well as the committees that develop the ASTM standards.
4. Adjudication Method for the Test Set
- Mechanical Testing: Adjudication is not applicable in the sense of expert review for diagnosis. The "adjudication" is based on comparing the quantitative results of the mechanical tests against the established performance criteria (e.g., strength, durability) and against the performance of the predicate devices. If the new device meets or exceeds the predicate device's performance, it's considered acceptable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- No MRMC study was done. This type of study is relevant for diagnostic devices or AI algorithms where human readers interpret medical images. The APEX Spine System is a physical surgical implant.
6. If a Standalone (algorithm only without human-in-the-loop performance) study was done
- Not applicable. This concept pertains to AI algorithms. The APEX Spine System is a medical device.
7. The Type of Ground Truth Used
- Ground Truth: For this device, the "ground truth" is primarily defined by established mechanical engineering principles, material science standards (ASTM), and the demonstrated performance of clinically accepted predicate devices. The goal is to show that the new components perform at least as well as existing, cleared devices.
8. The Sample Size for the Training Set
- Not applicable. This submission is not for an AI/ML device, so there is no training set in the AI sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 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.