(65 days)
The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications;
Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: Trauma ( i.e. fracture or dislocation ): spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated 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.
Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD) (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 ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Everest Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.
Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.
The purpose of this 510(k) submission is to add minimally invasive implants.
Here's an analysis of the provided text regarding the Everest Spinal System, focusing on acceptance criteria and the study proving device performance:
Summary of Acceptance Criteria and Device Performance for the Everest Spinal System
It's important to note that the provided document is a 510(k) summary for a spinal fixation system, and not a diagnostic AI device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are geared towards mechanical and design equivalence to predicate devices, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are typical for AI-powered diagnostic tools.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static Compression | Performed "equally to or better than" predicate devices in accordance with ASTM F1717 |
| Static Torsion | Performed "equally to or better than" predicate devices in accordance with ASTM F1717 | |
| Dynamic Compression | Performed "equally to or better than" predicate devices in accordance with ASTM F1717 | |
| Design Features | Design of components | "substantially the same as"predicate systems |
| Sizing of Components | Sizing of components | "substantially the same as"predicate systems |
| Material Composition | Materials used | Manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards (Implicitly accepted as equivalent to predicate devices through regulatory compliance) |
| Intended Use | Indications for Use | The system's indications for use are identical to those of the predicate K2M Range Spinal Systems (MESA and DENALI), demonstrating equivalence. |
2. Sample Size Used for the Test Set and the Data Provenance
Given this is a mechanical testing and design comparison, the concept of a "test set" and "data provenance" (country of origin, retrospective/prospective) as understood for AI/diagnostic studies is not directly applicable.
- Test Set Sample Size: The document does not specify a numerical sample size for the mechanical tests. It would typically involve a certain number of devices or components tested according to ASTM F1717.
- Data Provenance: Not applicable in the context of mechanical testing. The testing would be conducted in a laboratory environment following standardized procedures.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This category is not applicable for the Everest Spinal System 510(k) summary. "Ground truth" in this context refers to an objective standard, which for mechanical performance is established by the ASTM F1717 standard itself and the measured physical properties of the tested devices, not expert human assessment.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts in diagnostic studies. Here, the "truth" is determined by direct mechanical measurements against a standard.
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. This device is a surgical implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies for human reader performance with or without AI assistance are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Everest Spinal System is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Mechanical Measurement Results: Directly measured values from static compression, static torsion, and dynamic compression tests performed according to ASTM F1717.
- Predicate Device Performance: The accepted performance characteristics of the legally marketed predicate devices (K2M Everest Spinal System, K2M Range Spinal System, NuVasive SpherX, Globus Resolve). The new device's performance is compared against these established benchmarks.
- Design and Sizing Equivalence: Direct comparison of the physical design and dimensions of the new components to those of the predicate devices.
- Material Standards: Compliance with ASTM and ISO standards for Titanium Alloy and Cobalt Chrome.
8. The Sample Size for the Training Set
Not applicable. As this is a physical medical device undergoing mechanical testing and design comparison, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device submission.
§ 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.