(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:
Posterior non-cervical fixation as an adjunct to fusion for the following indications: 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); spinal stenosis; curvatures (i.e. scoliosis, kyphosis); tumor; pseudarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system the EVEREST Spinal System may also be used for the same indications as an adjunct to fusion.
When used for posterior non-cervical pediatic patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The EVEREST Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The subject 510(k) adds sterile packaged implants to the system.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.
This document describes a 510(k) premarket notification for the EVEREST Spinal System. Based on the provided text, the device is a spinal fixation system, and the submission is for adding sterile-packaged implants to the system. The acceptance criteria and supporting study details are primarily related to mechanical performance and material compatibility, not a diagnostic or AI-driven device.
Here's an analysis of the provided information:
Assessment of Acceptance Criteria and Proving Study:
The document describes pre-clinical performance evaluations, not clinical studies in the context of an AI/diagnostic device. The "acceptance criteria" and "study" are focused on the mechanical and material aspects of the spinal implant.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Type of Test) | Reported Device Performance (Summary) |
|---|---|
| Static torsion | Results comparable to previously cleared devices (predicate devices). (Performed per ASTM F1717) |
| Static compression | Results comparable to previously cleared devices (predicate devices). (Performed per ASTM F1717) |
| Dynamic compression bending | Results comparable to previously cleared devices (predicate devices). (Performed per ASTM F1717) |
| Bacterial endotoxin testing | Results provided to support substantial equivalence. (Specific values not given, but implied to meet standards) |
| Accelerated and real-time aging | Results provided to support substantial equivalence. (Performed per AAMI/ANSI/ISO 11607, specific values not given) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test, but implied to be sufficient for the mechanical and material tests performed according to recognized standards (ASTM F1717, AAMI/ANSI/ISO 11607). For mechanical testing of medical devices, sample sizes are typically determined by statistical methods or industry standards to ensure sufficient power to detect differences or confirm compliance.
- Data Provenance: The tests are non-clinical performance evaluations (i.e., laboratory testing). Therefore, there is no "country of origin of the data" or "retrospective/prospective" in the sense of patient data. The provenance is the results of laboratory tests conducted by the manufacturer or a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device submission. Ground truth, in the context of expert consensus, is relevant for diagnostic devices (especially those involving image interpretation or clinical assessment). For a spinal implant, "ground truth" relates to material properties and mechanical performance, which are evaluated through standardized physical testing, not expert interpretation of clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to resolve discrepancies among multiple expert readers. For mechanical testing, the results are quantitative measurements against predefined standards.
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:
This is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation, particularly when evaluating the impact of AI assistance on reader performance. The EVEREST Spinal System is a physical implant, not a diagnostic or AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This question refers to the performance of an AI algorithm in isolation. The EVEREST Spinal System is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance evaluation is based on established engineering and material science standards and specifications. For example:
- Mechanical Strength: The "ground truth" is passing the load and fatigue requirements specified in ASTM F1717 (e.g., maintaining structural integrity and specific mechanical properties under defined static and dynamic loads).
- Biocompatibility/Material Safety: The "ground truth" is meeting the bacterial endotoxin limits and aging requirements as per relevant ISO standards (e.g., AAMI/ANSI/ISO 11607 for packaging and sterility).
8. The sample size for the training set:
This is not applicable. The device is not an AI/machine learning device, so there is no training set in this context.
9. How the ground truth for the training set was established:
This is not applicable. As there is no training set (being a physical medical device), the concept of establishing ground truth for it does not apply.
§ 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.