(96 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 and/or lordosis); 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 pedicle screw fixation in pediatric 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 Everest Spinal System implants are manufactured from titanium alloy per ASTM F136 and F1472 and Cobalt Chrome per ASTM F1537. The subject 510(k) adds additional connectors and rods to the system.
Function: The system functions as an adjunct to provide immobilization and stabilization of the posterior thoracic and lumbar spine.
This document, a 510(k) Premarket Notification for the Everest Spinal System, primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel acceptance criteria for a new type of performance. Therefore, the provided text does not contain detailed information on acceptance criteria based on accuracy metrics for a medical device or a study designed to prove the device meets such criteria in the way envisioned by the prompt.
The document discusses the mechanical performance evaluation of the Everest Spinal System, which is a spinal fixation system, against established standards for such devices.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative acceptance criteria and reported device performance in a table format for accuracy or clinical effectiveness as one might expect for a diagnostic or AI-driven device. Instead, it states that:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | "results were comparable to previously cleared devices." |
| - Static Torsion | Met standards (implied by "comparable") |
| - Static Compression | Met standards (implied by "comparable") |
| - Dynamic Compression Bending | Met standards (implied by "comparable") |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "tests" referred to are mechanical evaluations of the physical device components, not clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable and not provided. The ground truth for mechanical testing is based on engineered specifications and standardized test protocols (ASTM F1717), not expert consensus from medical professionals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for clinical studies or image interpretations, not for mechanical engineering tests.
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 information is not applicable and not provided. The Everest Spinal System is a physical implant, not an AI-driven diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant to its evaluation here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The Everest Spinal System is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the mechanical performance evaluation is the established mechanical properties and performance standards for spinal fixation systems as defined by ASTM F1717. This is based on engineering principles and regulatory requirements for the device's function and safety, not clinical outcomes or expert consensus in the medical sense.
8. The sample size for the training set
This information is not applicable and not provided. As this is a mechanical device, there is no "training set" in the context of machine learning or algorithms. The design and manufacturing processes are likely informed by prior engineering knowledge and material science.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no "training set" or "ground truth for the training set" in the context of this device's evaluation.
Summary of what the document does provide:
- Device Type: Spinal fixation system (physical implant).
- Purpose of Study: To demonstrate substantial equivalence of new components (connectors and rods) to existing cleared devices based on mechanical performance.
- Methodology: Mechanical testing in accordance with ASTM F1717 (including static torsion, static compression, and dynamic compression bending).
- Conclusion: The mechanical test results were "comparable to previously cleared devices," suggesting the new components meet the established safety and performance profiles for this type of implant.
The document is a 510(k) submission, which aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design features, materials, and performance (often mechanical or bench testing for implants) rather than extensive clinical efficacy or accuracy studies that would involve large patient cohorts or expert assessments in the way the prompt implies.
§ 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.