(29 days)
RANGE/DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications:
Non-cervical fixation as an adjunct to 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; pseudoarthosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral the Range Spinal System may also be used for the same indications as an adjunct to fusion.
Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Range/Denali/Mesa Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The subject 510(k) adds additional screws and rods to the system.
Function: The system functions as a spinal fixation device to provide support and stabilization of the posterior thoracic and lumbar spine.
This document is a 510(k) premarket notification for a medical device called the RANGE/DENALI/MESA Spinal System. It's a regulatory submission to the FDA, not a clinical study report. Therefore, much of the requested information regarding acceptance criteria and clinical study details is not present in this type of document.
However, I can extract what is available and clarify what is not.
1. A table of acceptance criteria and the reported device performance
This document does not provide explicit acceptance criteria or reported device performance in the context of a clinical study. Instead, it describes a "Technological Comparison to Predicate(s)" and "Non-clinical Performance Evaluation."
- Acceptance Criteria (Implicit from Non-clinical Testing): The implicit acceptance criterion for the non-clinical performance evaluation is that the proposed implants (new screws and rods) are "substantially the same as the predicate devices" in terms of design features, materials, and sizes, and perform comparably in "worst case components" testing.
- Reported Device Performance (Non-clinical):
- Performance evaluations were previously conducted on constructs representing the worst-case components.
- Tests included: static torsion, static compression, and dynamic compression bending.
- These tests were performed in accordance with ASTM F1717.
- "Engineering rationales determined that the proposed implants were substantially the same as the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical performance evaluations (mechanical testing), not a clinical test set involving human subjects. Therefore, information about human sample size, data provenance (country, retrospective/prospective) is not applicable or provided.
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 is not applicable as there is no clinical test set or ground truth established by medical experts for device performance in this document. The "ground truth" for the non-clinical testing is compliance with ASTM F1717 and comparability to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no clinical test set or adjudication process described.
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
No, an MRMC comparative effectiveness study was not done. This device is a spinal fixation system (physical implant), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance evaluation, the "ground truth" is adherence to ASTM F1717 standards and demonstrating substantial equivalence in mechanical properties to previously cleared predicate devices. There is no clinical ground truth established or used in this submission.
8. The sample size for the training set
This is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
§ 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.