(99 days)
RANGE/ DENALI/ MESA and ARI 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, kyphosis; 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, in skeletally mature patients, 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; and/or lordosis); tumor; pseudoarthrosis; and failed previous 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 noncervical 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 Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) 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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting study for the Range Spinal System:
The provided text does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the way one would typically expect for a software or AI-driven medical device submission. This 510(k) is for a spinal implant system (mechanical device), and its evaluation relies on different methodologies.
Therefore, many of the requested fields cannot be answered from the provided text. I will fill in what can be inferred or explicitly stated, and note when information is absent.
Acceptance Criteria and Device Performance for the Range Spinal System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static Compression (ASTM F1717) | Tested in accordance with ASTM F1717. Determined to be "substantially equivalent to predicate devices." |
| Static Torsion (ASTM F1717) | Tested in accordance with ASTM F1717. Determined to be "substantially equivalent to predicate devices." | |
| Dynamic Compression (ASTM F1717) | Tested in accordance with ASTM F1717. Determined to be "substantially equivalent to predicate devices." | |
| Material Compatibility | Biocompatibility of Titanium Alloy and Cobalt Chrome | Materials meet ASTM and ISO standards. (Implied acceptance by meeting standards) |
| Design Equivalence | Design features and sizing comparability to predicate devices | "Substantially the same as these systems." |
| Functional Equivalence | Ability to provide immobilization and stabilization as an adjunct to fusion | "Substantially equivalent to these other devices in design, function, material and intended use." |
| Clinical Safety & Efficacy | Safety and efficacy established for similar devices | "Published clinical results for similar devices supported the safety and efficacy of these devices." (This is not direct device performance, but reliance on predicate's clinical history.) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of this submission. The "test set" here refers to mechanical testing. The submission does not specify the number of implants tested in the mechanical studies.
- Data Provenance: The mechanical tests were performed by K2M, Inc. to ASTM F1717 standards. The "clinical results" are from "similar devices" (predicates), implying published literature, but no specific provenance (country, retrospective/prospective) for these clinical results is provided for the original predicates' studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a mechanical implant. Ground truth as typically defined for AI/software devices (e.g., expert radiological reads, pathology) is not relevant here. The "truth" for this submission is established through engineering principles and compliance with mechanical testing standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of interpretations of clinical data.
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. This is a spinal implant, not an AI software device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a spinal implant, not an AI software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical performance, the "ground truth" is defined by the specifications and acceptable failure modes within the ASTM F1717 standard and the comparative performance to predicate devices.
- For the clinical aspects, the submission relies on the historical clinical safety and efficacy of the predicate devices, which would have been established through their own clinical trials or post-market surveillance. No new clinical ground truth was established for this specific 510(k).
8. The sample size for the training set:
- Not applicable. This is not an AI/software device that uses a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/software device that uses a "training set."
Summary of the Study per the 510(k):
The "study" or rather, the evaluation presented for the Range Spinal System in K121630, is primarily a comparative engineering and material performance assessment against predicate mechanical devices.
- Mechanical Testing: The Range Spinal System implants underwent static compression, static torsion, and dynamic compression testing in accordance with ASTM F1717. The results of these tests indicated that the implants were substantially equivalent to the predicate devices.
- Design and Material Comparison: The design features, sizing, and materials (Titanium Alloy and Cobalt Chrome per ASTM and ISO standards) were compared to predicates and found to be substantially the same.
- Clinical Efficacy (Indirect): The submission explicitly states that "Published clinical results for similar devices supported the safety and efficacy of these devices." This indicates reliance on the established clinical history of the predicate devices rather than new clinical data generated for the Range Spinal System itself.
Conclusion of the 510(k):
The submission concludes that there are "no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product." It is deemed substantially equivalent in design, function, material, and intended use to its predicates. The purpose of this specific submission was to expand the indications for use to include adolescent idiopathic scoliosis, based on this substantial equivalence argument.
§ 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.