(99 days)
The Range Spinal System is a non-cervical spinal fixation device intended for posterior, non-pedicle fixation 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.
The Range Spinal System is also intended for non-cervical pedicle screw fixation 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.
The Range Spinal System is a top-loading, multiple component, posterior system which consists of pedicle screws, rods, hooks, and transverse connectors. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Materials: The devices are manufactured from Ti6Al-4V ELI alloy and CP Titanium per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar and / or sacral spine.
The Range Spinal System is a spinal fixation system, and the provided documentation (K070229) describes its premarket notification to the FDA. The crucial information regarding acceptance criteria and performance data is found within the "510(k) Summary for the Range Spinal System" and the "Comparison of the technological characteristics of the device to predicate and legally marketed devices" section.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence: The device must demonstrate comparable technological characteristics, safety, and effectiveness to legally marketed predicate devices. This is assessed by comparing design, function, materials, and intended use. | The Range Spinal System was biomechanically tested and compared to other currently marketed systems (Denali Spine System and Mesa Spinal System, both from K2M, Inc.). The device "performed equal to these systems in ASTM testing to F1717." The design and sizing of components are "identical to these systems." It is manufactured from "the same FDA recognized materials and is indicated for the same intended uses as these systems." The conclusion states: "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use." |
| Material Compliance: Components must be manufactured from materials per established standards. | Manufactured from Ti6Al-4V ELI alloy and CP Titanium per ASTM and ISO standards. |
| Functional Equivalence: The system must function as an adjunct to fusion to provide immobilization of spinal segments in the thoracic, lumbar, and/or sacral spine for its stated indications. | The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar and/or sacral spine. (This is a statement of intended function, and its achievement is supported by the biomechanical equivalence to predicate devices.) |
| Biomechanical Performance: Must meet performance standards comparable to predicate devices in relevant biomechanical testing. (Specifically refers to ASTM F1717 for spinal implant constructs in this context). | "Performed equal to these systems in ASTM testing to F1717." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes biomechanical testing for the Range Spinal System. It states that the device "was biomechanically tested and compared to the other currently marketed systems and performed equal to these systems in ASTM testing to F1717."
- Test Set Sample Size: The specific sample size for the biomechanical tests (e.g., number of constructs tested, number of cycles) is not explicitly stated in the provided summary. It only refers to "ASTM testing to F1717."
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Biomechanical testing is typically conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This device is a mechanical implant, and the primary assessment of "ground truth" (or equivalence) is based on biomechanical performance standards (ASTM F1717) rather than expert review of clinical data or images. Therefore, the concept of "experts establishing ground truth" in the way it applies to diagnostic AI is not relevant here. The expertise lies in the engineers and technicians performing and interpreting the biomechanical tests and the committees that develop the ASTM standards.
4. Adjudication Method for the Test Set
N/A. As this is biomechanical testing against a standard, there is no "adjudication method" in the sense of reconciling differences in human reader opinions for a diagnostic task. The results are quantitative measurements against defined criteria within the ASTM standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
N/A. This is a spinal fixation system, a physical medical device. The evaluation is based on biomechanical performance and material compliance, not on diagnostic accuracy or interpretation by human readers. Therefore, an MRMC comparative effectiveness study, which is typically relevant for diagnostic imaging or AI systems that assist human interpretation, was not performed, nor is it applicable.
6. If a Standalone Performance Study was done
Yes, in a sense, a standalone performance assessment was conducted through the biomechanical testing to ASTM F1717. This testing evaluates the mechanical properties and performance of the device itself (the "algorithm only" equivalent for a physical device) against established standards and in comparison to predicate devices, without human-in-the-loop performance being a factor in the primary assessment for 510(k) clearance.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on established biomechanical performance standards (ASTM F1717) and the established safety and effectiveness of its predicate devices. The device's performance was compared to these standards and predicates to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
N/A. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data for model development.
9. How the Ground Truth for the Training Set was Established
N/A. As there is no "training set" for an AI or machine learning algorithm, this question is not applicable to the Range Spinal System.
§ 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.