(28 days)
Non-cervical spinal fixation devices 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); turnor; pseudoarthrosis; and failed previous fusion.
Non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis; 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 LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1,3 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 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 medical device being described is the Range Spinal System.
Here's an analysis of the provided text regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical/Biomechanical Performance: The device (Range Spinal System) must perform at least equally to, or better than, predicate devices and other currently marketed systems in ASTM F1717 testing, which likely encompasses various biomechanical tests related to spinal fixation systems (e.g., strength, stiffness, fatigue). |
Design Features and Sizing: The design features and sizing of components must be substantially the same as predicate systems, implying that it fits within established anatomical and surgical norms for spinal fixation.
Material Composition: Must be manufactured from FDA-recognized materials for spinal implants (specifically Ti6Al-4V ELI alloy per ASTM and ISO standards).
Intended Use: The device must be indicated for the same intended uses as legally marketed predicate devices, encompassing various spinal conditions requiring fixation (e.g., degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion, and severe spondylolisthesis at L5-S1 for pedicle screw fixation). | Mechanical/Biomechanical Performance: "The Range Spinal System was biomechanically tested and compared to the predicate systems and other currently marketed systems and performed equal to or better than these systems in ASTM testing to F1717."
Design Features and Sizing: "The design features and sizing of the components were also compared and the Range Spinal System found to be substantially the same as these systems."
Material Composition: "It is manufactured from the same FDA recognized materials [Ti6Al-4V ELI alloy per ASTM and ISO standards]."
Intended Use: "It is indicated for the same intended uses as these systems." (The specific indications are listed in section 5 of the 510(k) summary and reiterated in the Indications for Use document.) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a "test set" in the context of clinical data or patient outcomes. The evaluation is primarily based on biomechanical testing against established ASTM standards and comparison to predicate devices, and not on a clinical trial with a defined patient test set.
The data provenance is related to the biomechanical testing results of the Range Spinal System itself, compared against predicate devices. It is therefore prospective in the sense that the new device was tested, but the comparison is against established, already-marketed devices. The country of origin for the data is not specified, but the testing was done according to ASTM standards, which are international.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable to this document. The "ground truth" for this medical device's acceptance is based on adherence to biomechanical performance standards (ASTM F1717) and substantial equivalence to legally marketed predicate devices in terms of design, materials, and intended use. There is no mention of expert consensus on patient data or clinical outcomes being used to establish ground truth in this submission.
4. Adjudication Method for the Test Set
This information is not applicable as there is no human-adjudicated "test set" described in the context of clinical performance or diagnostic accuracy. The evaluation revolves around engineering and material properties, and comparison to predicate devices.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and their performance is compared with and without AI assistance. The Range Spinal System is an implantable spinal fixation device, not a diagnostic tool requiring interpretation by human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
N/A. This question is primarily relevant to AI/diagnostic algorithms. The Range Spinal System is a physical medical implant. The determination of its performance is through physical testing (biomechanical) and comparison to existing physical devices, not through an algorithm operating in isolation.
7. The Type of Ground Truth Used
The "ground truth" for the Range Spinal System's substantial equivalence determination is based on:
- Biomechanical performance standards: Compliance with ASTM F1717.
- Material standards: Use of Ti6Al-4V ELI alloy per ASTM and ISO standards.
- Comparison to predicate devices: Demonstration of "substantially the same" design, function, material, and intended use as other legally marketed spinal systems.
There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth for this 510(k) submission.
8. The Sample Size for the Training Set
This information is not applicable. The Range Spinal System is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
§ 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.