(83 days)
The Range Spinal System is a 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); 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; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. They are 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 Natural Bridge LP Transverse Connectors are devices intended to be used in conjunction with K2M's currently available pedicle screw and/or hook systems for stabilization of the spine. The connectors 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 devices are designed for attachment to the rods to enhance the torsional stability of the implanted spinal construct.
The provided text describes a 510(k) premarket notification for the Natural Bridge LP Transverse Connectors, a medical device for spinal stabilization. This submission primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices through material and functional comparisons, along with biomechanical testing.
However, the document does not contain the kind of detailed information about a clinical study, acceptance criteria, ground truth establishment, or human-in-the-loop performance that would be required to answer many of the questions you've posed. The provided text is a regulatory filing for a medical device that establishes substantial equivalence, primarily through non-clinical data (biomechanical testing) and comparison to existing devices, rather than a clinical trial with specific performance metrics against an established ground truth.
Here's an attempt to answer the questions based on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria or report device performance in the format of a clinical study with detailed metrics like sensitivity, specificity, or accuracy. The "acceptance criteria" in this context are implicitly met by demonstrating substantial equivalence through:
- Materials: Same as predicate (Ti6Al-4V ELI alloy per ASTM and ISO standards).
- Intended Use: Identical to predicate.
- Function: Designed for attachment to rods to enhance torsional stability, with no significant difference in performance as demonstrated by biomechanical testing.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Material | Device shall be manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards, identical to predicate devices. | Manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards. (Implied: Meets standard, same as predicate). |
| Intended Use | Indications for Use shall be identical to currently available predicate devices (K2M Natural Bridge Transverse Connectors). | Intended Use is identical to the predicate K2M Natural Bridge Transverse Connectors, specifically for non-cervical spinal fixation and pedicle screw fixation for various conditions (DDD, spondylolisthesis, trauma, stenosis, curvatures, tumor, pseudoarthrosis, failed fusion). |
| Function/Performance | No significant difference in performance compared to predicate devices, as demonstrated by biomechanical testing. (Specifically, related to enhancing torsional stability). | Biomechanical testing demonstrated no significant difference in performance compared to the original Natural Bridge Transverse Connectors. (Implied: Achieved torsional stability comparable to predicate). |
| Design | Designed for attachment to rods. | Designed for attachment to the rods to enhance torsional stability. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a clinical test set from this document. The "test set" here refers to the biomechanical testing. The document does not specify the number of samples or constructs used in the biomechanical testing.
- Data Provenance: Not applicable for a human test set. Biomechanical testing data would be generated in a lab setting. The country of origin for the device submission is the USA (Leesburg, VA). The biomechanical testing results are the "data" that supports the performance claim.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the submission relies on biomechanical testing as opposed to expert-derived ground truth from clinical images or data. No human experts are mentioned as establishing ground truth for device performance in this context.
4. Adjudication Method for the Test Set
- Not applicable, as there is no human-interpreted test set requiring adjudication in this regulatory submission. Biomechanical testing results are typically quantitative and directly measured.
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
- Not applicable. This device is a mechanical implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a medical device (spinal implant), not an algorithm or AI system. Its performance is evaluated through material properties, design, and biomechanical testing, not algorithmic output.
7. The Type of Ground Truth Used
- For the biomechanical performance, the "ground truth" would be the quantitative measurements obtained from controlled biomechanical tests (e.g., measuring forces, torques, displacement, or fatigue life) which are then compared to established standards and/or the predicate device's measured performance. The document explicitly states "no significant difference in performance as demonstrated by biomechanical testing."
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the machine learning sense. The design and manufacturing processes are likely informed by engineering principles, material science, and prior device designs, but not through training on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for an AI or algorithmic 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.