(59 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 stcnosis: curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor: pscudarthrosis: and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system 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 noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allografi. 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, hooks and rod connectors.
Materials: The devices are manufactured from Titanium and Cobalt Chrome per ASTM standards.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.
Purpose of Submission: To add sterile packaging.
This document is a 510(k) summary for the Range/Mesa/Denali Spinal System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies or establishing novel acceptance criteria for device performance beyond what is already accepted for predicate devices.
Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, or MRMC studies.
Here's why and what information is available:
- No specific acceptance criteria or reported device performance: The document states that "Performance evaluations were previously conducted on constructs representing the worst case components (including static torsion, static compression and dynamic compression bending in accordance with ASTM F1717) and the Range Spinal System was found to be substantially the same as predicate devices." This indicates that the device met existing standards (ASTM F1717) and was comparable to previously approved devices, but specific acceptance criteria and detailed performance metrics are not listed in this summary.
- No human subject studies (test set, training set, ground truth): The K141873 submission is for a spinal fixation system, which is a physical implant. The evaluation described ("static torsion, static compression and dynamic compression bending in accordance with ASTM F1717") refers to mechanical testing of the device components, not studies involving human patients or a process that would require a test set, training set, ground truth, or expert adjudication as typically seen in AI/diagnostic device submissions.
- No Multi-Reader Multi-Case (MRMC) study or Standalone AI performance: Since this is a physical medical device (spinal fixation system) and not an AI or diagnostic algorithm, these types of studies are not applicable and are not mentioned.
Summary of available information based on the request (with explanations for missing data):
| Feature | Information from Document |
|---|---|
| 1. Table of acceptance criteria & device performance | Acceptance Criteria: Not explicitly stated as pass/fail values. The document states: "Performance evaluations were previously conducted on constructs representing the worst case components (including static torsion, static compression and dynamic compression bending in accordance with ASTM F1717) and the Range Spinal System was found to be substantially the same as predicate devices." This implies that the device met the performance requirements of ASTM F1717 and was comparable to the predicate devices. Specific quantitative criteria or reported performance values are not provided in this summary. |
Reported Device Performance: No specific numerical performance values are reported. The conclusion is that the device is "substantially the same" as predicate devices based on these performance evaluations. |
| 2. Sample size and data provenance (test set) | Not applicable. The evaluation involved mechanical testing of device constructs, not data from a human test set. |
| 3. Number/qualifications of experts (ground truth) | Not applicable. Ground truth is not established by experts for mechanical testing of a physical device. |
| 4. Adjudication method (test set) | Not applicable. No adjudication method is relevant for mechanical testing. |
| 5. MRMC comparative effectiveness study | No. This is a physical spinal fixation system, not an AI or diagnostic tool that would involve human readers or MRMC studies. |
| 6. Standalone performance (algorithm only) | No. This is a physical spinal fixation system, not an algorithm. |
| 7. Type of ground truth used | Not applicable. The "ground truth" for this type of device is compliance with mechanical testing standards (e.g., ASTM F1717) and demonstrating equivalence to predicate devices, which is based on engineering principles and test results, not expert consensus, pathology, or outcomes data in the context of human studies. |
| 8. Sample size for training set | Not applicable. There is no "training set" for a physical medical device. |
| 9. How ground truth for training set was established | Not applicable. There is no "training set" for a physical medical 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.