(99 days)
RANGE /DENALI, MESA and SMALL STATURE 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. scollosis, 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 skelctally 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 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.
The purpose of this submission is to add modified Small Stature components (screws, hooks and connectors) to the system.
The provided text describes a 510(k) submission for the Range Spinal System, focusing on adding modified Small Stature components. This is a premarket notification for a medical device seeking substantial equivalence to legally marketed predicate devices, not a study reporting on the performance of an AI algorithm or diagnostic device. Therefore, much of the requested information (e.g., acceptance criteria for a diagnostic device, sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth details) is not applicable to this document.
However, I can extract the relevant information regarding the device's acceptance criteria (in terms of performance) and the study that demonstrates it meets these criteria based on the provided text.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in: | The modified implants were determined to be substantially equivalent to the predicate devices. |
| - Static compression performance (in accordance with ASTM) | The modified implants were compared with predicate devices that were previously tested in static compression. |
| - Static torsion performance (in accordance with ASTM) | The modified implants were compared with predicate devices that were previously tested in static torsion. |
| - Dynamic compression performance (in accordance with ASTM) | The modified implants were compared with predicate devices that were previously tested in dynamic compression. |
| No significant differences that would adversely affect use | There are no significant differences between the Range Spinal System and other systems currently being marketed which would adversely affect the use of the product. |
| Substantially equivalent in design, function, material, and intended use | "It is substantially equivalent to these other devices in design, function, material and intended use." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The text refers to "modified implants" and "predicate devices" but does not quantify the number of implants or tests performed.
- Data Provenance: Not explicitly stated, but the testing was conducted in accordance with ASTM standards, suggesting a controlled testing environment rather than patient data. It is neither retrospective nor prospective in the context of a human study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable. This document describes physical testing of spinal implants, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not applicable as it pertains to expert review of diagnostic data, which is not relevant here.
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
- This information is not applicable. This is not an AI-assisted diagnostic device, and no human reader studies are mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This document describes physical device testing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is the performance of the predicate devices as established through prior testing (static and dynamic compression, static torsion per ASTM). The modified implants' performance in these same physical tests serves as the comparison to demonstrate substantial equivalence.
8. The sample size for the training set
- This information is not applicable. There is no training set as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- This information is not applicable. There is no training set. The "ground truth" for the comparison was established by the previously validated performance of the predicate devices.
Summary of the Study:
The study proving the device meets its acceptance criteria is a mechanical performance study. The "modified implants" of the Range Spinal System were subjected to physical tests:
- Static compression
- Static torsion
- Dynamic compression
These tests were performed in accordance with ASTM standards. The results of these tests were then compared directly to the performance of predicate devices that had undergone the same battery of tests previously. The conclusion was that the modified implants were "substantially equivalent" to the predicate devices in these mechanical performance aspects, as well as in design, function, material, and intended use. This substantial equivalence determination allowed the device to proceed to market.
§ 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.