(127 days)
The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples. The Range 4.5mm Small Stature Rod System is indicated for the following:
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. 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.
Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion 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 in skeletally mature patients.
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, hooks, transverse connectors, and rod connectors (axial, parallel and offset lateral). The screws range from 4.5mm in diameter, 20mml 10mm in length and attach to a 5.5mm rod.
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 of the posterior thoracic and lumbar spine.
The provided text describes a 510(k) summary for the Range Spinal System, focusing on modifications. This document outlines the device, its intended use, and a comparison to predicate devices, particularly concerning its mechanical performance.
However, the provided text does not contain information about acceptance criteria for device performance in a clinical or diagnostic context, nor does it describe a study involving human subjects or AI performance. The "study" mentioned is a mechanical bench test comparing the modified implants to previous versions and predicate devices.
Therefore, I cannot populate most of the requested fields as they pertain to clinical performance studies, AI algorithms, human expert evaluation, or statistical analysis of diagnostic accuracy.
Here's a breakdown of what can be extracted and why other fields cannot be filled:
- Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (from text) |
|---|---|
| Mechanical: | "modified implants were tested... in static compression, static torsion and dynamic compression in accordance with ASTM F1717" |
| Not explicitly stated what "passing" values were for specific forces or cycles. | "The modified implants were determined to be substantially equivalent to the predicate devices." (This implies they met mechanical performance comparable to predicates under ASTM F1717.) |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be determined from the text. The "test set" refers to mechanical samples, not patient data. The text does not specify the number of modified implants tested or their origin.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No human experts were used to establish "ground truth" for this type of mechanical testing. The "ground truth" is defined by the ASTM F1717 standard itself for mechanical properties.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is relevant for mechanical bench testing.
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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
- No. This is a mechanical device, not an AI diagnostic tool. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a mechanical device, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the mechanical testing, the "ground truth" is the performance specifications outlined by ASTM F1717, which dictates how spinal implant assemblies should be tested for static and dynamic properties. The goal was to show "substantial equivalence" to predicate devices, implying performance within an acceptable range defined by industry standards and comparison to previously cleared devices.
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The sample size for the training set
- Not applicable. This is a mechanical device. There is no "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established
- Not applicable. As above.
In summary, the provided document details a regulatory submission for modifications to a spinal implant system, focusing solely on the mechanical performance of the modified components compared to existing predicate devices using standardized bench testing. It does not involve any clinical studies, AI, or human performance evaluations.
§ 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.