(258 days)
The RELIANCE Spinal Screw System is a pedicle screw systems 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The RELIANCE Spinal Screw System is also indicated for pedicle screw fixation 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.
When used posteriorly, the RELIANCE Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for, spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis), Levels of fixation are for the thoracic, lumbar and sacral spine.
The RELIANCE Spinal Screw System when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or . kyphosis), tumor, and previous failed fusion (pseudarthrosis).
When used in a percutaneous, posterior approach with MIS Instrumentation, the RELIANCE Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: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 Posterior RELIANCE Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated poly axial screws, cannulated reduction screws, hooks, reduction hooks, set screws, transverse connectors, The Anterior RELIANCE Spinal Screw System consists of two spinal rods, monoaxial screws, staples, and set screws. The Anterior RELIANCE staples and screws are intended to be attached to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section.)
The RELIANCE Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the RELIANCE Spinal Screw System are available in Cobalt Chrome conforming to ASTM F-75 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.
The provided text describes a 510(k) premarket notification for a medical device called the "Reliance Spinal Screw System". This type of document is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Key issues based on the request regarding acceptance criteria and study proving device meets them:
This document does not contain the level of detail typically found in a clinical study report or a robust performance study that would establish specific acceptance criteria and then demonstrate performance against them for an AI/software as a medical device (SaMD).
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices. For mechanical orthopedic implants like spinal fixation systems, the primary "study" to meet acceptance criteria often involves non-clinical (bench) testing to ensure mechanical performance, safety, and compatibility with the human body, rather than a clinical effectiveness study with human subjects, especially for a 510(k) pathway.
Therefore, for many of the requested points, the answer will be "Not applicable" or "Not specified in this document," as this information is generally not part of a 510(k) summary for a hardware medical device.
Here's the breakdown based on the provided text:
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A table of acceptance criteria and the reported device performance
This document mentions non-clinical testing but does not provide a table of acceptance criteria or specific reported device performance values. It states:
- Acceptance Criteria Mentioned: "The RELIANCE Spinal Screw System has undergone Non-Clinical Testing including Static Compressive, Static Torsion, and Dynamic Compressive in accordance with ASTM F1717." ASTM F1717 is a standard test method, implying the device met the performance requirements specified within that standard for spinal implant constructs. However, the exact numerical acceptance values or the specific numerical results obtained by the device are not listed.
- Reported Device Performance: Not explicitly stated in numerical terms within this summary. The successful 510(k) clearance implies that the device did meet the required performance criteria of the referenced ASTM standard. The device's performance is implicitly "substantially equivalent" to predicate devices, meaning it performs similarly or better on the relevant non-clinical tests.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This question is most relevant to clinical studies involving patient data.
- For the non-clinical (bench) testing mentioned (Static Compressive, Static Torsion, Dynamic Compressive), the "sample size" would refer to the number of physical device constructs tested. This information is not specified in the provided document.
- Data Provenance: Not applicable, as this refers to non-clinical bench testing, not patient data.
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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)
- This question is most relevant for diagnostic accuracy studies, especially with AI systems requiring expert interpretation for ground truth.
- This document describes physical spinal implants and their mechanical testing. Therefore, this information is not applicable. Ground truth for mechanical testing is typically established by physical measurements and engineering specifications, not expert consensus.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is most relevant for clinical studies or studies involving expert consensus (e.g., in diagnostic image interpretation).
- For the non-clinical (bench) testing, adjudication methods for establishing ground truth are not applicable. The "ground truth" (e.g., load to failure, fatigue life) is determined by the testing equipment and adherence to standard protocols.
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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
- This question is specifically for diagnostic accuracy studies, particularly those involving AI algorithms assisting human readers.
- This document is for a physical medical implant (spinal screw system). Therefore, this information is not applicable. An MRMC study would not be performed for this type of device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is specifically for AI/Software as a Medical Device performance.
- This document is for a physical medical implant. Therefore, this information is not applicable. There is no "algorithm only" performance for a spinal screw system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical (bench) testing, the "ground truth" is based on the physical properties and mechanical behavior of the device components and constructs, as measured against the specifications outlined in the ASTM F1717 standard. This involves quantifiable engineering measurements (e.g., force, displacement, cycles to failure). It's not based on expert consensus, pathology, or outcomes data in the clinical sense.
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The sample size for the training set
- This question is specifically for machine learning/AI models.
- This document describes a physical medical implant. There is no "training set" in the context of an AI model for this device. Therefore, this information is not applicable.
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How the ground truth for the training set was established
- This question is specifically for machine learning/AI models.
- This document describes a physical medical implant. There is no "training set" or corresponding ground truth establishment in this context. Therefore, this information is not applicable.
Summary of Device Acceptance Criteria and Performance (as much as can be extracted):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Conformance | Components are available in titanium alloy conforming to ASTM F-136, stainless steel conforming to ASTM F-138, and Cobalt Chrome conforming to ASTM F-75 specifications. |
| Mechanical Performance (Non-Clinical Testing) | Undergone Static Compressive, Static Torsion, and Dynamic Compressive testing in accordance with ASTM F1717. |
| Substantial Equivalence | Found by FDA to be "substantially equivalent" to legally marketed predicate devices (Medtronic TSRH, Medtronic CD Horizon, DePuy Expedium, etc.) in terms of material, intended use, levels of attachment, size range, and strength. This implies it meets similar safety and performance benchmarks as these existing devices. |
| Intended Use Safety/Efficacy | Intended for immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions, including degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Performance is considered adequate for these indications based on substantial equivalence to predicates. |
Important Note: This 510(k) summary is for a traditional physical medical device, not a software or AI-driven diagnostic device. Therefore, many standard questions about AI/SaMD studies are not applicable. The primary "study" for this device is non-clinical bench testing to demonstrate mechanical integrity and comparability to predicate devices.
§ 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.