(53 days)
The REVERE® or BEACON™ Stabilization System, when used as a posterior pedicle screw system, is 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, the REVERE® or BEACON™ Stabilization System is intended for 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 lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used as a posterior non-pedicle screw fixation system, the REVERE® or BEACON™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the REVERE® or BEACON™ Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
CoCr Rods consist of 5.5mm and 6.35mm rods manufactured from cobalt chromium molybdenum alloy. REVERE® and BEACON™ Stabilization System implants mate with these 5.5mm and 6.35mm diameter rods. The REVERE® and BEACON™ implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. CoCr Rods are composed of cobalt chromium-molybdenum alloy as specified in F1537.
Here's an analysis of the provided 510(k) summary for the CoCr Rods, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Performance | Compression-bending | Tested in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. | The document states testing was conducted in accordance with the guidance, implying the results met the criteria outlined in that guidance. Specific numerical results or pass/fail thresholds are not provided in this summary. |
| Mechanical Performance | Torsion | Tested in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. | Similar to compression-bending, this indicates compliance with the guidance, but specific quantitative results are absent. |
| Material | Biocompatibility | Composed of cobalt chromium-molybdenum alloy as specified in F1537. | This implies adherence to a recognized standard for surgical implant materials, which covers biocompatibility. No separate test results are presented. |
| Substantial Equivalence | Technical Characteristics | Similar to predicate devices. | The submission asserts similarity without specific details. |
| Substantial Equivalence | Material | Similar to predicate devices (CoCr-Mo alloy). | Directly mentioned in the device description. |
| Substantial Equivalence | Performance | Similar to predicate devices (based on mechanical testing). | Implied by the statement of "substantial equivalence" supported by mechanical testing. |
| Substantial Equivalence | Intended Use | Similar to predicate devices. | The stated indications for use are largely consistent with typical spinal stabilization systems. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document describes mechanical testing of the CoCr Rods. For such testing, the "sample size" refers to the number of physical rods and corresponding components subjected to the mechanical tests.
- Sample Size: The document does not explicitly state the number of rods or components used in the compression-bending and torsion tests.
- Data Provenance: The data provenance is pre-clinical mechanical testing, conducted by the manufacturer, Globus Medical Inc. There is no information suggesting external lab testing or geographical origin of the samples beyond the manufacturer's location in Audubon, PA. This is not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this submission. The "ground truth" in this context is established by engineering standards and physical measurements from mechanical stress tests, not by expert clinical consensus. There are no experts involved in establishing a "ground truth" for clinical outcomes in this 510(k) submission.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods are used in clinical studies or expert reviews to resolve discrepancies in observations or diagnoses. Mechanical testing results are objective measurements against predefined engineering standards.
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 question is not applicable. This 510(k) submission is for a medical device (spinal rods) and not for an AI/CAD (Computer-Aided Detection) system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable, as this is not an AI/CAD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on established engineering standards and material specifications.
- For mechanical testing (compression-bending, torsion), the ground truth is defined by the failure criteria outlined in the referenced FDA Guidance document ("Guidance for Spinal System 510(k)s", May 3, 2004), as well as the inherent mechanical properties of the material.
- For material composition, the ground truth is adherence to ASTM F1537 (Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloys for Surgical Implants).
8. The sample size for the training set
This question is not applicable. There is no AI algorithm being trained, so there is no training set.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set.
§ 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.