(132 days)
The REVERE® 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® 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® 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, and/or lordosis, Scheuermann's disease). fracture, pseudarthrosis, turnor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the REVERE® Stabilization System is intended for anterolateral screw (with or without staples or staple plates) 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, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, turnor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
The REVERE® Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking caps, tconnectors, offset housing clamps, head offset connectors, trans-illiac connectors, sacral and sacral-iliac plates, staples and staple plates, and associated manual surgical instruments. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. REVERE® implants mate with 5.5mm diameter rods; REVERE® 6.35 implants mate with 6.35mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples and staple plates are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod, trans-iliac connectors and sacral-iliac plates.
The most common use of this screw, hook, and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws and/or lamina, pedicle or transverse process hooks.
The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.
Screws and hooks attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae, pedicles, or transverse process of the posterior spine.
T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the t-connectors to the rods. Additional set screws secure the adjustable cross members at the desired length. T-connectors from the PROTEX® system may be used with 6.5mm, 6.0mm or 5.5mm rod systems. REVERE® t-connectors may only be used with 5.5mm rods; REVERE® 6.35 tconnectors may only be used with 6.35mm rods. Additional connectors may be used to connect two rods, and are also secured using set screws.
REVERE® hooks and t-connectors, and 5.5mm or 6.35mm diameter rods may be used with the BEACON® Stabilization System.
REVERE® screws and locking caps may be used with the TRANSITION® Stabilization System. Specifically, REVERE® polyaxial (solid, cannulated and dual outer diameter) screws and monoaxial screws 6.5mm diameter and larger, and 35mm length and longer, may be used with the TRANSITION® implant assemblies.
The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136. F1295, F1472, F67, F1537 and F138. All other REVERE® implants are composed of titanium alloy, stainless steel, and cobalt chromium molybdenum alloy, as specified in ASTM F136, F1295, F138, and F1537. The screws are available with hydroxyapatite (HA) coating, as specified in ASTM F1185. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium allov, or cobalt chromiummolybdenum.
The provided 510(k) summary for the REVERE® Stabilization System focuses on biomechanical performance of the device, rather than a clinical study involving human readers or AI. Therefore, most of the requested information regarding acceptance criteria and studies that prove the device meets these criteria in a medical image analysis context (like expert consensus, MRMC studies, training/test sets, etc.) is not applicable.
However, I can extract the relevant information from the provided document regarding the device's performance assessment.
Here's a breakdown based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | In accordance with ASTM F1717 and "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004. | "Performance data demonstrate substantial equivalence to the predicate device." "REVERE® additional implants perform as well as or better than the predicate devices." (Implies the device met or exceeded the performance of previously cleared devices under the specified standards). |
| Static Compression | As per ASTM F1717 and FDA Guidance | "Performance data demonstrate substantial equivalence to the predicate device." |
| Dynamic Compression | As per ASTM F1717 and FDA Guidance | "Performance data demonstrate substantial equivalence to the predicate device." |
| Static Torsion | As per ASTM F1717 and FDA Guidance | "Performance data demonstrate substantial equivalence to the predicate device." |
| Static Screw Head Pull-off | As per ASTM F1717 and FDA Guidance | "Performance data demonstrate substantial equivalence to the predicate device." |
| Material Composition | As specified in ASTM F136, F1295, F1472, F67, F1537, F138 (for rods, screws, hooks, etc.), and ASTM F1185 (for HA coating). | The document states the materials used are "titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel," and "titanium alloy, stainless steel, and cobalt chromium molybdenum alloy" (for other implants), with optional "hydroxyapatite (HA) coating" (for screws), all "as specified in" the referenced ASTM standards. This implies compliance with these material specifications. |
| Galvanic Corrosion Risk | Implied acceptance criterion: avoid galvanic corrosion. | "Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium molybdenum." (This is a cautionary statement regarding usage, implying that if used correctly, the risk is mitigated, but doesn't explicitly state a test for it). |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a "sample size" in terms of cases or patients. Instead, it refers to mechanical testing. For mechanical testing, the "samples" would be the physical devices or components tested. The number of devices or components tested is not explicitly stated.
- Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a physical implant, and its performance is evaluated via mechanical testing against established engineering standards, not through expert clinical consensus on images or outcomes.
4. Adjudication method for the test set:
- Not applicable. This is not a clinical study requiring adjudication of expert opinions. Mechanical tests have objective pass/fail criteria based on measured physical properties.
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:
- No, a MRMC comparative effectiveness study was not done. This device is a spinal implant, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's performance is defined by established engineering standards and guidance documents (ASTM F1717 and "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s"). The "truth" is that the device must meet or exceed the biomechanical properties (e.g., strength, stiffness, resistance to pull-out) specified by these standards.
8. The sample size for the training set:
- Not applicable. This is a physical device, and "training set" doesn't apply in the context of mechanical testing. Development of the device would involve engineering design and iterative testing, but not a "training set" as understood in machine learning.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document describes the mechanical performance evaluation of additional components for an already cleared spinal stabilization system. The acceptance criteria are essentially compliance with specific ASTM standards and FDA guidance for spinal systems. The "study" proving this compliance is the mechanical testing itself, which demonstrated "substantial equivalence" to predicate devices by meeting or exceeding their performance under these standards. The context of your questions (AI, expert readers, clinical data, ground truth for image analysis) does not align with the type of device and accompanying evidentiary information provided in this 510(k) summary.
§ 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.