(67 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, kyphosis, 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 illum 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, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudoarthrosis, tumor 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, 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.
The REVERE® Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking caps, t-connectors, offset housing clamps, head offset connectors, trans-iliac 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® 5.5 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, transiliac 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® tconnectors may only be used with 5.5mm rods; REVERE® 6.35 t-connectors 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 larger, may be used with the TRANSITION® implant assemblies.
The rods are composed of titanium allov, 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 or stainless steel, as specified in ASTM F136, F1295, and F138. The screws are available with or without 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 chromium-molybdenum.
The provided text is a 510(k) Summary for the REVERE® Stabilization System and primarily focuses on regulatory clearance for additional implants (specialty rods, HA coated screws, closed head screws, and washers). It describes the device, its intended use, and indicates that its technological characteristics are similar to predicate devices. Crucially, the "Performance Data" section states:
"Mechanical testing (static and dynamic compression and static torsional) was conducted in accordance with ASTM F1717 and, the '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."
This is a submission for a spinal implant system, not an AI/ML powered medical device. Therefore, many of the requested categories (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission. The "acceptance criteria" here are based on meeting established mechanical performance standards for spinal fixation systems and demonstrating substantial equivalence to pre-existing, legally marketed devices.
Here's the breakdown based on the provided document, addressing the relevant points and noting the non-applicability of others:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Reported Device Performance |
|---|---|
| Mechanical Safety & Performance (Static Compression) | Conducted in accordance with ASTM F1717. |
| Mechanical Safety & Performance (Dynamic Compression) | Conducted in accordance with ASTM F1717. |
| Mechanical Safety & Performance (Static Torsional) | Conducted in accordance with ASTM F1717. |
| Substantial Equivalence to Predicate Devices | Performance data demonstrate substantial equivalence to predicate devices. |
| Compliance with FDA Guidance | Tested in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004. |
Note: The document does not provide specific numerical values for the acceptance criteria or the test results. It states that testing was conducted according to specific ASTM standards and FDA guidance, and that the device data demonstrated substantial equivalence.
2. Sample size used for the test set and the data provenance
- Not applicable (N/A). This is a mechanical device submission. Performance is assessed through mechanical testing (in vitro), not clinical data or human-derived test sets in the context of AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable (N/A). Ground truth in the context of AI/ML performance evaluation (e.g., image interpretation) is not relevant for this mechanical device. Mechanical testing relies on standardized protocols and material science principles.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable (N/A). Adjudication methods are relevant for subjective human interpretations, typically in diagnostic evaluations involving AI. This is a mechanical device.
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
- Not applicable (N/A). MRMC studies are used for evaluating diagnostic performance, often with AI assistance for human readers. This device is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable (N/A). This refers to AI algorithm performance. The REVERE® Stabilization System is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A (for AI/ML context). In the context of mechanical testing for a spinal implant, the "ground truth" would be the established mechanical properties required by standards (e.g., ASTM F1717 for static and dynamic loading) and the performance characteristics of predicate devices. The device's performance data is compared against these established benchmarks.
8. The sample size for the training set
- Not applicable (N/A). There is no "training set" in the context of a mechanical device submission like this.
9. How the ground truth for the training set was established
- Not applicable (N/A). As there is no training set, this question is not relevant.
§ 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.