(80 days)
The REVERE™ Stabilization System, when used as posterior pedicle screw systems, are 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 Systems are 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 posterior non-pedicle screw fixation systems, the REVERE™ Stabilization Systems are 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 anterolateral thoracolumbar systems, the REVERE™ Stabilization Systems are 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.
The REVERE™ Stabilization Systems consist of a variety of shapes and sizes of rods, hooks, monoaxial screws, polyaxial screws, locking caps, tconnectors, staples, and associated manual surgical instruments. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and tconnectors are intended for posterior use only. Staples 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.
The rods are composed of titanium alloy, commercially pure titanium, or stainless steel, as specified in ASTM F136, F1295, F67, and F138. All other implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295, and F138.
The REVERE™ Stabilization System did not provide a typical "acceptance criteria" table as one might find for a diagnostic device. The provided document is a 510(k) summary for a medical device (spinal stabilization system), and regulatory submissions for such devices typically focus on demonstrating substantial equivalence to a legally marketed predicate device through mechanical testing, rather than reporting performance against a set of predefined clinical accuracy metrics.
Therefore, the "acceptance criteria" here are implied by the performance of the predicate devices and the mechanical testing standards for spinal systems. The "reported device performance" refers to the fact that the REVERE™ system met these implied criteria through its mechanical testing.
Here's the breakdown based on the provided text, and where information is not explicitly stated in the context of typical AI/diagnostic device studies, it will be noted as "Not applicable" or "Not specified."
Acceptance Criteria and Device Performance for REVERE™ Stabilization System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance Standards: Device must comply with the mechanical testing requirements outlined in the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. | Meets Guidance: "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." This indicates the device successfully underwent and met the specified mechanical testing standards. |
| Substantial Equivalence: Device must demonstrate substantial equivalence to legally marketed predicate devices (PROTEX™ Stabilization System and Stryker XIA Stainless Steel System) with respect to technical characteristics, performance, and intended use. | Demonstrates Equivalence: "The REVERE™ Stabilization System implants are similar to the predicate PROTEX™ (K040442, K052069) and Stryker Xia (K012870, K031090, K053115) thoracolumbar stabilization system with respect to technical characteristics, performance, and intended use." The FDA's 510(k) clearance explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. For a spinal stabilization system, "test sets" in the context of diagnostic AI algorithms are not relevant. The device undergoes mechanical testing based on specified standards, which involves a specific number of devices/components tested under simulated physiological conditions. The document does not specify the number of units tested in the mechanical assessment but references the governing guidance document.
- Data Provenance: Not applicable in the context of clinical patient data. The "data" here refers to the results of mechanical testing performed on the device components. The location of these tests is not specified in the summary but would typically occur in a controlled laboratory environment.
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 mechanical implant, not a diagnostic tool requiring expert interpretation of results. The "ground truth" for mechanical testing is established by engineering standards and validated testing methodologies.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements among human experts in interpreting diagnostic data. This is not relevant for mechanical testing.
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. This is not an AI-assisted diagnostic device, and therefore MRMC studies comparing human readers with and without AI assistance are 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 implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established by engineering standards and validated mechanical testing protocols. This involves evaluating the strength, fatigue resistance, and other mechanical properties of the device components under various loads as defined by the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s."
8. The sample size for the training set
- Not applicable. The concept of a "training set" is for machine learning models. For a physical device, the "training" involves engineering design, material selection, and manufacturing processes, with iterative testing. The document does not provide a "sample size" for this developmental stage.
9. How the ground truth for the training set was established
- Not applicable. As above, this concept refers to machine learning. The "ground truth" for design and development in medical device manufacturing is based on established biomechanical principles, material science, and prior knowledge from existing predicate devices. Successful mechanical testing (as mentioned in section 7) confirms that the design meets the required performance standards.
§ 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.