(52 days)
The REVOLVE™ 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 REVOLVE™ 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.
The REVOLVE™ Stabilization System consists of rods, polyaxial screws, locking caps, t-connectors, and associated manual surgical instruments. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. REVERE® locking caps are used to connect screws to the rod.
The most common use of this screw 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.
Screws 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.
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. REVERE® t-connectors may be used with 5.5mm REVOLVE™ rods.
REVOLVE™ implants are composed of titanium alloy, as specified in ASTM F136 and F1295.
The acceptance criteria for the REVOLVE™ Stabilization System are not explicitly stated in the provided text. Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device (REVERE® Stabilization System K061202) based on technical characteristics, performance, and intended use. The primary method for proving this equivalence is through mechanical testing.
Here's an analysis of the provided information, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific, quantitative acceptance criteria for the REVOLVE™ Stabilization System. Instead, it states that "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 implies that the device's performance was compared to the standards and benchmarks outlined in that FDA guidance document, rather than a predefined set of internal acceptance criteria explicitly listed here.
Thus, we can infer the acceptance criteria are implicitly those set by the FDA guidance for spinal systems, and the reported device performance is that it met these criteria, allowing for a finding of substantial equivalence.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Compliance with mechanical testing standards outlined in "Guidance for Spinal System 510(k)s" (May 3, 2004) | The device "presented" mechanical testing results that supported a finding of substantial equivalence to the predicate device. |
| Similar technical characteristics to predicate device (REVERE® Stabilization System K061202) | Stated that "REVOLVE™ Stabilization System implants are similar to the predicate REVERE® Stabilization System implants with respect to technical characteristics." |
| Similar performance to predicate device | Stated that "REVOLVE™ Stabilization System implants are similar... with respect to... performance." |
| Similar intended use to predicate device | Stated that "REVOLVE™ Stabilization System implants are similar... with respect to... intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document focuses on mechanical testing, not clinical studies with patient data. Therefore, there is no sample size for a "test set" in the context of patient data, nor is there information about data provenance (country of origin, retrospective/prospective).
For mechanical testing, the "sample size" would refer to the number of implants or constructs tested. This information is not provided in the excerpt.
3. 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 not applicable. The submission relies on mechanical testing against regulatory guidance, not expert consensus on clinical cases. Therefore, no experts were used to establish ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as there was no clinical test set requiring adjudication. The assessment of mechanical testing likely involves laboratory procedures and comparison to established engineering standards, rather than expert adjudication.
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 MRMC comparative effectiveness study was done. This device is a medical implant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is the standards and benchmarks for spinal system mechanical performance as defined by the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. This guidance likely references specific ASTM or ISO standards for testing spinal implants (e.g., fatigue strength, static strength).
8. The sample size for the training set
This question is not applicable. There is no AI or machine learning component to this device, 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 for an AI/ML model.
§ 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.