(84 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 illum 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, monoaxial screws, uniplanar screws, fracture 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 surqical condition. Screws are available with or without hydroxyapatite coating.
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® rods are composed of titanium alloy or cobalt chromium molybdenum (CoCr) alloy as specified in ASTM F136, F1295 and F1537. All other REVOLVE® implants are manufactured from titanium alloy as specified in ASTM F136 and F1295. Screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.
The provided text describes a 510(k) submission for "REVOLVE® Additional Implants," which are components for an existing spinal stabilization system. The submission aims to demonstrate substantial equivalence to previously cleared devices. The document is primarily focused on regulatory approval and mechanical testing, rather than a clinical study evaluating diagnostic or prognostic performance. Therefore, many of the requested categories in your prompt are not applicable or cannot be fully addressed from the given information.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Not Explicitly Stated as Numeric Values) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Must meet relevant ASTM standards for spinal systems. | "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 demonstrates substantial equivalence to the predicate devices." |
| Material Composition | Must conform to specified ASTM standards for implant materials. | REVOLVE® rods: ASTM F136, F1295, F1537. Other REVOLVE® implants: ASTM F136, F1295. HA coating: ASTM F1185. |
| Indications for Use | Must align with cleared predicate devices. | "See Indications for Use section (identical to predicate systems)" |
| Technical Characteristics | Must be similar to predicate devices. | "REVOLVE® additional implants are similar to the predicate REVOLVE® and REVERE® Stabilization System implants with respect to technical characteristics..." |
| Intended Use | Must be similar to predicate devices. | "...performance and intended use." |
| Substantial Equivalence | Must demonstrate substantial equivalence to predicate devices. | "The information provided within this premarket notification supports substantial equivalence to the predicate device(s)." |
Note: The document describes acceptance of the device based on mechanical testing and comparison to predicate devices for substantial equivalence, not on a clinical performance study with defined diagnostic metrics like accuracy, sensitivity, or specificity. The "acceptance criteria" here refer to demonstrating safety and effectiveness based on engineering and regulatory standards, rather than the accuracy of a diagnostic output.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document refers to mechanical testing of the implants themselves, not a test set of patient data for evaluating an algorithm's performance. The "sample" would refer to the number of implants tested mechanically, which is not specified.
- Data Provenance: Not applicable in the context of clinical data. The data provenance relates to mechanical testing performed on the physical devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This is not a study involving expert review of diagnostic output or establishing ground truth for a clinical dataset. The ground truth for mechanical testing would be the physical properties and performance measured against established engineering standards (ASTM).
4. Adjudication Method for the Test Set
- Not applicable. There is no expert adjudication process described for mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This submission is for mechanical implants and does not involve AI or human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This submission does not involve an algorithm.
7. The Type of Ground Truth Used
- For mechanical testing, the "ground truth" would be the established engineering standards (e.g., ASTM F1717) and the measured physical properties (e.g., static compression strength, dynamic compression fatigue, static torsional strength) of the devices. These are quantitative and objective measurements of the device's physical performance, not clinical outcomes or expert consensus on a diagnostic finding.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/algorithm submission requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/algorithm submission requiring a training set.
In summary: The provided document is a 510(k) summary for a medical device (spinal implants) that has undergone mechanical testing to demonstrate its safety and effectiveness by showing substantial equivalence to existing, legally marketed devices. It does not involve a clinical study with patient data, diagnostic algorithms, or human reader performance, which are the typical contexts for many of your prompt's questions.
§ 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.