(612 days)
The GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is a pedicle screw fixation system intended for 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) - · Spondylolisthesis - · Trauma (e.g., fracture or dislocation) - · Deformity or curvature (e.g., scoliosis, kyphosis, and/or lordosis) - Tumor - · Spinal stenosis - · Pseudarthrosis - · Failed previous fusion Paediatric Use: When used for posterior non-cervical screw fixation in paediatric patients, the GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is indicated as an adjunct to treat adolescent idiopathic scoliosis. Additionally, it is intended to treat paediatric patients diagnosed with the following conditions: - · Spondylolisthesis - · Spondylolysis - Fracture caused by tumor and/or trauma. Paediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
The posterior non-cervical pedicle screw spinal system consists of a body, bushing, and ball head screw. Inner Screw, rods complete the spinal construct. The body portion of the screw rotates about the ball head on the screw, which provides increased motion over a fixed post of the polyaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned. The Screws, Rods are fabricated from Titanium alloy. These implants are supplied non-sterile; the products have to be sterilized prior to use.
This document is a 510(k) Pre-market Notification for a medical device called the "GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System." It is a submission to the FDA seeking clearance to market this device, demonstrating its substantial equivalence to already legally marketed predicate devices.
The document does not describe or conduct a clinical study with acceptance criteria related to a device's performance in diagnosing or treating patients using metrics like sensitivity, specificity, or accuracy.
Instead, this submission focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Indications for Use: The intended medical conditions the device will treat.
- Material: The materials used in its construction.
- Mechanical Performance: How the device functions under various physical stresses.
- Dimensions: The physical size and shape of the device components.
The "acceptance criteria" discussed in this document refer to the performance standards that the device must meet to demonstrate its mechanical integrity and safety, not its clinical effectiveness in human subjects.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria values (e.g., specific load limits, displacement thresholds) and reported device performance values for a clinical study. Instead, it refers to compliance with established ASTM standards for mechanical testing. For the purpose of this type of submission, compliance with these standards serves as the "acceptance criteria" for mechanical performance.
| Acceptance Criteria (Applicable Standard) | Reported Device Performance |
|---|---|
| Material Standards: | |
| ASTM F136 | Complied |
| (Standard specification for wrought Titanium-6 Aluminium-4 Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications) | (Implies the device's materials meet this specification) |
| Performance Standards: | |
| ASTM F1717 - Static compression bending | Demonstrated performance |
| ASTM F1717 - Static torsion | Demonstrated performance |
| ASTM F1717 - Dynamic compression bending | Demonstrated performance |
| ASTM F1798 - Axial grip | Demonstrated performance |
| ASTM F1798 - Flexion-extension | Demonstrated performance |
Note: "Demonstrated performance" in this context means the device met the requirements of these standards. The document does not provide the specific numerical results of these tests, only that the device "has been demonstrated using the following performance testing" and "complied to following material standard."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the submission relies on non-clinical mechanical testing of the device components, not on a clinical test set from human subjects. The "samples" would be the manufactured implant components themselves, and the testing is performed in a laboratory setting. There is no mention of data provenance in terms of country of origin or retrospective/prospective data collection for clinical outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. Ground truth, in the context of clinical studies (e.g., for diagnostic accuracy), would typically be established by clinical experts. Since this submission focuses on mechanical and material equivalence, such experts are not involved in defining "ground truth" for the device's physical properties. The "ground truth" for mechanical properties is established by the ASTM standards themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies among expert readers. As this is a mechanical testing submission, no such adjudication method is used.
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices involving human interpretation of results, which is not the subject of this 510(k) submission. Therefore, there is no effect size reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical implant (pedicle screw system), not an algorithm or a software device, so the concept of standalone algorithm performance does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's mechanical and material properties is established by compliance with the internationally recognized ASTM material and performance standards (ASTM F136, ASTM F1717, ASTM F1798). These standards define the acceptable physical and mechanical characteristics for such spinal implants.
8. The sample size for the training set
This information is not applicable. This is a physical medical implant, not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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.