(97 days)
The Zavation Spinal System is a pedicle screw system intended to provide immobilization 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal turnor, and failed previous fusion (pseudarthrosis).
The Zavation Spinal System is also indicated for pedicle screw fixation for the 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 lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Zavation Spinal System when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The Zavation Spinal System Fenestrated Screws are intended to be used with saline and radiopaque dye.
The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and cross connectors. The Zavation Spinal System can be used for single or multiple level fixations. The standard pedicle screws have various options in lengths and diameters as well as a sterile packaged Hydroxyapatite (HA) coated option. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.
The safety and effectiveness of the fenestrated screws have not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). The device is intended only to be used with saline or radiopaque dye.
The provided document is a 510(k) summary for the Zavation Spinal System, which is a medical device. It does not describe any acceptance criteria or studies related to device performance in a clinical or diagnostic context (e.g., accuracy, sensitivity, specificity) involving AI, imaging, or human readers.
Instead, the document focuses on regulatory approval based on substantial equivalence to predicate devices, primarily through mechanical testing of the implant's physical properties.
Therefore, most of the requested information cannot be extracted from this document as it pertains to different types of device validation.
Here's what can be extracted and a clear statement regarding what cannot:
1. A table of acceptance criteria and the reported device performance:
This document describes mechanical testing for the Zavation Spinal System. The "acceptance criteria" can be inferred as meeting or exceeding the performance of predicate devices according to established ASTM standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformity to ASTM F1717 (Static/Dynamic Compression Bending, Torsion) | Mechanical test results demonstrated substantial equivalency to the predicate device. |
| Conformity to ASTM F1798-21 (Tulip Disassociation Testing) | Mechanical test results demonstrated substantial equivalency to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample size for test set: Not explicitly stated in terms of number of devices or constructs tested for the mechanical evaluation.
- Data provenance: Not applicable in the context of mechanical testing of physical implants. The testing was conducted in a lab setting.
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):
Not applicable. This is mechanical testing of an orthopedic implant, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is mechanical testing, not a study involving human adjudication of results.
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 document does not describe a clinical study of diagnostic or AI-assisted performance, nor does it mention AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document does not describe the performance of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. For mechanical testing, the "ground truth" is adherence to established engineering standards (ASTM) and performance comparable to a predicate device.
8. The sample size for the training set:
Not applicable. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established:
Not applicable. This document does not describe a machine learning algorithm or a training set.
In summary: The provided FDA 510(k) summary focuses on the mechanical and material properties of an orthopedic implant (Zavation Spinal System) to demonstrate substantial equivalence to existing predicate devices. It does not contain any information related to studies involving AI, diagnostic accuracy, human readers, clinical endpoints, or ground truth establishment in a clinical context.
§ 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.