(76 days)
The GSS Pedicle Screw System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 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.
In addition, the GSS 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 Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism.
The GSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The GSS Pedicle Screw System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the GSS Pedicle Screw System.
The provided text describes the "GSS Pedicle Screw System" and its 510(k) submission. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic AI device submission would.
Instead, this document focuses on demonstrating substantial equivalence to previously approved predicate devices based on mechanical testing, as is typical for implantable medical devices like pedicle screw systems.
Therefore, many of the requested points are not applicable or cannot be answered based on the provided text.
Here is a breakdown based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Equivalence | To demonstrate equivalence to predicate devices based on mechanical testing requirements as per ASTM F1717. | "Mechanical testing as listed in APPENDIX 10 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable for this type of device submission. The study described is mechanical testing, not a clinical study with a "test set" of patients or data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. Ground truth, in the context described (expert consensus for diagnostic AI), is not relevant for this device's submission. Mechanical testing relies on standardized methodologies, not expert interpretation of patient data.
4. Adjudication Method for the Test Set
- Not applicable. There is no "test set" of cases/data that would require adjudication in the context of this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is for evaluating diagnostic performance (e.g., how human readers perform with vs. without AI assistance). The "GSS Pedicle Screw System" is an implantable medical device, and its submission relies on mechanical testing, not diagnostic performance studies.
6. Standalone (Algorithm Only) Performance Study
- No. This device is not an algorithm or AI. It is a physical implantable device.
7. Type of Ground Truth Used
- Mechanical Test Standards (ASTM F1717): For this device, the "ground truth" for proving performance is adherence to and successful completion of standardized mechanical tests, showing the device is robust and performs as expected under simulated physiological loads. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic tools, but rather a demonstration of structural integrity and functional capability relative to established standards and predicate devices.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" as this device is not an AI/algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no "training set" or corresponding ground truth establishment process for this type of device.
Summary of the Device's Approval Approach:
The GSS Pedicle Screw System gained clearance via the 510(k) pathway by demonstrating substantial equivalence to existing legally marketed devices (Global Spinal Fixation System (K001668) and OPTIMA™, Spinal System (K031585)). This equivalence was primarily proven through mechanical testing in accordance with ASTM F1717, which showed that the subject device performs comparably to the predicate devices in terms of its physical and mechanical properties. The focus of this type of submission is on the device's design, materials, and functional performance under simulated conditions, rather than clinical diagnostic accuracy or reader performance.
§ 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.