(118 days)
The GSO GS1 Cannulated Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO GS1 Cannulated Screw System should be removed after fusion.
As a pedicle screw system, the GSO GS1 Cannulated Screw System is intended for patients: (a) having severe spondylolisthesis (Grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass.
In addition, when used as a pedicle screw system, the GSO GS1 Cannulated Screw System is indicated for 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).
When used as a posterior, non-cervical, non-pedicle screw and/or hook fixation system, the GSO GS1 Cannulated Screw System is indicated for:
- Degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Idiopathic scoliosis
- Kyphotic deformities of the spine
- Paralytic scoliosis and/or pelvis obliquity
- Vertebral fracture or dislocation
- Neuromuscular scoliosis associated with pelvic obliquity
- Vertebral fracture or dislocation
- Tumors
- Spondylolisthesis
- Stenosis
- Pseudarthrosis
- Unsuccessful previous attempts at spinal fusion
For posterior, non-pedicle, screw use, the GSO GS1 screws are intended for sacral/iliac attachment only and the GSO GS1 hooks and crosslinks are intended for thoracic and/or lumbar use only.
The GSO GS1 Spinal System consists of rods, screws, hooks, and connecting components that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are attached to the spine posteriorly by means of screws and/or hooks joined with rods.
The current submission, the GSO GS1 Cannulated Screw System, adds the following components to the GSO GS1 System: 5.5mm and 1/4" straight longitudinal rods in lengths of 50 - 480mm; 5.5mm and 1/4" pre-bent rods in lengths of 30 - 120mm; and multi-directional cannulated screws with standard or reduction heads in diameters of 5.5mm - 8.5 and lengths of 25mm - 100mm (depending on the screw diameter) to fit either 5.5mm or 1/2" rods. These additional components are compatible with the previously cleared GSO GS1 rods, screws, hooks and connectors. The GSO GS1 Spinal System can be installed with any suitable instrumentation.
The GSO GS1 Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6Al-4V Titanium alloy conforming to ASTM F136.
The provided 510(k) summary for the GSO GS1 Cannulated Screw System describes a medical device, not an AI/Software as a Medical Device (SaMD). Therefore, the questions related to acceptance criteria, study design, expert involvement, and ground truth for AI performance are not applicable in this context.
This regulatory submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through device description and non-clinical testing.
Here's a breakdown of what is provided in relation to the device's acceptance:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Indications for Use: Same as predicate device | The GSO GS1 Cannulated Screw System has the same indications for use as the predicate GSO GS1 Spinal System (K070966). |
| Design: Similar to predicate device | The GSO GS1 Cannulated Screw System has a similar design to the GSO GS1 Spinal System cleared in K070966. The cannulated screw components are also similar in design to other predicate cannulated screw systems (DePuy Spine VIPER System and Medtronic Sofamor Danek CD Horizon Spinal System). |
| Material: Same as predicate device | The GSO GS1 Spinal System components are manufactured from CP Titanium (ASTM F67) and Ti-6Al-4V Titanium alloy (ASTM F136), which is the same material as the predicate GSO GS1 Spinal System. |
| Performance (Non-Clinical Testing): Failure loads substantially equivalent to predicate device | Testing conducted according to ASTM F1717-12 demonstrated that the failure loads for the GSO GS1 Cannulated Screw System were substantially equivalent to the failure loads for the predicate GSO GS1 Spinal System. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This is a mechanical device, and "test set" in the context of AI/SaMD (which implies a dataset of patient information) is not relevant. The testing was non-clinical (mechanical).
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. There was no ground truth based on expert review of patient data for this mechanical device. The "ground truth" for mechanical testing would be the established engineering standards and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, which is not part of mechanical testing for a medical implant.
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 device is a spinal implant, not an AI system or an imaging modality requiring human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical testing, the "ground truth" was based on established engineering standards (ASTM F1717-12) for mechanical properties, specifically failure loads. The performance of the new device was compared against these objective, verifiable mechanical measurements for the predicate device.
8. The sample size for the training set:
- Not Applicable. There is no "training set" in the context of an AI/SaMD for this mechanical device.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not applicable.
§ 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.