(106 days)
The GSO GS1 Spinal 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 Spinal System should be removed after fusion.
As a pedicle screw system, the GSO GS1 Spinal 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 Spinal 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 Spinal 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.
In all cases, instrumentation must be at least 1 cm from any major vessel.
The GSO GS1 Spinal System consists of rods, screws, hooks, and adjustable crosslink that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are a vophed to the spine posteriorly by means of screws and/or hooks joined with rods. Crosslink components are used to attach two rods in parallel. 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-6A1-4V Titanium alloy conforming to ASTM F136. Devices are available in various diameters, lengths and sizes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GSO GS1 Spinal System:
This document is a 510(k) summary for a spinal implant system, and as such, it focuses on demonstrating substantial equivalence to already legally marketed devices, rather than establishing de novo performance criteria through extensive clinical trials for new medical devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from predicate devices) | Reported Device Performance (GSO GS1 Spinal System) |
|---|---|---|
| Mechanical Performance | Failure loads meet or exceed those of the predicate devices (CD Horizon Spinal System and Synergy Spinal System). (Implicit, as "substantial equivalence" means performing at least as well as the predicates). | Failure loads for the GSO GS1 Spinal System are greater than published failure loads for the Synergy Spinal System (one of the predicate devices). |
| Indications for Use (Pedicle Screw System) | Same as predicate devices: | The GSO GS1 Spinal System has the same indications as both predicate devices (CD Horizon and Synergy) when used as a pedicle screw system. |
| - Severe spondylolisthesis (Grade 3 and 4) of L5-S1 vertebral joint | ||
| - Fixed or attached to lumbar and sacral spine (L3 and below) | ||
| - Fusions using autogenous bone graft only | ||
| - Device removed after solid fusion mass | ||
| - Treatment of acute/chronic instabilities/deformities of thoracic, lumbar, sacral spine: degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis). | ||
| Indications for Use (Posterior, non-cervical, non-pedicle screw and/or hook fixation system) | Same as predicate device (Synergy Spinal System): | The GSO GS1 Spinal System has the same indications as the Synergy Spinal System. (Implied, as Synergy is the relevant predicate for this usage). |
| - Degenerative disc disease | ||
| - Idiopathic scoliosis | ||
| - Kyphotic deformities of the spine | ||
| - Paralytic scoliosis and/or pelvis obliquity | ||
| - Vertebral fracture or dislocation (listed twice) | ||
| - Neuromuscular scoliosis associated with pelvic obliquity | ||
| - Tumors | ||
| - Spondylolisthesis | ||
| - Stenosis | ||
| - Pseudarthrosis | ||
| - Unsuccessful previous attempts at spinal fusion | ||
| Material Composition | Made from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136. (This is a characteristic, not a performance criterion for substantial equivalence, but it's part of the substantial equivalence claim, implicitly matching or being equivalent to predicate materials). | GSO GS1 Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136 (stated explicitly as a characteristic of the device). The predicates are "manufactured from the same materials." |
| Design | Similar design to predicate devices. (This is a characteristic, not a performance criterion, but a requirement for substantial equivalence). | The GSO GS1 Spinal System has a "similar design" to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: The primary "test set" for this submission was the mechanical testing of the GSO GS1 Spinal System components. The document does not specify a numerical sample size for the mechanical tests (e.g., number of rods, screws tested), but it states that testing was "conducted according to ASTM I-1717." ASTM standards typically specify sample size requirements for such tests.
- Data Provenance: The mechanical testing data was generated prospectively by Gold Standard Orthopaedics, LLC. The location of the testing is not specified, but it would have been conducted in a qualified lab for such ASTM standards. There is no mention of "country of origin of data" in the context of clinical data for this 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This submission relies on non-clinical mechanical testing and comparison to predicate device characteristics/indications. It does not involve human interpretation of medical images or clinical outcomes that would require "experts to establish ground truth" in the way a diagnostic AI device would. The "ground truth" for mechanical testing is derived from the established ASTM standard and the measured failure loads compared to published data from predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. As above, this is a mechanical testing and substantial equivalence submission, not a study requiring adjudication of expert opinions on clinical cases.
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
- No, an MRMC comparative effectiveness study was not done. This 510(k) is for a spinal implant, which is a physical medical device, not an AI-powered diagnostic tool. Clinical testing (including MRMC studies) was explicitly stated as "not necessary to demonstrate the substantial equivalence of the GSO GS1 Spinal System to the predicate devices."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a spinal implant, not an algorithm or AI device.
7. The Type of Ground Truth Used
- For mechanical performance: The "ground truth" was established by standardized mechanical testing (ASTM I-1717), which measures physical properties like failure loads. The acceptance criterion was based on the "published failure loads" of predicate devices, essentially using their established performance as a benchmark.
- For indications for use, materials, and design: The "ground truth" for substantial equivalence was the characteristics and indications of the legally marketed predicate devices (CD Horizon Spinal System Medtronic Sofamor Danek, Inc. (K031833) and Synergy Spinal System Interpore Cross International (K010515)).
8. The Sample Size for the Training Set
- Not applicable. This submission is for a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.