(109 days)
The GSO GS1 Spacer is intended for use in the thoracolumbar spine (i.e., T1 - L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The GS1 Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The GS1 Spacer is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. Supplemental internal fixation is required to properly utilize this system.
The GSO GS1 Spacer is a slightly curved, hollow spacer with pyramidal teeth on the superior and inferior ends to resist expulsion. The device contains openings to allow the surgeon to pack the device with bone graft (autograft or allograft) prior to insertion. Openings in the anterior-posterior direction permit bone growth through the device. The GSO GS1 Spacer is intended for use with supplemental internal fixation.
The GSO GS1 Spacer is fabricated from medical grade titanium alloy.
Here's an analysis of the GSO GS1 Spacer's acceptance criteria and the study that proves it meets those criteria, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device (spinal spacer), not a research paper on an AI/machine learning device. Therefore, many of the requested categories like "Adjudication method," "MRMC comparative effectiveness study," "Training set sample size," and "Ground truth for training set" are not applicable. The device is a physical implant, and its "performance" is assessed through biomechanical testing, not diagnostic accuracy.
Acceptance Criteria and Reported Device Performance for GSO GS1 Spacer
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Meets or exceeds the performance requirements published for the ROI Spacer. | The GSO GS1 Spacer meets its functional requirements (based on static axial compression, dynamic compression, static torsion, dynamic torsion, and expulsion testing). |
| Substantial Equivalence (Design) | Similar design to predicate devices (Radiotransparent Open Implant (ROI) LDR Spine USA (K043349) and CAS Spine Spacer System - EBI, L.P. (K042268)). | The GSO GS1 Spacer has a similar design to the predicate CAS Spine Spacer System devices. |
| Substantial Equivalence (Sizes) | Offered in similar sizes to predicate devices. | The GSO GS1 Spacer is offered in similar sizes to the predicate CAS Spine Spacer System devices. |
| Substantial Equivalence (Material) | Manufactured from the same material as predicate devices. | The GSO GS1 Spacer is fabricated from medical grade titanium alloy, the same material as the predicate CAS Spine Spacer System devices. |
| Substantial Equivalence (Indications for Use) | Has the same indications for use as predicate devices. | The GSO GS1 Spacer has the same indications for use as the predicate CAS Spine Spacer System devices. Its intended use includes partial replacement in the thoracolumbar spine (T1 - L5) for tumors or fractures, to achieve anterior decompression, restore height, and restore biomechanical integrity with supplemental internal fixation. |
| Safety and Efficacy Differences | No significant differences that could affect safety or efficacy. | There are no significant differences between the GSO GS1 Spacer and the predicate devices that could affect the safety or efficacy of the device. |
Study Details
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Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not explicitly stated as a "sample size" in the context of human data. For mechanical testing, the number of units tested for each type of test (static axial compression, dynamic compression, static torsion, dynamic torsion, and expulsion) is not provided.
- Data Provenance: The testing was non-clinical mechanical testing, performed in a lab setting to established ASTM standards. No geographical or retrospective/prospective human data provenance is applicable.
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Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. The ground truth for this device (a physical implant) is based on engineering and material science principles, and adherence to established mechanical testing standards (ASTM F2077). Expert medical opinion would be involved in defining the clinical context and predicate devices, but not in establishing "ground truth" for the mechanical performance of the test set in the way it's understood for diagnostic AI.
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Adjudication Method for the Test Set:
- Not applicable. This is not an AI/diagnostic study requiring adjudication of interpretations. The "adjudication" would be based on whether the physical device passed the mechanical tests according to predefined thresholds.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance for diagnostic tasks, which is not applicable to a physical spinal implant.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. There is no algorithm or AI component to this device. The "standalone" performance refers to the device's mechanical integrity as measured by physical tests.
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The Type of Ground Truth Used:
- Ground Truth: Mechanical performance standards (e.g., ASTM F2077) and the established performance of legally marketed predicate devices (ROI Spacer and CAS Spine Spacer System). The "ground truth" is that the device must withstand certain forces and loads as defined by these standards and comparative data.
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The Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this physical medical device.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.