(30 days)
The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to LS) to replace 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 GEO structure is also indicated for treating fractures of the thoracic and lumbar spine. The GEO Structure 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.
The GEO Structure is a vertebral body replacement device manufactured from surgical implant grade titanium alloy as described by ASTM F-1108 (Ti 6Al 4V). The implant has a satin finish surface and is available in various shapes and sizes. The GEO Structure is provided either sterile or nonsterile.
The provided text is a 510(k) summary for the GEO™ Structure, a vertebral body replacement device. It mentions "nonclinical tests" and states that "Data regarding the functional performance of the proposed GEO Structure has been generated and indicates that the proposed GEO Structure meets or exceeds all functional requirements and supports its suitability for use." However, it does not provide specific acceptance criteria or details of the study that proves the device meets those criteria.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that "Data regarding the functional performance... indicates that the proposed GEO Structure meets or exceeds all functional requirements," but it does not specify what those functional requirements (acceptance criteria) are, nor does it present the reported performance data in a quantifiable manner. For medical devices, acceptance criteria typically involve biomechanical tests (e.g., compression strength, fatigue life, torsional stability) compared against established standards or predicate device performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document refers to "nonclinical tests" but does not specify sample sizes or data provenance. "Nonclinical tests" usually refer to laboratory bench testing or in-vitro studies, not human clinical trials.
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)
- Cannot be provided. This question is relevant for studies involving human interpretation (e.g., imaging studies). The provided document discusses nonclinical performance testing of a physical implant, not diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. This is relevant for studies where expert consensus is needed. The document does not describe such a study.
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
- Cannot be provided. This describes a clinical study design typically used for AI-powered diagnostic tools. The GEO™ Structure is a physical surgical implant, and the document discusses nonclinical testing of its functional performance, not AI diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. This is relevant for AI algorithms. The GEO™ Structure is a physical surgical implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. For nonclinical tests of a physical device, ground truth would typically be derived from engineering specifications, material properties, and established biomechanical standards, as opposed to medical diagnoses or patient outcomes. The document does not specify these.
8. The sample size for the training set
- Cannot be provided. "Training set" is relevant for machine learning/AI. This document describes a physical medical device and its nonclinical testing.
9. How the ground truth for the training set was established
- Cannot be provided. Similar to point 8, this is not applicable to the type of device and testing described.
§ 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.