Search Results

The Ogmend® Implant Enhancement System is intended to augment pedicle screw fixation when a screw has lost purchase due to screw loosening, back-out, or breakage. The Ogmend® Implant Enhancement System is for use with rigid, thoracolumbar pedicle screw systems where a screw is inserted posteriorly, through the pedicle, and into the vertebral body. The Ogmend® Implant Enhancement System is for use in skeletally mature patients.

The implant of the Ogmend® Implant System consists of sterile, single-use devices intended to provide supplemental fixation to restore stability when the screw-to-bone interface becomes mechanically compromised. The system includes a permanently implanted sleeve ("Ogmende Implant" or "Ogmend®" or "Sleeve") and an inserter ("Ogmend® Inserter Instrument" or "Inserter") to insert the Ogmend® Implant.

When inserted into a prepared bone hole, the Ogmend® Implant is designed to use the principles of interference fit, surface area contact, and pressure distribution to secure a screw to bone and achieve stability at the screw-to-bone interface to allow for subsequent healing.

The Ogmend® Implant is manufactured from polyethylene terephthalate (PET) monofilament fibers and provides a helically braided structure that is captured by a screw when the screw is advanced during placement. Ogmend® has an inner diameter of 6.5mm and an outer diameter of 7.5mm, and can be used with screws ranging in diameter from 3.5mm. Ogmend® is supplied at a length of 100mm and is cut intra-operatively to the appropriate length.

The sole instrument used with the Ogmend® Implant System is the Inserter, which is used to insert the Sleeve into the hole. The Ogmend® Inserter is a stainless-steel rod with beveled ends. It can be used to insert multiple sleeves in a single operative procedure. It is provided sterile as a disposable, single-use device. The Inserter is compatible with sterilization by gamma radiation.

The Ogmend® Implant Enhancement System is intended to augment pedicle screw fixation when a screw has lost purchase due to screw loosening, back-out, or breakage. The device is for use with rigid, thoracolumbar pedicle screw systems where a screw is inserted posteriorly, through the pedicle, and into the vertebral body, and is for use in skeletally mature patients.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria were not explicitly stated in the provided text. However, the performance data presented suggests that the device aims to prevent screw loosening or back-out. The clinical data reported "no screw loosening or backouts in screws augmented with the Ogmend® device," indicating successful performance in this regard.

2. Sample Sizes and Data Provenance

The provided text only mentions a "prospective, multicenter, non-controlled, clinical trial" for the Ogmend® Implant Enhancement System. It does not specify the sample size for this trial or the countries of origin for the data. The trial is described as "prospective," meaning data was collected forward in time from the point of enrollment.

3. Number of Experts to Establish Ground Truth and Qualifications

This information is not provided in the supplied text. The method for establishing ground truth for the clinical trial is not detailed.

4. Adjudication Method

This information is not provided in the supplied text.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No information regarding an MRMC comparative effectiveness study or the effect size of AI assistance for human readers is present in the provided text.

6. Standalone (Algorithm Only) Performance Study

The Ogmend® Implant Enhancement System appears to be a physical implant and inserter, not an AI/algorithm-based device. Therefore, a standalone algorithm performance study is not applicable and not mentioned. The performance data refers to the performance of the physical implant in a clinical setting.

7. Type of Ground Truth Used

For the clinical trial, the ground truth for "screw loosening or backouts" would likely be based on clinical examination, imaging studies, and potentially surgical re-intervention, assessed by medical professionals. The text states that the clinical data "revealed no screw loosening or backouts," implying clinical assessment of outcomes.

8. Sample Size for the Training Set

As the Ogmend® Implant Enhancement System is a physical medical device and not an AI/algorithm, there is no "training set" in the context of machine learning. The device's design and functionality are based on engineering principles and preclinical testing, not on statistical learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of an AI/algorithm. The device's development would involve engineering specifications, material testing, and preclinical (bench and animal) studies, rather than ground truth establishment for a training dataset.

Ask a specific question about this device