(150 days)
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.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Screw Loosening | Not explicitly stated (likely 0%) | 0% |
| Screw Back-out | Not explicitly stated (likely 0%) | 0% |
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.
§ 888.3043 Screw sleeve bone fixation device.
(a)
Identification. A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone and provides increased surface area to create an interference fit to restore stability of the implant construct.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In vivo performance testing under anticipated conditions of use must demonstrate:
(i) The device provides sufficient stability to allow for fracture healing; and
(ii) A lack of adverse biologic response to the implant through histopathological and histomorphometric assessment.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must:
(i) Assess the stability of the device in a rescue screw scenario;
(ii) Demonstrate that the device can be inserted and removed without damage to the implant or associated hardware;
(iii) Demonstrate the device can withstand dynamic loading without device failure; and
(iv) Characterize wear particle generation.
(3) The device must be demonstrated to be biocompatible.
(4) The device must be demonstrated to be non-pyrogenic.
(5) Performance data must demonstrate the sterility of the device.
(6) Performance data must support the labeled shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the established shelf life.
(7) Labeling must include:
(i) A detailed summary of the device technical parameters;
(ii) Information describing all materials of the device;
(iii) Instructions for use, including device removal; and
(iv) A shelf life.