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510(k) Data Aggregation
(28 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 Ogmend® Implant Enhancement System is a sterile, single-use device intended to provide supplemental fixation to restore stability when the screw-to-bone interface becomes mechanically compromised. The Ogmend® Implant Enhancement System includes a permanently implanted sleeve ("Ogmend® Implant") and an inserter ("Ogmend® Inserter").
The Ogmend® Implant Enhancement System 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.
The Ogmend® Implant is offered in two sizes:
- Medium: For use with screws ranging in diameter from 3.5mm - 6.5mm.
- Large: For use with screws ranging in diameter from 6.5mm 10.5mm.
The Ogmend® Inserter is used to insert the Ogmend® Implant into the bone hole and can be used with both size Ogmend® Implants. The Ogmend® Inserter is a stainless-steel rod with beveled ends. It can be used to insert multiple sleeves within one operative procedure. It is provided sterile as a disposable, single-use device. The Inserter is compatible with sterilization by gamma radiation.
Acceptance Criteria and Device Performance Study for Ogmend® Implant Enhancement System (K233223)
This response describes the acceptance criteria and study details for the Ogmend® Implant Enhancement System, based on the provided FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for K233223 focuses on demonstrating substantial equivalence to a predicate device (K223075) through performance testing. The document states that the data presented "demonstrates that the proposed Ogmend® Implant is substantially equivalent... to the pre-determined acceptance criteria." While specific numerical acceptance criteria were not explicitly defined in the provided text (e.g., a specific pullout strength value), the underlying acceptance criterion is that the device's performance is comparable to or better than the predicate device (K223075) and suitable for its intended use.
The following table summarizes the performance tests conducted, with the understanding that "reported device performance" implies the device met the implicit acceptance criteria by demonstrating substantial equivalence to the predicate.
| # | Performance Test | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|---|
| 1 | Screw Axial Pullout | Demonstra te pullout strength comparable to or better than the predicate device (K223075) to ensure adequate fixation. | The study data was submitted to the FDA to support substantial equivalence, indicating that pullout strength met the acceptance criteria. |
| 2 | Sleeve Insertion Force | Demonstrate appropriate insertion force that allows for surgical usability without excessive force or material damage. | The study data was submitted to the FDA to support substantial equivalence, indicating that insertion force met the acceptance criteria. |
| 3 | Screw Insertion Torque | Demonstrate appropriate screw insertion torque within acceptable surgical ranges. | The study data was submitted to the FDA to support substantial equivalence, indicating that screw insertion torque met the acceptance criteria. |
| 4 | Screw Removal/Extraction Torque | Demonstrate appropriate screw removal/extraction torque without compromising the implant or surrounding bone. | The study data was submitted to the FDA to support substantial equivalence, indicating that screw removal/extraction torque met the acceptance criteria. |
| 5 | Sleeve End Closure Strength | Demonstrate sufficient integrity of the sleeve's end closure to prevent unraveling or failure during use. | The study data was submitted to the FDA to support substantial equivalence, indicating that sleeve end closure strength met the acceptance criteria. |
| 6 | Device Breakage - Sleeve Durability | Demonstrate sufficient durability of the sleeve to withstand the intended surgical and physiological stresses without breakage. | The study data was submitted to the FDA to support substantial equivalence, indicating that sleeve durability met the acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes (number of tests or specimens) used for each performance test. It only lists the types of performance tests conducted.
The data provenance is from bench tests (in vitro testing) and is conducted by Woven Orthopedic Technologies, LLC. No information is given about country of origin of the data beyond the manufacturer's location in Manchester, CT, USA. The study design is inherently prospective for these bench tests, as they were specifically designed and executed to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device and study. The studies described are bench tests evaluating mechanical properties, not diagnostic or interpretive tasks requiring human expert ground truth establishment. The "ground truth" for these tests is the objective measurement of physical properties.
4. Adjudication Method for the Test Set
This section is not applicable to the bench testing described. Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation or subjective assessments, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document does not mention any studies involving human readers or comparative effectiveness for diagnostic or clinical tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The Ogmend® Implant Enhancement System is a mechanical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests conducted is based on objective physical measurements obtained through standardized mechanical testing methods for medical implants. For example, for "Screw Axial Pullout," the ground truth would be the force measured at which the screw pulls out, determined by test equipment. This is distinct from expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or clinical studies.
8. The Sample Size for the Training Set
This section is not applicable. The Ogmend® Implant Enhancement System is a mechanical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reason as above; there is no training set for this device.
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(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.
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