(114 days)
The Biomet Microfixation OmniMax MMF System is indicated for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery and for post-operative fracture healing in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.
The Biomet Microfixation OmniMax MMF System is composed of metallic plates (arch bars) and locking screws that provide temporary stabilization of mandibular and maxillary bone during fracture healing and/or temporarily maintain a stable occlusion during surgery. Mandibular and Maxillary Fixation (MMF) is achieved through application of fixation plates and locking screws to bone; wire or elastics are then secured around hooks. The arch bar plate is manufactured from Commercially Pure Titanium; the locking screws are manufactured from Titanium Alloy (Ti-6Al-4V); and wires (if used) are manufactured from Stainless Steel.
The provided text describes a 510(k) premarket notification for the Biomet Microfixation OmniMax MMF System. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, with the key difference being the addition of MR Conditional labeling for the subject device. The study described focuses on establishing the device's safety within an MRI environment.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (MRI Safety) | Reported Device Performance |
|---|---|
| Static Magnetic Field Exposure | Safe for 1.5T and 3.0T MR systems. |
| Maximum Spatial Gradient Field | Safe for a maximum spatial gradient field of 3,000 gauss/cm (30 T/m). |
| Maximum MR System Reported, Whole Body Averaged Specific Absorption Rate (SAR) | Safe for a maximum MR system reported, whole body averaged SAR of 2.0 W/kg (Normal Operating Mode). |
| Maximum Temperature Rise (after 15 minutes of continuous scanning) | Expected to produce a maximum temperature rise of less than 6°C. |
| Image Artifact | Image artifact extends approximately 1.4cm from the device when imaged with a gradient echo pulse sequence and a 3.0T MRI System. |
Study Details:
The study was a non-clinical performance study focusing on MRI safety.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states "implant models" were used for modeling and simulation, and "actual heating was measured" using the worst-case heating locations. It doesn't specify a numerical sample size for individual devices tested beyond "worst-case locations."
- Data Provenance: The data is from non-clinical testing (modeling and simulation, and physical implant testing), not human or patient data. Therefore, concepts like country of origin or retrospective/prospective are not applicable in the human data sense. It is laboratory-generated data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This type of study does not involve human experts establishing ground truth in the traditional sense of clinical diagnosis. The "ground truth" for MRI compatibility is established by adherence to recognized ASTM standards for MRI safety testing (ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182) and the scientific principles behind MRI physics and heat transfer.
- The "experts" would be the personnel conducting and interpreting the engineering and physics tests, who would have qualifications in fields like biomedical engineering, materials science, and MRI physics. Their number and specific qualifications are not detailed in this document.
4. Adjudication Method for the Test Set
- Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for human expert review of imaging. This is not applicable here as the test set involves physical and simulated tests, not human assessments against a ground truth developed by multiple experts. The results are based on objective physical measurements and simulation outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This study is focused on the intrinsic MR safety properties of the device itself ("standalone" performance in an MRI environment), not on how human readers' performance improves with or without the device. The "effect size" of human readers with/without AI assistance is not relevant to this type of device safety testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study (in terms of device performance in an MRI environment) was conducted. The testing evaluated the device's behavior (heating, artifact, displacement) directly when exposed to MRI conditions, without human intervention in the device's function or the MRI assessment process. The "algorithm" here refers to the physical interactions of the device with the MRI field.
7. The Type of Ground Truth Used
- The ground truth is derived from established scientific principles, engineering models, and validated physical measurement techniques as defined by the referenced ASTM standards. It's an objective measurement of physical phenomena (temperature rise, artifact size, displacement) under controlled MRI conditions. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- This concept is not applicable. This is not an AI/machine learning study that requires a training set. The "modeling and simulation testing" refers to engineering simulations, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
- This is not applicable, as there is no training set in the context of this device safety evaluation.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.