(309 days)
The Biomet Microfixation OmniMax MMF System is indication 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 OmniMax MMF system includes a fixation plate (also known as an arch bar) that has an in-plane bend to provide an initial approximation of mandibular and maxillary anatomy. The plate also features slots for locking screw fixation. These slots allow for a maximum of 12 fixation points in the bone as well as screw placement variation within the slot to avoid tooth roots. The OmniMax locking screws are 2.0mm in diameter and vary in length from 7mm to 11mm. The screw head also features a low-profile design to minimize irritation and palpability.
The document provides information about the Biomet Microfixation OmniMax MMF System, specifically for its 510(k) submission, K202969. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with diagnostic AI/ML device submissions (e.g., performance metrics like sensitivity, specificity, AUC).
Instead, the non-clinical performance data section focuses on validation testing for the cleaning process and biocompatibility assessment as the primary acceptance criteria for this specific submission, which seems to be an update or modification rather than a completely new device that requires extensive clinical performance evaluation.
Here's a breakdown of the information available based on your request, highlighting what is present and what is explicitly stated as not necessary or not evaluated:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cleaning Validation: Meets standards outlined in FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." | "Testing passed all Cleaning validation meets the standards outlined in FDA guidance document acceptance criteria." |
| Biocompatibility Assessment: Adherence to predicate device standards per ISO 10993-1, following manufacturing process flow updates and review of contact materials. | "Process monitoring results and review of contact materials has passed acceptance criteria established by the predicate device per ISO 10993-1." |
Study Details (Based on the provided document)
Since the submission primarily focuses on updates to the cleaning process and biocompatibility, and explicitly states that clinical testing was not necessary for substantial equivalence, many of the typical elements of a clinical performance study (like those involving AI/ML devices) are not applicable or not provided in this document.
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Sample size used for the test set and the data provenance: This information is not provided as there wasn't a clinical performance study in the traditional sense for diagnostic accuracy. The "test set" here refers to the materials and controls used for cleaning validation and biocompatibility testing. The document does not specify their origins.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided as it's not relevant for cleaning validation or biocompatibility assessments.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided as it's not relevant for cleaning validation or biocompatibility assessments.
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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: This is not applicable. This device is a bone plate and screw system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Cleaning Validation: The ground truth is established by the ability to meet the acceptance criteria derived from FDA guidance documents and industry standards for sterility/cleaning.
- For Biocompatibility: The ground truth is established by meeting acceptance criteria based on ISO 10993-1 standards and predicate device performance, often involving laboratory tests for material safety and biological responses.
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The sample size for the training set: This information is not provided as there was no AI/ML training set.
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How the ground truth for the training set was established: This information is not applicable as there was no AI/ML training set.
§ 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.