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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

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. The sample size for the training set: This information is not provided as there was no AI/ML training set.

8. How the ground truth for the training set was established: This information is not applicable as there was no AI/ML training set.

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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

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.

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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; and the locking screws are manufactured from Titanium Alloy (Ti-6Al-4V).

This document describes the Biomet Microfixation OmniMax MMF System, a medical device for temporary stabilization of mandibular and maxillary fractures. It does not contain information about an AI/ML device or its performance criteria, nor does it detail a study involving AI. Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies proving the device meets them based on AI/ML performance.

The document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and device characteristics. It mentions "Non-Clinical Performance Data: All non-clinical performance testing passed according to the acceptance criteria" and lists the types of tests conducted:

• Screw: Insertion/Fracture Torque, Bending/Shear, Push-Through
• Plate and Screw Construct: Static and Fatigue Testing
• Simulated Use Cadaver Lab

However, it does not provide the specific numerical acceptance criteria for these tests or the reported performance values. It also explicitly states, "Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence."

Without information related to AI/ML, I cannot provide details on:

• Acceptance criteria and reported device performance for an AI/ML component.
• Sample sizes, data provenance, or ground truth for test sets for an AI/ML component.
• Number of experts or their qualifications for establishing ground truth related to AI/ML.
• Adjudication methods for AI/ML test sets.
• Multi-reader multi-case (MRMC) comparative effectiveness studies involving AI assistance.
• Standalone performance of an algorithm.
• Type of ground truth used for AI/ML.
• Sample size or ground truth establishment for a training set for an AI/ML component.

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