Search Results

The Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

The Mandible External Fixator consists of the following components: Adjustable Parallel Pin Clamp; Adjustable Clamp; 2.5mm/4.0mm Schanz Screws; 2.0 mm K-wires; 2.5 mm K-wires;; 4.0 mm Pre-bent Titanium Rods; and 4.0 mm Carbon Fiber Rods. The rods and Schanz screws are available in various lengths.

This document is a 510(k) premarket notification for a medical device called the "Mandible External Fixator - MR Conditional." It focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices, particularly regarding its MRI compatibility.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document doesn't present a formal table of acceptance criteria with specific numerical thresholds for general device performance. Instead, it describes the acceptance criteria implicitly through the non-clinical tests performed for MR Conditional labeling. The "reported device performance" is then stated as successfully meeting the requirements of these tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "Non-clinical testing to support MR Conditional labeling include assessments of magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts."

• Sample size: The document does not specify the sample size used for these non-clinical tests. It implies that the tests were performed on representative samples of the Mandible External Fixator components.
• Data provenance: The data is non-clinical performance data (laboratory testing) conducted to support the MR Conditional labeling. The country of origin of the data is not explicitly stated, but as the submitter is "Synthes USA Products, LLC" in "West Chester, PA, United States of America," it is likely that the testing was performed in the United States or at facilities supporting their US operations. The data is not retrospective or prospective clinical data as no clinical testing was performed for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this submission. The "ground truth" for non-clinical MR Conditional testing is based on established industry standards and regulatory guidance for evaluating the safety of devices in an MRI environment (e.g., ASTM standards for MR safety). It does not involve expert consensus on medical images or clinical outcomes. Therefore, no experts were used to establish ground truth in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as the evaluation of MR safety testing results does not involve human adjudication in the way clinical diagnostic studies might. The results are typically objectively measured and compared against predefined safety thresholds.

5. 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (Mandible External Fixator) and focuses on its material properties and safety in an MRI environment, not on diagnostic image interpretation or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a physical fixator, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical MR Conditional evaluation is based on established scientific principles, engineering standards (e.g., ASTM F2503 for MR Conditional labeling), and regulatory guidance concerning the interaction of materials with magnetic fields, radiofrequency energy, and their impact on image quality. It's an objective measurement against defined safety limits, not a subjective assessment by medical experts or clinical outcomes data.

8. The sample size for the training set

This question is not applicable. Since no AI algorithm is involved, there is no "training set." The testing performed was non-clinical and focused on the physical device's characteristics.

9. How the ground truth for the training set was established

This question is not applicable as there was no training set since no AI algorithm was developed or evaluated.

Ask a specific question about this device