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The Lorenz Self-Drilling IMF Screw is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible.

The Self-drilling IMF bone screw for maxillomandibular fixation is 2.0mm in diameter and the thread lengths may range from 5mm - 11mm. The head has a relief groove which may or may not have a hole in which wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible.

This document is a 510(k) premarket notification for a medical device (Lorenz Self-Drilling IMF Screws). It primarily serves to demonstrate substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria based on performance studies.

Therefore, many of the requested categories (acceptance criteria table, sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable or not provided in this type of regulatory submission.

The document focuses on comparing the new device's technological features and intended use to a previously cleared predicate device. It demonstrates similarity in materials and application, rather than presenting a performance study with detailed acceptance criteria and results from clinical or experimental trials.

Here's a breakdown based on the provided document:

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

• Not Applicable / Not Provided. This document is a 510(k) summary for substantial equivalence. It does not present specific performance criteria or results from a study designed to meet those criteria. The main "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device.

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

• Not Applicable / Not Provided. No performance study with a test set is described in this 510(k) summary.

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):

• Not Applicable / Not Provided. No ground truth establishment for a test set is described.

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

• Not Applicable / Not Provided. No test set or adjudication process is described.

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. This device is a bone screw (mechanical device), not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• No. This device is a mechanical bone screw. "Standalone" performance in the context of algorithms is not relevant.

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

• Not Applicable / Not Provided. No ground truth, in the context of evaluating diagnostic or AI performance, is established or used here. The "ground truth" for a 510(k) typically relates to the safety and effectiveness of the predicate device based on its prior clearance.

8. The sample size for the training set:

• Not Applicable / Not Provided. There is no "training set" as this is a mechanical medical device, not an AI or diagnostic algorithm requiring data for training.

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

• Not Applicable / Not Provided. (See point 8).

Summary of the document's content:

The document (K040983) is a 510(k) premarket notification for the "Lorenz Self-Drilling IMF Screw." It demonstrates substantial equivalence to a predicate device (Lorenz IMF Screw, K983728).

• Device Description: The self-drilling IMF bone screw is 2.0mm in diameter with thread lengths from 5mm-11mm. It has a head with a relief groove for wire or elastic band wrapping.
• Intended Use: Temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible.
• Technological Features Comparison: Both the new and old devices are made of non-absorbable titanium. Both are implanted in bone during surgery for temporary fixation of the maxilla and mandible for fracture stabilization.
• Conclusion: The use of the modified IMF screws and the predicate IMF screws is substantially similar.

The "study" in this context is the comparison of technological features and intended use to the predicate device to establish substantial equivalence as required by the 510(k) process. This is a regulatory pathway, not a performance study in the traditional sense of evaluating specific metrics against predefined acceptance criteria for AI or diagnostic devices.

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