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The KLS Martin Drill Free® MMF Screws is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.

The KLS-Martin Drill Free® MMF Screw provides temporary occlusal and fracture stabilization. These screws may be applied prior to or after exposure of the fracture.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KLS Martin Drill Free® MMF Screw.

Unfortunately, the provided text does not contain any information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) summary and the FDA's clearance letter for the KLS Martin Drill Free® MMF Screw. It focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data from a specific study against predefined acceptance criteria.

Therefore, I cannot populate most of the requested sections. Here's what I can extract from the provided text based on the limited information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample size for test set: Not specified.
• Data provenance: Not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not applicable as no specific study data or ground truth establishment is described in the provided document.

4. Adjudication Method for the Test Set

• Not applicable as no specific study data or adjudication is described in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, there is no mention of an MRMC study.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as this is a medical screw, not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? No, there is no mention of a standalone performance study. This device is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used

• Not applicable as no specific study data or ground truth is described in the provided document.

8. Sample Size for the Training Set

• Not applicable as no "training set" is relevant for this type of medical device submission.

9. How the Ground Truth for the Training Set Was Established

• Not applicable as no "training set" is relevant for this type of medical device submission.

Summary of Document's Content:

The provided documents describe the submission of a 510(k) premarket notification for the KLS Martin Drill Free® MMF Screw. The core of the submission is to demonstrate substantial equivalence to existing predicate devices based on:

• Identical intended use: For maxillomandibular fixation to stabilize fractures of the maxilla, mandible, or both.
• Similar application: Compared to other drill-free and anchorage systems.
• Key difference: The new device is "drill-free" (self-tapping), while its primary predicate required a pilot hole.

The FDA's clearance letter confirms their determination of substantial equivalence, allowing the device to be marketed. This type of submission relies on comparisons to already cleared devices rather than a de novo study with acceptance criteria for a novel device.

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