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This device is intended for use in selective trauma of the cranial surgery and reconstructive procedures.

The LeForte Neuro System is designed for use in selective trauma of the craniofacial skeleton, craniofacial surgery and reconstructive procedures. The LeForte Neuro System consists of bone plates in a variety of shapes and sizes, bone screws to secure the plates, convenience kits of bone plates and bone screws, and accessories to assist in the operational procedures. The LeForte Neuro System Bone Plate & Screw is made of pure titanium (ASTM F67) and titanium Alloy (ASTM F136). It is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.

The provided text describes the LeForte Neuro System Bone Plate & Screw, a medical device used in craniofacial surgery. The submission focuses on demonstrating substantial equivalence to a predicate device through performance testing.

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:

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

The document does not explicitly state the specific sample sizes (number of plates and screws) used for the performance tests. The provenance of the data is that it was generated through laboratory testing of the "modified LeForte Neuro System plates" and "modified LeForte Neuro System bone screws." It does not mention country of origin or whether it was retrospective or prospective, as these are not relevant for benchtop mechanical testing.

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

Not applicable. The "ground truth" for this device, which is a mechanical implant, is based on pre-set engineering criteria and objective physical measurements (tensile strength, torsion, pull-out force), not expert clinical judgment.

4. Adjudication Method for the Test Set:

Not applicable. As the testing involves objective mechanical measurements against pre-defined numerical thresholds, there is no need for adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. This is a mechanical device, not an imaging or diagnostic AI tool. Therefore, an MRMC study is not relevant, and no effect size for human readers improving with AI assistance would be applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is not an algorithm or AI device; it is a physical medical implant. The performance assessment is standalone in the sense that the device's mechanical properties were tested independently.

7. The Type of Ground Truth Used:

The ground truth used for evaluating this device is objective engineering specifications and pre-defined mechanical thresholds. These thresholds (e.g., N150 for tensile strength, 0.20Nm for torsion, 20N for pull-out) represent the minimum performance required for the device to be considered safe and effective for its intended use.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" for physical medical devices of this type. Performance is evaluated through direct mechanical testing against established criteria, not through machine learning or algorithm training.

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

Not applicable, as there is no training set. The "ground truth" (acceptance criteria) for the performance tests would have been established by engineering standards, industry best practices for similar devices, and potentially regulatory guidance for neurosurgical fixation systems.

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