Search Results

The Lorenz Fiducial Screw is intended for establishing fixed reference point(s) in patients requiring stereotactic surgery. The Fiducial Screw can be used as an accessory with frameless navigation systems, as appropriate, from other manufacturers.

The Lorenz Fiducial Screw is a self drilling metallic fixation device with a stop used only as a reference point during stereotactic procedures.

This document is a 510(k) summary for the Lorenz Fiducial Screw, a medical device. It does not contain information about acceptance criteria or a study proving device performance in the way typically seen for diagnostic or AI-powered devices.

The document indicates that the device's substantial equivalence was established by comparing it to predicate devices already on the market (Howmedica Leibinger, Inc. Ost-Reg Marker System for Stereotaxic Navigation, K961120 and Lorenz 1.0mm, 1.5mm, 2.0mm systems, K953385). This means that the device is considered safe and effective because it is substantially similar to devices that have already been cleared by the FDA.

Therefore, many of the requested elements (like a table of acceptance criteria and reported device performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's how to address the request based on the provided text:

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

Not applicable. This 510(k) submission relies on substantial equivalence to predicate devices rather than demonstrating performance against specific acceptance criteria through a novel study. The "performance" is implicitly tied to the established safety and effectiveness of the predicate devices for their stated intended uses.

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

Not applicable. No new test set data was generated for a performance study. Substantial equivalence is based on comparing the new device's design, materials, and intended use to existing, cleared devices.

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. No ground truth establishment by experts for a test set was performed as part of this substantial equivalence submission.

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

Not applicable. No test set requiring adjudication was used.

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

Not applicable. This is not a diagnostic or AI-powered device, and no MRMC study was conducted.

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

Not applicable. This is a physical medical device (fiducial screw), not an algorithm or AI system.

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

Not applicable. The "ground truth" equivalent in a 510(k) for a simple device like this is the established safety and effectiveness profile of the predicate devices.

8. The sample size for the training set

Not applicable. No training set was used as this is a physical device, not a machine learning model.

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

Not applicable. No training set or associated ground truth establishment was performed.

Summary of the Document's Approach to Demonstrating Safety and Effectiveness:

The document establishes the safety and effectiveness of the Lorenz Fiducial Screw through substantial equivalence to predicate devices. This means the device is considered safe and effective because it shares the same intended use and similar technological characteristics (design, materials, etc.) as devices already legally marketed. The submission does not involve new clinical performance studies or the establishment of specific acceptance criteria against empirical data for its clearance.

Ask a specific question about this device