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Internal fixation devices to aid the surgeon in the stabilization of oral cranio-maxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, for the fixation of fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures.

The self drilling screws are 2.4 mm in diameter and the lengths may range up to 12mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used.

This document is a 510(k) premarket notification for a medical device called the "Lorenz 2.4 Self Drilling Screw". It does not describe an acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is not available in the provided text.

Here is the information that can be extracted or inferred from the document:

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

• Not Applicable. The document does not describe specific performance acceptance criteria or results from a study testing these criteria. The entire submission is based on demonstrating substantial equivalence to a predicate device, not on meeting new, specified performance thresholds.

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. No test set or associated data provenance is described as this is a substantial equivalence submission, not a performance study.

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 is described.

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

• Not Applicable. No adjudication method 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

• Not Applicable. This is a hardware device (a screw for bone fixation), not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a hardware device.

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

• Not Applicable. The concept of "ground truth" as it pertains to AI or diagnostic studies is not relevant to this 510(k) submission. The "truth" in this context is that the device is substantially equivalent to a legally marketed predicate device.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is a hardware device and not an algorithm requiring training.

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

• Not Applicable.

Summary of what the document does convey:

This 510(k) submission (K032228) for the Lorenz 2.4 Self Drilling Screw relies on demonstrating substantial equivalence to a previously cleared predicate device, the "Lorenz Self Drilling Screw" (K013954). The document states that a substantial equivalence comparison table is included (TAB 3) and the predicate's prior clearance (TAB 4).

The FDA's letter confirms that they reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This means the device is considered as safe and effective as the predicate device without requiring new clinical trials or performance studies that would generate the kind of data requested in the prompt.

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