Search Results

The Set Screw for Ti Trochanteric Fixation Nail (TFN) is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.

The Set Screw for Ti Trochanteric Fixation Nail (TFN) is an additional offering for use with the existing TFN System. The Set Screw prevents sliding and rotation of the head element (TFN Screw or helical blade) within the nail for fixation of proximal femur fractures.

The provided 510(k) summary (K120083) for the "Set Screw for Ti Trochanteric Fixation Nail (TFN)" describes a mechanical testing study to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic or prognostic performance. Therefore, many of the requested categories regarding clinical study design, expert evaluation, and ground truth are not applicable.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the mechanical testing. Mechanical tests typically use a certain number of samples, but the exact count is not mentioned in this summary.
• Data Provenance: The data is likely from in-vitro mechanical testing conducted by the manufacturer, Synthes. The summary does not specify a country of origin for the data beyond being part of the manufacturer's submission. It is prospective in the sense that the tests were designed and executed to support this 510(k) submission.

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

• Not Applicable. This was a mechanical performance study, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is the objective measurement of mechanical properties, specifically "peak slip load," under controlled conditions.

4. Adjudication Method for the Test Set

• Not Applicable. As a mechanical test, there is no human adjudication process involved. The results are based on physical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not Applicable. This is a mechanical device study, not an AI-assisted diagnostic study involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a mechanical device study, not an algorithm performance study.

7. The Type of Ground Truth Used

• Mechanical Measurement (Peak Slip Load): The ground truth for this study was the objectively measured mechanical characteristic of "peak slip load" under specified test conditions.

8. The Sample Size for the Training Set

• Not Applicable. This is a mechanical device study, not a machine learning study requiring a training set. If referring to the development of the device itself, the summary does not provide details on R&D processes beyond the final mechanical testing.

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

• Not Applicable. As there is no training set in the context of this mechanical performance study, this question is not relevant.

Ask a specific question about this device