Search Results

The SIGN Pediatric Fin Nail is indicated for internal fixation of diaphyseal fractures of the femur, osteotomies, correction of malunions and nonunions on patients who are anatomically suited to receive the device.

SIGN Pediatric Fin Nail is an Intramedullary Fixation Rod designed to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments The SIGN Pediatric Fin Nails are available in a variety of lengths, shaft diameters, and fin diameters to accommodate a variety of patient anatomies. Each nail has a proximal bend and a slot at the proximal end to accept a solid 4.5mm diameter cortical bone screw for fixation and uses rigid distal fins for rotational stability. The Pediatric Fin Nail may be removed upon fracture healing. The Pediatic Fin Nail is a single use device, supplied non-sterile, and manufactured from stainless steel in accordance with ASTM F 138.

This document describes the SIGN Pediatric Fin Nail, an intramedullary fixation rod designed for femur fracture fixation in pediatric patients. The study supporting its acceptance is a non-clinical performance (bench) testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that the device "met all acceptance criteria" for the mechanical performance tests, but does not provide specific numerical values for the acceptance criteria or reported values.

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

• Test Set Sample Size: Not specified in the provided text. The tests were "bench testing" of the device itself, implying a number of manufactured devices were tested.
• Data Provenance: Non-clinical setting (bench testing). No information on country of origin or whether it was retrospective/prospective is applicable as it's not human subject data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This device is a mechanical implant, and the testing was non-clinical bench testing. Ground truth in this context typically refers to the physical properties and mechanical behavior of the device under specific loads, which are measured using scientific instrumentation and engineering standards, not expert human interpretation.

4. Adjudication Method for the Test Set:

Not applicable. As described in point 3, the evaluation was based on objective mechanical measurements against engineering standards, not human interpretation requiring adjudication.

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

No. This type of study (MRMC) assesses the performance of humans, often with and without AI assistance, in interpreting medical images or data. It is not relevant for the evaluation of a mechanical orthopedic implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:

Yes, in a way. The performance testing described is standalone in that it evaluates the mechanical properties and performance of the device itself (the "algorithm" equivalent for a physical product) without any human interaction being part of the primary functional assessment. The device's ability to withstand compression, torsion, and fatigue was assessed directly.

7. Type of Ground Truth Used:

The ground truth used was based on engineering standards and predetermined mechanical performance specifications for orthopedic implants, specifically intramedullary rods for fracture fixation. The tests evaluated the device's axial strength, rotational stability, and ability to withstand fatigue under simulated physiological loading.

8. Sample Size for the Training Set:

Not applicable. As a manufactured physical medical device, there is no "training set" in the sense of machine learning algorithms. The design and manufacturing processes are informed by engineering principles, material science, and prior knowledge of similar devices, but not through a "training set" of data.

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

Not applicable. (See answer to point 8). The design parameters, material selection, and manufacturing specifications are established through engineering design processes, material science research, and adherence to relevant ASTM standards (e.g., ASTM F138 for stainless steel). The "ground truth" for its design is rooted in established biomechanical principles and regulatory requirements for implantable devices.

Ask a specific question about this device