Search Results
Found 1 results
510(k) Data Aggregation
(30 days)
AOS Galileo Trochanteric Nail System
The AOS Galileo™ Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.
The AOS Galileo™ Trochanteric Nail System is a single-use, open reduction and internal fixation device, comprised of the Trochanteric Intermedullary Nail, Telescoping Lag Screws, Anti Rotation Screw, Cortical Locking Bone Screws, and their dedicated accessories, and sterilization trays. The trochanteric nail is a side specific cannulated femoral intramedullary nail with a proximal bend that is designed to enter through the greater trochanter, for the treatment of fractures to the femur, including peritrochanteric, intertrochanteric, high subtrochanteric fractures, and combinations thereof. The device is meant to be used as a load sharing device, and it may be removed once the fracture is healed.
This document is a 510(k) summary for the AOS Galileo™ Trochanteric Nail System. It describes the device, its indications for use, and its substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided text in the context of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabular format as would typically be seen for AI/software-as-a-medical-device (SaMD) performance. Instead, it describes a comparison to predicate devices for mechanical properties.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate mechanical properties/strength | "The AOS Galileo™ Trochanteric Nail System was subjected to functional testing and strength comparison analysis. The results demonstrate that the Galileo™ Intramedullary Nails and accessories are substantially equivalent to the predicates." |
| Same intended use, patient population, operating principle, risk profile | "The subject AOS Galileo™ Trochanteric Nail System, the predicates... have the same intended use, patient population, operating principle, and risk profile." |
| Identical manufacturing, packaging, sterilization, and shipping | "They have identical manufacturing, packaging, sterilization parameters, and shipping processes, all of which will be conducted under the same quality management system." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the context of AI/SaMD performance evaluation. The "testing" mentioned is functional and strength comparison analysis of the physical device. Therefore, a sample size for a test set and data provenance for a clinical study are not applicable or provided here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD that requires human expert ground truth for image interpretation or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD.
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 document pertains to a physical orthopedic implant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a physical orthopedic implant.
7. The Type of Ground Truth Used
For the functional and strength testing, the "ground truth" would be the established mechanical standards and performance characteristics of the predicate devices, against which the new device was compared. This is based on engineering principles and material science, not clinical outcomes or expert consensus in the typical sense for AI.
8. The Sample Size for the Training Set
Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document describes "functional testing and strength comparison analysis" as the study performed to demonstrate that the AOS Galileo™ Trochanteric Nail System is substantially equivalent to its predicate devices. The study concluded that the new device's performance is substantially equivalent, implying it meets the mechanical and functional requirements of the predicate. This is a non-clinical study focused on the physical device's characteristics rather than a clinical trial measuring patient outcomes or an AI model's diagnostic accuracy.
Ask a specific question about this device
Page 1 of 1