(23 days)
The Omega™ Plus, Omega™ 2, and Omega™ 3 Systems are intended for use in the temporary stabilization of types of fractures of the proximal and distal femur. The subject devices are indicated for fixation of proximal and distal femoral fractures including:
- Intracapsular and basal neck fractures including transcervical and subcapital fractures .
- Intertrochanteric fractures .
- Subtrochanteric fractures .
- Supracondylar fractures .
- Intracondylar fractures t
- Osteotomies for patients with diseases or deformities of the hip ●
- Hip arthrodesis .
The Omega™ 3 Trochanteric Stabilizing Plate is a compression screw system designed to treat various types of fractures of the proximal femur.
The Omega™ 3 Trochanteric Stabilizing Plate is a compression screw system designed to treat various types of fractures of the proximal femur. The study conducted to demonstrate its safety and effectiveness was a mechanical testing study comparing the new device to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Comparable mechanical properties to predicate devices | Mechanical testing demonstrated comparable mechanical properties to the predicate components. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific numerical sample size used for the mechanical testing, nor does it detail the provenance of the data (e.g., country of origin, retrospective or prospective). It simply states "Mechanical testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. The basis for substantial equivalence was mechanical testing, not expert-adjudicated clinical or image data.
4. Adjudication Method for the Test Set:
This information is not applicable. The study involved mechanical testing, not human adjudication of a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study was focused on the mechanical properties of the device itself, not on human reader performance with or without AI assistance.
6. Standalone Performance Study:
A standalone performance study was conducted in the form of mechanical testing of the device. This testing assessed the device's inherent mechanical properties without human intervention or interpretation as part of the primary outcome.
7. Type of Ground Truth Used:
The "ground truth" for this study was the established mechanical properties and performance of legally marketed predicate devices. The new Omega™ 3 Trochanteric Stabilizing Plate was compared to these existing devices.
8. Sample Size for the Training Set:
This information is not applicable. The study involved mechanical testing of a medical device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there was no training set for a machine learning algorithm. The ground truth for the comparison was based on the established mechanical performance of predicate devices.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.