(59 days)
The aap LOQTEQ® Olecranon Plates are indicated for fixation of fractures, osteotomies and nonunions of the olecranon, particularly in osteopenic bone.
The aap LOQTEQ® Olecranon Plate consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).
The aap LOQTEQ® Olecranon Plate System consists of:
• LOQTEQ® Olecranon Plate (left and right)
to be used with
• LOQTEQ® Cortical Screw 2.7, small head T8, self-tapping
• Cortical Screw 2.5, small head T8, self-tapping
• LOQTEQ® Cortical Screw 3.5, T15, self-tapping
• Cortical Screw 3.5, self-tapping
• Set of Instruments aap LOQTEQ® Olecranon Plate
The provided documentation describes the aap LOQTEQ® Olecranon Plate, a metallic bone fixation appliance. The study conducted to demonstrate its acceptance criteria focuses on non-clinical mechanical testing to establish substantial equivalence to predicate devices.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance of the aap system to be substantially equivalent to predicate devices. | Customized 4-point bending tests (static and dynamic) based on ASTM F382-99 demonstrated substantial equivalence with respect to mechanical performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific number of aap LOQTEQ® Olecranon Plates or predicate devices tested for the mechanical evaluation. It refers to "tests" and "test results" in the plural, implying multiple tests were conducted, but the exact sample dimension is not provided.
- Data Provenance: The data is from non-clinical testing conducted by the manufacturer, aap Implantate AG, in Germany. This is a prospective evaluation of the device's mechanical properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This question is not applicable as the study described is a non-clinical mechanical testing study, not a study involving human diagnosis or interpretation where expert ground truth would be established. The "ground truth" here is the physical performance data against established ASTM standards.
4. Adjudication Method for the Test Set
- This question is not applicable for a non-clinical mechanical testing study. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved.
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
- This question is not applicable. The provided document describes a medical device (bone plate), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. As mentioned above, the device is a physical bone plate, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" for this non-clinical study is defined by established mechanical testing standards, specifically ASTM F382-99, and the performance of the legally marketed predicate devices. The acceptance criterion for the new device was to demonstrate "substantial equivalence" to the mechanical performance of these predicate devices.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" in the context of this non-clinical mechanical testing study. Training sets are relevant for machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reasons as #8.
§ 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.