(269 days)
The aap LOQTEQ® Large Fragment Set is intended for: Fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation of non-unions or malunions.
Bone plates and screws are used for fixation of bone fragments, i.e., for treatment of bone fractures and other bone injuries. Bone plates are fixed by the use of bone screws. Bone plates and bone screws are implants. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation). The LOQTEQ® Large Fragment Set consists of: • LOQTEQ® Narrow Plate 4.5, • LOQTEQ® Broad Plate 4.5, • LOQTEQ® Cortical Screw 4.5, T25, self-tapping • Cortical Screw 4.5, self-tapping • Set of Instruments, Large Fragment Set
Here's a summary of the acceptance criteria and the study details for the aap LOQTEQ Large Fragment Set, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance of the aap plates should show substantial equivalence to the predicate device. The device should be safe and effective, and its performance should meet pre-defined requirements and intended uses. | "Substantial equivalence with respect to the mechanical performance of the aap plates could be stated due to the test results gained. The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses." |
| Must pass static and dynamic 4-point-bending tests according to ASTM F 382-99. | Tests were performed: "Static and dynamic 4-point-bending test of bone plates according to ASTM F 382-99." The results led to the conclusion of substantial equivalence and safety/effectiveness against acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for the "test set" in terms of number of devices. However, the study involved non-clinical mechanical tests:
- Static and dynamic 4-point-bending tests of bone plates according to ASTM F 382-99.
The data provenance is not specified beyond being "non-clinical tests" performed by the manufacturer, aap Implantate AG in Berlin, Germany. These are in vitro tests and not directly tied to patient data, retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for the mechanical performance is the standard ASTM F 382-99. The assessment of test results against this standard would likely be performed by engineers or technical experts, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided as the study is a non-clinical mechanical performance assessment against a standard, not a clinical study involving human judgment that would typically require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study is a non-clinical mechanical performance test of a medical device (bone plates and screws), not an AI-assisted diagnostic or imaging device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A (Not Applicable). This is a mechanical device, not an algorithm. The "standalone" performance refers to the device's mechanical integrity and function as assessed by the ASTM F 382-99 standard.
7. The Type of Ground Truth Used
The ground truth used for performance validation is the requirements and specifications outlined in the ASTM F 382-99 standard for static and dynamic 4-point-bending tests of bone plates. This is a scientific and engineering standard.
8. The Sample Size for the Training Set
This information is not applicable/not provided. There is no "training set" as this is a non-clinical mechanical device performance study, not a machine learning or AI algorithm development study.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as in point 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.