(50 days)
The aap LOQTEQ® Proximal Medial Tibia Plate 3.5 is indicated for:
- Metaphyseal fractures of the medial tibial plateau .
- Split fractures of the medial tibial plateau .
- Medial split fractures with depression ●
- Split or depression fracture of the medial tibial plateau ●
In addition, the plates may be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as multi-fragment fractures of the proximal tibia.
The aap LOQTEQ® Proximal Lateral Tibia Plate 3.5 is indicated for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, and fractures with associated shaft fractures.
The aap LOQTEQ® Proximal Tibia Plate 3.5 System 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® Proximal Tibia Plate 3.5 System consists of:
LOQTEQ® Proximal Medial Tibia Plate 3.5 (left and right) LOQTEQ® Proximal Lateral Tibia Plate 3.5 (left and right) to be used with LOQTEQ® Cortical Screw 3.5, T15, self-tapping Cortical Screw 3.5, self-tapping LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapping Cortical Screw 3.5, small head, self-tapping
Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3)
The aap LOQTEQ® Proximal Tibia Plate 3.5 System is a device used in internal fixation of bone fragments, specifically for fractures of the proximal tibia. The acceptance criteria for this device and the study proving it meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in terms of intended use, design, functionality, components, and materials. | Documented, including mechanical testing, demonstrated substantial equivalence to the predicate device. |
| Safety and effectiveness of the device. | Non-clinical tests were performed and showed the effectiveness and safety of the device. |
| Mechanical performance of the implant system, specifically under fatigue loading representing worst-case clinical scenarios. | The implant fatigue tests with progressive loadings demonstrated substantial equivalence in mechanical performance to the predicate device. The subject device was found to be safe and effective, meeting the requirements of its pre-defined acceptance criteria and intended uses. |
2. Sample size used for the Test set and the Data Provenance
The provided text does not specify a sample size for a test set in the context of clinical trials involving human subjects or real-world data. The evaluation was primarily based on non-clinical tests, specifically mechanical fatigue tests.
The data provenance for these non-clinical tests is not explicitly stated in terms of country of origin, but it can be inferred that the tests were conducted by the manufacturer, aap Implantate AG, located in Berlin, Germany. The tests were retrospective in the sense that they were performed on the device components in controlled laboratory conditions rather than prospectively in a clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation was based on non-clinical mechanical testing, not a study requiring expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the evaluation was based on non-clinical mechanical testing, not a study requiring adjudication of expert opinions.
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
This information is not applicable. The device is a bone plate system for internal fixation, not an AI-assisted diagnostic tool. Therefore, an MRMC study and the concept of "human readers improve with AI" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests was established by engineering standards and specifications for mechanical performance and fatigue life in medical implants. The objective was to demonstrate substantial equivalence to existing predicate devices through direct comparison of mechanical properties under standardized testing conditions.
8. The sample size for the training set
This information is not applicable as the evaluation was based on non-clinical mechanical testing, not a machine learning model requiring 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 model. The "ground truth" for the non-clinical tests was based on established engineering principles and comparative analysis with 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.