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The indication for use of the aap LOQTEQ® Osteotomy System are:

LOQTEQ® High Tibial Osteotomy Plate 4.5:

• Open-wedge osteotomies at the proximal medial tibia .
• Treatment of bone and joint deformities .
• Treatment of malpositions caused by injuries or disorders such as . osteoarthritis

LOQTEQ® Distal Femur Osteotomy Plate 4.5:

• Closed-wedge osteotomies of the medial distal femur .
• Treatment of bone and joint deformities .
• Treatment of malpositions caused by injuries or disorders such as . osteoarthritis

The aap LOQTEQ® Osteotomy 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 osteotomy of medial proximal tibia and medial distal femur. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).

The aap LOQTEQ® Osteotomy System consists of:
LOQTEQ® LOQTEQ® High Tibial Osteotomy Plate 4.5
LOQTEQ® LOQTEQ® Distal Femur Osteotomy Plate 4.5 (left and right)
LOQTEQ® Cortical Screw 4.5, small head, T25, self-tapping
Cortical Screw 4.5, small head, self-tapping
LOQTEQ® Cortical Screw 4.5, T25, self-tapping
Set of Instruments aap LOQTEQ® Osteotomy System Set of Instruments

This document describes the aap LOQTEQ® Osteotomy System, a medical device consisting of bone plates and screws designed for internal fixation after osteotomy procedures (medial proximal tibia and medial distal femur). The information provided focuses on its substantial equivalence to predicate devices and its non-clinical performance.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated as this is a non-clinical study. The "test set" refers to mechanical test samples, not patient data.
• Data Provenance: Non-clinical tests (lab-based mechanical testing). The country of origin for the testing data is not specified, but the sponsor is based in Berlin, Germany. The study is prospective in the sense that the tests were designed and conducted to evaluate the device.

3. Number of Experts and Qualifications

This document describes non-clinical mechanical testing, not a study involving human experts for ground truth establishment. Therefore, this information is not applicable.

4. Adjudication Method

Not applicable, as this is a non-clinical mechanical performance study, not a study evaluating human interpretation or expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document describes non-clinical mechanical testing of a medical device, not a comparative effectiveness study involving human readers and AI.

6. Standalone Performance Study (Algorithm Only)

Not applicable, as this is a physical medical device (bone plates and screws), not an algorithm or AI. The "standalone performance" refers to the mechanical performance of the device itself.

7. Type of Ground Truth Used

The "ground truth" for this non-clinical study is established through physical mechanical testing according to predefined test protocols, likely based on industry standards (e.g., ISO, ASTM) and worst-case scenarios with respect to clinical use. The comparison is made against the mechanical performance of the predicate devices.

8. Sample Size for the Training Set

Not applicable. This is a non-clinical evaluation of a physical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of this non-clinical mechanical performance study.

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