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LOQTEQ® VA Distal Medial Tibia Plate 3.5:
Fixation of complex intra- and extra-articular fractures of the distal tibia; osteotomies of the distal tibia

LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5:
Fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone

LOQTEQ® VA Distal Fibula Plate 2.7/3.5:
Fractures, osteotomies, and non-unions of the distal fibula, especially in osteopenic bone

The aap LOQTEQ® VA Distal Tibia Plate 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, osteotomies or non-unions.
The system includes anatomically preformed and angle-stable small fragment plates, which are available as right and left versions as well as in different lengths. The geometrical shape of those plates is based on the anatomy and biomechanical stress of the distal tibia/distal fibula. A flat plate design, smooth transition of cross sections, chamfers and roundings preserve soft tissue irritation. The tapered tip of those shafts enable a minimal invasive surgery. For a minimization of the contact between bone (tibia) and plate, all holes of the shaft zone are tunneled and the bottom of the plates is structured.
All plate holes, with exception of the oblong hole, are compatible with unidirectional locking screws as well as cortical screws. The use of locking screws is state of the art and particularly important in osteoporotic bones or for stabilizing comminuted fractures. The elongated hole can be used to adjust the height as well as the initial fixation of the plate. The use as a conventional bone plate and screw osteosynthesis is also possible with standard cortical screws.
The System incorporates:
• LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5, right/left
• LOQTEQ® VA Distal Medial Tibia Plate 3.5, right/left
• LOQTEQ® VA Distal Fibula Plate 2.7/3.5, right/left
• LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapping
• Cortical Screw 2.5, small head, T8, self-tapping
• LOQTEQ® Cortical Screw 2.7, small head, T8, self-tapping
• Cortical Screw 3.5, T15, self-tapping
• LOQTEQ® Cortical Screw 3.5, T15, self-tapping
• LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapping

The provided text is a 510(k) summary for the LOQTEQ® VA Distal Tibia Plate System, indicating that no acceptance criteria in the traditional sense of AI/algorithm performance are relevant here. This document is for a medical device (bone plates and screws) that is a physical implant, not an AI or software device.

Therefore, many of the requested categories in the prompt (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of device and submission.

However, I can extract and structure the information related to the device's performance and safety as described in the 510(k) summary.

Acceptance Criteria and Device Performance for LOQTEQ® VA Distal Tibia Plate System

The submission asserts "substantial equivalence" to predicate devices, meaning the new device is as safe and effective as legally marketed devices. The "acceptance criteria" here relate to meeting or exceeding the mechanical performance and biocompatibility standards demonstrated by the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. For physical medical devices, "test sets" typically refer to samples of the device undergoing mechanical and biocompatibility testing, not patient data sets. The documents refer to mechanical testing samples (e.g., plates and screws). The exact number of samples tested for each mechanical test is not specified in this summary but would be detailed in the full test reports.
• Data Provenance: Not applicable in the context of patient data. The tests are non-clinical, conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. "Ground truth" in this context would refer to objective measurements from validated mechanical tests and material characterization, not expert clinical interpretations.

4. Adjudication Method for the Test Set

• Not applicable. This concept applies primarily to studies involving human interpretation or clinical outcomes, not to mechanical performance testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human readers interpret cases. This device is a physical implant. The submission states, "Clinical data and conclusions were not needed for this device."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• Mechanical Testing Results and Biocompatibility Assessment: The ground truth is established through objective, standardized mechanical tests (e.g., ASTM F 382-14) and material biocompatibility assessments, which measure physical properties and interactions to ensure safety and performance.

8. The Sample Size for the Training Set

• Not applicable. This device does not use a "training set" as it is not an AI or machine learning device.

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

• Not applicable. This device does not have a "training set."

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