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The aap LOQTEQ® Elbow System consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments of the distal humerus. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).

The aap LOQTEQ® Elbow System consists of:
LOQTEQ® Distal Dorsolateral Humerus Plate (left and right) LOQTEQ® Distal Medial Humerus Plate (left and right) 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® Elbow System

AI/ML Overview

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Device: aap LOQTEQ® Elbow System (a bone fixation system)

Note: The provided document is a 510(k) summary for a medical device (aap LOQTEQ® Elbow System). For this type of device, "acceptance criteria" and "performance" primarily refer to the mechanical and physical properties of the implant, demonstrating its ability to function as intended and its substantial equivalence to a predicate device. It's not about an AI algorithm's diagnostic performance, but rather the device's structural integrity and biological compatibility. Therefore, some of the requested points related to AI algorithms (like MRMC studies, training sets, adjudication methods, and human reader improvement with AI) are not applicable to this document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance (Result)
Mechanical Performance (Static and Dynamic System Tests): Comparing the mechanical performance of the aap LOQTEQ® Elbow System to the predicate device (Synthes (USA) 3.5 mm LCP Distal Humerus System). The acceptance criteria would be that the aap LOQTEQ® Elbow System demonstrates equivalent or superior mechanical properties under worst-case clinical scenarios, ensuring it can withstand the forces expected in vivo without failure, fracture, or loosening, and function effectively for internal fixation of bone fragments.	Substantial Equivalence: The assessment of test results stated, "Substantial equivalence with respect to the mechanical performance of the aap system 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." This indicates that the device met the mechanical performance standards necessary to be considered substantially equivalent to the predicate device. While specific quantitative results (e.g., stiffness values, fatigue cycles survived, load-to-failure data) are not provided in this summary, the conclusion confirms that the device's performance aligns with the established acceptance criteria for mechanical integrity and functionality.
Biocompatibility: The material (Ti6Al4V) used for the implants generally has established acceptance criteria for biocompatibility, ensuring it does not cause adverse biological reactions when implanted in the human body.	Material Selection: Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3). This material is a well-established and approved medical-grade alloy with a known history of biocompatibility. By using a standard material that meets these specifications, the device inherently meets established biocompatibility acceptance criteria. (No explicit test results are detailed in this summary, but reliance on standard materials is a common approach for biocompatibility in 510(k) submissions).
Functional Equivalence: The device's components (plates and screws) and their interaction should allow for internal fixation of distal humerus fractures as intended, similar to the predicate device.	Similar Design and Functionality: The summary states, "The Substantial Equivalence of the new device and the predicate device is based on similar intended use, design, functionality, components and materials in use." This indicates that the device's overall functional performance, including its ability to achieve internal fixation via bone plates and screws, was found to be equivalent to the predicate.

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

Sample Size for Test Set: The document mentions "Static and dynamic system tests, representing worst case scenario with respect to clinical use." It does not specify the exact number of samples (e.g., number of plates or screws) tested, but refers to "tests" in the plural, implying multiple tests were conducted. Standard practice for such mechanical testing involves a statistically relevant number of samples to ensure robust results.
Data Provenance: The tests are non-clinical (laboratory-based mechanical tests). The country of origin for the data is not explicitly stated, but the sponsor, aap Implantate AG, is based in Berlin, Germany. Therefore, it is highly probable the testing was conducted either in Germany or by an accredited testing facility that supports their regulatory submissions. The data is prospective in the sense that these specific tests were performed for this 510(k) submission to demonstrate equivalence.

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

Not applicable (N/A). This refers to bone fixation implants, not an AI diagnostic device. The "ground truth" for mechanical testing is established by engineering standards, validated testing protocols, and comparison to the predicate device's known performance. There isn't a concept of "experts establishing ground truth" in the same way as for medical imaging diagnosis. The evaluation and interpretation of the test results would be performed by qualified engineers or scientists.

4. Adjudication Method for the Test Set

Not applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for expert consensus on diagnostic imaging. For mechanical testing, the results are quantitative and compared against predefined engineering specifications and the predicate device's performance. The outcome is typically based on whether the measured values fall within acceptable ranges and demonstrate equivalence.

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

No. This type of study (MRMC for human readers with/without AI assistance) is not applicable to a bone fixation system. MRMC studies are relevant for diagnostic devices that involve interpretation by human readers.

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

Not applicable (N/A). This product is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

Engineering Standards and Predicate Device Performance: For the mechanical tests, the "ground truth" is defined by:
- Applicable international and national standards for medical device materials and mechanical performance (e.g., ISO, ASTM standards for bone plates and screws).
- The established performance characteristics of the legally marketed predicate device (Synthes (USA) 3.5 mm LCP Distal Humerus System), which serves as the benchmark for substantial equivalence. "Worst case scenarios with respect to clinical use" also define the parameters against which the device's performance is measured.
- Biocompatibility "ground truth" is based on established material specifications (ASTM F136 or ISO 5832-3 for Ti6Al4V).

8. The Sample Size for the Training Set

Not applicable (N/A). This product is a physical implant, not a software algorithm that requires a training set.

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

Not applicable (N/A). No training set is involved for this type of device.

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