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The aap LOQTEQ® Proximal Humerus Plate 3.5 System includes LOQTEQ® Proximal Humerus Plate 3.5 short and LOQTEQ® Proximal Humerus Plate 3.5 long. The plates accept 3.5 mm cortical locking screws and 3.5 mm cortical screws as well as 3.8 mm cancellous locking screws. They are intended for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone

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 with 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® Proximal Humerus Plate 3.5 System consists of: LOQTEQ® Proximal Humerus Plate 3.5, short . LOQTEQ® Proximal Humerus Plate 3.5, long ◆ . LOQTEQ® Cortical Screw 3.5, T15, self-tapping LOQTEQ® Cancellous Screw 3.8, T15 ● . Cortical Screw 3.5, self-tapping . Set of Instruments, Proximal Humerus Plate Material: Plates are made of Ti6Al4V (ASTM F136 or ISO 5832-3) Screws are made of Ti6Al4V (ASTM F136 or ISO 5832-3)

The device in question is the LOQTEQ® Proximal Humerus Plate 3.5 System. The study supporting its acceptance is a non-clinical mechanical testing study.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "Fatigue implant tests with progressive loadings, representing worst case scenario," but does not give a specific number of implants tested.
• Data Provenance: The study was a non-clinical (mechanical) test, implying it was conducted in a laboratory setting, not on human subjects. The company, aap Implantate AG, is based in Berlin, Germany, suggesting the tests were likely performed in Germany or under their direct supervision. The data is retrospective in the sense that it was conducted before the submission for regulatory approval.

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

This question is not applicable to this submission. The "ground truth" for a mechanical testing study is typically defined by engineering specifications, material science principles, and established testing standards, not by expert consensus in a clinical context. The "experts" involved would be engineers and material scientists conducting and evaluating the tests, but their number and specific qualifications are not detailed here.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert opinions for ground truth establishment. For mechanical testing, the "adjudication" is based on objective measurements and comparison against predefined engineering standards.

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

No. This was a non-clinical mechanical testing study, not a clinical study involving human readers or comparative effectiveness with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This was a physical medical device (bone plate and screws) being tested for its mechanical properties, not an algorithm.

7. Type of Ground Truth Used

The ground truth used was based on engineering specifications and mechanical performance standards. The study aimed to demonstrate "substantial equivalence with respect to the mechanical performance" to a predicate device, and that the device "meets the requirements of its pre-defined acceptance criteria." These criteria would be derived from biomechanical principles and established performance benchmarks for such implants.

8. Sample Size for the Training Set

No training set was used in this context. This was a non-clinical validation study for 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 was no training set.

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