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For fractures and osteotomies of the calcaneus, including, but not limited to
-extra-articular, intra-articular
-joint depression
-tongue type
-severely comminuted fractures

The LOQTEQ® VA Calcaneus Plate 3.5 is an anatomical, polyaxial angular stable, asymmetrical titanium plate (L/R version) for the treatment of calcaneus fractures. The shape of the plate is adapted to the lateral, anatomical shape of the calcaneus.

The polyaxial, angle-stable plate-screw-connection (VA technology) allows up to 15° angulating of the screws. Thus, the screws can be placed under the posterior articular facet into the sustentaculum tali, ensuring a stable supply of the fracture.

The provided text describes a medical device, the LOQTEQ® VA Calcaneus Plate 3.5, and its substantial equivalence to predicate devices, focusing on mechanical safety testing. However, it does not contain information relevant to the acceptance criteria and study proving device meets the criteria for an AI/ML powered medical device as requested in the prompt.

Specifically, the document discusses:

• Device Name: LOQTEQ® VA Calcaneus Plate 3.5
• Intended Use/Indications for Use: Temporary fixation, correction or stabilization of the calcaneus for fractures and osteotomies (extra-articular, intra-articular, joint depression, tongue type, severely comminuted fractures).
• Predicate Devices: Synthes Locking Calcaneal Plate (K991407 - Primary) and aap Bone Plate and Screw Implants (K072411).
• Testing Performed: Customized static and dynamic 3-point-bending tests of bone plates according to ASTM F2193 and ASTM F382, and mechanical testing for screws according to ASTM F543.
• Conclusion: The device functioned as intended, had similar results to predicate devices, and was found to be substantially equivalent.

The document does NOT contain any of the following information:

• A table of acceptance criteria and reported device performance (for an AI/ML device)
• Sample size used for the test set or data provenance
• Number of experts used to establish ground truth or their qualifications
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• If a standalone (algorithm only) performance study was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How the ground truth for the training set was established

Therefore, I cannot fulfill your request using the provided text. The document describes a traditional medical device (bone plate and screws) and its mechanical testing, not an AI/ML medical device.

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