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The AFT™ Proximal Humerus Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The AFT™ Proximal Humerus Fracture Plate is a low-profile, anatomically shaped plate which matches the natural contour of the proximal humerus. The plate is available in 'long' and 'short' configurations with left and right options. The plate contains holes for 3.5mm locking and nonlocking screws and 4.5mm partially threaded screws. The screws are available in various lengths. Both the plates and the screws are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for single-use.

K121672 is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions regarding AI/ML device performance, such as sample size for test sets, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, and training set information, are not applicable.

Here's a breakdown of the available information relevant to this device's acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable. This is a hardware device (bone plate), and the "test set" refers to mechanical testing of the device itself, not patient data in the context of an AI/ML study. The 510(k) summary does not specify the number of devices tested, but the standard ASTM F382-99 would dictate the number of samples required for static and dynamic testing. Data provenance for such mechanical testing typically pertains to the testing laboratory and its adherence to standards, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. Ground truth in the context of expert review for medical imaging or clinical outcome is not relevant for this type of mechanical device submission. The "ground truth" for mechanical testing is established by the ASTM F382-99 standard and the physical properties observed in controlled laboratory conditions.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are used to resolve discrepancies in expert opinions on ground truth, which is not relevant for mechanical testing of a hardware device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This device is a bone plate, so it does not involve human readers, AI, or MRMC studies.

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

• Not Applicable. This device is a bone plate and does not involve any algorithms or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Mechanical Performance Standards. For this device, the "ground truth" is defined by the established industry standards for mechanical testing of bone plates (ASTM F382-99). The device's performance is compared against the known safe and effective performance of the predicate devices according to these standards.

8. The sample size for the training set

• Not Applicable. This device is a bone plate and does not involve AI or training sets.

9. How the ground truth for the training set was established

• Not Applicable. This device is a bone plate and does not involve AI or training sets.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" conducted for the AFT™ Proximal Humerus Fracture Plate to demonstrate it meets acceptance criteria and is substantially equivalent was primarily a mechanical performance study coupled with a comparison to predicate devices for materials and design.

• Study Type: Mechanical Testing and Substantial Equivalence Comparison.

• Methodology:

  • Mechanical Testing: The device underwent static and dynamic bending testing according to the ASTM F382-99 standard. This standard prescribes methods for quantitatively determining the bending stiffness and strength of metallic bone plates. The 510(k) summary explicitly states this testing was performed "to demonstrate substantial equivalence." This implies that the device's performance in these tests was found to be comparable to or better than the predicate devices, thereby meeting the necessary mechanical acceptance criteria for safety and effectiveness.
  • Predicate Device Comparison: The submission also relies heavily on direct comparison to legally marketed predicate devices (Synthes LCP Proximal Humerus Plate, Synthes 4.5mm Non-Locking Cannulated Screw, Zimmer NCB Proximal Humerus Non-Locking Screw). The manufacturer asserts that the AFT™ Proximal Humerus Fracture Plate has the "same 'Indications for Use'," uses similar materials (Ti-6Al-4V, a common and accepted material for such implants), and has a comparable design (low-profile, anatomically shaped, accepts standard screws).

• Conclusion: Based on the mechanical testing (meeting ASTM F382-99 standards) and the comparison of indications, materials, and design to the predicate devices, the FDA concluded that the AFT™ Proximal Humerus Fracture Plate is "substantially equivalent" to the predicate devices. This determination signifies that the device meets the necessary safety and effectiveness criteria for market clearance.

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