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The TopFix System is indicated for the fixation of fractures and ostectomies of the distal femur and proximal tibia related to the treatment of bone and joint deformities and / or malalignment caused by injury or disease (e.g., osteoarthritis).

The Trifix Large System is indicated for the fixation of fractures (including periprosthetic), non-unions of the femur and tibia in adult patients with normal or osteopenic bone.

The Newnecks System is indicated for the fixation of fractures of the femoral trochanteric region (e.g., simple intertrochanteric, reverse oblique trochanteric, complex multi-fragmentary, and fractures with associated medial cortex instability).

The TDM Large Bone Plate and Screw System contains the TopFix System, Trifix Large System, and the Newnecks System, which comprise a family of flat and contoured plates and screws. The plates are constructed from Titanium alloy (Ti-6AL-4V) and come in a variety of configurations. The plates are intended to be used with solid locking and non-locking screws and non-locking low profile screws. The screws are constructed from Titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, cannulated screws from 4.0mm to 6.5mm in diameter and range from 12mm to 100mm in length.

This FDA 510(k) premarket notification summary describes a orthopedic device, not an AI/ML device, therefore the requested information for acceptance criteria and study details for an AI/ML device are not applicable.

The document discusses the substantial equivalence of the TDM Large Bone Plate and Screw System to previously cleared predicate devices. The "acceptance criteria" discussed are primarily related to mechanical performance testing against established ASTM standards and biocompatibility.

Here's a breakdown based on the provided text, noting where the requested AI/ML specific information is not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set: Not explicitly stated as a "test set" in the context of an AI/ML device. The testing involved bench testing of the physical device components (plates and screws).
• Sample Size:
  • For mechanical testing, the number of samples tested per configuration is not detailed in this summary but would be specified in the full test reports.
  • Biocompatibility likely involved material testing and review, not a "sample size" in the traditional sense of patient data.
• Data Provenance: Not applicable as this is a physical device, not a data-driven AI/ML model. The "data" comes from engineered bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Ground Truth Establishment: Not applicable. The "ground truth" for mechanical performance is defined by engineering standards (ASTM F382-17, ASTM F543-17) and FDA guidance documents related to orthopedic fracture fixation plates/screws. There are no clinical experts establishing "ground truth" for the mechanical properties of a bone plate.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Bench tests are assessed against objective, predefined engineering performance criteria, not requiring expert adjudication.

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

• MRMC Study: No. This is a physical orthopedic implant, not an AI/ML device.

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

• Standalone Performance: Not applicable. This is a physical orthopedic implant, not an AI/ML device.

7. The type of ground truth used

• Ground Truth: Engineering specifications, material standards (ASTM F136, ASTM F67), and mechanical testing standards (ASTM F382-17, ASTM F543-17), along with relevant FDA guidance documents ("Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway" and "Orthopedic Non-Spinal Metallic Bone Screws and Washers -Performance Criteria for Safety and Performance Based Pathway").

8. The sample size for the training set

• Training Set: Not applicable. This is a physical orthopedic implant.

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

• Ground Truth for Training Set: Not applicable. This is a physical orthopedic implant.

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