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The Ortho Solutions Plating System is indicated for use in stabilization of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, including the toes, talus, and calcaneus; the distal fibula and tibia; as well as the fingers, hands, and wrists.

In addition, the non-locking screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The Ortho Solutions Plating System is a set of implantable metallic (Titanium Alloy) bone plates, locking and non-locking screws of various lengths. The system consists of a series of tubular plates of varying lengths as well as anatomically contoured plates. Locking and non-locking screws are provided in Ø2.7mm, Ø3.5mm, & Ø4.0mm in various lengths and are compatible with all plates. All implants are made from Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 and are provided non-sterile.

This document is a 510(k) Premarket Notification from the FDA regarding the "Ortho Solutions Plating System." As such, it does not contain the information requested about acceptance criteria for an AI/device performance study. The document is about a bone fixation device, not an AI or diagnostic tool.

The requested information:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

None of this information is available in the provided text because the device is a physical bone plating system, not a software or AI-driven diagnostic device.

The "Performance Analysis" section on page 3 simply states:
"Performance testing per ASTM F382, engineering analysis and rationale was completed for the plates to demonstrate substantial equivalence for static and fatigue bending strength. Performance testing was completed for the screws per ASTM F543 to demonstrate substantial equivalence with respect to torsional strength, insertion torque, and pullout strength."

This refers to mechanical engineering tests for physical product performance, not clinical or algorithmic performance, and it does not describe study methodologies relevant to AI/software.

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