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The Orthofix Titanium Humeral Plating System is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.

The Orthofix Titanium Humeral Plating System consists of bone plates and locking screws, made of a titanium alloy. The bone plate included in the system is designed to treat fractures of the proximal humerus and come in a right and left version.

The plate has several locking options for the insertion of Fragment Fixations System implants (FFS), thus allowing a customized fragment adapted approach. Accessories include a cover to protect the ends of the FFS and a screw to lock this cover on the plate.

Instrumentation is available for the insertion of the plates and screws.

The provided document is a 510(k) summary for the Orthofix Titanium Humeral Plating System "LSP". This document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria related to AI or algorithm performance.

Instead, it's a submission for a medical device (bone plate system) seeking marketing clearance based on substantial equivalence to a predicate device. This type of regulatory submission primarily focuses on demonstrating that the new device is as safe and effective as another legally marketed device, rather than on proving performance against a set of quantitative metrics for an AI system.

Therefore, I cannot provide the requested information from the given text because it is not present in this 510(k) summary.

Here's why and what kind of information is present:

• Type of Device: The device is a "Orthofix Titanium Humeral Plating System 'LSP'", which consists of bone plates and locking screws. This is a physical orthopedic implant, not an AI/software device.
• Regulatory Pathway: The submission is a 510(k) for substantial equivalence. This pathway typically compares a new device's design, materials, and intended use to an existing predicate device to demonstrate similar safety and effectiveness.
• Lack of Performance Study for AI: The document does not describe any AI/algorithm component, nor does it refer to any studies evaluating AI or algorithmic performance, acceptance criteria for such, or involvement of experts for ground truth establishment.

The document primarily states:

• Intended Use: For fractures, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
• Substantial Equivalence: The device is considered substantially equivalent to a predicate device based on similarities in design, materials, and intended uses.

To directly answer your request based on the absence of the information in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance: Not present for AI/algorithm performance. The document focuses on substantial equivalence to a predicate device, not on specific quantitative acceptance criteria for an AI system.
2. Sample size used for the test set and the data provenance: Not applicable or not provided, as no AI performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth for an AI assessment is described.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) document is for a traditional medical device (bone plate system) and does not contain any information related to AI or algorithmic performance, acceptance criteria, or studies as requested.

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