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The I.T.S. Humeral Head Plate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal humerus in the shoulder. Indications for Use include fracture and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The I.T.S. Humeral Head Plate with Angular Stability is a low-profile universal left and right titanium 4, 6, and 8 hole plate with various length cancellous self-tapping stabilization screws. The humeral head plate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.

The provided text describes a 510(k) premarket notification for a medical device called the "Humeral Head Plate with Angular Stability." This document focuses on demonstrating the device's substantial equivalence to previously approved devices, rather than conducting a de novo study to establish new performance criteria. Therefore, the information requested regarding acceptance criteria, study details, and AI-related performance metrics is not directly present in the provided text.

Specifically:

• Acceptance Criteria and Reported Device Performance: This device is undergoing a 510(k) review, which means it aims to demonstrate substantial equivalence to predicate devices already on the market. The provided text doesn't define specific quantitative acceptance criteria for performance; instead, it focuses on the device's design, materials, and intended use being similar to existing, legally marketed devices. Therefore, a table of acceptance criteria and reported device performance as would be found in a performance study is not available here.

• Sample Size for Test Set and Data Provenance: Not applicable, as this is not a clinical performance study with a test set of data. The document focuses on regulatory approval based on equivalence.

• Number of Experts and Qualifications: Not applicable. There is no information on expert review for ground truth establishment for a test set.

• Adjudication Method: Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was done or is described. The device is a bone plate, so AI assistance for human readers is not relevant in this context.

• Standalone (Algorithm Only) Performance: Not applicable. This is a physical implant, not an AI algorithm.

• Type of Ground Truth Used: Not applicable, as there's no performance data being evaluated against a ground truth.

• Sample Size for Training Set: Not applicable. There is no AI model or training set involved.

• How Ground Truth for Training Set Was Established: Not applicable.

However, based on the information provided, we can infer the "acceptance criteria" and "study" in the context of a 510(k) submission:

1. Acceptance Criteria (for 510(k) Substantial Equivalence):

2. The "Study" (in the context of 510(k)):

The "study" that proves the device meets the acceptance criteria is the 510(k) Premarket Notification process itself, specifically the provided Summary of Safety and Effectiveness. In this context, the "study" is a comparative assessment against legally marketed predicate devices, and it relies on non-clinical data (e.g., material testing, mechanical testing, design comparisons, and adherence to recognized standards for bone plates).

• Data Provenance: The nature of a 510(k) implies that the "data" is primarily based on engineering analysis, material specifications, and comparative design reviews against established predicate devices. There is no mention of clinical data or patient outcomes in this summary. The materials comply with ASTM standards (F 67-00, F 136-02), indicating adherence to recognized engineering and material specifications.
• Ground Truth: For a 510(k) submission, the "ground truth" is typically the established safety and effectiveness profile of the predicate devices. The new device aims to demonstrate that it is as safe and effective as these already approved devices.
• Sample Size for Test/Training set & Ground Truth Establishment: These concepts are not directly applicable since this is a regulatory submission for a physical implant based on substantial equivalence, not a clinical trial or an AI performance study. The "evidence" is the comprehensive documentation submitted to the FDA demonstrating that the device is comparable to predicates in terms of intended use, technological characteristics (materials, design), and performance (implied by material and design similarity, and adherence to standards).

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