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GMReis Ankle Plating System are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle.

GMReis Ankle Plating System consists of plates and screws in a variety of designs and sizes that are commonly used in trauma and reconstructive surgery. The bone plates and screws are made from titanium alloy. The plates range in thickness from 1.8 to 3.6 mm, and the screws range in diameter from 2.7 to 3.5 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture. GMReis Ankle Plating System are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.

This document, K242998, describes a 510(k) premarket notification for the "GMReis Ankle Plating System." This is a medical device, specifically bone plates and screws, and the submission aims to demonstrate its substantial equivalence to previously marketed predicate devices.

The request asks for information about the acceptance criteria and the study that proves the device meets them, specifically in the context of an AI/software-driven medical device. However, the provided document does NOT contain information about an AI/software component, nor does it detail acceptance criteria related to a diagnostic or analytical performance study typical of AI/software devices.

Instead, this document focuses on establishing substantial equivalence for a physical orthopedic implant through:

• Comparison of Technological Characteristics: Showing similarity in design, intended use, materials, manufacturing processes, and sterilization methods to predicate devices.
• Performance Data (Mechanical Testing): Demonstrating the physical performance of the plates and screws according to well-established ASTM standards for metallic bone fixation devices.

Therefore, I cannot provide the requested information regarding AI/software specific acceptance criteria, test set sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, or training set details, as this information is not present in the provided document.

The "acceptance criteria" for this specific device (GMReis Ankle Plating System) are implicitly met by demonstrating that its mechanical performance is comparable to or better than the predicate devices, and that its materials and manufacturing processes are substantially equivalent.

Here's a breakdown of what can be extracted from the document, tailored to the spirit of your request but acknowledging the different nature of the device:

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

Note: The document states "Based on submitted testing data, the subject device is equivalent to the predicate devices." The specific numerical or statistical results of these mechanical tests that demonstrate equivalency are not provided in this summary, but the assertion is that the acceptance criteria for mechanical performance (i.e., meeting or exceeding predicate performance as per ASTM standards) were met.

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

• No information provided regarding sample sizes for human clinical data or diagnostic test sets, as this is a mechanical device primarily evaluated through engineering tests, not a diagnostic AI.
• Data Provenance: The mechanical testing data would typically be generated in a lab setting, presumably by the manufacturer (GM Dos Reis Industria e Comercio Ltda) from Brazil, as they are the submitter. The document does not specify the country of origin of the test data directly, but it would be expected to come from their internal or contracted testing facilities.

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. This pertains to establishing ground truth for diagnostic accuracy, which is not relevant for this physical device. Mechanical testing results are based on objective physical measurements against standards, not expert interpretation.

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

• Not applicable. No expert adjudication is described or required for mechanical testing of this nature.

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 system, not an AI diagnostic tool. No MRMC study was conducted.

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

• Not applicable. This refers to AI algorithm performance.

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

• Not applicable directly. For mechanical testing, the "ground truth" is defined by the objective performance requirements outlined in the ASTM standards (e.g., specific load-bearing capacities, fatigue life). Compliance with these standards serves as the "truth" for the device's physical performance.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set."

In summary, the provided FDA 510(k) clearance letter and summary for the GMReis Ankle Plating System clearly indicate that this is a physical implant device, and its safety and effectiveness (specifically substantial equivalence) are demonstrated through a comparison of physical characteristics and mechanical performance testing, not through AI/software validation studies.

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