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Versalock Upper Limb Plating System are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, and ulna.

Versalock Upper Limb 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 or pure titanium. The plates range in thickness from 1.4 to 3.5 mm, and the screws range in diameter from 2.0 to 3.5 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture. Versalock Upper Limb Plating System are for single use and the devices are provided non-sterile. They must be properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.

This document describes the Versalock Upper Limb Plating System, a medical device for internal bone fixation. However, it is a 510(k) Premarket Notification for a Class II medical device, specifically metallic bone fixation appliances and accessories. These types of devices generally rely on mechanical testing to demonstrate substantial equivalence rather than clinical studies involving human patients or AI performance metrics.

Therefore, many of the requested elements for a study proving acceptance criteria (such as sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance) are not applicable in this context. The acceptance criteria and "study" described herein are based on mechanical performance standards.

Here's an analysis of the provided information, focusing on what is available:

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

Explanation: The acceptance criteria for this device are defined by its ability to meet established mechanical testing standards (ASTM F382 for plates and ASTM F543 for screws) and demonstrate substantial equivalence to legally marketed predicate devices. The "reported device performance" is that it successfully met these criteria.

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

• Sample size: Not explicitly stated as a "test set" in the context of clinical or AI performance. For mechanical testing, the sample size would refer to the number of plates and screws tested per configuration. This information is typically detailed in the test reports, which are not included in this summary.
• Data provenance: Mechanical testing is conducted under controlled laboratory conditions, not on human data. The specific lab where the testing was performed is not mentioned, but the manufacturer is based in Brazil.

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

• Not Applicable. This device does not involve expert-established ground truth in the way an AI diagnostic device would. Its performance is assessed through objective mechanical properties.

4. Adjudication method for the test set

• Not Applicable. There is no "adjudication method" as understood in clinical studies with human observers. Mechanical testing results are compared against the accepted performance parameters of the ASTM standards and the predicate devices.

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 is not an AI-assisted device, nor is it a diagnostic device that would involve human readers.

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

• Not Applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this medical device is adherence to established mechanical performance standards (ASTM F382 and F543) and factual data demonstrating substantial equivalence in material, design, and performance to legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI model.

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

• Not Applicable.

In summary: The provided document is an FDA 510(k) clearance for a bone plating system. The "study" proving the device meets acceptance criteria is a series of mechanical tests conducted according to ASTM standards (F382 for plates, F543 for screws), which confirmed the device is mechanically equivalent to its predicate devices. The acceptance criteria are essentially defined by these standards and the equivalence to existing cleared devices. Information relevant to AI/clinical performance metrics (like expert reviews, reader studies, ground truth establishment for AI) is not relevant to this type of device submission.

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