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The AURORA™ Screw System is a bone screw system consisting of solid and cannulated screws for treatment and fixation of fractures, fusions and osteotomies of bones in the Foot, Ankle, Hand, and Wrist. The screws are available in different diameters from Ø2.7mm to Ø7.5mm, are solid or cannulated with lengths ranging from 18mm to 160mm. All screws are manufactured from Ti-6AI-4V ELI alloy (ASTM F136-13). Optional washers are available for certain screws; the washers are also made from Ti-6AI-4V ELI alloy (ASTM F136-13). The screws and washers are intended to be implanted until bone healing. Implants are single use and the system is provided non-sterile.

AI/ML Overview

This document is a 510(k) Premarket Notification from MiRus, LLC to the FDA for their AURORA™ Screw System. It seeks to demonstrate substantial equivalence to previously cleared devices.

Based on the provided text, the AURORA™ Screw System is a medical device, specifically a bone screw system, not an AI/ML powered device. Therefore, the questions related to acceptance criteria and studies for AI/ML device performance (such as sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes of AI assistance) are not applicable to this submission.

The acceptance criteria and performance data for this type of device are primarily focused on mechanical testing and engineering analysis to demonstrate the device's physical properties and safety.

Here's the information that can be extracted from the provided document regarding acceptance criteria and performance data for the AURORA™ Screw System:

Acceptance Criteria and Device Performance (Non-AI Device)

Acceptance Criteria Category	Description	Reported Device Performance/Validation Method
Mechanical Performance	The device must meet the mechanical performance requirements for bone fixation fasteners to ensure adequate strength and durability for its intended use (repair of fractures, fusions, and osteotomies of bones and bone fragments).	Mechanical testing (ASTM F543) was performed and submitted.
Biocompatibility	The materials used (Ti-6AI-4V ELI alloy) must be biocompatible for implantation in the human body.	Not explicitly detailed as "acceptance criteria" but implied by the use of ASTM F136-13 compliant material, which is a standard for biocompatible titanium alloy.
Substantial Equivalence	The device must be demonstrated as substantially equivalent to legally marketed predicate devices in terms of intended use, indications for use, materials, technological characteristics, and labeling, without raising new questions of safety or efficacy.	Predicate device comparison and Engineering Analysis were conducted. The conclusion states that the device "does not raise any new questions of safety or efficacy when compared to the predicate device(s)" and "is substantially equivalent in mechanical performance, indications for use, intended use, technological characteristics, materials and labeling."
Manufacturing Quality	The device must be manufactured under good manufacturing practice (GMP) requirements (21 CFR Part 820).	Not part of the performance data section, but a general regulatory requirement that MiRus, LLC must comply with (as stated in the FDA letter).
Sterility	(Implied) If provided sterile, it must meet sterility requirements. However, the document states "implants are single use and the system is provided non-sterile."	Not applicable as the system is provided non-sterile.

Since this is a non-AI/ML medical device submission, the following AI/ML specific questions are not addressed by the provided document:

Sample sizes used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the 510(k) premarket notification for a traditional bone screw system, not an AI/ML-powered device. The reported performance data focused on mechanical testing (ASTM F543) and engineering analysis to demonstrate substantial equivalence to predicate devices, which is standard for this class of non-AI medical devices.

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