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Optimus Neuro System is intended for use in selective trauma of the cranial surgery and reconstructive procedure.

The Optimus NEURO System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.8mm in lengths of 3.0 to 6.0mm. It is made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.

The device is packed separately in a PE bag. The plate and screw are single use only, non-sterile products. The devices must be sterilized before use.

Optimus NEURO System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient

This document describes the Optimus Neuro System, a device intended for use in cranial surgery and reconstructive procedures. It's important to note that this submission focuses on the device itself (plates and screws), not an AI algorithm. Therefore, many of the requested AI-specific details are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the "4 Point Bending Test" or "Packaging Process Validation Test." It refers to "the subject device and the predicate devices," suggesting that a sufficient number of units were tested to draw conclusions.

• Data Provenance: The manufacturing company, Osteonic Co., Ltd., is based in Seoul, Korea. The tests were likely conducted in a controlled lab environment. The study is retrospective in the sense that it's comparing a modified device to an existing predicate, and the testing isn't on human subjects for clinical outcomes, but rather on the physical properties of the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as this is a submission for a medical device (plates and screws), not an AI algorithm requiring expert ground truth for image or data interpretation. The "ground truth" here is based on engineering standards and physical test results.

4. Adjudication Method for the Test Set

This is not applicable as it pertains to expert disagreement in AI-driven diagnostic tasks, which is not relevant to this device's testing.

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

This is not applicable as this is a medical device (plates and screws), not an AI algorithm.

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

This is not applicable as this is a medical device (plates and screws), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Engineering Standards: Adherence to material specifications (ASTM F67, ASTM F136) and performance standards (e.g., implied stress/strain limits for the 4-point bending test).
• Physical Test Results: Direct measurements of mechanical properties (bending strength) and packaging integrity.
• Previous Validation Data: Relying on sterilization and biocompatibility data from the primary predicate device (K141911).

8. The Sample Size for the Training Set

This is not applicable as this is a medical device (plates and screws) and does not involve AI or machine learning models that require a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reasons as above.

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