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The Optimus Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.

The Neuro Plating 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 comes in 3 anodized colors (silver, blue and gold). The screws range in diameter from 0.8mm to 1.95mm and in lengths of 3.0mm to 6.0mm. They are made of Ti- 6Al-4V ELI titanium alloy (ASTM F136) and come in 3 anodized colors (silver, green and gold).

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

The Neuro Plating System has two types of sterilization methods: 1.) the Neuro Plating System is non-sterile state packed in a PE bag which must be sterilized before use; and 2.) the Neuro Plating System - Sterile Kit is provided sterile using gamma sterilization packed in Tyvek and PET. Both are single use only.

The provided text describes the regulatory clearance of a medical device, the Optimus Neuro Plating System, and details its substantial equivalence to predicate devices. It does not present a study proving the device meets specific acceptance criteria in terms of AI or algorithm performance.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to regulatory acceptance for market clearance based on substantial equivalence to existing devices, rather than performance metrics for an AI-powered system or diagnostic accuracy study.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of submission.

Here's how the provided information relates to your request:

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

The document doesn't present "acceptance criteria" in the sense of performance metrics for an AI system. Instead, it presents a comparison table demonstrating the "substantial equivalence" of the modified device to its predicate devices across various attributes. The "performance" here refers to the device proving it is as safe and effective as the predicate, not a quantifiable clinical outcome or AI accuracy.

Table: Comparison of Modified Device to Predicate Devices for Substantial Equivalence

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

• Test Set Description: The "test set" in this context refers to the samples of the physical device that underwent non-clinical laboratory testing (e.g., mechanical strength, sterilization validation).
• Sample Size: The document does not specify the exact number of units used for each test (e.g., how many plates/screws for the 4-point bending test). It only states that "The following tests were performed on the modified devices."
• Data Provenance: The tests were performed by Osteonic Co., Ltd. (the manufacturer) in South Korea. The data would be internally generated "non-clinical tests." The provenance typically refers to the source of the clinical data (e.g., patient records), which is not relevant here as this is a device clearance based on engineering and material testing. The tests are prospective as they were conducted for this submission.

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 submission is for a physical medical implant, not an AI or diagnostic imaging device that requires interpretation by medical experts to establish ground truth for performance evaluation. The "ground truth" for the device's characteristics (e.g., material strength, sterility) is established by standardized engineering tests and established quality control methods, not expert consensus on medical images.

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

• Not applicable. This refers to a method used to resolve discrepancies in expert interpretations (e.g., for image annotations or diagnoses), which is not relevant to the non-clinical engineering and material tests performed for this device.

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 a type of study performed for diagnostic AI tools to evaluate their impact on human interpretation. This submission is for a physical neuro plating system.

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

• Not applicable. This describes the performance evaluation of an AI algorithm in isolation. The Optimus Neuro Plating System is a physical implant, not an algorithm.

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

• For the physical device, the "ground truth" for demonstrating substantial equivalence is based on:
  • Engineering specifications and standards: ASTM F67, ASTM F136, ISO 10993.
  • Validated test methods: 4 Point Bending Test, Torsion Test, Axial Pullout Strength Test, Packaging Process Validation Test, Gamma Sterilization Validation, Shelf life, MR safety tests.
  • Comparison to predicate device performance data in these established physical and biological safety metrics.

8. The sample size for the training set:

• Not applicable. This is relevant for AI/ML models. This document describes a physical medical device.

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

• Not applicable. Relevant for AI/ML models.

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