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The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulations outside the incubator.

NidOil™ is a light, highly purified, paraffin oil product to be used as an overlay for gamete and embryo culture in the incubator, and for manipulations outside the incubator. Shelf life of two years from production date in unopened bottle Spec. density of 0.82 - 0.87 glcm; Dynamic viscosity (20 ℃) 25.0 - 80.0 mPas Cinematic viscosity (40 ℃)

This document describes a 510(k) submission for a medical device called NidOil™. It's a reproductive media product. Crucially, this document is a 510(k) summary, not a detailed study report. Therefore, much of the information you've requested regarding specific study details, sample sizes, expert qualifications, and detailed performance metrics is not present in the provided text.

The primary method for demonstrating safety and effectiveness in a 510(k) submission is to show substantial equivalence to a predicate device, not necessarily to perform extensive de novo clinical trials with detailed performance acceptance criteria as might be expected for novel AI/diagnostic devices.

Here's an analysis based on the provided text, highlighting what is and isn't available:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in a typical quantitative sense (e.g., sensitivity, specificity thresholds) is not explicitly detailed in the provided K012123 document. The acceptance criteria for a 510(k) submission like this, seeking substantial equivalence, generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Table of Acceptance Criteria and Reported Device Performance

• Shelf life: two years from production date in unopened bottle
• Spec. density: 0.82 - 0.87 g/cm³
• Dynamic viscosity (20 ℃): 25.0 - 80.0 mPas
• Cinematic viscosity (40 ℃):

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