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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 ℃) < 33.5 mm 2/s MEA tested Sterilized by filtration during aseptic filling Packaged in amber borosilicate glass bottles with silicone stoppers and Tamper-proof seals Storage of unopened bottles at ambient temperature Opened bottles can also be stored at ambient temperature, if opened only under sterile conditions. NidOil™ is CE marked in countries of the European Union. It is supplied in 100 and 250 ml bottles.

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

Study Details (Based on available information):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not specified in this document. The document mentions "clinical trials and comparative testing" but does not provide any details on the sample size, type of study (e.g., retrospective vs. prospective), or data provenance. This level of detail is typically found in the full 510(k) submission, not the summary exhibit.

2. 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 / Not specified. This device is a reproductive media product, not an imaging diagnostic device that would require expert adjudication of "ground truth" in the way an AI diagnostic tool would. The "ground truth" for this device would likely be related to embryo development rates, fertilization rates, etc., which are observable biological outcomes, rather than expert interpretation.

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

   • Not applicable / Not specified. See point 2.

4. 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 diagnostic device; it is an oil overlay for embryo culture. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

   • Not applicable. This is a physical product (oil overlay), not an algorithm or AI.

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

   • For this type of device, the "ground truth" for its effectiveness would typically be outcomes data such as:
     • Fertilization rates in vitro.
     • Embryo cleavage rates and quality (morphology).
     • Development to blastocyst stage.
     • Possibly live birth rates, though this may not be required for 510(k) of an ancillary product like an oil overlay.
   • The document states "results of clinical trials and comparative testing," implying these biological outcomes were measured, but specific details are not provided.

7. The sample size for the training set

   • Not applicable / Not specified. This is not an AI/machine learning device that uses a "training set."

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

   • Not applicable. See point 7.

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