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The IVF Media G-FERTTM in the so called GIII Series has been on the market for a number of years and Vitrolife Sweden AB has now made some product changes in order to further improve the robustness of this media. This improved media is called G-IVFTM/G-IVFTM PLUS. G-IVFTM/G-IVFTM PLUS is used for preparation and handling of gametes and for in vitro fertilization. G-IVF™ PLUS contains HSA which has been added during the manufacturing, while HSA has to be added to G-IVF™ by the clinics before use.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (IVF Media), not an AI/ML SaMD. Therefore, many of the requested categories are not applicable. The provided text describes the device, its intended use, and its substantial equivalence to a predicate device, focusing on regulatory approval for manufacturing and marketing rather than a performance study with detailed acceptance criteria and ground truth in the context of an AI/ML model.

Here's the information that can be extracted or that is not applicable given the nature of the document:

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

Acceptance Criteria	Reported Device Performance
Not explicit in document. The document focuses on showing substantial equivalence to a predicate device, suggesting an implicit acceptance criterion of being "essentially similar" to the predicate device in terms of safety and effectiveness.	The device, G-IVF™/G-IVF™ PLUS, is a modification of G-FERT™ (K022245). The technological characteristics are "essentially similar" to the predicate device. "None of the differences between the predicate device and G-IVFTM /G-IVFTM PLUS do raise any new questions of safety or effectiveness."

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

Not applicable. This document describes a 510(k) premarket notification for an IVF media, not a device that involves statistical testing with a "test set" in the context of AI/ML performance. The review focuses on substantial equivalence based on product formulation and intended use.

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. There is no "ground truth" establishment in the context of AI/ML evaluation for this type of medical device submission. The assessment is based on comparison to an existing predicate device and regulatory requirements for manufacturing and product characteristics.

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

Not applicable. This concept does not apply to a 510(k) submission for IVF media.

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 not an AI/ML enabled device, so no MRMC study would be conducted.

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

Not applicable. This device is a culture media, not an algorithm.

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

Not applicable. The "truth" in this context is established through demonstrating that the modified IVF media (G-IVF™/G-IVF™ PLUS) performs its intended function (preparation and handling of gametes and in vitro fertilization) without raising new safety or effectiveness concerns compared to the legally marketed predicate device (G-FERT™ GIII Series). This is a regulatory assessment, not a data-driven ground truthing for an AI model.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" and associated ground truth for this type of device submission.

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