(137 days)
G-IVFTM/G-IVFTM PLUS is intended for preparation and handling of gametes and for in vitro fertilization
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.
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.
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.