(56 days)
Medium for In Vitro Fertilization Procedures
Bicarbonate buffered medium containing Hyaluronan. For use after the addition of G-MM™ or HSA-solution™ and pre-equilibration at +37°C and 6 % CO2
The provided text is a Premarket Notification Summary (510(k)) for the G-FERT™ Assisted Reproduction Media. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study with acceptance criteria in the manner typically seen for new diagnostic algorithms or devices requiring robust performance validation against specific metrics.
Therefore, the information requested regarding acceptance criteria, study design elements (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies), and training set details are not present in this type of regulatory submission. The 510(k) process primarily relies on showing that the new device is as safe and effective as a legally marketed predicate device.
However, based on the provided text, I can infer the "acceptance criteria" were related to establishing substantial equivalence, and the "study" was a comparison to a predicate device.
Here's a breakdown of what can be extracted and what information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (Inferred from 510(k) process) |
|---|---|
| Substantially equivalent to predicate device (IVF™) in technological characteristics. | "The technological characteristics of G-FERT™ are essentially similar to those of the predicate device." |
| No new questions of safety or effectiveness raised by differences from predicate. | "None of these differences raise new questions of safety or effectiveness." |
| Intended Use is consistent with predicate. | "Medium for In Vitro Fertilization Procedures" (Consistent with general use of reproductive media). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The 510(k) summary does not describe a formal "test set" or clinical study with sample sizes. Substantial equivalence is often demonstrated through comparisons of materials, manufacturing, and existing scientific literature/data for the predicate, not necessarily new clinical trials for a Class II device like this.
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/Not Available. There is no mention of experts establishing ground truth for a test set in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Available. No test set or adjudication method is mentioned.
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
- No. This device is an assisted reproduction medium, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Available. The concept of "ground truth" as used in diagnostic performance studies doesn't directly apply to the establishment of substantial equivalence for an IVF medium. The "truth" in this context is the established safety and effectiveness of the existing predicate device.
8. The sample size for the training set
- Not Applicable/Not Available. There is no "training set" as this is not a machine learning device.
9. How the ground truth for the training set was established
- Not Applicable/Not Available. As above, no training set for ground truth establishment.
Summary of the "Study" (as presented in the 510(k)):
The "study" to prove the device meets acceptance criteria (i.e., substantial equivalence) was a comparison of the G-FERT™ with its predicate device, IVF™. The submission states: "The technological characteristics of G-FERT™ are essentially similar to those of the predicate device. The G-FERT is a modification of the predicate device and is intended to be supplemented with albumin prior to use. Other formulation changes were made to improve the performance of the G-FERT device. None of these differences raise new questions of safety or effectiveness."
This means the "study" involved a detailed technical comparison of the formulation and intended use, asserting that any changes from the predicate device do not introduce new safety concerns or alter its fundamental effectiveness, thus demonstrating substantial equivalence. The FDA concurred with this assessment in their letter.
§ 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.