(56 days)
Medium for In Vitro Fertilization Procedures
Medium for sperm preparation.
Bicarbonate buffered medium containing Hyaluronan. For use after the addition of G-MMTM or HSAsolution™ and pre-equilibration at +37°C and 6 % CO2.
The provided document is a 510(k) premarket notification summary for the G-SPERM™ Assisted Reproduction Media, submitted by Vitrolife Sweden AB. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the typical format of a device performance study as might be expected for an imaging or diagnostic device.
The main purpose of a 510(k) summary like this is to establish that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics as the predicate, or, if there are differences, those differences do not raise new questions of safety or effectiveness.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not applicable to this type of regulatory submission and are not found in the provided text.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided 510(k) summary. The document states that "The technological characteristics of G-SPERMTM are essentially similar to those of the predicate device. The G-SPERM 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-SPERM device. None of these differences raise new questions of safety or effectiveness." This statement implies that the performance is considered acceptable because it's equivalent to the predicate, but no specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the provided 510(k) summary. The document does not describe a clinical study or a test set as part of its substantial equivalence claim.
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):
This information is not applicable and not present in the provided 510(k) summary. "Ground truth" in the context of device performance studies (especially for AI or diagnostic tools) is not relevant for this type of submission which relies on demonstrating equivalence to a predicate device for an assisted reproduction medium.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not present in the provided 510(k) summary as there is no described test set or study requiring adjudication.
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:
This information is not applicable and not present in the provided 510(k) summary. This type of study is relevant for diagnostic devices (especially those utilizing AI to assist human readers), which is not the nature of the G-SPERM™ Assisted Reproduction Media.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not present in the provided 510(k) summary. The G-SPERM™ is a culture medium, not an algorithm or a device that functions in a "standalone" algorithmic capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable and not present in the provided 510(k) summary. As explained in point 3, the concept of "ground truth" for this type of product and submission is not relevant.
8. The sample size for the training set:
This information is not applicable and not present in the provided 510(k) summary. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
This information is not applicable and not present in the provided 510(k) summary.
In summary, the provided document is a regulatory submission for premarket notification (510(k)) that focuses on demonstrating "substantial equivalence" to a predicate device. It does not contain the detailed performance study information with acceptance criteria, sample sizes, and ground truth establishment that would be present for a novel device or an AI-enabled diagnostic tool.
§ 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.