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G-MOPS™ is indicated for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.

G-MOPS™ PLUS is indicated for handling/manipulating oocytes and embryos in ambient atmosphere.

The IVF Media GIII Series have 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 these media. These improved media are called IVF Media G5 Series.

G-MOPSTM is used for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere.

G-MOPSTM PLUS is used for handling/manipulating oocytes and embryos in ambient atmosphere.

The provided document is a 510(k) premarket notification summary for an IVF media device (G-MOPS™/G-MOPS™ PLUS). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and studies for a novel device. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and comparative effectiveness studies is not present in this document.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided document. The 510(k) submission generally asserts substantial equivalence based on technological characteristics and intended use, rather than presenting a detailed table of performance metrics against predefined acceptance criteria for a new device.

2. Sample size used for the test set and the data provenance

This information is not available in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device (G-MOPS™ GIII Series, K021893) and does not describe a new clinical or performance test set with a specific sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available in the provided document. As there's no described test set requiring expert ground truth, this detail is absent.

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

This information is not available in the provided document.

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 available in the provided document. The device is IVF media, not an AI-assisted diagnostic tool that would involve human readers.

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

This information is not applicable and not available in the provided document. The device is IVF media, not an algorithm.

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

This information is not available in the provided document. This type of detail would relate to performance studies, which are not explicitly detailed in this 510(k) summary. The "ground truth" for a device attempting to demonstrate substantial equivalence would generally refer to the performance of the predicate device, or in vitro/in vivo studies designed to show similar biological outcomes, but specific methods are not described here.

8. The sample size for the training set

This information is not available in the provided document. This device is not an AI algorithm requiring a training set.

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

This information is not applicable and not available in the provided document.

Summary of what the document does provide:

• Device Name: G-MOPSTM / G-MOPSTM PLUS
• Intended Use: G-MOPSTM is for oocyte collection and for handling/manipulating oocytes and embryos in ambient atmosphere. G-MOPS™ PLUS is for handling/manipulating oocytes and embryos in ambient atmosphere.
• Predicate Device: G-MOPSTM (K021893)
• Technological Characteristics Comparison: The document states, "The technological characteristics of G-MOPSTM/G-MOPSTM PLUS are essentially similar to those of the predicate device. None of the differences between the predicate device and G-MOPS™ / G-MOPS™ PLUS do raise any new questions of safety or effectiveness." This is the core argument for substantial equivalence in a 510(k) submission.

In conclusion, the document provided is a premarket notification for demonstrating substantial equivalence for an IVF media. It does not contain the detailed performance study information typically associated with establishing acceptance criteria for a novel device or an AI algorithm.

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