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ARTSMedia Oocyte Aspiration Medium (AM-Oocyte Aspiration) is intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes.

ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration) is intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes.

ARTSMedia Oocyte Aspiration Medium consists of physiological salts, energy substrates, buffering agents, Human Serum Albumin, Gentamicin Sulphate, and water.

Furthermore, ARTSMedia Oocyte Aspiration Medium is aseptically filtered and provided in a volume of 20 mL, 50 mL, and 100 mL in pre-sterilized glass bottles closed with Fluorotec-coated stoppers and aluminum caps. The ARTSMedia Oocyte Aspiration Medium is tested for pH, osmolality, embryotoxicity, endotoxin, and sterility, before lot release. The device has a shelf-life of 18 months when stored at 2-8°C and is for single-use only.

This document is a 510(k) Premarket Notification from the FDA for a medical device called ARTSMedia Oocyte Aspiration Medium. It primarily focuses on demonstrating the substantial equivalence of this new device to a legally marketed predicate device (K991327 Medi-Cult Flushing Medium).

The information provided does not include details about a study proving that a device (algorithm/AI) meets certain acceptance criteria. Instead, it describes non-clinical performance testing for a medical medium (a solution). Therefore, the requested information regarding AI/algorithm performance, such as sample sizes for test sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance, cannot be extracted from this document.

The document discusses the physical and chemical properties of the medium and its biological effects on mouse embryos as part of its performance testing.

Here's a breakdown of the acceptance criteria and performance for the medical medium, as much as can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance (for the medical medium)

The document states these specifications were met at Time 0 and Time 18 months for shelf-life testing.

Information Not Applicable or Not Provided in the Document:

The following points are either not applicable to a medical medium or the required details are not present in this 510(k) summary, which focuses on substantial equivalence rather than a full clinical trial for an AI/algorithm.

2. Sample size used for the test set and the data provenance: This refers to testing of a medical medium, not an AI/algorithm on a "test set" of patient data. The document mentions "testing" (e.g., biocompatibility on samples, shelf-life testing of the product itself) but does not delineate a "test set" in the context of diagnostic performance on patient data. No data provenance (country, retrospective/prospective) is relevant or provided for this type of device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic algorithm is not relevant to testing a chemical medium.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 for AI/diagnostic algorithms.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the chemical and biological performance of the medium against established scientific/regulatory standards (e.g., USP monographs, ISO standards, specific MEA criteria).
8. The sample size for the training set: Not applicable. This is a medical medium, not a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the non-clinical performance testing for a medical medium (ARTSMedia Oocyte Aspiration Medium) to demonstrate its substantial equivalence to a predicate device, focusing on its physical, chemical, and certain biological properties. It does not describe a study for an AI/algorithm-based device.

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