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Gems Oocyte Retrieval Buffer is used in the removal of oocytes from ovarian follicles.

The Gems Oocyte Retrieval Buffer is an assisted reproduction medium used for removal of oocytes from ovarian follicles. It consists of salts, energy substrates, amino acids buffering agents, stabilizers and antibiotics. This device has direct contact with the patients and oocytes.

This product is a single-use device that is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10-3. It is tested for pH, osmolality, embryotoxicity, endotoxin and sterility before lot release and has a shelf-life of 30 weeks.

The provided text does not contain information about an AI device or a study comparing AI with human readers. It describes a submission for a medical device called "Genea Biomedx Gems Oocyte Retrieval Buffer ORB-20, ORB-50," which is a reproductive medium used for oocyte retrieval.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies related to an AI device or human-in-the-loop performance. The document focuses on demonstrating the substantial equivalence of the Oocyte Retrieval Buffer to a legally marketed predicate device through non-clinical performance testing.

However, I can extract the acceptance criteria and a summary of the non-clinical performance testing for the described Genea Biomedx Gems Oocyte Retrieval Buffer device.

Acceptance Criteria and Reported Device Performance (Table for the Oocyte Retrieval Buffer)

Study Details (for the Oocyte Retrieval Buffer):

The document describes non-clinical performance testing to support the substantial equivalence of the "Genea Biomedx Gems Oocyte Retrieval Buffer ORB-20, ORB-50" to a predicate device. This is not a study involving AI or human readers.

1. Sample size used for the test set and the data provenance: The document does not specify a "test set" in the context of an AI algorithm. For the MEA (Mouse Embryo Assay), "one-cell mouse embryos" were used. The exact number of embryos or experimental replicates is not provided in this summary. The data provenance (country of origin, retrospective/prospective) for these non-clinical tests is not detailed, though Genea Biomedx Pty Ltd is based in Australia.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI study requiring expert ground truth for image interpretation or similar tasks.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. 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. No AI component is described.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI algorithm is described.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance tests listed, the "ground truth" or reference was based on established scientific and regulatory standards/methods (e.g., USP <71> for sterility, USP <85> for endotoxin, ISO standards for biocompatibility, and a pre-defined blastocyst development rate for MEA).

7. The sample size for the training set: Not applicable. This document pertains to a medical product, not an AI model requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

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