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GM501 Wash with Phenol Red and Gentamicin is intended for in vitro procedures involving handling and micromanipulation of human oocytes and embryos outside of a CO2 incubator. Include oocyte and embryo washing (e.g. after oocyte aspiration, after hyaluronidase treatment to remove cumulus cells, before and after cryopreservation, and before embryo transfer) and micromanipulation procedures (e.g. assisted hatching). GM501 Wash with Phenol Red and Gentamicin is not intended for use in transferring embryos into the uterine cavity.

GM501 Wash with Phenol Red and Gentamicin is a ready-to-use solution providing supporting conditions for human oocytes and embryos during in vitro Assisted Reproduction Technology (ART) procedures taking place outside of a CO2 incubator, including washing and micromanipulation procedures. GM501 Wash is aseptically filled into sterilized bottles (20 and 50 ml) and has a six-month shelf-life when stored as recommended. This product can also be used for up to seven days after bottle opening.

GM501 Wash with Phenol Red and Gentamicin is identical to the predicate GM501 Wash with the exception of the addition of gentamicin sulfate (10 mg/liter) and phenol red (3 mg/liter).

Here's a breakdown of the acceptance criteria and study information based on the provided text, structured to address your specific points:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for the "test set" in terms of human subjects or embryos. The primary performance data presented is the 1-Cell MEA (Mouse Embryo Assay) which uses mouse embryos. The specific number of mouse embryos used in this assay is not provided.

The data provenance (country of origin, retrospective/prospective) is also not explicitly stated in the provided text.

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 document. The device is a reproductive media for in vitro procedures. Its performance is assessed through laboratory assays (like MEA) and chemical/physical property measurements, not through expert interpretation of images or clinical diagnoses.

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

This information is not applicable and not present in the document. The device's performance is determined by objective laboratory measurements (MEA, pH, osmolality, endotoxins, sterility) rather than subjective human interpretation.

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 document. The device is a reproductive media, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to this submission.

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 document. The device is a biological/chemical media, not an algorithm.

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

The "ground truth" for assessing the performance of GM501 Wash with Phenol Red and Gentamicin is based on:

• Laboratory Assay Results: Primarily the Mouse Embryo Assay (MEA), which assesses the ability of the media to support blastocyst development from 1-cell mouse embryos.
• Chemical/Physical Specifications: Adherence to defined ranges for pH, osmolality, and endotoxin levels.
• Sterility Testing: Confirmation of absence of microbial contamination.
• Stability Testing: Demonstrating that the media maintains its specifications over its shelf-life and use-life.

8. The sample size for the training set

This information is not applicable and not present in the document. The device is a reproductive media, not an AI model that requires a training set.

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

This information is not applicable and not present in the document. The device is a reproductive media, not an AI model.

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GM501 SpermAir is intended for the handling and preparation of sperm for use in assisted reproduction procedures. GM501 SpermAir is not intended for use in intrauterine insemination procedures.

GM501 SpermActive is intended for the handling and preparation of sperm for use in assisted reprocedures. GM501 SpermActive is not intended for use in intrauterine insemination procedures.

GM501 SpermAir and GM501 SpermActive are ready-to-use solutions for handling and preparation of sperm cells during assisted reproduction procedures. Both devices are aseptically filled into sterilized bottles and sealed. GM501 SpermAir comes in three volumes: 2 ml, 20 ml, and 50 ml. GM501 SpermActive comes in two volumes: 20 ml and 50 ml. Both media have a six-month shelf-life when stored as recommended and can be used for up to seven days after opening.

Here's a breakdown of the acceptance criteria and study information for the GM501 SpermAir and GM501 SpermActive devices, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Additional Study Information:

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state the sample sizes for the individual performance tests (pH, osmolality, sterility, endotoxins, HSSA, shelf-life, stability after opening, aseptic filling, shipping).
   • The data provenance is not specified (e.g., country of origin, retrospective/prospective). These were non-clinical performance tests, usually conducted in a controlled laboratory environment.

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

   • This information is not provided as the tests are for objective analytical performance rather than subjective interpretation by experts. For example, pH is measured by a meter, not by expert consensus.

3. Adjudication method for the test set:

   • Not applicable, as the tests are objective analytical measurements against predefined criteria.

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:

   • No MRMC study was conducted. This device is a reproductive media for sperm handling, not an AI or imaging device involving human readers.

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

   • Not applicable. This device is a chemical medium, not an algorithm. The performance tests are measurements of its chemical and biological properties.

6. The type of ground truth used:

   • For most parameters (pH, osmolality, endotoxins, sterility), the ground truth is established by objective analytical measurements using validated laboratory methods and instruments, comparing them to established scientific or regulatory limits (e.g., USP standards).
   • For the Human Sperm Survival Assay (HSSA), the ground truth is based on biological outcomes (sperm motility compared to a control) measured quantitatively.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set. The performance studies are conducted to characterize the product's properties.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

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