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Multipurpose Handling Medium™ (MHM™) is intended for use in assisted reproductive procedures which involve the manipulation of gametes or embryos. Specifically, Multipurpose Handling Medium™) is indicated for use as an oocyte retrieval medium during ovarian follicle aspiration procedures (not for flushing ovarian follicles), washing sperm prior to IVF and ICSI fertilization procedures, and for transport of the embryo to the uterus during embryo transfer procedures.

The Multipurpose Handling Medium™ (MHM™) is based upon the mHTF (K983586) formulation. The formula for the Multipurpose Handling Medium™ (MHM™) is based upon the composition of modified HTF, K983586. The medium uses a buffering system composed of HEPES (N-2-Hydroxyethylpiperazine-N1 - - 2 - - ethanesulfonic acid). MOPS . (3 Morpholinopropane - 1- sulfonic acid) and Sodium Bicarbonate. This buffering system provides pH maintenance over the physiologic range and does not require the use of a CO2 Incubator. - The product also contains 10 ug/mL gentamicin.

Multipurpose Handling Medium™ (MHM™) has utility as an oocyte retrieval medium, in procedures that aspirate oocytes from the patient's ovarian follicles. Multipurpose Handling Medium™ (MHM™) is used only in the oocyte collection vessel and is not for use in flushing oocytes from ovarian follicles. Once the oocyte has been retrieved, it is placed into a culture dish with an appropriate amount of a culture medium (does not include MHM™), as specified by the user's internal procedures, and fertilization is allowed to occur. Multipurpose Handling Medium™ (MHM™) can also be used to wash sperm in preparation for fertilization by conventional IVF or ICSI procedures. The fertilized oocyte (zygote) is allowed to grow in the culture dish, supported by a culture medium (does not include MHM™), as specified by the user's internal procedures, and an appropriate protein supplement, in a carbon dioxide incubator at 37°C until the desired stage of development is achieved. The embryo is removed from the culture dish, placed into an appropriate amount of Multipurpose Handling Medium™ (MHM™) for transfer into the uterus.

Multipurpose Handling Medium™ (MHM™) is supplied as a ready to use liquid, in 100 and 500 mL bottles.

Here's a breakdown of the acceptance criteria and the study details for the Multipurpose Handling Medium™ (MHM™) device, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample Sizes and Data Provenance

• Test Set (MEAs): The MEA testing was performed at three (3) different test facilities. The document does not specify the number of individual embryos or mouse embryos used per test, nor the country of origin of the data. The data is retrospective as it was performed as part of design validation prior to release.
• Test Set (HSSA): The HSSA was performed on donor specimens. The number of donor specimens is not specified. The data is retrospective as it was performed prior to release. The document does not specify the country of origin.
• Training Set: The sample size for the training set is not explicitly stated. This is likely because the MHM™ is a medium and its "training" or formulation development would involve biochemical and cell culture experiments rather than machine learning on a dataset in the traditional sense. The formulation is based on existing, predicate devices (mHTF and G-MOPS™/G-MOPS™ PLUS).

2. Number of Experts and Qualifications for Ground Truth (Test Set)

• The document does not explicitly state the number of experts used to establish the ground truth for the test set or their qualifications. For MEAs and HSSAs, the "ground truth" is typically the quantitative results of the assay (e.g., percentage of embryos reaching a certain stage, percentage of motile sperm), which are objectively measured by laboratory personnel, rather than through expert consensus on qualitative observations.

3. Adjudication Method for the Test Set

• The document does not mention an adjudication method. For quantitative assays like MEAs and HSSAs, adjudication is generally not applicable in the same way it would be for qualitative assessments (e.g., image interpretation). The results are based on objective measurement.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not conducted. This type of study is typically relevant for medical devices that involve human interpretation (e.g., diagnostic imaging AI). The MHM™ is a cell culture medium, and its performance is evaluated through biological assays.

5. Standalone Performance (Algorithm Only)

• Yes, standalone performance was done in the sense that the medium itself (the "device") was tested directly in the described assays (MEA, HSSA) without human intervention in the assay's outcome interpretation beyond standard laboratory procedures. There is no "algorithm" in the traditional sense for this device; its performance is intrinsic to its chemical composition and how it supports biological processes.

6. Type of Ground Truth Used

• Mouse Embryo Assay (MEA): The ground truth is established by the biological outcome of the assay, specifically the percentage of one-cell mouse embryos that develop to a specific stage (not explicitly stated, but typically blastocyst stage, or viability at 24/48/72 hours) after exposure to the medium. This is a direct measure of embryo toxicity/support.
• Human Sperm Survival Assay (HSSA): The ground truth is the percentage of motile human sperm after 24 hours at 37°C in ambient air, following exposure to the medium. This directly assesses sperm viability and function.

7. Sample Size for the Training Set

• As noted above, the sample size for a "training set" in the context of this biological medium is not applicable or explicitly stated in the document. The formulation was based upon existing predicate devices (mHTF and G-MOPS™/G-MOPS™ PLUS), implying an iterative development process informed by previous research and established formulations.

8. How Ground Truth for the Training Set Was Established

• The ground truth for the development of the MHM™ (the "training" equivalent) would have been established through pre-clinical research and development experiments focused on optimizing the medium's composition to support gamete and embryo viability and function. This includes:
  • Literature review and knowledge of existing formulations: The MHM™ is "based upon" the mHTF formulation, which itself has established efficacy.
  • Benchtop biochemical analysis: Measuring pH, osmolality, and sterility, and ensuring non-toxic component levels.
  • Pilot biological assays: Performing MEAs, HSSAs, and potentially other cell culture tests on various prototype formulations to identify those that yield optimal biological outcomes.
  • The document specifically mentions that MHM™ is assayed by MEA and HSSA prior to release, which serves as a final validation step to ensure consistency, not necessarily the ground truth establishment for training the initial formulation.

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Embryo Freeze Media Kit is intended for use in the assisted reproductive procedure, of embryo cryopreservation. The two media kit is designed to protect human cleavage-stage embryos during rapid freezing procedures and during frozen storage.

Embryo Thaw Media Kit is intended for use in the assisted reproductive procedure of thawing frozen cleavage-stage embryos. The three media kit is designed to protect human cleavage-stage embryos during warming and thawing after cryopreservation.

The five media that comprise the two kits, Embryo Freeze Media Kit and Embryo Thaw Media Kit are all based upon the formulation of modified human tubal fluid (K983586). The two media in the Embryo Freeze Media kit are intended to be used sequentially, for the preparation for, and cryopreservation of, human blastocysts. The first medium to be used, F1, which is used in preparation for freezing, contains 1.5M PROH. The second medium, F2, to be used during cryostorage, containing 1.5M PROH and 0.1M sucrose. Both F1 and F2 are also supplemented with human serum albumin (HSA).

The three media in the Embryo Thaw Media kit are also intended for sequential use in the thawing and recovery of cryopreserved human embryo. The first medium used in the thawing process, T1, contains 1.0M PROH and 0.2M sucrose. The second medium, T2 contains 0.5M PROH and 0.2M sucrose. T3 contains 0.2M sucrose. Each T1, T2 and T3 contain HSA. All five media contain gentamicin sulfate.

The media in the Embryo Freeze Media Kit, F1 and F2 are designed to be used sequentially for the preparation of embryos for cryopreservation, and as the protective media during cryostorage. The media in the Embryo Thaw Kit, T1, T2 and T3 are also designed for sequential use, in the thawing and recovery of cryopreserved human embryos. None of the media are intended to contact the patient.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Irvine Scientific Embryo Freeze Media Kit and Embryo Thaw Media Kit:

Given the nature of the product (embryo cryopreservation and thawing media) and the provided text, the "acceptance criteria" discussed are primarily related to general performance and suitability for the intended use, rather than specific numerical performance metrics typical of AI medical devices. The "study" refers to performance evaluations conducted by independent laboratories.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document explicitly states that the studies were performed using "mouse embryos". No specific number of mouse embryos is provided.
• Data Provenance: The studies were conducted by "five independent field laboratories." The country of origin is not specified, but the submission is to the US FDA, implying that some or all of these labs could be in the US. The studies were retrospective in the sense that they were conducted to support the 510(k) submission, but the specific nature of the data collection (e.g., from existing cryopreservation programs or newly designed experiments) is not detailed. Given they use mouse embryos, it's highly likely they were specifically designed experimental studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The studies were conducted by "five independent field laboratories," but it's not stated how many experts within these labs assessed the outcomes or their specific qualifications. The "ground truth" here would likely be the assessment of embryo viability, cryosurvival, and developmental potential post-thaw, as determined by standard laboratory protocols and expert observation.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the product, adjudication might involve comparing the performance of the test media to existing control media, potentially through observational assessment by lab personnel.

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

• No, an MRMC study was not done. This type of study (MRMC) and the concept of "human readers improving with AI assistance" are relevant for AI/radiology devices. This product is a cryopreservation media kit, not an AI diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, this is not applicable. This product is a biological medium, not an algorithm. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" was established by the performance of mouse embryos in terms of freezing, thawing, and recovery using the media kits. This would involve observable outcomes like:

• Survival rate post-thaw.
• Morphology and developmental progression (e.g., re-expansion, hatching potential) of the thawed embryos.
• Comparison of these metrics against a "control freeze/thaw media."

This can be considered laboratory-based observational and biological outcomes data, assessed by the staff of the independent laboratories.

8. The Sample Size for the Training Set

This information is not applicable/provided. The product is a chemical media kit, not an AI model. Therefore, there is no "training set" in the machine learning sense. The formulation would have been developed through R&D and optimization, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the reasons stated in point 8.

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