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V-HEPES PLUS is intended for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity.

V-HEPES PLUS is a medium for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity. The medium is aseptically filtered and provided in a volume of 100 mL in pre-sterilized PETG bottles. V-HEPES PLUS has a shelf-life of 12 months when stored at 2-8°C and can be used for up to seven days after bottle opening.

Here's a breakdown of the acceptance criteria and study information for the V-HEPES PLUS device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Differences: The table highlights some differences in specifications between the subject device (V-HEPES PLUS) and the predicate device (LifeGlobal Global Total W/HEPES W/HSA). The FDA document explicitly states that these differences (e.g., pH range, endotoxin level, MEA exposure time) do not raise different questions of safety and effectiveness.

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

The document does not provide details on specific "test set" sample sizes in the context of human data. The performance testing relies on:

• Animal Testing (MEA): Mouse embryos are used. The specific number of embryos or experimental replicates is not given but implied to be sufficient for statistical significance in the "≥80% blastocyst development" criterion.
• Laboratory Testing: For sterility, pH, osmolality, endotoxin, and appearance, the "sample size" would refer to the number of batches or samples of the medium tested. This information is not explicitly provided.
• Biocompatibility Testing: The number of biological samples or replicates used for cytotoxicity, sensitization, and vaginal irritation tests are not specified.

Data Provenance: The studies are non-clinical (laboratory and animal-based). No human data or specific country of origin is mentioned for the data used in these performance tests. The studies are prospective in nature, designed specifically to test the performance of the V-HEPES PLUS device against its predefined specifications.

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

This question is not applicable to the provided document. The "ground truth" for the performance tests (sterility, pH, osmolality, MEA, endotoxin, appearance) is established by objective, quantifiable laboratory measurements and standardized protocols (e.g., USP, ISO, FDA guidance documents). These tests do not rely on expert interpretation in the way that, for example, image analysis by radiologists would.

4. Adjudication Method for the Test Set

This question is not applicable as there is no mention of expert review or adjudication in establishing the results of these non-clinical performance tests. The results are quantitative and objective.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. There is no mention of any MRMC comparative effectiveness study in this document. This device is a reproductive medium, not an AI or imaging diagnostic device that would typically involve human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This question is not applicable. The device is a biological medium, not an algorithm or software.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is based on objective laboratory measurements and validated biological assays:

• Sterility: Defined by "no growth" in culture, per USP <71>.
• pH, Osmolality, Endotoxin: Quantitative measurements against specified ranges/limits, per established laboratory methods (e.g., USP <85> for Endotoxin).
• Mouse Embryo Assay (MEA): Defined by the percentage of embryos reaching the expanded blastocyst stage within a specified timeframe, according to FDA guidance.
• Appearance: Visual inspection against an objective description ("Pink rose color, no precipitates").
• Biocompatibility: Results of standardized in vitro (cytotoxicity) and in vivo (sensitization, irritation) tests as per ISO 10993 standards.

8. The Sample Size for the Training Set

This question is not applicable. The V-HEPES PLUS is a biological medium, not an AI model or algorithm that requires a "training set."

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

This question is not applicable, as there is no training set for this device.

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