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Vita Vitro® Sperm Washing Medium is intended for preparation and washing of sperm for use in assisted reproduction procedures. Vita Vitro® Sperm Washing Medium is also intended for use in intrauterine insemination procedures.

VitaVitro® Sperm Gradient Medium is intended for separation of motile sperm from seminal fluid for use in assisted reproduction procedures.

VitaVitro® Sperm Washing Medium and VitaVitro® Sperm Gradient Medium are ready-to-use solutions intended for preparing sperm for use in assisted reproductive procedures:

• VitaVitro® Sperm Washing Medium is for sperm washing and for intrauterine insemination procedures.
• VitaVitro® Sperm Gradient Medium is for sperm density-gradient centrifugation and separation from seminal fluid.

Both devices have a similar base formulation; however, the VitaVitro® Sperm Gradient Medium formulation differs as it contains silane silica and does not contain Human Serum Albumin (HSA). The silane silica in the VitaVitro® Sperm Gradient Medium (upper layer 80%) generates the density gradient for sperm separation procedures.

The subject devices are aseptically filtered, colorless solutions, contained in transparent and sterilized (gamma irradiation) polyethylene terephthalate glycol (PETG) bottles, sealed with high density polyethylene (HDPE) closures, provided in cardboard boxes, individually labeled and with an instruction for use provided as a package insert.

The devices are provided in the following volumes:

• VitaVitro® Sperm Washing Medium: 30mL, 60mL, and 125mL
• VitaVitro® Sperm Gradient Medium: 12mL, 30mL, and 125mL

Both devices have a two-year shelf-life when stored as recommended. These devices are for single-used only.

The provided text describes two medical devices, VitaVitro® Sperm Washing Medium and VitaVitro® Sperm Gradient Medium, and their substantial equivalence to predicate devices. However, the document does not contain information about a study that assesses a device's performance against detailed acceptance criteria in the context of AI/ML or image analysis, which the requested output format implies. The acceptance criteria described are for the physicochemical properties and biological performance of the media themselves, not for an AI device.

Therefore, many of the requested fields cannot be populated as they are not relevant to the provided text. I will fill in the relevant information based on the provided document.

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

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" in the context of AI/ML or image analysis. Performance testing was conducted on samples of the media devices themselves. The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned for these tests.

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

Not applicable. The ground truth for the performance of these media is established by standardized laboratory tests (e.g., USP monographs, ISO standards, ASTM standards) rather than expert consensus on complex diagnostic interpretations.

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

Not applicable. This concept is typically relevant for studies involving human interpretation and is not mentioned for the chemical, physical, and biological testing of these media.

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 not an AI/ML device, nor does the document describe any MRMC studies involving human readers or AI assistance.

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

Not applicable. This is not an AI/ML device.

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

The ground truth for the media's performance is established through:

• Standardized analytical measurements (e.g., pH, osmolality, specific gravity, endotoxin levels).
• Standardized microbiological testing (sterility).
• Standardized biological assays (Human Sperm Survival Assay, biocompatibility tests).
• Functional assessment of sperm separation effectiveness.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable.

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VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization.

VitaVitro® Gamete Buffer Medium is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI).

VitaVitro® Flushing Buffer Medium is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures.

This submission includes three media products:

• . VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization. Media provided in volumes of 30 ml and 60 ml.
• . VitaVitro® Gamete Buffer Medium intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI). Media provided in a single volume of 60 ml.
• . VitaVitro® Flushing Buffer Medium intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection. Media provided in volumes of 60 ml and 125 ml.

All devices are aseptically filled into radiation-sterilized PETG bottles, are single-use only, and have a shelf-life of six-months when stored as recommended at 2-8°C.

The device in question consists of three media products: VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, and VitaVitro® Flushing Buffer Medium. The provided document is a 510(k) Summary, which is a premarket notification to demonstrate that the device is substantially equivalent to legally marketed predicate devices. This type of submission focuses on comparing the new device against existing ones rather than providing a standalone clinical study for efficacy against a disease endpoint. Therefore, the information regarding acceptance criteria and studies is framed within the context of demonstrating substantial equivalence.

Here's the breakdown of the acceptance criteria and the studies performed to meet them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not provide specific sample sizes for each test conducted. It states that "The testing... apply to each of the subject media products," indicating that tests were performed on samples of each of the three media.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, as it's part of a 510(k) submission, the testing would have been conducted by or for the manufacturer (Shenzhen VitaVitro Biotech Co., Ltd., China) as part of their premarket activities. These were non-clinical performance studies.

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

This type of information is not applicable to the non-clinical performance studies described. The "ground truth" for these tests refers to the established scientific and regulatory standards (e.g., USP monographs, ISO standards, ASTM standards, FDA guidance documents) for chemical, biological, and physical properties of the media. The "experts" would be the scientists and technicians conducting the validated assays and interpreting results against predefined quantitative specifications.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, quantitative laboratory assays with predefined acceptance criteria. There is no subjective interpretation or need for expert adjudication in the way typically seen in image or clinical diagnostic studies.

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

No. An MRMC comparative effectiveness study is not relevant for this type of medical device (reproductive media). These studies are typically used to assess the diagnostic performance of software or imaging devices where human readers interpret results.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in a sense. The studies described are standalone performance evaluations of the physical and biological characteristics of the media products themselves. There is no "human-in-the-loop" component to the performance of these media, as they are chemical formulations used in assisted reproduction, not diagnostic tools interpreted by humans in real-time. The in-vitro performance (e.g., MEA) demonstrates the intrinsic function of the media in supporting embryo development.

7. Type of Ground Truth Used

The ground truth for these non-clinical studies is based on:

• Established scientific and regulatory specifications: pH, Osmolality, Endotoxin limits are set by pharmacological and regulatory standards.
• Biological performance standards: MEA (Mouse Embryo Assay) is a standard biological assay used to assess the suitability of media for supporting embryo development. The "ground truth" here is the observed blastocyst development rate in comparison to established benchmarks (≥80%).
• Sterility and Biocompatibility Standards: Ground truth is defined by the absence of microbial growth and the lack of adverse biological reactions (cytotoxicity, sensitization, irritation) as determined by validated test methods (e.g., USP <71>, ISO 10993 series).

8. Sample Size for the Training Set

Not applicable. These are finished medical products (media formulations), not algorithms or AI models that require a training set.

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

Not applicable, as there is no training set for these media products.

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