(182 days)
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
| Specification | Acceptance Criteria (Subject Devices) | Reported Device Performance (Subject Devices) |
|---|---|---|
| Specific gravity (per USP ) | N/A (Washing Medium), Lower layer 80%: 1.10±0.03 g/mL, Upper layer 40%: 1.05±0.03 g/mL (Gradient Medium) | Lower layer 80%: 1.10±0.03 g/mL, Upper layer 40%: 1.05±0.03 g/mL (VitaVitro® Sperm Gradient Medium) |
| pH (per USP ) | 7.2 - 7.6 (Washing Medium), 7.4 - 7.8 (Gradient Medium) | 7.2 - 7.6 (VitaVitro® Sperm Washing Medium), 7.4 - 7.8 (VitaVitro® Sperm Gradient Medium) |
| Osmolality (per USP ) | 270-300 mOsm/kg (Washing Medium), Lower layer 80%: 300-360 mOsm/kg, Upper layer 40%: 270-330 mOsm/kg (Gradient Medium) | 270-300 mOsm/kg (VitaVitro® Sperm Washing Medium), Lower layer 80%: 300-360 mOsm/kg, Upper layer 40%: 270-330 mOsm/kg (VitaVitro® Sperm Gradient Medium) |
| Endotoxin (per USP ) | ) | No microbial growth |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating (for Sperm Washing Medium) | Device formulation demonstrated to be non-cytotoxic, non-sensitizing, and non-irritating. |
| Shelf-life | 2 years | 2 years (met at time 0 and after accelerated aging) |
| Transportation Testing | Performance meets ASTM D4169-16 | Performed successfully |
| Sterile filtration/aseptic fill | Conforms to ISO 13408-1:2008 and ISO 13408-2:2018 | Performed successfully |
| Sperm Assessment (Gradient Medium) | Effectiveness in sperm separation (motility, morphology, viability, purity) | Assessed for effectiveness when used as intended. (Specific quantitative results not provided in this summary) |
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.
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.