(247 days)
V-PVP is intended for use as an aid in the immobilization of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.
V-PVP is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracvtoplasmic sperm iniection (ICSI) procedures.
V-PVP is a clear solution with a formulation consisting of polyvinylpyrrolidone, human serum albumin, physiological salts, HEPES Human Tubal Fluid (HTF), pyruvate, lactate, qlucose, and gentamicin. This product is aseptically filtered into 2 mL bottles with caps made from polypropylene copolymer and is provided in a volume of 0.5 mL. V-PVP has a one-year shelf-life when stored as recommended and can be used for up to seven days after opening.
The provided text describes the acceptance criteria and performance testing for a medical device called V-PVP, specifically for its premarket notification (K232125).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists several specifications for V-PVP and indicates that shelf-life testing demonstrated the product met these specifications at time 0 and after accelerated aging. While specific numerical results for each test (e.g., exact pH measured) are not provided, the "acceptance criteria" themselves are listed as the "product specifications."
| Acceptance Criteria (Product Specifications) | Reported Device Performance (as demonstrated by Shelf-life testing) |
|---|---|
| Clarity/Color: Pink rose color, no precipitates | Met specification |
| pH, per USP: 7.25-7.45 | Met specification |
| Osmolality, per USP: 300-330 mOsm/kg | Met specification |
| Endotoxin, per USP : : No growth | Met specification |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the performance tests conducted (e.g., number of replicates for pH, Osmolality, Endotoxin, MEA, HSSA, Sterility tests).
The data provenance is not specified in terms of country of origin, nor is it explicitly stated whether the studies were retrospective or prospective. However, based on the context of premarket notification for a new device, these would typically be prospective studies performed by the manufacturer to demonstrate compliance.
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 tests described are primarily laboratory-based (chemical, physical, biological assays), not reliant on expert interpretation of complex clinical data.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The performance tests are objective laboratory assays with well-defined measurement methods and acceptance ranges, not requiring human adjudication of ambiguous results.
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. V-PVP is a reproductive media/supplement, not an AI-powered diagnostic device that would involve human readers or MRMC studies. The "Comparative assessment of sperm immobilization of the subject device (7% PVP) to a 10% PVP comparator device" mentioned is a direct comparison of the substance's efficacy, not a human-AI interaction study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. V-PVP is a chemical solution, not an algorithm or software. Its performance is evaluated through laboratory assays, not by an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests is established by objective laboratory measurements and universally accepted biological and chemical standards.
- pH, Osmolality, Endotoxin: Measurements against recognized USP standards.
- MEA (Mouse Embryo Assay): A standard biological assay to assess toxicity or suitability for embryo development, with a specified percentage of embryo development as the "ground truth."
- HSSA (Human Sperm Survival Assay): A standard biological assay to assess the compatibility and non-toxicity to human sperm, with a specified percentage of control motility as the "ground truth."
- Sterility: Absence of microbial growth, a standard microbiological "ground truth."
- Clarity/Color: Visual inspection against an expected appearance.
8. The Sample Size for the Training Set
This information is not applicable. V-PVP is a formulated chemical product, 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 as there is no training set for this type of device.
§ 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.