(269 days)
V-GRAD is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures.
V-GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes that is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures. Available as a 100 % stock solution (V-GRAD 100) and as 40% or 80% ready-to-use solutions (V-GRAD 40 and V-GRAD 80) with HEPES buffered Human Tubular Fluid (HTF) medium. V-GRAD 100 is a stock solution for preparing a density gradient system for semen preparation. The V-GRAD Kit consists of two bottles of V-GRAD 40 and V-GRAD 80. V-GRAD is aseptically filtered and provided in pre-sterilized 12 mL glass bottles closed with flourotec rubber stoppers and flip-tear off caps or 100 mL PET(G) bottles closed with HDPE screw caps. V-GRAD has a shelf-life of one year when stored at 2-8°C and can be used for up to seven days after bottle opening.
The provided text describes the regulatory clearance of a medical device, V-GRAD, which is a reproductive medium used for sperm separation. It outlines the device's technical specifications and compares them to a legally marketed predicate device (ORIGIO Gradient). However, the document primarily focuses on non-clinical performance testing to support substantial equivalence and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/human-in-the-loop system.
The device, V-GRAD, is a laboratory reagent (colloidal suspension for density gradient sperm separation), not an AI-powered diagnostic or assistive tool. Therefore, the concepts of "acceptance criteria" and "study" as typically applied to AI-driven medical devices (e.g., using a test set, expert ground truth, MRMC studies, standalone performance) are not applicable to the V-GRAD submission as described.
The "performance testing" mentioned in the document refers to traditional lab-based tests for reproductive media:
- Aseptic filtration and aseptic filling validation: Ensures the sterility of the manufacturing process.
- Shelf-life testing: Verifies that the product maintains its specifications (appearance, pH, osmolality, endotoxin, density, Human Sperm Survival Assay (HSSA), sterility) over its stated shelf life after accelerated aging and simulated use.
- Transportation testing: Ensures the product integrity during shipping.
- Sperm evaluation: Confirms that sperm separated using the device exhibit comparable motility, morphology, and purity to those separated with the predicate device.
Since the prompt asks for details related to AI/human-in-the-loop medical device evaluation, and the provided text does not describe such a device or study, I cannot fulfill the request using only the given input.
Therefore, for each point, the answer will be "Information not available in the provided text" or "Not applicable as the device is not an AI/human-in-the-loop system."
Based on the provided text, here is the information:
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A table of acceptance criteria and the reported device performance
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Acceptance Criteria and Reported Device Performance: The document lists "product specifications" that are met during shelf-life testing, which implicitly serve as acceptance criteria for the quality and performance of the medium itself. These are not performance metrics for an AI system.
Criteria/Specification Acceptance Limit (Implied) Reported Performance (Implied, "met specifications") Appearance Pink rose (V-GRAD 40), light pink (V-GRAD 80), colorless (V-GRAD 100) Met pH 7.2-7.9 Met Osmolality (mOsm/kg) 310-340 (V-GRAD 40/80), 300-330 (V-GRAD 100) Met Endotoxin (EU/mL) ) No growth Sperm Evaluation (Motility, Morphology, Purity) Comparable performance with predicate device and other cleared devices Demonstrated comparable performance Shelf-Life 1 Year Supported (met specifications at time 0 and after accelerated aging)
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Sample sizes used for the test set and the data provenance: Information not available in the provided text. The studies described are non-clinical lab tests of the medium itself, not a clinical test set for an AI device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the device is not an AI/human-in-the-loop system requiring expert-adjudicated ground truth. The "ground truth" for V-GRAD's performance is established by standardized laboratory assays (e.g., pH meters, osmometers, endotoxin testing, HSSA).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as the device is not an AI/human-in-the-loop system.
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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 as the device is not an AI/human-in-the-loop system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as the device is not an AI/human-in-the-loop system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance of the V-GRAD medium, the "ground truth" is defined by established laboratory methods and controls for measuring characteristics like pH, osmolality, sterility, and the biological response in an HSSA. For "Sperm separated using the subject device were evaluated for motility, morphology, and purity," the ground truth would be the measurement outcomes from standard semen analysis techniques, compared to controls (predicate device or other cleared devices).
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The sample size for the training set: Not applicable as the device is not an AI/machine learning system.
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How the ground truth for the training set was established: Not applicable as the device is not an AI/machine learning system.
§ 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.