(257 days)
Sydney IVF Gamete Buffer is used to physically wash and store gametes in preparation for the IVF process.
Sydney IVF Gamete Buffer is a HEPES buffered physiologic solution used to physically wash gametes in preparation for the fertilization step in the IVF process. Sydney IVF Gamete Buffer can be used for both sperm and oocytes. This solution can be used to wash oocytes of excess blood following aspiration and also as a short term storage solution until transfer to a fertilisation medium. Sydney IVF Gamete Buffer is based upon the formulation of a 20 mM HEPES buffered media containing salts, non-essential amino acids, glucose, 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. Sydney IVF Gamete Buffer is packaged in 20, 50 or 100 mL borosilicate Type I glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices. It has a shelf life of 20 weeks when stored at 2 - 8 °C.
This document describes the Sydney IVF Gamete Buffer and its substantial equivalence to a predicate device. However, it does not contain the information you requested regarding the acceptance criteria and a study proving a new device's performance against those criteria in the context of an AI/human-in-the-loop system.
This document is a 510(k) summary for a medical device (a buffer solution for IVF), not for a device that involves AI, image analysis, or human reader performance. The "performance data" section refers to bench testing for the buffer solution itself (pH, osmolality, endotoxin, etc.), and functional tests like the 2-cell Mouse Embryo Assay (MEA) and Human Sperm Survival Assay (HSSA) to confirm its suitability for its intended use. It's a comparison to ensure the new buffer is as safe and effective as an existing one, not a study of algorithm performance.
Therefore, I cannot extract the requested information from the provided text.
Here's why each point you asked for cannot be answered from this document:
- A table of acceptance criteria and the reported device performance: While the document lists performance specifications (pH, osmolality, endotoxin, MEA, HSSA) for the Sydney IVF Gamete Buffer and implies they are similar to the predicate, it doesn't present them in a formal acceptance criteria and reported performance table for a new device's diagnostic or AI performance.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to samples of the buffer solution or biological assays, not a set of clinical data for an AI system.
- Number of experts used to establish the ground truth... and their qualifications: Not applicable. Ground truth for an AI system is established by human experts, not through chemical and biological assays of a buffer solution.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to a gamete buffer solution.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the context of AI. The "ground truth" for the buffer solution's performance is derived from standardized laboratory tests (e.g., pH meter readings, osmolality measurements, biological assay results).
- The sample size for the training set: Not applicable. There is no AI model being trained.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a medical device of a completely different nature than what your questions target.
§ 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.