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Sydney IVF Sperm Medium is intended for use during in vitro fertilization procedures to process sperm.
Sydney IVF Sperm Gradient Kit is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma.
Sydney IVF Spermient is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma.

The Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit and Sydney IVF Spermient are used for processing sperm during in vitro fertilization procedures.
Sperm Medium is used to provide a "liquid" and nutritious environment for the sperm to maintain its motility for the "swim up" procedures and the following fertilization process. The medium contains 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. It is available in 20, 50 or 100 mL vials.
Sydney IVF Sperm Gradient Kit is used to separate sperm based on density, using density gradient solutions. Sperm Gradient Kit contains both 40% density solutions and is comprised of silane coated silica particles which are diluted in a HEPES buffer. The sperm gradient has the dual purpose of enriching motile sperm populations and removing sperm inhibitory compounds normally present in the eiaculate. It contains 10 mg/mL HSA and 0.01 mg/mL Gentamicin. Sydney IVF Sperm Gradient Kit is available in 20 or 50 mL vials, packaged in a carton box, consisting of one vial filled with the 40% sperm gradient solution, and a second vial filled with the 80% sperm gradient solution.
Sydney IVF Spermient is intended to separate sperm based on density, using density gradient solutions. This is achieved by diluting the Spermient into various concentrations with a HEPES buffered solution. It contains colloidal silica coated with an inert polymer (silane) and has been formulated to be isotonic. Spermient contains 10 mg/mL HSA and 0.01 mg/mL Gentamicin. It is available in 20 or 100 mL vials.
The Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit and Sydney IVF Spermient are provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal.. These products are single use, sterile (aseptic filtration) devices.

The provided document is a 510(k) summary for the Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit, and Sydney IVF Spermient. This document indicates that the device's main modification from its predicate was an extended shelf-life. The acceptance criteria and the study that proves the device meets them are described in the "PERFORMANCE DATA" section.

Here's the breakdown:

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 explicitly state the sample size for the test set. It mentions "stability studies" and "testing" without providing numerical details for the number of batches or samples tested for each parameter.

The provenance of the data is not explicitly stated as "country of origin." However, the applicant is William A. Cook Australia Pty Ltd, so the testing likely occurred in Australia or through their affiliated labs. The studies appear to be prospective as they were conducted to validate the extended shelf-life and other performance characteristics of the modified device.

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

This information is not provided in the document. For in vitro fertilization media, "ground truth" often refers to the validation results of specific assays (like MEA or HSSA) performed by trained lab personnel rather than experts establishing a "ground truth" in the diagnostic sense.

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

This information is not applicable and is not provided. The testing involves laboratory assays with established protocols and quantitative results, not subjective interpretation requiring adjudication.

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 is not applicable as the device is a reproductive medium/supplement, not an AI-assisted diagnostic imaging device that involves human readers.

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

This is not applicable as the device is a medical product (media/supplement) and not an algorithm or AI.

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

The "ground truth" for this device is based on laboratory analytical and biological assays (e.g., endotoxin limits, pH, osmolality, sterility, Mouse Embryo Assay, Human Sperm Survival Assay) that demonstrate the media's ability to maintain a suitable environment for sperm and not be toxic to embryos.

8. The sample size for the training set:

This is not applicable since the device is a medical product (media/supplement) and not an AI algorithm requiring a training set.

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

This is not applicable as there is no training set for this type of device.

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