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Sydney IVF Embryo Biopsy Medium is intended for use in assisted reproduction technologies to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis.

Sydney IVF Embryo Biopsy Medium is bicarbonate based, free of calcium and magnesium to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis of the embryo. Embryos are placed in this medium for approximately five minutes to break down gap junctions between blastomeres. One or two blastomeres are removed, and the embryo is then returned to Cleavage Medium or Blastocyst Medium for further culture.

Sydney IVF Embryo Biopsy Medium contains Human Serum Albumin (5 mg/mL) and Gentamicin (0.01 mg/mL). The device is available as a 20 mL fill only.

The Sydney IVF Embryo Biopsy Medium is 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sydney IVF Embryo Biopsy Medium, incorporating the requested information where available:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on the comparison to a predicate device and stability studies. Specific, quantified acceptance criteria for clinical performance are not explicitly stated in a typical format (e.g., sensitivity, specificity). Instead, the performance is demonstrated through meeting established specifications and validating shelf-life.

2. Sample Size Used for the Test Set and Data Provenance

The document describes stability studies as the primary performance validation.

• Sample Size for Test Set: Not explicitly stated for each specific test (e.g., number of vials tested for endotoxin, number of MEAs performed). However, stability studies typically involve multiple samples tested at various time points.
• Data Provenance: Not explicitly stated. The manufacturer is William A. Cook Australia Pty Ltd, so the testing likely occurred in Australia or through their designated testing facilities. The study appears to be prospective with regard to the shelf-life validation, as the product's performance was evaluated over time to determine its stability.

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 device is a culture medium, and its performance is assessed against physical, chemical, and biological specifications rather than through expert interpretation of clinical outcomes directly from the medium's use. The "ground truth" for the tests (e.g., what constitutes an acceptable osmolality reading) would be based on established scientific and regulatory standards for reproductive media.

4. Adjudication Method for the Test Set

• This information is not provided and is generally not applicable to this type of device and testing. Performance appears to be assessed against predefined quantitative specifications (e.g., numerical ranges for pH, osmolality, endotoxin).

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive devices that assist human readers. The Sydney IVF Embryo Biopsy Medium is a laboratory reagent, not an AI or diagnostic tool.

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

• Not applicable. This device is a culture medium, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the performance validation relies on:
  • Validated laboratory methods and established specifications: For chemical (pH, osmolality, proline, pyruvate, ammonia), physical (sterility), and biological (endotoxin, Mouse Embryo Assay for embryo toxicity) tests.
  • Predicate device characteristics: The similar chemical formulation and performance specifications (osmolality, endotoxin, MEA) of the previously cleared predicate device K023850 served as a benchmark for comparison.

8. The Sample Size for the Training Set

• Not applicable. As this is a biological/chemical product evaluated through laboratory testing and stability studies, there is no "training set" in the context of machine learning or AI models. The testing involved samples of the manufactured medium.

9. How the Ground Truth for the Training Set was Established

• Not applicable. (See point 8).

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